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The Piper Sandler 35th Annual Healthcare Conference

Nov 30, 2023

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Good morning, everyone, and thank you for joining our third day of our Piper Sandler Healthcare Conference. Really excited to be featuring the team from Pliant Therapeutics here with us. We have quite a bit to cover over the next 25 minutes. Would love to get started, actually. I've been going in order of upcoming catalysts and chronological order as I start these fireside chats. And start off with PSC, actually. I think coming off of the AASLD meeting, which was two weeks ago, could you maybe capture what was the sentiment among docs who saw for the first time the PSC data? There were a lot of discussions on the results that they had seen for the first time. So if you could capture that, it would be really helpful for investors who didn't attend.

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, I think the key opinion leaders and also, excuse me, the PIs in the trial, we had quite a quite a few meetings over, obviously, at AASLD, and we had also advisory boards there.

The sentiment was really very positive. Because I think, you know, first of all, they haven't been thinking about enriching trials the way we did.

In the sense that most of the trials were enriched for patients with high ALP values. This was a bit of a different design, and also the fact that the drug was safe, showed an effect on, you know, fibrosis biomarkers and also the imaging.

The MRI imaging was really, for them, an additional evidence of the treatment effect. Of course, there was the itch fewer events of cholangitis in the active arm compared to the placebo arm. So altogether, I think it really came out very nicely, and they're very, very excited about the program.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Great.

Bernard Coulie
President and CEO, Pliant Therapeutics

Also, there was a presentation at the late breaker session which was, to start with, very well attended. I think we went over time in just addressing all the questions because there was, you know, it it created definitely some, how would I say? A lot of interest.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Great. Yeah, and, and as we were there, we saw the same enthusiasm, so thank you for capturing that. Team, you know, the next, the next readout now for us is to see the 320 mg dose group data that's expected in 1Q. I think a lot of investors are gonna expect that the data disclosure will be very similar than you did for the cohort you reported out in September. Is that fair, or will it have some measures that we didn't see or vice versa? So if you could just talk about the type of data that you're gonna have versus the initial data set.

Éric Lefebvre
CMO, Pliant Therapeutics

So the next readout will be the 12-week analysis of that 320 mg cohort. So this will be the apples-to-apples comparison with all the other doses. So you should expect to see exactly the same content, with the 320 mg dose being added. I think just pointing out also that, the way we did our design the placebo patients were embedded in each of those, the dose level in a 3:1 randomization ratio. So we'll have a few more placebo patients also, so that the placebo results might change slightly because of these seven more patients that will be there.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay. And just to kind of level set so that investors don't forget, when you did an IPF and you showed the high dose, you came and you replotted the numbers, and so you showed us the values for. So that way we could see the, all dose cohorts plus the added placebo. So that, it seems that's gonna be. You guys are gonna be doing the same thing for PSC.

Éric Lefebvre
CMO, Pliant Therapeutics

That's right.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Then I think investors will remember that because of adding the additional placebo patients, the numbers of the MMRM may change a little bit, right? Like, could some numbers in the lower dose cohorts change a little bit or probably stay the same?

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, we don't have the same.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Statistical.

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, exactly. MMRM, we have it as part of our statistical analysis plan for some of the biomarkers. But overall, we're not reporting MMRM for these types of readouts.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

For example, MRI is not MMRM, so it shouldn't affect it that way.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

But it could be that, for example, for the differences in terms of AEs and things like that, or, even the number of patients for the MRI findings for placebo it might change a little bit.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay. I think the next question that a lot of investors are asking is, is like, and that will come up in your one-on-ones, is what do you want to see in this 300 larger, the 320 mg dose cohort across the biomarkers, like base as well as imaging?

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, I mean, primarily good safety like we've seen before, so that would be really important. I would say that if the 320 mg mg dose delivered results similar to the 160 mg dose which performed the best out of the lower doses we read out on, then that would really be a positive.

Because we don't know how discriminate these circulating biomarkers are in terms of selecting a dose.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

Right? So they... But, certainly, I think that, the evidence that we saw, that you could blunt the fibrosis production with FVC at 160, pretty much so. Something like that would be important, and if we get further reduction, that's great.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

Let's say the same results would be great as well.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay. When you had a chance to discuss these results at the liver meeting, did you get a feel for what the consensus were on which biomarkers the physicians were more relating to and getting more excited about versus others? Like, were there things that everybody was aligned and talked about, "Oh, wow, we saw ALP PRO-C3?" if you could just talk about, like, what were things that they pointed out to you that they were excited about?

