Conference Transcript - ASMB 2026-06-03

Katie Catrino, Analyst — SVB Securities

Really great to have Assembly Biosciences with us today, Jason Okazaki, CEO, and Katie Catrino's SVB of Preclinical R&D. Welcome. I think before we get into Q&A, why don't I pass it to you, Jason, for just some high-level thoughts around Assembly and upcoming catalysts to pay attention to.

Jason A. Okazaki, CEO

So I think, as you might recall, last year was a pretty big year for us from an ASV standpoint. So our two flagship molecules, 5366 and 1179, both demonstrated high proof-of-concept data in the phase 1B studies. We actually ended the year with Gilead opting in to both of those programs under the collaboration. So as of December when they opted in, they now control development and commercialization efforts going forward. The next catalyst on that collaboration front that we're expecting imminently, I would say, is we're expecting the clinical development plan from Gilead. Well, they'll inform us as to which molecule, if not both, they're planning on moving forward into phase two and phase three, and then the commercialization plan as well. And then based on that, we have an option to opt into a 40-60 U.S. cost-profit share split. So we'll evaluate that, and our guidance is that we'll make that decision in the mid-year. So that'll be the next catalyst for the HSV-2 program. for 6250, which we've been developing for the past few years for hepatitis delta. Last year, we announced very positive, not positive, phase 1A data that showed target engagement of bile acid elevation, which is exactly what we're hoping for. We've now finished chronic talks on that molecule and plan to initiate the phase 2 study for delta by end of this year, expecting data second half of next year. And most recently, two weeks ago, seems like an attorney ago, but two weeks ago, we announced expansion of 6250 into PBC PSC and that's based on you know really over the past year year and a half we've been talking to KOL's both from a mechanism standpoint and from a clinical standpoint as to potential uses for the mechanism I know talk a lot about this the NTCP inhibitor which inhibits basically bile acid entry into the hepatocytes the use of that for cholestatic liver diseases so we've been doing a deep dive into that including having a pre-IND meeting with fda two weeks ago which culminated in us announcing the program and receiving funding for that program throughout the phase two so we expect to initiate those studies for the phase two studies for pbc and psc a by first quarter 2027 and expect data on those in first half 2028 so you know while this is was more of an execution year i think with the addition of pbc psc it just kind of increases our catalyst for you know starting second half of next year and beyond.

Katie Catrino, Analyst — SVB Securities

Great. I think first on the kind of mid-year decision on whether to opt in or not, can you just talk us through what you're hoping to see from Gilead in terms of that clinical development plan, and what are those factors that you're looking at to inform your decision there?

Jason A. Okazaki, CEO

Yeah, and obviously, you know, certainly before Gilead took over, we had our design of a clinical development plan. So, you know, all we're looking to see really is how are they approaching the chronic suppressor, the phase two, the phase three? Are they going to look for, you know, you know, indication expansions to run other trials. And it's a largely a cost estimate, right? So, I mean, it's a largely quantitative analysis where certainly we'll do an NPV analysis of the costs and the profit share from the U.S., compare that against the milestones and the royalty structure, in which case we would not be bearing any kind of cost for phase two, phase three or commercialization and kind of see where that lays out. You know, I think from a qualitative standpoint, you know, the good news is, well, the good news is we don't have a co-promote right on that. so it's not like we would have to you know think about building out a commercial organization so it is largely quantitative but i think would say the other competing factors are you know certainly even a fund a 40 share of a phase two phase three and commercialization launch it's going to be significant raise down the road so you always think about dilution right the shareholders always think about that but i think you know largely the focus will be on long-term value of course which is our responsibility and you know we'll think about is that 40 profit share outweigh the cost from an FPV standpoint. So we'll expect to, you know, very much dig into that development plan and make sure we agree with it, A. And then, B, just make sure the costs align with our expectations and then look at the profitability long-term.

Katie Catrino, Analyst — SVB Securities

Got it. Do you have any kind of initial thoughts in terms of whether or not Gilead would move forward with one over the other or both?

