Kyverna Therapeutics, Inc. · NASDAQ:KYTX
Kyverna Therapeutics — Investor Presentation (September 2026)
37 slides from Kyverna Therapeutics's investor presentation, September 2026
Slide 1: Transforming the Treatment Paradigm in Neurologic Autoimmune Diseases
Transforming the Treatment Paradigm in Neurologic Autoimmune Diseases September 2026
Slide 2: Disclaimer and Forward-Looking Statements
Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that are based on management’s beliefs and assumptions and information currently available to management of Kyverna Therapeutics, Inc. (“Kyverna”, “we”, “our,” or the “Company”). All statements other than
Slide 3: Pioneering Differentiated Therapies with Curative Potential to Free People from Life-long Autoimmune Diseases
Pioneering Differentiated Therapies with Curative Potential to Free People from Life-long Autoimmune Diseases and Chronic Therapy Innovating to Expand Access Focused Neurologic Extend leadership by broadening Autoimmune Strategy access and choice for patients Transformative (e.g., indication expansi
Slide 4: Miv-cel's Differentiated CAR Construct Reinforces Potential First-in-Class and Best-in-Class Profile
Miv-cel's Differentiated CAR Construct Reinforces Potential First-in-Class and Best-in-Class Profile in Autoimmune Mivocabtagene Autoleucel (miv-cel)1,2 • Deep depletion of peripheral and tissue- Only Fully Human Autologous CD19 resident B cells to support broad immune CAR T With CD28 Costim reset a
Slide 5: Established, Validated, and Scalable Manufacturing Process
Established, Validated, and Scalable Manufacturing Process Miv-cel is produced using a well-established, and validated manufacturing process similar to those used in commercially available CD19 autologous CAR T-cell therapies Dual-source U.S. manufacturing strategy >98% manufacturing success rate dr
Slide 6: Miv-cel's Profound MOA and Ability to Penetrate the CNS
Miv-cel’s Profound MOA and Ability to Penetrate the CNS CNS Penetration and Expansion Broad Immune Reset CAR+ Miv-cel Expansion Detected in CSF Naïve B Cells in SPS Regulatory T Cells in SPS at Day 14 in Progressive MSa 10000000 10 6 1000000 105 Cell Count by Flow Cytometry 100000 104 10000 103 1000
Slide 7: Potential First-Approved Therapy for SPS Represents a Valuable Commercial Neuroimmunology Opportunity
Potential First-Approved Therapy for SPS Represents a Valuable Commercial Neuroimmunology Opportunity Compelling SPS Targeted Launch Strategy Market Dynamics to Maximize Value Creation • Progressive rare disease with no approved therapies • First-in-indication rare disease launch • ~6K U.S. diagnose
Slide 8: Robust Near-Term Catalysts for Prioritized Neurologic Pipeline Indications
Robust Near-Term Catalysts for Prioritized Neurologic Pipeline Indications Indication Anticipated Milestones Stiff Person Syndrome Complete rolling BLA submission in Q4 2026 RMAT, ODD Positioned for potential commercial launch in 2027 Generalized Myasthenia Gravis Complete enrollment in Phase 3 expe
Slide 9: Stiff Person Syndrome (SPS)
Stiff Person Syndrome (SPS) 9
Slide 10: SPS is a Debilitating, Progressive Autoimmune Disease with No FDA-Approved Therapies
SPS is a Debilitating, Progressive Autoimmune Disease with No FDA-Approved Therapies SPS impacts the inhibitory signaling Devastating Impact on Patients pathways, which are the body’s braking system and the target of 80% of patients lose mobility, needing autoantibodies produced by B walking aid ass
Slide 11: KYSA-8 Patient Perspectives: Before and After Treatment with Miv-cel
KYSA-8 Patient Perspectives: Before and After Treatment with Miv-cel Case Studies View Video View Video 11
Slide 12: Potential for Miv-cel to Quickly Set Treatment Standard in SPS with >2,000 Patients Immediately Addressable
Potential for Miv-cel to Quickly Set Treatment Standard in SPS with >2,000 Patients Immediately Addressable Miv-cel Addressable Market2,3 ~6k Immediately Addressable Total Miv-cel Market Addressable Market U.S. Diagnosed SPS Patients1,2 ~2.0 to 2.5k Patients ~5.5k Patients 30-40% of total diagnosed
Slide 13: SPS Treaters Show Strong Enthusiasm for Early Adoption of Miv-cel
SPS Treaters Show Strong Enthusiasm for Early Adoption of Miv-cel Survey of 20 high volume Product profile based on SPS treaters in U.S. miv-cel topline data 80% view efficacy data 90% view profile as 85% would use miv-cel and one-time treatment compelling versus current for moderate-to-severe as ke