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah. ELF, for them, is certainly, very, very interesting because there's so much validation that's been done for ALF, and we know it's really can. R eally be a good prognostic biomarker in PSC, because EASL now recommends-... performing a yearly ELF test in PSC patients.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

So that's giving you the sense. They're also interested by PRO-C3 data but there's a little bit less data PRO-C3 compared to ELF. The other aspect, which was really an exploratory measure in our in our study, was the MRI contrast with the gadoxetate agent.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

They hadn't seen this type of data before. Still some, you know, curious about it how to completely interpret it.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

But at the same time, the key takeaway for that was that you continue to see a difference between active and placebo, and we should really think about this new technology.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

We'd want to know more about it.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay. Is the ELF recommended on for an annual checkup just to see where you're progressing in fibrosis over time? Is that their tool?

Éric Lefebvre
CMO, Pliant Therapeutics

It's really for prognostic value.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

Exactly, and they also recommend, these also recommend a yearly Fibroscan or transient elastography.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

So those are the two, that they recommend, just for, to prognosticate, basically and make sure that the patients are not going in, you know, more advanced clinical liver fibrosis.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Is there, as you look at the guidelines, a lot of times we get this question is, you know, what change in these ELF PRO-C3 could alarm a physician to say, "Hey, I'm now thinking you could be at risk of, you know, worsening of fibrosis or potentially cirrhosis?" Like, what are those numbers?

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, PRO-C3 that's not really well known, but for ELF, there are some different categories.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

Right? So according to the threshold you have a low risk of fibrosis an indeterminate risk of fibrosis, and then a high risk of fibrosis.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

That's more helpful, I would say, because typically the way that these doctors will will look at the ELF test is looking at the category the patient was in when they started following them up, and then where they end up.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

So, for example, they increase in a category that's higher risk that usually requires more, evaluation and assessment, and potentially follow-up as well.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Great. And then, team, obviously, after that data is available, a lot of clients are going to be interested in, is this the time when you start engaging with the agency, or would you want to wait for your 24-week data to then discuss next steps? So what will happen post the 1Q readout to start the process?

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, so we don't need to wait for the 24-week data for the 320 to really engage with the, FDA, because, in fact, the apples to apples comparison at 12 weeks is it's at 12 weeks.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

Right? So then we have all we need there. So as soon as we get these data we'll write up a meeting package and engage with FDA, and we expect that to happen potentially midyear next year. And that would be about talking about the late-stage study design and, you know, the way we would think about the primary and secondary endpoints.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay. Last time, it's funny because the way the data came out in IPF was in a similar format, right? You had the 320 mg dose group starting engaging with the FDA, and then you started mid this year, and we'll talk about Beacon. So is it fair to assume that time from the high dose cohort to starting to engage with the agency and then designing the pivotal study, sort of that sequence or that timeframe could be the same for PSC potentially? Or could it be a little longer just because, you know, it's PSC development is a little bit more... requires maybe a little bit more discussion with the agency?

Bernard Coulie
President and CEO, Pliant Therapeutics

Yeah, I think in the ideal circumstances, I don't think there would be much of a difference in terms of timing. As we had it, the cadence with IPF versus PSC. I think that the bigger difference now, or the situation has changed in the sense that we are doing doing BEACON.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

That's really kind of the focus of the company and also in terms of allocation of resources. So, timing is not just execution or operational timing in PSC as it relates to 24-week readout, the interactions with the FDA, and all, all of those plans that we are kind of rolling out. It's also the availability of cash, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

And so for us, it will be critically important to at least have, I would say, three threshold issues solved before we engage in a phase III or a pivotal trial kind of program. First, the 320 data.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Eric can speak to that as well in terms of what we expect, but we think it will be a confirmation.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

We're pretty confident it will be a confirmation of what we have seen. Second, will be feedback from the FDA.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Is this a reasonable path to NDA?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? Because now we are a frontrunner in PSC.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

That means that we have are paving the way.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Nobody has ever succeeded in completing a phase III. And then thirdly is, you know, do we have the resources to execute on that program that we could agree with with the FDA? And that needs to come from additional capital.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

Obviously, we're not going to raise capital at this point in time for a PSC trial.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

We are actively looking at generating non-dilutive capital to potentially fund a pivotal or, you know, a registrational program in PSC. Obviously, we have our earlier stage programs in DMD and oncology that, you know, are progressing but they are definitely generating a lot of potential partnership interest where we could kind of find that additional non-dilutive capital also.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

But how challenging would it be to partner for PSC, but then keep IPF for yourself? Like, that's, that's always gonna be-

Bernard Coulie
President and CEO, Pliant Therapeutics

It is, it's definitely challenging.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

It's not impossible.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

It's definitely challenging. I think a partnership for PSC is something that, became apparent with the data, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

I mean, to be quite honest, we didn't expect the PSC data, this, this to be this kind of positive right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I mean, most of the analysts and investors were already happy if there was some. You know, if it was safe,

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Good signal.