Jason A. Okazaki, CEO

You know, we don't. I mean, you know, it's such a close call because both those molecules have great profiles and both of our companies' TPPs, which is an oral small molecule, once-weekly dosing, and what we saw in the phase 1b is it has the high potential of superior efficacy to the Valtrex, which is TPP. So I think you're honestly looking at there's a potency difference, slight potency difference between 1179 and 5366. Formulation is slightly different, but nothing that you would say clearly puts one ahead of the other. And of course, 5366, because of its long half-life, has the potential to be a monthly program as well. So I think it's an interesting choice from Gilead's standpoint to pick one, and, you know, they could have the option to pick both as well and move them both forward.

Katie Catrino, Analyst — SVB Securities

Okay, great. I think definitely very exciting news on 6250. Can you talk a little bit more about the mechanism there? Kind of what was the thinking behind moving it into PBC and PSC in addition to HEPD? And then also kind of what you saw in that phase 1A that gave you confidence to do so?

Jason A. Okazaki, CEO

Yeah, I alluded a little bit to it. You It's really disgusting with KOLs and the fact that we really think of 60-50 as a hepatoprotective molecule that's preventing bile acid entry in the hepatocytes, and if you think about cholecytic liver diseases, particularly PBC, PSC, you know, they're driven by bile acid uptake, so I think, you know, mechanistically, there's a very clean logic to it, and Katie can kind of go more into that, but it's one of those things that the more we thought about it, the more we tested the hypothesis with KOLs, and we thought about the clinical study design, which makes a lot of sense for, you know, testing against current standard of and potential add-on therapy, the resounding feedback was positive as to, yeah, that's definitely something that would benefit patients and something that would be worthwhile to do.

Nicole S. White

Yeah, so in terms of the mechanism, I mean, when we initiated this study, it really was to identify small molecule inhibitors of NTCP for the treatment of chronic hepatitis delta. And, you know, NTCP is the receptor that hepatitis delta uses to enter the cells, and we had the clinical proof of concept from all the efficacy and safety data from Bolivartide. So it was a natural fit there to go forward and look at this molecule for HDB, and the results we got in the Phase Ia study where we saw dose-dependent elevations in serum bile acids, those elevations were either consistent with or actually higher than what's been observed with both the 2 milligram and 8.5 milligram doses of Bolivartide. Additionally, as we were doing the preclinical testing with 6250, you know, as Jason noted, we had demonstrated that 6250 also had low nanomolar potency against bile acid transport, and that resulted in starting to think about the hepatoprotective effects of 6250 for colostatic liver disease. And I think, again, the elevated serum bile acids that we see in the Phase Ia study suggests that we are having a hepatic protective effect preventing those bile acids from getting into the liver and that's why we're going ahead with the cholestatic liver disease study.

Katie Catrino, Analyst — SVB Securities

Got it. And the phase two is a basket study with PSC and PBC. So talk a little bit about kind of the feedback you got with you from the FDA with the pre-identity meeting, kind of the protocol there and what you're looking for in that trial to see see a signal on moving forward on one or both.

Nicole S. White

Yeah, so, you know, the basket study really allows us to be very efficient from an operational standpoint. It allows us to have one study, open one site, open a site, and then how that site can enroll both PBC and PSC patients. So, it should allow us to get to proof of concept more quickly.

Jason A. Okazaki, CEO

It will also facilitate our discussions with the regulatory agencies as we generate a body of data and then decide, you know, what the next steps are in cholestatic liver disease. got it yeah as far as the feedback too I think you know part of the timing was that was the last I would say gating on if you will and it was missing a check the box which is you know a tribute to the preparation we've done ahead of time with KOLs carefully I kind of think it through the study design and the way we've designed the study is it is very interesting and also makes sense is how you basically market commercially right so we're gonna have three arms one will be you know standalone 6 250 and second line other will be you know third line on top of PPAR and it kind of exemplifies how we think we could win with 6250 and that you know that given the mechanism you could have a scenario where you are a second line single agent and that would be obviously the the home run scenario but we also see a scenario where additive benefit with PPAR is going to lead to potentially second line therapy and improve alka-fosk reduction or normalization so I think the way we've done that trial will really kind of also just frame how we have would fit commercially on that so a lot of thought kind of went into that as well got it Okay.

