Nurix Therapeutics, Inc. Common stockNRIX
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Nurix Therapeutics, Inc. Common stock Wells Fargo 21st Annual Healthcare Conference

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Derek ArchilaSenior Biotech Analyst

All right, everyone. I think we'll get started here with our next fireside discussion. My name's Derek Archila. I'm one of the Senior Biotech Analysts here at Wells. I'm very excited to have with us Nurix Therapeutics. From the company, we have Jason Kantor, Chief Business Officer. Jason, good to see you.

Jason KantorChief Business Officer

Good to see you, Derek. Thank you so much for having us.

Derek ArchilaSenior Biotech Analyst

Yeah. Maybe just to start off, a lot of things going on at Nurix. You guys announced a big deal on bexobrutideg and other things. Maybe give us the state of the business first, and then we can get into more specific questions.

Jason KantorChief Business Officer

Sure. Terrific. For those who don't know Nurix well, we are a multi-product, multi-therapeutic area, biopharma focused on targeted protein degradation. Our lead asset is a degrader of BTK, which is a central node in B-cell signaling as well as other immune cells. It's in pivotal studies for CLL and is moving into phase II for chronic spontaneous urticaria, CSU, and also multiple sclerosis, MS. We've got partnerships with Roche, as you mentioned, for bexobrutideg, but also discovery partnerships with Gilead, Sanofi, and Pfizer. We've got our lead programs in those collaborations, include a STAT6 degrader with Sanofi and an IRAK4 degrader with Gilead, and I'm very happy to be here. Thank you very much. Yeah.

Derek ArchilaSenior Biotech Analyst

To start off just on bexobrutideg and what underpinned the deal with Roche in terms of the strength of the data in CLL and the promise in some of these I&I indications.

Jason KantorChief Business Officer

Yeah. It's a great question. What I'll say is last year, as we were thinking about our strategy around this product, one of the things that was really clear was in order to achieve the right kind of value inflection for the program, we wanted to, one, establish the efficacy, two, establish long-term durability. On the efficacy side, we had 83% response rate in heavily refractory patients. We had 22.1 month median PFS. We wanted to be able to have an established dose to take into pivotal, and we did a randomized study for Project Optimus.

Jason KantorChief Business Officer

Having the data package in place, and being on the cusp of phase III, doing the deal at this point is ideal for us because not only does it de-risk us financially in terms of our ability to execute, but it expands the indication space we can go into, which increases the total addressable market. That includes not only the malignant heme, but also I&I and neuro, and Roche is the ideal partner for us in this respect.

Derek ArchilaSenior Biotech Analyst

In terms of just the CLL opportunity, you guys had already started the late line trial, and obviously, the Roche partnership opens up early in line. How do you think about the competitive dynamics with the next gen BTK inhibitors versus a BTK degrader? Within that class, how do you guys feel like you're differentiated versus the BeiGene or BGB-16673 molecule?

Jason KantorChief Business Officer

Yeah. A fantastic question. The BTK inhibitor space obviously started with ibrutinib and then acalabrutinib, zanubrutinib, and then the non-covalents like pirtobrutinib. With each of those, it has been the goal of getting better selectivity, better safety, and then ultimately to increase the therapeutic footprint into I&I. Degraders bring an entirely new modality to a target that is proven. In CLL, the BTK space right now is $13 billion annually. It is growing at close to 15%, and the indication space keeps growing. The BTK degraders are really the first to try to cross both oncology and I&I. The inhibitors have tended to do one or the other. But the BTK degraders, such as bexobrutideg, have the advantage of removing the protein, doing it catalytically, and being able to address mutations as well as wild type.

Jason KantorChief Business Officer

The data has been, I think, remarkable, and we are full steam ahead on all of that. In terms of differentiation versus our closest competitor, BGB-16673, it is hard to say right now. They are both showing fantastic efficacy in the 80s percent range, which is remarkable. I think ultimately, probably where we will see the differentiation is on the safety side. We think we have a safer molecule. We think we have a more selective molecule, and we will just have to see that play out over time.

Derek ArchilaSenior Biotech Analyst

Got you. I guess when you think about the Roche deal in terms of the economics to you guys and ultimately the development plans too in terms of the costs, can you just walk us through stepwise how you go from where we are today and then building out the overall set of CLL opportunities?

Jason KantorChief Business Officer

Yeah, sure. We announced the deal back in early June, so it was not long ago. It was the largest single degrader deal to date in terms of upfront. It was a $700 million upfront payment, $2.3 billion total milestone and upfront package. The cost sharing is 40/60 on the development costs, and it is a U.S. 50/50 profit share ex-U.S. royalty. People have asked, "Oh, is Roche taking over?" No, this is truly a collaboration. We have equal representation in all the joint governance, and we are working together on a very ambitious CDP. That CDP includes the randomized phase III study that we talked about, which is head to head versus pirtobrutinib, which is the standard of care in this second-line setting.

Jason KantorChief Business Officer

We are about to kick off a phase I-B/II study in combination with venetoclax in order to enable the potential for maybe fixed duration, shorter course therapies that could get to very deep and durable responses. You ask how we're thinking about covering the CLL landscape. Well, Roche is the perfect partner because they have all of the potential combination drugs, including venetoclax, CD20 antibodies, and the CD19 bispecifics. We're also looking to expand into Waldenstrom and mantle cell. That just covers the Heme space.

Derek ArchilaSenior Biotech Analyst

Got you. So maybe we're going to get some updates, I think later this year. What should we be paying attention to for the bexobrutideg, additional CLL data, and anything else in the Heme space?

Jason KantorChief Business Officer

Yeah. So in terms of bexobrutideg data, we are also, in addition to having the ongoing studies in Heme, we are running a healthy volunteer SAD/MAD study with a new tablet formulation, which is designed to initially go into our studies for CSU and MS. We'll have disclosures around that phase 1 data set this year. We're also working towards an IND in CSU as well as MS. CSU would come first, MS to follow. Then in terms of the cadence of news flow on the clinical side in CLL and NHL, we typically present data at ASH and at EHA. So that's the American Society of Hematology is in December, and the European Hematology Association is in June, and we'll have updates on our phase I-B cohorts at that time.

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