Yes, we're gonna be doing this for Tony.Good afternoon, everyone.Thank you so much for joining our Piper Sandler Healthcare Conference.
Rod MacKenzie
CMO, Sagimet Biosciences
My water.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Really excited to have the team from Sagimet Biosciences here.Lots to cover in the next 25 minutes.Maybe a great place to start is AASLD, right?We just recently came from the conference.Could you maybe kinda capture your high takeaways from the liver meeting, and then go into what was the new data that Sagimet presented at the conference?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.AASLD, you know well.The pinnacle of...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
Liver disease.Lots to learn.There were four pieces of data, which are actually not drug specific that I thought were very good.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
Rod MacKenzie
CMO, Sagimet Biosciences
One modeling study is showing that NASH will go up by about 25% over the next couple of decades.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
NASH-related cirrhosis by 50% over the next couple of decades.So staggering.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Staggering amount.The second has to do with AI pathology which is definitely gaining ground.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
I think, we've seen several presentations by the major players.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
It's becoming more and more important for us to better understand disease response.The third one was, Rohit Loomba presented an analysis from MAESTRO-NASH, which...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
MIT, yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
... in a pre-specified manner, confirmed that PDFF is one of the best.NITs, among other...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...pieces, but PDFF in particular.And finally, data from the NAFLD NIT Consortium that Stephen Harrison presented.Over 6,000 patients from several drug trials.Actually, we are...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
... we are part of the companies that give data, and they found a number of ways through NITs to better screen patients to reduce screen failure.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Among all the things that they presented, FAST Score.Was the best one.And we know that screen failure rates and NASH are very high.This is very useful.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
No, that's very helpful.And could you maybe also talk about, you had, two posters that were presented there.What was the data presented in the poster, and how does this data increase our conviction column?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
We'll talk about FASCINATE-2 quite a bit.
Rod MacKenzie
CMO, Sagimet Biosciences
So the main poster for that would be the lipidomics poster.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
So, what we showed this time was we reproduced...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...and improved on the findings.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
F rom the phase 2A, showing that lipotoxic issues are reduced by denifanstat, and changing also the composition of triglycerides to a more favorable one.Lipotoxicity is one of the three key drivers of NASH, and of course, denifanstat as we know, hits all three.But lipotoxicity is where it all starts.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
So that was one of the posters goes without saying.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
That increases our confidence.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
In the phase 2b.The other poster was a preclinical work looking at semaglutide and a FASN inhibitor in, mice and...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...in the obese mice, showing that the combination is better than the parts knowing that the number of patients on GLP-1s coming into NASH study is going to increase considerably.That, in our opinion, is a valuable finding as well.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Thank you.Is there - h ave you guys had a chance to look at how much GLP-1 usage is present currently in your FASCINATE-2 study?
Rod MacKenzie
CMO, Sagimet Biosciences
We haven't disclosed that information.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
Rod MacKenzie
CMO, Sagimet Biosciences
But what I can tell you is, in conversations with our advisors...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
... they're saying that they expect the GLP-1s to be in about 50% of patients...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Oh, wow.
Rod MacKenzie
CMO, Sagimet Biosciences
...entering NASH trials.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay, now, at this junction, given that it's...
Rod MacKenzie
CMO, Sagimet Biosciences
Yep.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
...the uptake.Perfect.Would love to kind of now dig in into FASCINATE-2.
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
I think obviously the readout is expected in 1Q.I think you're gonna share the histological findings from the study.So I guess the first question that everybody has to ask is, as we head into the data, what would be considered a positive signal to warrant moving forward into a phase 3?So if you could talk about what, in your view, is considered, you know, the bar for success across the, you know, NASH resolution and 1-point improvements.