Katie Catrino, Analyst — SVB Securities

Can you elaborate a little bit on kind of the endpoints that you're looking to evaluate there and what do you think good data would look like that would prompt you to move forward?

Nicole S. White

Yeah, so we're taking a pretty comprehensive approach in terms of our efficacy endpoints. We'll be looking at biochemical endpoints such as alkaline phosphatase, ALT, bilirubin. We're also going to be looking at non-invasive biomarkers of fibrosis, of FibroScan, things like that, ELF score. we'll be looking at pruritus, itch scores, as well as overall quality of life scores. In terms of what endpoints we are looking for, I think that's a little different depending on whether you're talking about PBC or PSC. So we know from other studies as well as discussions with the agency that biochemical endpoints are an approvable endpoint for PBC. So I think we'll be very focused on changes in alkaline phosphatase in the phase two and then that will help us determine assuming positive results which dose to take forward into phase three and then that would continue to be the approvable endpoint moving forward. For PSC it's a little bit different right now it's clinical outcomes which is really the approvable endpoint you know there's a lot of activity in this space a lot of ongoing discussions with the agency so that could change But for right now, because this is a 12-week study that we're planning for Phase II, we're not really going to have enough time to look at clinical outcomes. So what we're looking for is directional changes in a variety of these efficacy biomarkers. And I think we can look to a study in PSC recently with Ella Fibonor Phase II that was published earlier this year that showed directional improvement in ALP, fibrosis, as well as pruritus scores. And so that's really what we're looking for for phase two. And then assuming positivity, that would then be an ongoing discussion with the agency to see what we would need to do in order to get approved in phase three.

Katie Catrino, Analyst — SVB Securities

Got it. Is time of development also a factor in terms of whether or not to move into one or the other or both of these indications, given biomarker outcomes are obviously much quicker to get to instead of clinical?

Nicole S. White

I mean, certainly the PSC studies would be longer, but, you know, I mean, we'll have to kind of see what the data looks like in phase two and then kind of map all that out. I mean, if things look good for both PBC and PSC, you know, we might be able to get a quicker win with PBC, but I think, you know, PSC could follow along from there. Got it.

Katie Catrino, Analyst — SVB Securities

And on safety and tolerability, anything that you are looking out for in terms of off-target effects? I know pruritus is a big thing for PBC as well. So what are your expectations on that as well?

Nicole S. White

Yeah, so from the phase 1a study, we had over 10 days of dosing. We had a good safety profile, no AEs of pruritus. Additionally, we've completed our chronic toxicology studies, and we have really great safety margins, no safety signals of note that we need to be following up there. Certainly, we will be continuing to monitor with pruritus. You know, I think what we've seen is that it's the interhepatic bile acid levels are what's driving both the disease as well as the itch. So when you have elevated levels of bile acids in the liver, those results in triggering the FXR pathway to shut down de novo synthesis of bile acids, and that triggers elevations in IL-31 levels. And it's been seen that elevations in IL-31 levels seem to be driving itch. So if you look at PPAR agonists where they've resulted in reductions in intrahepatic bile acid levels as well as reductions in IL-31 levels, that seems to be driving lower levels of itch. For 6250, which is going to prevent bile acids from getting into the liver, we think that will drive lower levels of intrahepatic bile acids as well as lower levels of IL-31. And so we think we may be resulting in lower levels of itch. At the very least, we're looking for neutrality with itch, but we think we could potentially get to lower levels of itch.

Katie Catrino, Analyst — SVB Securities

Okay, great. And then on PBC, you talked about kind of positioning second line as a single agent versus third line on top of PPAR. What are the considerations there in terms of, first, what you want to see in the data, and also commercially how those markets would work and where 6250 could fit?

