Form 8-K - Current report

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): June 14, 2024

   

Kyverna Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)


Delaware	001-41947	83-1365441
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

5980 Horton St., STE 550
Emeryville, California		94608
(Address of Principal Executive Offices)		(Zip Code)

    Registrant’s Telephone Number, Including Area Code: (510) 925-2492

   

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.00001 per share	KYTX	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 14, 2024, Kyverna Therapeutics, Inc. (the “Company”) hosted an industry symposium at EULAR in Vienna with a data update on KYV-101, its lead CAR T-cell therapy candidate. A copy of the Company’s presentation is being furnished as Exhibit 99.1. The Company’s presentation is current as of June 14, 2024, and the Company disclaims any obligation to update this material in the future.

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits



Exhibit		Description
99.1		Presentation - Anti-CD19 CAR T-Cell Therapy in Rheumatologic Autoimmune Diseases and Beyond, dated June 14, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


			KYVERNA THERAPEUTICS, INC.

Date:	June 14, 2024	By:	/s/ Ryan Jones
			Name: Ryan Jones Title: Chief Financial Officer

Lupus warrior Anti-CD19 CAR T-Cell Therapy in Rheumatologic Autoimmune Diseases and Beyond Welcome and Introductions Peter Maag, PhD Chief Executive Officer, Kyverna Therapeutics June 14, 2024 Exhibit 99.1

Time Session Title Presenter 8:15-8:20 Welcome and Introduction Peter Maag, PhD Kyverna Therapeutics 8:20-8:35 Long-Term Clinical Experience and Mechanistic Insights Gerhard Krönke, MD Charité – University Medicine Berlin 8:35-8:50 Experience in Advancing CAR T Trials in Rheumatologic Diseases Peter A. Merkel, MD, MPH University of Pennsylvania 8:50-9:05 KYV-101 Experience Across Multiple Diseases and Sites James Chung, MD, PhD Kyverna Therapeutics 9:05-9:30 Panel Discussion Gerhard Krönke, MD – Charité – University Medicine Berlin Richard Furie, MD – Northwell Health Dominic Borie, MD, PhD – Kyverna Therapeutics James Chung, MD, PhD – Kyverna Therapeutics Moderator: Peter A. Merkel, MD, MPH University of Pennsylvania

Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management of Kyverna Therapeutics, Inc. (“Kyverna”, “we”, “our,” or the “Company”). All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward looking statements include, but are not limited to, statements concerning: the Company’s future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies and named patient activities, ongoing clinical trials, research and development costs, plans for manufacturing, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed or may subsequently file with the U.S. Securities and Exchange Commission. Actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. When evaluating Kyverna’s business and prospects, careful consideration should be given to these risks and uncertainties. These statements speak only as of the date of this presentation, and Kyverna undertakes no obligation to update or revise these statements. This presentation also contains estimates made by independent parties relating to industry market size and other data. These estimates involve a number of assumptions and limitations and you are cautioned not to give undue weight on such estimates. We have not independently verified the accuracy or completeness of such information and we do not take any responsibility with the accuracy or completeness of such information. This presentation contains references to trademarks and marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this presentation may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. The Company does not intend its use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of the Company by, any other companies. This presentation includes results from named patient activities. Named patient activities are not part of our clinical trials for KYV-101 and data from these trials and activities are reported by the relevant investigators and physicians. Such data are not obtained using a single protocol or designed to be aggregated or reported as study results and may be highly variable. While we do not expect to be able to use the results from these investigator-initiated trials or named patient activities in our applications for marketing approval to the U.S. Food and Drug Administration or other foreign regulatory agencies, we believe that this strategy may provide some competitive advantage as we will be able to acquire additional clinical insights beyond highly focused clinical trials in specific geographies.