Bernard Coulie
President and CEO, Pliant Therapeutics

Some signal. Every signal points toward an antifibrotic effect, which for me, the key value of that is actually how it tells you something about the asset itself.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? Partnership in PSC, there are creative solutions.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

But it's a challenge, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I mean, you don't want to end up in court for years because you split indications. A cross one single asset afterwards.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

But with the PSC data, obviously, suddenly there was inbound interest, outbound interest coming inwards. In terms of, you know, companies that are specifically interested in PSC.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm.

Bernard Coulie
President and CEO, Pliant Therapeutics

And so we are looking at that and see what we can do. Without obviously diluting the value of the asset or jeopardizing it.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

It's potential in IPF, and also kind of it has to have a win-win situation. F or the company as well, so.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

I think a lot of investors going into the data may wanna also figure out, and one key: would you be in a position, once you saw the next dose cohort, to kind of, in broad strokes, tell us about how you're thinking or how you're what type of a study you would potentially propose to the agency? Or should we just set the right expectations, say: "Guys, you're gonna get the data, we'll engage with the agency, and then we'll come back to you and tell you, like, what we negotiated." Or will you share potentially at the time of the top line, how you're thinking about your proposal to the FDA?

Éric Lefebvre
CMO, Pliant Therapeutics

I mean, I can, I can address some of that now.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

I absolutely would- we would provide more details, but certainly there is a straight-to-phase III path in, in PSC.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

Right? It's been done by Gilead and others.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

So we would like to take that path because of the length of these trials.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

As you know, the Gilead and the Dr. Falk trials which were, which are. One was terminated, but the other one is still going on. It's a European program, so they have a two-year duration that's required by EMA and FDA. And so doing a phase IIb approach you know, what would you really win?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

Would you lose a lot of time?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

And then potentially carrying two doses into a phase III would make more sense, and that's the way we're thinking now . And certainly something we'll discuss with the regulators. And the other part of the story is that histology is the approvable endpoint surrogate endpoint, but the, there's an open door to consider noninvasive with histology as potentially composite endpoint. So that, that's the type of discussion we want to have with them as well.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yes. No, that's very helpful. Team, maybe now transitioning to Beacon. Could you maybe give us, you know, the study has begun enrollment across 150 sites, that's the target sites that you hope to activate. Could you kind of give us some thoughts how enrollment is progressing? You know, how is your work with your CRO and the enthusiasm that you see among the community? So I think a lot of investors are gonna try to track, because I think you guys have said enrollment within one year, Beacon started middle of the year, the middle of 2024, you would want to be done with enrollment. So based on what you see, how do we feel about achieving that?

Éric Lefebvre
CMO, Pliant Therapeutics

Well, you know, we haven't revised our guidance and we don't yet have enough runway in terms of enrollment to really predict exactly when that will, you know, the end of enrollment will happen. But we, we are still targeting a year from midyear this year, which would be midyear next year, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

I can tell you that sites are being activated on a daily basis so that, exercise is going really well.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

Sites, the sites are activated or screening. I would say there, there's quite a lot of enthusiasm around the results.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

There have been some really key differentiators for our program, including great safety.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

I mean, that's what the PIs and IPF leaders are telling us, and certainly they understand the mechanism of TGF-β inhibiting TGF-β as a way to inhibit fibrosis. So I think those two things make it really easy for them to think about the trial.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

Yeah, we're getting quite a lot of engagement, and I think so we should be able to deliver on our goals.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Great. Just in the last couple weeks, we've seen quite a bit of surprises on the management, on execution, on pivotal studies and important studies. It has created quite a bit of fear. Could you maybe talk about what you do with your team in regards to oversight? Like, I hate to say this, but micromanaging—like, what is the level of managing your CRO and your engagement there? Because I think this is gonna be a very important topic for various-

Éric Lefebvre
CMO, Pliant Therapeutics

You absolutely have to be on top of your CRO.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

I mean, that's even the best CRO, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

So, you have to communicate the sense of urgency what you're expecting as well.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Éric Lefebvre
CMO, Pliant Therapeutics

These are things that, you know, we're very comfortable with, and certainly Bernard can speak about a recent hire also, that we've had to really help with with that aspect specifically. But, yeah, so we have, you know, in terms of even the data integrity piece we really will have real-time review of FVC data that comes in a blinded way.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Wow! Okay.