Jason A. Okazaki, CEO

Yeah, certainly it's data-driven, right? So obviously, as you think about Alka-Foss reduction and I think it's just coming from easel most if not all the companies are talking and the chaos are talking about Alka-Foss normalization right so there's your obvious like if we're able to normalize more people than people are alone or you know that that's your win right so we think it's additive people are you're normalizing most if not all people or in place of people are that's the most obvious win right that that's obviously high bar because people are quite good but something that because it's a different mechanism you know I think it's a unique mechanism and given that most of the bile acids are coming through NTCP. We think, you know, there is a good possibility of that being a superior outcome. So that's the first, you know, the highest kind of commercial potential. But like I mentioned earlier, I think, you know, if your quote-unquote worst-case scenario is additive PPAR and that's still getting patients to normalization, which is the ultimate goal, I think that's another, you know, huge on that need because, you know, once you get to UDC USA and then also PPAR, if you're still not normalized, they're still that big on that need regardless. So that's why we like 6250 in the markets in general is because, you know, you don't have to necessarily beat PPARs. I think you can work together with them. I think we're uniquely situated where, you know, we're testing very low doses. We're going to be testing like one milligram or less. So as you think about, you know, co-formulation, et cetera, I think it's conducive to doing that. So you could have, you know, co-formulated products down the road that are added to the patients, you know, or you could have standalone agents.

Katie Catrino, Analyst — SVB Securities

So we like the flexibility that 6250 could provide. are there any kind of considerations in terms of safety and tolerability on that combo and also on efficacy how do you see the mechanisms is there kind of a synergistic component potentially to them as well yeah so I mean I think for you know you've got kind of multiple intervention points when you think about bile acid and bile acid flow through the body you've got the IBAT inhibitors You've got PPAR agonists, and then you've got NTCP inhibitors.

Nicole S. White

You know, from a safety standpoint, you know, again, we've had really good results with 6250. We also think that 6250 is directly preventing the bile acids from getting into the hepatocyte, so that really is going to have a direct hepatoprotective effect. Additionally, we know that the majority of bile acids, anywhere from 75% to 95% of the bile acids, are recycled in the body, as opposed to de novo production, which is, you know, a lower percentage. So we think there could actually be an improvement with 6250 in terms of achieving biochemical outcomes relative to the pupar agonists. and yeah no I'm from a safety standpoint I think and pruritus we talked about that before where you know it seems to be driven by the interherbatic bile acid levels elevations in IL-31 we anticipate with 6250 because we're blocking the bile acids from getting into the liver that we will hopefully see reductions in itch there.

Katie Catrino, Analyst — SVB Securities

Is it reasonable to assume or possible to assume that you could see pruritus lower than P-PAR on its own in the combination? I think that's possible.

Nicole S. White

I mean, you know, obviously we have to do the study and find that out. But, yeah, I think it's unknown with all these different intervention points what percentage of those is driving the elevations in intrahepatic bile acid levels. So it's difficult to know whether which drug or which combinations of drugs because it's going to result in the greatest reduction in interherbatic bile acid levels and then the best outcomes for patients.

Katie Catrino, Analyst — SVB Securities

Switching gears to hepatitis B, that data is a little bit more near term. Just remind us the trial design there, again, endpoints, and what you're looking for in terms of good data.

Jason A. Okazaki, CEO

Delta.

Nicole S. White

Delta, yes. Yeah, so there we're looking to do a longer-term study, probably 24, 48 weeks, looking at multiple doses. The target there is to achieve elevations in serum bile acids that are going to be either consistent or greater than boulevertide. We know from those bile acid elevations with boulevertide that that drives multiple log reductions in RNA, good ALT normalization. So that's what we're aiming for there.

Katie Catrino, Analyst — SVB Securities

Okay. And how are you thinking about 6-2-50 as a small molecule versus some of the other platforms that have come out against hepatitis delta?