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.We have not, of course...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...disclosed the assumptions...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...in the protocol.What I can tell you is that we are powered...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...well enough to hit the endpoints...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...that we believe we'll hit.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Then have an end of phase 2 meeting with FDA.Right now, we have to hit one of the primary endpoints...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
David Happel
CEO, Sagimet Biosciences
...either NASH improvement, or NASH resolution, or NASH plus NASH improvement.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
David Happel
CEO, Sagimet Biosciences
I think your question bodes well, though, and that is what would spur us on to phase 3, and I think the combination of hitting those endpoints is gonna be...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay..
David Happel
CEO, Sagimet Biosciences
...really important.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Rod, is there a certain treatment effect size that you would want to see, or as long as you show statistical separation in one NAS or NASH resolution, warrants you to move forward?
Rod MacKenzie
CMO, Sagimet Biosciences
If, again, we have not disclosed...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...treatment size.We are adequately forward...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah, okay.
Rod MacKenzie
CMO, Sagimet Biosciences
...to have a good result.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.The other question that comes up is, the central reader that you guys are conducting, it's a central.It's a single reader.And there is also what we realize as you will be moving forward to a registrational path, you may have a pair or, or two pathologists reading it.So is there an opportunity, maybe not a top line, but at some junction, to maybe when you identify a second reader and then have the analysis done retrospectively with single and both readers?How do you visualize this?Because a lot of-
Rod MacKenzie
CMO, Sagimet Biosciences
Uh...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
The next question for investors after the Phase IIb data will be: What is the translation of biopsy results from Phase IIb to Phase III?
Rod MacKenzie
CMO, Sagimet Biosciences
Uh-huh.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Going from a single reader to a dual reader?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.Several points...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...to the question.The first one, and it's important, is a single reader result...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...from the IIb is enough.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...for the end of phase II.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah .
Rod MacKenzie
CMO, Sagimet Biosciences
Of course, this is what we agreed upon...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...with FDA.We can retrospectively look...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...at the data...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...if we elect to do so.When you have a single reader of the caliber of ours, and I can tell you...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...Pierre Bidossef...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...France, probably one of the best...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Best, yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...in the world.Data that come from him are very solid.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
For the phase III, as you said, about a panel...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...and FDA encourages companies to discuss...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...how a panel would look...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...the important thing is that at the start of the trial the panel...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...is trained together.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
I see.
Rod MacKenzie
CMO, Sagimet Biosciences
So that they are in good agreement as to how to call a balloon hepatocyte ballooning...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...and so on and so forth.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
No, that's very helpful.And team, I guess, the other question that comes up is, you've also been very vocal that you're utilizing the AI pathology HistoIndex to benchmark similar.Will that data be also available at the top line?
Rod MacKenzie
CMO, Sagimet Biosciences
Yes.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
How do you hope to make that translation between both the, you know, per-person versus AI machine learning?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.The data, yes...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...we'll be releasing AI pathology...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...with a HistoIndex.The correlations can only go to a certain extent...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay
Rod MacKenzie
CMO, Sagimet Biosciences
...because of the way the platform is...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...we gain that beautiful quantitative assessment of response that is not possible with a human.You can have an idea about the stages...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...but also they don't quite overlap with the nature of how the data are analyzed.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
But they do add to the...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...pathologist, and they bring back to your question...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...about the phase 3, those data will...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...bring more, even more confidence into the translation to a Phase III.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay, very helpful.Is there an opportunity to, I guess, my question is, post that readout, how soon could you actually - how much of the safety data set could you be presenting also at the top-line data to us?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.We'll be presenting the...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...safety data.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
As you may imagine, it's the...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...top-line safety...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...the key parameters.One thing we know about the drug is we don't have limitations.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
We remain blinded to the Phase 2b.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
But we do have, as we mentioned, an independent data monitoring committee, and that committee has assessed the study.They are completely unblind.They're completely unblinded to all data, safety, efficacy...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...you name it.They've assessed told us, "Continue as planned, no signals, no issues.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Then, I guess, how soon after the Phase IIb study would you be able to start engaging with the regulatory agency to discuss next steps?
Rod MacKenzie
CMO, Sagimet Biosciences
Sure.Once we have the results, we will work as expeditiously...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
You know what I mean?