Éric Lefebvre
CMO, Pliant Therapeutics

But to look at whether we need to retrain some of the sites, because there's too much variability there.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Éric Lefebvre
CMO, Pliant Therapeutics

You know, that hasn't happened yet. But we're gonna put all the measures in place, so we really have the best data coming in you know, to the database.

Bernard Coulie
President and CEO, Pliant Therapeutics

Yeah. I think we saw, we see execution of the trial as the. That's kind of the next thing for us.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

I think to a large extent, bexotegrast has been de-risked from safety perspective.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

We seem to have an efficacy signal in two different indications, so I'm less worried about that.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

It relates to the phase II B readout. So execution is key. One has to realize our two main competitors are large pharma.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

We are the only biotech company still

in that stage of IPF

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-development. So we have to get our act together.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

And long before all of-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

This happened, not that I knew that this was going to happen, but, I mean, we working with one of the top-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

CROs in the space, just in clinical development space. But we were able to attract talent from outside, Minnie Kuo-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-who joined us as Chief Development Officer, and she was responsible for-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-all development at, Tir.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

and was also part of the Oleta team, the Hep C team at-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-Gilead.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Right.

Bernard Coulie
President and CEO, Pliant Therapeutics

I mean, talking about-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-uh, flawlessly-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-executed-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-clinical trials-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

at top speed.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

That's, that's her, right? And so bringing her in and then really kind of building-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-a clinical operations group, or further expanding our clinical operations group, has been critical.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm.

Bernard Coulie
President and CEO, Pliant Therapeutics

So we don't kind of... I don't truly believe in a completely outsourced model-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-where you have-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

One person overseeing.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Got it

Bernard Coulie
President and CEO, Pliant Therapeutics

-a massive-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-design, massive study.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I think that's part of the issue-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? I mean, of course, CROs will make mistakes.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

and are sloppy, but you also have to have

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-over oversight, and we have a big team actually, covering all the different-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

geographical areas that we are, you know, are doing or executing our study in, so.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Great. No, that's helpful. The other question also comes up as the study continues, is discontinuations, how they're monitored. So if you could talk about, are you blinded? Do you get notified if discontinuations occur? If discontinuations occurred, you know, what happens with the data? You know?

Bernard Coulie
President and CEO, Pliant Therapeutics

Yeah.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

So the first part, we have language in our protocol-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-that, requires investigators to let us-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

know in a short order if any of their patients-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-have temporary-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-interrupt, temporarily, in interrupted drug or, just-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-a discontinued drug. And advise the, you know, the sponsor-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

the medical monitor, so we can have a conversation

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

with that PI about what was the issue.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Right.

Bernard Coulie
President and CEO, Pliant Therapeutics

That's something we want to track very carefully.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

Because we have covered. We've put enough buffer in our-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

sample size to account for

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

the typical type of discontinuation.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

rates you see in IPF trials. But we want to do better than that

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-because we know that every patient we keep in-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-and maybe, you know, you have two examples of the in our IPF study, the-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

phase II study, patients discontinuing for mild diarrhea.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah. Right.

Bernard Coulie
President and CEO, Pliant Therapeutics

Why?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

You know, why weren't they-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-restartled?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Right.

Bernard Coulie
President and CEO, Pliant Therapeutics

Those things we want to avoid at all costs.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

In terms of the... what we do with the missing data, they're just missing, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

In terms of there's no imputation assumption-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-in the MMRM.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Okay.

Bernard Coulie
President and CEO, Pliant Therapeutics

The data for these patients up to a certain

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

up to the point that they were in the trial

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

will be used in the model.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

But after that, they-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

Don't have any data to provide in the model.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

so they, they can't influence the model.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Got it.

Bernard Coulie
President and CEO, Pliant Therapeutics

So it will be, and we're doing that exactly like you, we did for INTEGRIS-IPF.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

and we will do for late stage as well, right?

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Right.

Bernard Coulie
President and CEO, Pliant Therapeutics

For phase III.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

And team, I think a lot of clients are starting to also pay attention for the competitive landscape in IPF.