Nicole S. White

Yeah. I mean, at the end of the day, everything is an entry inhibitor, right? They're all preventing entry of the virus into the cells. You know, I think where we think 6-2-50 brings benefit is that it is a small molecule. So, you know, it is a daily oral medication. these patients are also infected with hepatitis B. They're already taking a daily oral medication with their nuke, and with the low dose that we're anticipating bringing forward with 6250, we think that sets it up to be easily co-formulated with a nuke, so patients could continue taking one pill once a day, and they could be treating both viruses.

Jason A. Okazaki, CEO

But even as a standalone, I think this is a situation where being late to the game, as far as commercialization, we think is to our advantage, right? obviously kill i just got a delivered to prove in the u.s so they're going to obviously spend a lot of time building market you've got veer mirror and blue jay so i think that's a benefit for us because obviously they'll help they'll build the market but you know our experience and a lot of experience in virology is simple usually wins right so you've got a small molecule oral whether or not it's a you know taken as a cool formula nuke one pill once a day versus you know weekly versus monthly infusion they have to go in a clinic you know i think it's going to be interesting commercial to question but we feel confident about you know our ability to have a small molecule for simplicity and adherence. So again, we actually like having the market being built up ahead of us. So it's kind of a nice kind of like roadmap.

Katie Catrino, Analyst — SVB Securities

Right, and patients would prefer that ease of use anyway. PSC, I think we didn't really touch on enough. That's a relatively more white space compared to PVC. So how are you thinking about commercial positioning there? Yeah.

Jason A. Okazaki, CEO

Yeah, like Katie said, it's going to be obviously data dependent, but it's hard to know if it's an outcomes trial or not, right? So I think, obviously, good news, it's a white space, right? So if you're the first or only molecule to be approved for PSC, you've got a wide open commercial space. The hard part is, you know, what is the end point? How long does that study, right? Because an outcomes study is going to take, you know, five, seven years to do, and then that's a long development plan. So I think that's something that, you know, there are companies ahead of us in that space as well. They're having discussions with FDA, So maybe that will elucidate kind of either surrogate markers or kind of ultimate pathways. So I think the good news is as we generate this phase two data and, you know, figure out where all COFOS is going, all the other markers, hopefully that will kind of play into our case or our discussions with the agency based on these other companies' discussions of what that next pathway is. And if it is an outcome study, and depending on how the data is, it may very well justify doing that. And I think, again, the good news is we have, you know, a year or two to kind of sort out the data to make sure we see what it is. And also, you know, keep in mind, this is all part of the collaboration, so likely we'll have discussion with Gilead as to, you know, if they end up opting in on this, it's going to be a large discussion with them, similar to thinking about that cost share, right, for HSV2. We would have that same kind of dynamic here, so I think as we think about the development plan, or Gilead thinks about the development plan, if they opted into this molecule, it kind of creates other kind of avenues for kind of multiple ways to attack, kind of, to maximize the success of the molecule.

Katie Catrino, Analyst — SVB Securities

Right, and Gilead has opt-in on the molecule for hepatitis B as well, but it sounds like they will have opt-in rights for the other indications as well.

Jason A. Okazaki, CEO

Yeah, the way the opt-ins work is per program, so 6250 is a quote-unquote program, so I guess this is, I would say, a good problem to have that I don't think this collaboration or most collaborations anticipate that you're going to have one molecule that could have three potential blockbuster indications. So I think there are some logistical things we're going to have to discuss with them because obviously it's three separate data points, And so whereas HSV-2 was relatively simple, although, you know, we had two molecules, so it's a little bit complicated there as far as when the opt-in actually takes effect, whereas this one certainly would expect the delta data in advance of PPC-PSC. So I think we'll have to talk about logistically how that works. But the good news is either way, on the back end of it, if they opt-in, we would have the same milestones, royalties on all therapies, like what I said, the 4060 costure. It's just a matter of how you could sort out kind of those development plans and all that kind of stuff. But I think that's all kind of good problems to have and good discussions I'm sure we'll have with Gilad in the coming months.

