Kyverna Therapeutics (KYTX) Morgan Stanley 24th Annual Global Healthcare Conference summary

Strategic progress and clinical milestones

• Leading development of cell therapy for autoimmune diseases, with stiff person syndrome as the first indication and BLA filing on track for Q4, aiming for first approval in this area.

• Expanding neuroimmunology portfolio to include myasthenia gravis and progressive MS, leveraging early clinical success to build a broader pipeline.

• miv-cel, a next-generation CAR T-cell therapy, shows strong efficacy and safety in over 100 patients, with no high-grade CRS or ICANS reported.

• Manufacturing uses a traditional, validated process with a 98% success rate, supporting scalability and safety.

• RMAT designations and positive FDA interactions support accelerated development and regulatory review.

Clinical data and patient impact

• Stiff person syndrome patients showed reversal of disability, with two-thirds no longer needing walking aids after treatment.

• One-time miv-cel therapy enables patients to discontinue chronic background therapies, achieving drug-free, disease-free remission.

• Pivotal trial data showed a 46% improvement in the 25-foot walk test, with significant results across all endpoints.

• Early patients in both stiff person syndrome and myasthenia gravis remain disease-free and off immunosuppressants beyond two years.

• Myasthenia gravis data show dramatic reductions in MG-ADL and QMG scores, with most patients reaching minimal symptom expression.

Commercialization and market strategy

• Preparing for commercial launch of miv-cel in stiff person syndrome, targeting 10 initial centers and working closely with payers and advocacy groups.

• Over 90% of physicians support the therapy’s profile, and 85% would use it for moderate to severe patients.

• Pricing strategy targets a premium above current CAR T therapies ($500,000–$600,000), justified by high value and cost savings from reduced chronic care.

• Commercial infrastructure for stiff person syndrome will be leveraged for myasthenia gravis and future indications, maximizing synergies.