Bernard Coulie
President and CEO, Pliant Therapeutics

Mm.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

They understand you're the only biotech in this space and, with a very promising study. How do you, how do you think the competitive space will play out? And as of right now, based on the data that you have, what is the product profile?

Bernard Coulie
President and CEO, Pliant Therapeutics

Yeah. I think to, to Éric's point, the feedback we got from KOLs and our clinical investigators-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

This is an easy drug.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

It has no side effects.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Safety, I mean, tolerability profile-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

Looks really great once daily dosing.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I think those are kind of the key, key aspects here. It works at least based on our phase IIa data.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

The competitors, the two main competitors, are Boehringer Ingelheim with a PDE4B inhibitor.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

That's a known mechanism in COPD. It's anti-inflammatory-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

But has no antifibrotic activity.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

that we are aware of.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

There's no evidence-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

that this actually does

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Right

Bernard Coulie
President and CEO, Pliant Therapeutics

have an antifibrotic activity. So let's see how that-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

52-week trial plays out.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right. Of course, Boehringer may not be a scientific-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

Or clinical threat, but could be a commercial threat.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? I mean, they're really big in the-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

IPF space, so we better kind of, you know, we shouldn't be dismissive of that.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

The key issue with that drug is diarrhea.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

That was already generating quite a high dropout rate in their phase IIa-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

after 12 weeks only-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

at the high dose. So they're running now a two-dose phase III, have fully enrolled that study.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

Let's see how that tolerability issue-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

Kind of plays out, because it's on top of standard of care.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? And there-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

You have the same thing with their own-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-you know, approved drug. BMS, so Bristol has a ALK1 blocker-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-that's antifibrotic.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

We know that's a relevant mechanism.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah. Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I think based on the data we have seen, they've published, they show that at ATS, it has a modest effect-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

on top of standard of care.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Where we saw a very clear effect-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-on top of standard of care. That was a -month trial, 200+ patients.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

I think that's a very relevant size in order to be predictive-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

for what, what the outcome of a phase III would look like. From a timing perspective, they are just initiating-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-their phase III. So it is-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

... I anticipate their phase III data and our phase IIb data may-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

come around the same time.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Same time, yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Those are the key ones. But, you know, don't forget, we don't have any drug-drug interaction issues.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm. Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

If need be, they can be combined-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-mechanistically-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

Definitely with the BMS drug, it makes sense.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

to combine an ALK blocker with, you know

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

an integrin blocker, as we have. So ultimately, the market will be orals.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm.

Bernard Coulie
President and CEO, Pliant Therapeutics

New orals-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

with better safety tolerability profiles than what we have now, and we anticipate, based on

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

market research, we have found that that will be about

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

-at least 60% of the total IPF market.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

No, very helpful. Given that we're coming to the end of the year, a lot of investors wonder, right, Pliant has had a phenomenal year in terms of execution and data. So then raises the question, why, why own now, right? Like, what is, what and we talked about the PSC readouts, we talked about enrollment. So, you know, like, if somebody. You were gonna get that. Why should I buy the stock today? You know, like, not just wait for maybe-

Bernard Coulie
President and CEO, Pliant Therapeutics

To be-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

A quarter or two quarters. Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Yeah. I mean, why buy now? I think, there will be more catalyst in-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

in the coming years, in the coming year, for sure, before even we have the phase IIb data.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

We have our Oncology Program, DMD Program. The platform itself-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

is of great interest.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

I anticipate there will be more BD to happen.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

Right? And so partnerships obviously are something that we are exploring, as I said, around oncology, DMD, and even platform. So yeah, I mean, there is definitely a lot of interest in the lead asset-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

to partner at this point in time. It's something that we, you know, have been reluctant to do because we don't want to dilute-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

the value of the asset. Ultimately, what our investors, potential partners-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Mm-hmm

Bernard Coulie
President and CEO, Pliant Therapeutics

are looking for, actually, the data we have

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

Seem to be enough.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah.

Bernard Coulie
President and CEO, Pliant Therapeutics

But I think going to phase IIb data will be critically important because I think that will be the true-

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

Yeah

Bernard Coulie
President and CEO, Pliant Therapeutics

-value creator, at least for the bexotegrast assets.

Yasmeen Rahimi
Managing Director and Senior Research Analyst in Biotechnology, Piper Sandler

No, that's wonderful. Well, the 25 minutes flew by. It's been a pleasure hosting you. Just want to say thank you on behalf of all, all of us here at Piper Sandler.

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