Katie Catrino, Analyst — SVB Securities

And remind us, when is the opt-in triggered for this program?

Jason A. Okazaki, CEO

Yeah, so the opt-ins in general in the collaboration are end of phase one or end of phase two. And obviously, since we're initiating phase two for Delta and also PBC, PSC, over the next six to 12 months, the opt-ins would be triggered after the phase two data. And I think that's where the timing logistics come in, because if we've got what's just called phase two data for Delta first, but then the PBC, PSC data is six months behind, how does that plan do? Because it was really a one-op then, so I think that's the only logistical thing, but that's something I wouldn't anticipate we could solve.

Katie Catrino, Analyst — SVB Securities

Okay, got it. Are there other liver diseases or any other indications that you've kind of explored in your conversations with KOLs and in your preclinical and phase 1a data as well?

Nicole S. White

Yeah, I mean, certainly cholestatic liver disease makes up a broad swath of liver diseases. You know, many of them are rare, and, you know, there's really limited, if any, treatment options for those patients. So there's a great patient need there. You know, for now, we're focusing on PBC and PSC because there's a larger number of patients there, which will allow us to more quickly get to proof of concept and demonstrate if 6250 can work in this space. I think from there, in parallel with moving forward on longer-term studies in PBC and PSC, we would look to expand into some of these other rare disease indications. You could think about biliary atresia or PFIX for a few examples, but I think there could be a number of other diseases on the table at that point.

Katie Catrino, Analyst — SVB Securities

Got it. And I know this is probably a little farther away, but how are you thinking about pricing going into hepatitis delta and then PSC, PBC, and maybe more of the ultra-rare liver diseases as well?

Jason A. Okazaki, CEO

Yeah, it's an interesting question. I think there's a few ways to think about it, right? One is, you know, obviously you could do an indication split, which is not necessarily the easiest thing to do, but depending on your doses, it might be easier, right? So if you've got a quarter milligram dose for Delta and it's like a milligram dose for PBC, obviously it makes it a little easier, but you probably still have to do separate trials. The other way, you know, we think about it is, the good news is these are not, it's not like you're going to have a discrepancy where you've got a $5,000 a year treatment and then a $500,000-year treatment. So I think there's some flexibility. I'm sure the pricing will evolve as well. Obviously, Gillian announced the WAC for $280,000 for Bolivir-T, and I think the average PVC therapy for PPAR is like $150,000. So there's a gap there, but it's not like a 10X gap. But the other advantage we have, and again, we may or may not be in control of pricing systems, depending on Gillian Opsin or not, but being a small molecule, frankly, the cost of goods are pretty low, right? So you've got a lot of flexibility on pricing. So, you know, strategically, you've got to think about, you know, I don't know that you want to do what happened in the Hep C days where, you know, everyone's kind of undercut, but I think you've got optionality there that you could do. But I think the reality is, you know, given the unmet need, and it's really going to be based on data-driven, and, you know, I think we'll just figure it out from there.

Katie Catrino, Analyst — SVB Securities

Okay, great. Hepatitis B. So 4334, sole rights were returned to assembly. How are you thinking about progressing with that program? How are partnering discussions? We'd love to just hear an update on that.

Jason A. Okazaki, CEO

Yeah, so as far as partnering discussions, we started a formal process and have a bank looking for potential partners globally, right? So I think coming off of Easel, obviously there was the BEPI data, JSK, very encouraging, but it also shows there's still a greater need there for the combination therapy to get to a wider cure number. So we have and always have thought that the CAM is going to be one of the cornerstones of cure together with the NUC backbone. So we continue to believe that. It's just we don't possess, you know, that third component, an immunomonitorial component to do that. So ideally, as we think about partnering, you know, first and foremost is finding a good partner that has, you know, multiple components that could logically lead to a cure, and they could put that in the clinic. But I think most important for us is making sure somebody could actually take that to the next stage because it just doesn't make sense for us from a priority standpoint to do it. But certainly we're focused, you know, for years we've been focused on how to be cured and continue to be active in the D space, which obviously has overlapped B. So our hope is to find a partner that would have that, whether it's the third and or fourth combo mechanism, to put that back in a clinic and get to that proof of concept on a broader cure base.