Slide 14: Focused Launch Strategy Targeting ~10 High-Value SPS Centers
Focused Launch Strategy Targeting ~10 High-Value SPS Centers • Thought leaders / SPS high-volume treaters Neuro Leadership • Institutional support for miv-cel • Meaningful portion of immediately addressable patients at Addressable Patients ~10 centers • Strong referral network • Commercial CAR T exp
Slide 15: SPS Registrational Trial – Rolling BLA Submission Underway
SPS Registrational Trial – Rolling BLA Submission Underway; On track to Complete Submission in Q4 2026 KYSA-8: Open-label, single-arm, multicenter study N = 26 Primary endpoints: • Age 18 to 75 years Miv-cel • Change from baseline in T25FW at 16 weeks Low-dose Cy/Flu • Safety • Diagnosis of SPS prec
Slide 16: Primary Endpoint Met - Continued Reversal of Disability and Nearly All Patients Remaining Off Chronic Immunotherapies
Primary Endpoint Met - Continued Reversal of Disability and Nearly All Patients Remaining Off Chronic Immunotherapies Through 1 Year Significant T25FW Improvement and Reduced Walking Aid Use • 95% of patients who achieved a clinically meaningful improvement (≥20% reduction from 16-week primary endpo
Slide 17: Statistically Significant Improvements Continued in All Primary and Secondary Endpoints Through 1 Year
Statistically Significant Improvements Continued in All Primary and Secondary Endpoints Through 1 Year 16-wk timepoint 1-Yr follow-up Primary Endpoint P Value P Value Timed 25-Foot Walk 0.0003 <0.0001 Secondary Endpoints P Value P Value Modified Rankin Scale <0.0001 0.0003 Distribution of Stiffness
Slide 18: Single-dose Miv-cel Led to Substantial Improvements in Physical and Mental Functioning
Single-dose Miv-cel Led to Substantial Improvements in Physical and Mental Functioning 36-Item Short Form Health Survey (SF-36): 6-Minute Walk Test (MWT): >4-fold improvement Week 16 scores comparable to healthy adults over clinical minimally important change1 for most domains2,3 89-meter median imp
Slide 19: Robust Miv-cel Expansion Led to Complete Peripheral B-cell Depletion and Reductions in Autoantibody Titers
Robust Miv-cel Expansion Led to Complete Peripheral B-cell Depletion and Significant Reductions in Autoantibody Titers • Robust CAR T-cell Expansion Deep B-cell Depletion Reduced GAD65-IgG Median IQR Median IQR P < .0001 56% median GAD65-IgG by RIA, nmol/L 750 reduction 500 250 0 Baseline Week 16 n=
Slide 20: Single-dose Miv-cel Induced Markers of Broad Immune Reset
Single-dose Miv-cel Induced Markers of Broad Immune Reset B-Cell Phenotypes Regulatory T Cells Regulatory T Cells Naïve Non-Class Switched Class Switched Memory Memory • Newly emerging B-cell population showed significantly increased naïve • Significant increase in phenotype with concomitant decreas
Slide 21: Consistent Safety Profile Maintained in 1-Year Follow-Up With No High-Grade CRS or ICANS
Consistent Safety Profile Maintained in 1-Year Follow-Up With No High-Grade CRS or ICANS and No IEC-HS Treatment-Related Adverse N = 26 Events, n (%) • No high-grade CRS or ICANS observed Any grade ≥3 CRS 0 (0) Any grade ≥3 ICANS 0 (0) • No IEC-HS observed Any grade IEC-HS 0 (0) • All Grade 3/4 neut
Slide 22: Natural History Study Contextualizes Transformative Miv-cel Data
Natural History Study Contextualizes Transformative Miv-cel Data and its Opportunity to Change the Treatment Paradigm Natural History Study Large, multicenter, retrospective study assessing T25FW KYSA-8 SPS Registrational Trial in patients with SPS (n=153) over 10-year period Earlier in disease cour
Slide 23: Generalized Myasthenia Gravis (gMG)
Generalized Myasthenia Gravis (gMG) 23
Slide 24: Despite Available Treatment Options, High Disease Burden Remains
Despite Available Treatment Options, High Disease Burden Remains • gMG is a B-cell and antibody-mediated Current State of Treatment neuromuscular autoimmune disease that causes fluctuating muscle weakness and Inadequate symptom control3,4 fatigue1,2 Few reach minimal symptom expression (MSE)1,5-6 No
Slide 25: Miv-cel's Potential: Durable, Drug-free, Disease-free Remission with Single Dose
Miv-cel’s Potential: Durable, Drug-free, Disease-free Remission with Single Dose Miv-cel Addressable Market1,3 ~80k Initial Total Miv-cel Priority Addressable Market U.S. Diagnosed gMG Patients1,2 ~12k Patients ~40k Patients 15% of total diagnosed 50% of total diagnosed Patients with inadequate Pati
