Kyverna Therapeutics, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Sure. Mike, thanks very much for hosting us. It's been a great day so far. I'd like to just start off by saying Kyverna's really excited about the tremendous progress we're making. We're leading the world in bringing cell therapy to autoimmune patients, starting with our first indication with stiff person syndrome. We're on track to finish filing our BLA as of Q4 of this year, which would put us on track to be the first approved therapy in this terrible condition that has no approved therapies. More importantly, it puts us on track to be the first cell therapy company anywhere in the world with an approved therapy in autoimmune diseases.

Really excited about that tremendous progress there, but this really opens up the aperture for the rest of our neuroimmunology strategy and portfolio that we're building here and looking at additional indications with myasthenia gravis and progressive MS and other things that will continue to build and grow our company as we continue to navigate this space. More importantly, help these patients that desperately need something new in terms of a new therapy that can transform their lives.

I think what's really important here is that miv-cel, unlike other CAR T therapies, has been specifically designed for autoimmune diseases. This construct was in-licensed from the NIH as a next-generation construct for potency in these conditions, but more importantly, significantly improved safety.

Yeah. We're the only CD19 with a CD28 costimulatory domain in the autoimmune space with a fully human design as well, and other changes to the CAR construct that provide this improved safety profile.

We're now seeing that bear out in the over 100 patients that we've now treated. We're seeing these remarkable clinical results, but at the same time, no high-grade CRS, no high-grade ICANS, no incidences or reported cases of ICANS. All these things are really important when you're looking at developing a construct that's going to help patients more broadly across these conditions.

Yeah. First of all, I think it's really unfortunate that these cases were announced and the impact that it has on these patients and these programs. But I do think it really underscores what we're doing at Kyverna is very different, and very different on two important ways. First, the construct itself, and I touched on this a little bit in my opening, but miv-cel's been uniquely designed for use in autoimmune patients, and it's been designed for significantly improved safety. Like I said, this has been bearing itself out in the clinical profile that we've now seen in over 100 patients treated. Again, no high-grade CRS, no high-grade ICANS, no cases of the ICANS, which some of these other constructs have been associated with.

I think that's critically important to keep in mind that we're dealing with a construct like miv-cel that has this prominent safety profile and proven safety profile.

Yeah. In addition, what's also really important is the manufacturing.

We're not using a rapid manufacturing process. In fact, we're using a traditional, well-established, tried-and-true manufacturing process that has been, again, well-validated and established in the over 100 patients we've now treated. We see 98% manufacturing success rates.

Yeah. We believe this combination of the construct and the manufacturing is what's contributing to the overall promising safety profile that we're announcing.