Katie Catrino, Analyst — SVB Securities

Got it. How much of a priority is it to find a partner with, for example, an ASO, where you can combine that? Or are there any other mechanisms you think would be nicely paired with the CAM?

Jason A. Okazaki, CEO

Yeah, I mean, obviously you've seen a few deals with ASOs and CAM, So I think that's a logical option, but I think there's also kind of other pathways we're thinking about and other partners that kind of have expressed interests that might have alternative pathways. So I think we're more kind of agnostic as a mechanism. It's more just kind of scientifically what the rationale is and kind of how it would work and kind of advancement in the field.

Katie Catrino, Analyst — SVB Securities

In terms of those alternative pathways, can you elaborate a little bit more on that?

Jason A. Okazaki, CEO

Yeah, I mean, I would say there's some novel things that EZLA we saw that might be combined with. I don't think I named directly, but there's that. And, you know, I mean, unfortunately, there's fewer people in the HPV space, so I think your field is a little bit more narrow. But I think, you know, given some of that easel data and some of the companies working on other adjunct therapies, I think there was a place where, you know, cam and or nuke therapy on top of certain other kind of therapies would make a lot of sense to either aid in suppression and or kind of go direct it to a cure.

Katie Catrino, Analyst — SVB Securities

Got it. I mean, you mentioned the BEPI data as well. What were kind of your impressions of the data and where a cam could fit in, obviously as a backbone, but maybe layering in additional alternative mechanisms as well?

Jason A. Okazaki, CEO

Yeah, I mean, I think one supposition, right, is that if you're taking the next second-gen cams plus new because you're going to eventually lower S, right, and I think the idea could be that you lower S to the level where you can treat with a BAPI, right, to get the cure. And then the question is, I still probably think the cure rate's at 19% or, you know, probably a bit on the low side, so it would be more of a long-shot bet to get to that point. So, obviously, if you can improve upon the 19% or 26%, you know, that would be the first priority to do a direct combination, I think.

Katie Catrino, Analyst — SVB Securities

Got it. And then in exploring, I guess, the BD aspect of this program, is there an ideal structure that you're hoping to get in terms of, for example, going out for just worldwide rights and, like, a full outright out-licensing or maybe bi-geography, et cetera?

Jason A. Okazaki, CEO

Yeah, I don't think we're really focused on that. I think it's more kind of finding the right partner, right? So ideally, obviously, it's easiest to have a global partnership, right, where somebody would take over global development. And then, you know, as far as structure, you know, again, really not, you know, focused on, you know, upfront payment versus background payment. I think we're flexible in structure, and, you know, that's our background. My background is, you know, deal-making, so I think we can find ways to do deal-making that would make sense for both parties. So I'm not worried about getting to an arrangement. I think it's more just kind of finding that partner that we think will really advance the asset and drive the community faster, closer to the cure.

Katie Catrino, Analyst — SVB Securities

Great. Okay. In our last 30 seconds or so, remind us of your cash runway and time to these important calluses.

Jason A. Okazaki, CEO

Yes, our last published cash runway was into 2028. We haven't updated our cash runway since doing the $115 million financing recently. Reason being is that the way we think about it, it will certainly fund beyond the PBC-PSC trials in 2028, but given we're expecting the clinical development plan from Gilead soon and then we'll make that opt-in decision on the 60-40 split. Once we make that decision, we'll update the runway. But I think it's safe to say we're into second half of 2048 and it could be longer depending on where we come out on the development plan. And also our guidance does not include extension fees that Gillette would pay us or the warrants or anything like that. So we're pretty conservative on our guidance.

Katie Catrino, Analyst — SVB Securities

Okay, great. Thank you so much for being here.