Slide 26: SPS Lays Foundation for Rapid and Efficient Market Entry in gMG
SPS Lays Foundation for Rapid and Efficient Market Entry in gMG SPS gMG Target ~10 centers at launch Expand to ~50-75 total centers at peak • Meaningful portion of SPS patients at • MG/neuro centers of excellence approximately 10 centers and high-volume treaters • High-volume SPS treaters, including
Slide 27: Phase 3 Ongoing with Enrollment Expected to be Completed Mid-2027
Phase 3 Ongoing with Enrollment Expected to be Completed Mid-2027 ~60-patient, global, open-label, randomized controlled Phase 2/3 trial with crossover design Co-Primary Endpoints (MG-ADL & QMG) Miv-cel Screening, Low-dose Cy/Flu preconditioning + N = ~60 Single infusion of 1×108 CAR T cells Follow
Slide 28: Robust and Durable Effects Sustained Through At Least 1-Year Across MG-ADL and QMG
Robust and Durable Effects Sustained Through At Least 1-Year Across MG-ADL and QMG MG-ADL Score QMG Score Change from BL Change from BL Baseline Baseline Week 2 Week 24 Week 52 Week 2 Week 24 Week 52 Mean MG-ADL 11.0 –6.9 –8.3 –8.2 Mean QMG 16.9 –8.6 –11.7 –12.8 24-week primary endpoint 24-week prim
Slide 29: Single-dose Miv-cel Continues to Deliver Clinically Meaningful Reductions in MG Outcome Scores
Single-dose Miv-cel Continues to Deliver Robust and Clinically Meaningful Reductions in MG Outcome Scores and Treatment Burden Substantially improved clinical outcomes MG-ADL QMG 100% had clinically meaningful response 100% had clinically meaningful response (≥2-point reduction vs baseline) (≥3-poin
Slide 30: Consistent Safety Profile Maintained in Long-term Follow-Up With No High-Grade CRS and No ICANS
Consistent Safety Profile Maintained in Long-term Follow-Up With No High-Grade CRS and No ICANS or IEC-HS Treatment-related AEs, n (%) Patients (n=7) • No high-grade CRS and no ICANS observed Any grade ≥3 CRS 0 (0) • No IEC-HS observed Any grade ICANS 0 (0) • All Grade 3/4 treatment-related AEs Any
Slide 31: Robust CAR T-cell Expansion Led to Deep B-cell Depletion
Robust CAR T-cell Expansion Led to Deep B-cell Depletion Robust CAR T-cell expansion Deep B-cell depletion • B-cell recovery was detected in 2 patients at weeks 12 and 16, respectively N=7. Data cutoff: February 2026. 31 BL, baseline. ©2026 Kyverna Therapeutics, Inc.
Slide 32: Miv-cel Reduced Autoantibody Levels While Preserving Humoral Immune Responses
Miv-cel Reduced Autoantibody Levels While Preserving Humoral Immune Responses Reduction of autoantibodies Preservation of humoral immunity Autoantibody Ref Range BL Last visit (Wk) AChR, nmol/L Neg: ≤ 0.3 5.6 0.8 (Wk 52) 20 AChR, nmol/L Neg: ≤ 0.3 71.5 0.7 (Wk 52) Autoantibodies Percent Change from
Slide 33: Opportunity to Achieve Drug-Free, Disease-Free Remission with Single Dose Miv-cel
Opportunity to Achieve Drug-Free, Disease-Free Remission with Single Dose Miv-cel Note: These observations are derived from separate clinical settings; comparisons across trials are not based Approved Investigational on head-to-head studies. FcRn Complement CD19 BCMA mRNA Miv-cel Inhibitor1 Inhibito
Slide 34: Progressive Multiple Sclerosis (PMS)
Progressive Multiple Sclerosis (PMS) 34
Slide 35: Progressive Multiple Sclerosis (PMS): Encouraging IIT Data Highlight Broad Opportunity
Progressive Multiple Sclerosis (PMS): Encouraging IIT Data Highlight Broad Opportunity with Miv-cel in Neuroimmunology Phase 1 IIT Studies at Stanford (N=6) and UCSF (N=2) Stanford uses alternative bendamustine lymphodepletion regimen Biological Activity Efficacy Safety • Robust CAR T cell • All pat
Slide 36: Miv-cel's Compelling Value Proposition Supports Strong Commercial Potential
Miv-cel’s Compelling Value Proposition Supports Strong Commercial Potential Across Multiple Autoimmune Diseases Miv-cel’s Potential - Today’s Treatment Paradigm Drug-Free, Disease-Free Remission Chronic therapy Single dose Inadequate disease management Immune reset Transient benefit Durable benefit
Slide 37: Pioneering Differentiated Therapies with Curative Potential to Free People from Life-long Autoimmune Diseases
Pioneering Differentiated Therapies with Curative Potential to Free People from Life-long Autoimmune Diseases and Chronic Therapy Miv-cel BLA Submission Best-in-Class Profile Valuable Commercial Underway for SPS Unique miv-cel construct and Opportunity in SPS Further strengthened by 1-year validated
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