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
That word.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Expeditiously.
Rod MacKenzie
CMO, Sagimet Biosciences
Expeditiously...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...as we can to have a meeting...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...as early as possible.We cannot commit to the timeline because the agency dictates...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...the timelines...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Right.
Rod MacKenzie
CMO, Sagimet Biosciences
...not us.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.And then in terms of phase 3 design, I assume, you know, your plan is to be very much in alignment of other historical-
Rod MacKenzie
CMO, Sagimet Biosciences
Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Phase III designs that we've seen.
Rod MacKenzie
CMO, Sagimet Biosciences
Very much so.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Is there some thought process behind designing a study that...
Rod MacKenzie
CMO, Sagimet Biosciences
Oh.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
...is different than what we have seen so far?
Rod MacKenzie
CMO, Sagimet Biosciences
We're thinking a lot.That's a very good...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...we're thinking a lot..
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...of course, of the phase III.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
The good news is, as you said, other companies, in particular, Madrigal-
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
They set a good footprint...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...for us to follow.We are...Of course, the thing about Phase III is you have the guidance.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...from the agency that you have to follow.But roughly speaking-
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
Those studies look very much alike...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...in size, duration...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...and all that.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
So this is, it's good to come behind...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...and learn behind a successful Phase III and learn what worked, what didn't work.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.No, that's great.And then, is there an opportunity to also...What we're seeing is that once companies initiate their phase 3, they also start a cirrhosis trial because that could be supplemented as an outcome.Would you be taking a similar approach, like sort of like a F2, F3 population?Plus a cirrhosis outcome study, that is?
Rod MacKenzie
CMO, Sagimet Biosciences
It's a good question.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
That's the alternative...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay
Rod MacKenzie
CMO, Sagimet Biosciences
...approach that FDA...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...suggests to accelerate...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Right
Rod MacKenzie
CMO, Sagimet Biosciences
...outcomes in the end.Cirrhotics is part...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...are part of our focus.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
We have a hepatic impairment...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
Rod MacKenzie
CMO, Sagimet Biosciences
...study going on... and that study is important...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...as part of the regulations...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...to go into cirrhotics.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
It's a population that we're definitely interested in.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay..
Rod MacKenzie
CMO, Sagimet Biosciences
It's high on our agenda to...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
Rod MacKenzie
CMO, Sagimet Biosciences
...to do that pathway.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Have you guys had generated any data in cirrhotics so far?
Rod MacKenzie
CMO, Sagimet Biosciences
No.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
No.
Rod MacKenzie
CMO, Sagimet Biosciences
No, you have to have the hepatic impairment.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
Rod MacKenzie
CMO, Sagimet Biosciences
Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Oh, to have it completed before...
Rod MacKenzie
CMO, Sagimet Biosciences
Yes.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
...you actually initiate the...
Rod MacKenzie
CMO, Sagimet Biosciences
Actually, to this point that you made, in cirrhotics, for registration you need outcome...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...not histology.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah, right.
Rod MacKenzie
CMO, Sagimet Biosciences
Really, what you want to do is, am I okay to go?
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Totally.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
We expect to be...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Totally fine, and then you see how things move.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
One important thing that we learned from different...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...studies in cirrhosis is the patients do have a significant...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...amount of fat in the...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...hepatocytes, and you can bring that down.You can bring inflammation...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...and so on and so forth.So, yes, it's a population that does make sense.It's a population that mechanistically does make sense for us.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Yes, it's high on the list.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
I think the natural question from investors upon FASCINATE-2 being successful will be.And it is around also the same time as we will be seeing potentially the first approvable of the first NASH drug in end of the first quarter.So I think the question comes up is: How do you hope to differentiate, right?Like, what is the differentiation that denifanstat brings?Let's say, let's take it under the assumption that another oral resmetirom doesn't get approved, and there are a couple other agents that are maybe slightly ahead of you.What is the differentiation that denifanstat would bring versus other mechanisms in this very large population?Not, I mean, not the-
David Happel
CEO, Sagimet Biosciences
Right.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
The size of the big market.
