Lyell Immunopharma, Inc. Common Stock 2026 Global Healthcare Conference

Thanks. Well, I'm delighted to be here and have a chance to tell you about Lyell Immunopharma. For those of you who are not as familiar with Lyell, we are a cell therapy company focused on next.

Well, thank you. I'm delighted to have a chance to tell you about Lyell Immunopharma. For those of you who are not as familiar, Lyell is a cell therapy company focused on next generation CAR T-cell therapies for patients with cancer, specifically hematologic malignancies, as well as solid tumors. We have two programs in the clinic. Our lead program is ronde-cel, which is a next generation CD19, CD20 CAR T-cell therapy in two pivotal trials for large B-cell lymphoma. We have a single arm study, the PiNACLE study, which is going to have a significant data update this year, and we expect our first BLA submission next year. Lyell is on its way to hopefully becoming a commercial company. We also have a first of its kind, head-to-head CAR T-cell therapy company of our product, ronde-cel, versus investigators' choice of one of the approved CD19 CARs, axicabtagene ciloleucel or lisocabtagene maraleucel.

Then we have a second program in the clinic, we call LYL273, which is a GCC-targeted CAR T-cell therapy for patients with metastatic colorectal cancer. It's a full lineup, and I'm pleased to report we also have our own manufacturing facility, which gives us a lot of control over our destiny, because that's a very important component of cell therapy.

Sure. Just to back up a little bit, I think many people are aware that CD19 CARs have really transformed the treatment for patients with large B-cell lymphoma, which was really a very deadly disease in the past, and they've made great benefit. But what became quite apparent is there's still significant room to improve upon outcomes, particularly driving more patients to complete remission or complete response, as well as driving longer duration of response. Because what patients are really looking for is this treatment-free, disease-free interval. The beautiful thing about CAR T-cell therapy is it's a one-time treatment, which really is designed to bring those sorts of meaningful responses. The inventor of Ronde-cel is an engineer turned biologist, a really brilliant scientist, Yvonne Chen at UCLA, who really rationally designed this CAR T-cell therapy.

What she did is she wanted to design a CAR that was full potency at either CD19 or CD20. This is really important because some malignant B cells have no CD19, and so therefore CD19 CAR T-cell therapy won't benefit the patients at all. In this case, if the patient has either CD19 or CD20, we can benefit them, and that's expected to drive more complete responses. In addition, we know that one of the main causes of escape from CD19 CARs is that the malignant B cells can drop the CD19 antigen itself as sort of this evolution to avoid therapy. Well, it's very difficult for these malignant B cells to drop two antigens. By having a dual targeted CAR, we can drive more complete responses and longer duration of responses.

She did one more thing, which was really quite special, is the field has really learned that if your CAR T-cell therapy product includes naive or central memory T cells, these are the, think of as the more fit and healthy younger T cells, that actually those are the cells that are associated with longer overall survival, for example, in the ZUMA trials of axicabtagene. She really designed this product to specifically have a high percentage of naive T cells. So we think it's this combination of the dual targeting plus this very novel manufacturing process that is helping with the benefits that we're seeing.

We just in early summer presented data on the first 100 patients that we've treated. We had a 97% success rate in delivering product to patient, and the median vein to site time is 16 days. So very much in line with axicabtagene and better than what liso-cel or BREYANZI brings.