Adlai Nortye Ltd. American Depositary Shares Morgan Stanley 24th Annual Global Healthcare Conference
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All right. Afternoon, everyone. My name is Robert Klingenberger with Morgan Stanley. Excited to welcome the Adlai Nortye team here to our conference. Just before we get started, just want to refer everyone to the Morgan Stanley Research Disclosures website. If you have any questions, reach out to your Morgan Stanley representative. Like I said, very excited to have the Adlai Nortye team here. I'm joined by Brittany Stoppa, Director of IR, and Alex Yee, the CFO. We'll be diving into some good questions here. Thank you guys for coming.
Thank you for having us.
Sure. Thank you for Maybe just to start off, you all, I think, described the strategy of the company and really the two pillars, both the Precision RAS pathway targeted therapies, and then next generation PD-L1 pathway modulation.
Can you just talk about how you feel like at a high level, those two come together and form the portfolio that you all have today?
Yeah, great. Well, thanks for having us, Bob. We are really thrilled to be here at the Morgan Stanley conference. Adlai Nortye is a clinical stage biotechnology company that is targeting RAS from multiple angles. And we have a mission to transform deadly cancer into a chronic and eventually curable disease. We are approaching that with. We have a global team which has operations in the U.S., Singapore, and China. And we have an in-house R&D team that has synthesized over 1,000 RAS(ON) inhibitor molecules. And we have a proprietary RASiCA platform, which is our RAS Inhibitor Conjugated Antibody platform. We are advancing first-in-class and potential best-in-class molecules with our three lead oncology assets. We have two innovative RAS modalities, so that includes AN9025, which is a potential best-in-class pan-RAS(ON) inhibitor oral small molecule, and AN4035, which is a first-in-class pan-RAS(ON) inhibitor ADC targeting CEACAM5.
We also have a next generation immunotherapy, that is AN8025. That is a potential first-in-class multifunctional T cell/APC modulator. For now, our focus is squarely upon our RAS programs, which we think could be quite differentiated in addressing the over 175,000 patients diagnosed in the U.S. every year with RAS-addicted PDAC, non-small cell, and colorectal cancers.
Great. Well, I think in terms of the RAS platform, we should just start. You introduced AN9025 and AN4035. I'll try and get those right throughout the questions. Maybe just to start on the small molecule pan-RAS AN9025, just maybe give us a little bit of overview of the molecule and where you all sit today in terms of development, and we'll dive into some of the details from there.
Yes. AN9025, like I said, is our pan-RAS(ON) inhibitor oral small molecule. That's been developed all in-house, and it's been developed to address multiple RAS mutant solid tumors. The way that we've designed the molecule is that it has about 250x higher potency relative to the first generation pan-RAS(ON) inhibitor, divarasib, and that higher potency is driven by stronger CypA binding and slower dissociation, as well as stronger binding to RAS(ON) and slower dissociation. So you get a more stable tri-complex formation. That is leading to what we've seen in the preclinical setting, including more durable RAS signaling inhibition, deeper tumor regression, and more delayed adaptive resistance formation. We're excited about the potential and what we're seeing in the preclinical profile there, and we're hoping that translates into the clinic. So right now we're in a global phase I trial.
We began enrolling patients in the QD arm in February, and in July, we actually activated a QW arm, and that intermittent dosing schedule was enabled by, like I said, that preclinical profile and the durability of signaling inhibition that we saw. What we'll look forward to doing is we're continuing to dose escalate on both arms, but we're looking towards providing an update in the first half of 2027 on that program, which will be the full phase 1a data for the QD arm, as well as an early look at the QW arm.
Great. You referenced some of the preclinical data both on potency and durability, and half-life. Maybe just as we think about that first half 2027 disclosure, what should we be looking for to demonstrate that kind of best-in-class potential that you've been talking about?
Yeah. I think for the molecule AN9025, if fully translated 100% from preclinical to the clinical, I think we would be expect to see a better safety and tolerability profile, also with better efficacy, compared with the current players. But this need to be 100% translate. I think right now, based on the initial clinical data we see, it's a little bit early, but I would say it's not far away. Probably we need probably two or three months to really understand the profile. Initially, as we briefly mentioned, we already released to public, we just initiated the expansion cohort for our QD dosing for the small molecule, which implies we have been seeing pretty good human PK data compared with. It's highly correlated with what we see from preclinical. We also are being observed and seeing preliminary efficacy with better tolerability profile in the human data.
And I know you all have, in your corporate deck too, extensive kind of preclinical package. Any particular kind of data, especially as you think about relative to some of the other players in the space that you want to highlight as we sort of are thinking about expecting the clinical data next year? Yeah. As we always saying, the reason we initiate the human data is we want to really further confirm with the preclinical finding. But if you're just looking for a few preclinical data, we've been demonstrating our corporate deck. We have been doing very extensive preclinical CDX model to compare our molecule with current market players. I think with all those G12X, G13X CDX model, we have been showing very good deeper tumor inhibition in the in vivo level.
We also showing potentially in the QD dosing, we have a very comparable therapeutic window with the. Yeah. And you touched on, I think, where I wanted to go kind of with the next question, just in terms of, excuse me, both the QD dosing and then the weekly kind of intermittent cohort that you started this summer would be really curious to hear a little of how the internal thinking is around which one of those kind of. How you look at both arms playing out and in parallel, and what you're looking for in terms of what you might be taking forward as you advance the program further.
The idea we initiate the QD dosing early this year for our oral small molecule is that we hopefully were able to see the differentiate just by the QD dosing, which is very comparable with what other market players is doing, using a once a day of the dose regimen. By the QD dosings data right now, we have been feel very comfortable. We just initiated dose expansion, but we also share to public and investors saying we are not reaching the MTD yet. We are continue to doing dose escalating the QD dosing. Of course, we also initiated weekly dosing about two months ago. But we want to highlight is that we initiate a weekly dosing is not because we are not able to really doing a daily dosing. It's just for the weekly dosing give us additional optionality.
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