David Happel
CEO, Sagimet Biosciences
It's a growing population.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
I mean, it continues to grow, and I think we owe some support for our friends that are sponsoring-
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
David Happel
CEO, Sagimet Biosciences
GLPs, right?
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
I mean, certainly driving awareness and identification of these...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
David Happel
CEO, Sagimet Biosciences
...of these patients.So I think your point-your question is a really important one, and, and I think what we bring to the table is a really unique molecule, right?I think you pointed out that it's highly differentiated.It's really the only one that targets fat inflammation and fibrosis independently.It doesn't rely on just fat reduction...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...to translate into...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...a downstream effect.I think what's really important about that is that we are the only fat inhibitor, right?Everybody else that has a product on the market...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...is a fat burner or a fat oxidizer.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
While we are extremely confident that our molecule can be...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...a standalone therapy, it also can work very well...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Combination
David Happel
CEO, Sagimet Biosciences
...as a companion...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...as a completely separate mechanism for a companion approach...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...to treating these patients that are almost certainly...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...going to need it.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
And I think that really should be highly effective...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...to the scientific community as well as the investment community.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.And, I think one of the things that, as you guys know, it's taken quite a bit of pressure on the- on many NASH stocks, as including yours, has been this continuous outflow of, you know, the GLP-1, and that the GLP-1 is gonna take significant market share.And obviously, you guys alluded to the preclinical work that you have, which is the synergy between your product.
David Happel
CEO, Sagimet Biosciences
Right.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
And that, you know...Could you maybe talk about your discussions with physicians, and what you've learned at the liver meeting on why aren't the GLP-1 the answer for now, right?Because I think that is, like, such a misconception for many investors.But it would be definitely worth to tackle that.
Rod MacKenzie
CMO, Sagimet Biosciences
Yeah.So the two things, the two key things we learned was, one, come, our trial...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...or any other trial, about half the patients coming in-
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...will be on a GLP-1.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
That expectation tells you that they don't...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...solve the disease.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Weight loss matter.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
There will be some patients...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...that will respond, but we were also told...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...by our KOLs, that there will be a very large...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...proportion of patients that need something...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...that is NASH...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...specific.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Got it.
David Happel
CEO, Sagimet Biosciences
Yeah, no, I think, you kinda hit it.I think the two main areas are tolerability.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
You know, you're gonna have a very large percentage of population that are gonna be episodic on GLPs.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
They're gonna go on them...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
David Happel
CEO, Sagimet Biosciences
...for as long as they can tolerate them, then they'll go off of them.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
It'll be very similar, I think, in many ways...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...to a lot of weight loss medications that have existed
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...for the last 30 years.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
While patients are on it, yes, they will definitely see fat reduction.There's little doubt about that, but they haven't been able to translate it into fibrosis improvement.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
You know, the two main studies that have been conducted, and I know it's just a singular GLP part of the equation.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
But semaglutide in 72 weeks, and basically, the population that we're evaluating showed zero benefit in fibrosis despite showing...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...improvements in NAS and NASH resolution.And then, in the 52-week study that was just published by Rohit Loomba in Lancet last year, showed that if, you know, there was definitively.No improvement in fibrosis nor in NASH resolution...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...in the F4 cirrhotic population.To date, the fat reduction hasn't necessarily translated automatically...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...into, excuse me, into fibrosis improvement, which is, as you know...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...the key to a...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...successful medication.So I think we'll continue to see these medications used, and frankly, I think we all should be thrilled that they are.Because, again, I think they're increasing awareness.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
Diagnosis and identification of these patients.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
And then disease-modifying medications like ourselves or a THR Could potentially step in and really...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...push these patients across...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...the line to...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Faster.
