Assembly Biosciences, Inc H.C. Wainwright 28th Annual Global Investment Conference

Yeah. We advanced four different programs through phase I last year, and our lead candidate for the HSV program was licensed by Gilead by the end of last year. They're taking it into phase II for recurrent genital herpes by the end of this year. We have ABI-6250, we were originally developing for hepatitis delta virus. That's going to plan to start a phase II study by the end of this year. We also recently announced that we're expanding into cholestatic liver diseases, and we'll be taking a phase II study for PBC and PSC next year. Other than that, we also have ABI-7272, which is a pan-herpes program for transplant patients, which we hope to be. It's right now in IND-enabling studies, and we hope to get it into the clinic next year.

We have a very strong research engine that's working on the next wave of pipeline.

Yeah. We entered back a few years ago, and it's a long-term collaboration where they have the right to license any of our programs that we discover. They did license Great the HSV program, and we opted in to share 40% of the costs and profits in the U.S.

Traditionally, we still get milestones and royalties, and we'll still have those ex-U.S. We thought that that 40% milestone royalty in the U.S. was meaningful to opt into.

Why is that? I can take this one.

Hepatitis delta is a co-infection with HBV, and typically for HBV, you would be on NUC therapy. While NUCs are good at basically suppressing replication of the hepatitis B virus, it does not fully typically eliminate the surface antigen, which is what delta relies on for propagation. Even if you're able to suppress the hepatitis B virus, you still have propagation of the hepatitis delta virus. In general, hepatitis delta leads to a more significant liver-related death over time.

That's a great question. We're really excited to see the bulevirtide approval in the U.S. It's been approved in other regions for longer, and it's had a really meaningful benefit for those patients that have been infected with hepatitis delta. What we've seen as more treatments emerge is that typically testing has improved. We've seen this most recently with the Roche high-throughput assay for hepatitis D, as well as Labcorp has also launched a new testing option. Our hope is with these new testing options that are available, it leads to not only earlier diagnosis of hepatitis delta, so earlier intervention, but also better long-term treatment options.

Right now we're estimating, I think what's out there is about only 10% of those with hepatitis D in the U.S. have been diagnosed. We expect with better treatments, better testing, that this patient number will increase over time.

Sure. Yeah, boceprevir is also an NTCP inhibitor, which is great because it validates the target. As I mentioned, we've already seen some meaningful benefit in patients out there. The big difference is that bulevirtide is a large molecule that must be injected daily, and ABI-6250 is a small molecule with potentially ability to dose once daily oral. This really provides a nice convenience benefit for patients, perhaps better adherence. The other thing is that Gilead's published some modeling where you don't see full target engagement over the 24-hour period, so the receptor occupancy is not 100%, where we feel with ABI-6250 in a small molecule, we may have ability to achieve more target coverage over the 24-hour period, which could provide a meaningful benefit to patients.