Cullinan Therapeutics, Inc. Common Stock Stifel 2026 Virtual Immunology and Inflammation Forum

Thanks for the invitation, Alex. Look, the first thing I'd say is that, as a company, we're very pleased to have what we consider a leading T cell engager portfolio of potential best-in-class and clinical stage programs across both immunology and oncology, as we head into a very exciting period for the company. CLN-978 is our CD19 T cell engager, which we're developing across rheumatic diseases. So that includes lupus, RA, and Sjögren's disease. Back in June at EULAR, we shared the initial single target dose data. As we highlighted in our corporate update this morning, we look forward to providing a comprehensive update across all indications in December, and I'll come back to that theme.

velinotamig is our BCMA T cell engager, and there our partner in China, Genrix Bio, is generating important proof of concept data in SLE, which will be shared at the upcoming ACR meeting in November. We're very much looking forward to advancing that program in diseases driven by plasma cells, starting with autoimmune cytopenias in the early part of 2027. CLN-049, that's another T cell engager, this time in oncology. So that's our FLT3 T cell engager, which we're developing in AML. We were very pleased after a successful end of phase I meeting with the FDA this past summer. Our team is rapidly setting up our potentially registrational phase II study in relapsed refractory AML.

Lastly, although not a T cell engager, zipalertinib is our oral tyrosine kinase inhibitor, which is being developed for EGFR exon 20 non-small cell lung cancer, which we're developing with our partners Taiho Oncology. There we recently shared data from the frontline study, the REZILIENT3 study of zipalertinib plus chemotherapy at the recent World Conference on Lung Cancer, in Seoul, South Korea. There we demonstrated potentially practice-changing results for the frontline patient population of exon 20 non-small cell lung cancer.

I think the other thing I would add is, our collaboration with Taiho is also strategic and financial in the sense that it does offer us significant near-term non-dilutive capital in the form of regulatory milestone payments for U.S. approvals of both frontline and second-line disease, as well as a 50/50 profit share in the U.S., which does allow us to continue to invest in our promising T cell engager pipeline across immunology and oncology. Then let me get to your question about our update this morning. So now in December, we plan to provide an update for our multi-dose regimen data across all of our indications, so lupus, RA, and now Sjögren's disease, as well as providing an update on the single target dose data across all of those indications. Here, context is important. I think once, Alex, we understood that we now have the opportunity to have multi-dose Sjögren's disease data available in December, we felt strongly that a comprehensive update across all disease areas at the same time, which by the way, we expect to be the most comprehensive clinical data set for a CD19 T cell engager to date, it really allows us the opportunity to share a much larger data set for the market to interpret.

It also provides the opportunity for cross-indication validation across things like disease-related biomarkers, clinical activity, et cetera. Overall, we just felt that this was a much better approach than single indication sequential rollout of data. Specifically for RA, it does allow us to provide more data and longer follow-up.

Every way you look at it, for us, it was strategically much better just to present all of the indications at the same time, and so that was the reason for the update this morning.

That's a good way of looking at it, because if you remember, Immunology Day, we had essentially the single target dose data with just a little bit of multi-dose data. Here we now have both multi-dose data across all indications.

Yeah We now have longer follow-up for the single target dose data as well.

So I think it provides us a great opportunity to showcase all of those data.