David Happel
CEO, Sagimet Biosciences
You know, a better...Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
Exactly.A faster, better clinical outcome.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yep.No, absolutely.Do you think now, as you guys are obviously awaiting data, we're getting this question quite a bit?Is that right now the guidance is 1 Q?Is there a point at which you plan on fine-tuning the guidance more narrowly and give, like, sort of a monthly basis, and we'll have data on this month?Is that-
Rod MacKenzie
CMO, Sagimet Biosciences
We are working as expeditiously...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...as we can.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
To really deliver data as...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...early as possible.You may imagine a lot of data...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...generated...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...in a study takes time to become...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...available.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah, to make sure that it's...
David Happel
CEO, Sagimet Biosciences
We're providing a pretty comprehensive data set here.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.
David Happel
CEO, Sagimet Biosciences
Right?I mean, it's, it's not only the human histology...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...as you pointed out, but also the digital pathology...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah
David Happel
CEO, Sagimet Biosciences
...as well.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
As well as many of the NITs, I think.
Rod MacKenzie
CMO, Sagimet Biosciences
Correct.
David Happel
CEO, Sagimet Biosciences
All of the key NITs.
Rod MacKenzie
CMO, Sagimet Biosciences
Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
That will be presented.
David Happel
CEO, Sagimet Biosciences
Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
That is...
David Happel
CEO, Sagimet Biosciences
Yeah.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Is there a reason to also, given that the EASL conference is gonna be around the corner, potentially save some of the data for that?
Rod MacKenzie
CMO, Sagimet Biosciences
So we...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Will the EASL be, or will there always be an opportunity to do both, yeah?
Rod MacKenzie
CMO, Sagimet Biosciences
Our goal is to present the data...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...at EASL.And without a doubt...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
There will be new data.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
Given the sheer amount of...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...the volume of data.
David Happel
CEO, Sagimet Biosciences
Right.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
That come from a IIb.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Right.
Rod MacKenzie
CMO, Sagimet Biosciences
The key data will be the top line.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
But, absolutely, there will be new information...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Additional.
Rod MacKenzie
CMO, Sagimet Biosciences
...at EASL and at other conferences...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Got it.
Rod MacKenzie
CMO, Sagimet Biosciences
...as we dig...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
Rod MacKenzie
CMO, Sagimet Biosciences
...dig more and more.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Okay.And then maybe, like, another question is, what is the current like, sort of cash...I don't have Tony up here, but the current cash, the cash runway, because I think the next step for a lot of company and for a lot of investors are, how do you think about partnership interest, partnering this asset at this junction or conducting a phase 3 on your own?
David Happel
CEO, Sagimet Biosciences
Yeah, no, look, I think we've just reported our earnings for the third quarter.We're just a little bit over $100 million...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...in cash.We've been very conscientious in how we're handling that, and we'll continue to do so.Our cash runway, it takes us out into the first quarter of 2025.But I think, as you pointed out..
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...is with positive results.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
As we anticipate with our IIb in the first quarter, we're going to have to go out and...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...pursue financing...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...to get the phase 3 started and keep the timelines intact.That's really all of the money that we generated from the IPO is...
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
...with the exception of a very small subset we're developing for acne, is really dedicated to match and all the efforts to support that.So, will we consider strategic options?Absolutely.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Yeah.
David Happel
CEO, Sagimet Biosciences
You know, we're going to be very opportunistic as we as we pursue the best path forward.Our goal is to get this product out as quickly as we can.We think it would be highly invaluable to the community, and patients will benefit enormously, so.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
Great.Well, team, we have covered a lot.We really can't wait for the data, which is pretty, you know, imminent in the first quarter.We're wishing you the best of luck.
Rod MacKenzie
CMO, Sagimet Biosciences
Thank you.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
We can't wait...
David Happel
CEO, Sagimet Biosciences
Thank you.
Prakhar Agrawal
Equity Research Analyst, Piper Sandler
...to see it, and have a great 2024 as you have ahead of you.So I want to say thank you on behalf of all of us here at Piper Sandler.