Note: Timeline not to scale. CAR, chimeric antigen receptor; IND, investigational new drug. 1. Brudno JN, et al. Nat Med. 2020;26:270-280. 2. Mougiakakos D, et al. N Engl J Med. 2021;385:567-569. 3. Mackensen A, et al. Nat Med. 2022;28:2124-2132. Kyverna’s First IND Cleared Kyverna’s CD19 CAR T-cell Hypothesis Kyverna's 6 Years of Dedication to Autoimmune Disease 50 PATIENTSTREATED WITH CAR IN KYV-101 MAY 2024 NATURE MEDICINE BRUDNO1 February 2020 Nature Medicine Article Safety and Feasibility of Anti-CD19 CAR T Cells With Fully Human Binding Domains in Patients With B-Cell Lymphoma NIH KYVERNA FOUNDED FOR AUTOIMMUNE DISEASES MAY 2018 NEJM SCHETT2 August 2021 New England Journal of Medicine Correspondence CD19-Targeted CAR T Cells in Refractory Systemic Lupus Erythematosus NATURE MEDICINE SCHETT3 September 2022 Nature Medicine Correspondence Anti-CD19 CAR T Cell Therapy for Refractory Systemic Lupus Erythematosus

Is a Reset of the Immune System Possible?

Cell Therapy Is Shifting the Paradigm in Autoimmune Diseases VALUE TIME Small molecules Biologics / mAB Cell therapy / CAR T Methotrexate KYV-101 Mycophenolate Cyclophosphamide CAR, chimeric antigen receptor, mAB, monoclonal antibodies.

Early KYV-101 Data Demonstrate Promising Outcomes Across Multiple Indications Total of 50 Patients Treated With CAR in KYV-1011,2 Hematology Neurology Rheumatology CAR, chimeric antigen receptor. 1. Brudno JN, et al. Nat Med. 2020;26:270-280. 2. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. CAR T-Cell Expansion B-Cell Depletion Autoantibody Reduction Disease Impact DIFR (Durable Immunomodulator-Free Response) Early Experience

Patients and Their Families for their courage and trust Care Givers and Collaborators for their partnership Kyverna Employees for their hard work and dedication Acknowledgments – Creating the Kyverna Village

KYV-101 Experience Across Multiple Diseases and Sites Anti-CD19 CAR T-Cell Therapy in Rheumatologic Autoimmune Diseases and Beyond James Chung, MD, PhD Chief Medical Officer, Kyverna Therapeutics June 14, 2024

Commitment to Generating Clinical Insights Along 3 Pillars Strategy Patient-Centric “Named Patient Use” In patients with highly-refractory, serious autoimmune disease with limited or no treatment options Indications include MG, SSc, and rare autoimmune diseases such as SPS and autoimmune encephalitis Kyverna-Sponsored (KYSA) Clinical Trials Phase 1/2 rheumatology protocols in US and EU LN, SSc: enrolling Phase 2 neurology protocols in US and EU MG, MS: in activation Investigator-Initiated Clinical Trials Focuses on the interests and unmet needs as defined by scientific community Informs indication selection Drives long-term collaboration with top-tier academic centers 3 Pillars of Emerging Experience LN, lupus nephritis; MG, myasthenia gravis; MS, multiple sclerosis; SPS, stiff person syndrome, SSc, systemic sclerosis.

CAR, chimeric antigen receptor; costim, costimulatory; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; NIH, National Institutes of Health; scFv, single-chain variable fragment; TM, transmembrane. 1. Brudno JN, et al. Nat Med. 2020;26:270-280. 2. Alabanza L, et al. Mol Ther . 2017;25(11):2452-2465. 3. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. First-in-Class, KYV-101, an Autologous, Fully Human, Anti-CD19 CAR T-Cell Therapy Human Anti-CD19 scFv Human CD8α Hinge Human CD8α TM Human CD28 Costim Human CD3ζ KYV-101 (Hu19-CD828Z) Engineered for improved safety profile Developed at the NIH to improve upon axicabtagene ciloleucel (YESCARTA®)1,2 Fully human single-chain variable fragment compared with murine CD8𝛼 hinge and TM domains compared with CD28 hinge and TM domains Safety of CAR construct validated by clinical data 20 patients with B cell lymphoma treated in Phase 1 trial by NIH1 Lower cytokine levels, neurotoxicity and immunogenicity 30 patients with autoimmune indications3 Low levels of cytokine release (CRS, ICANS)

50 Patients Across Diverse Indications Treated With the KYV-101 CAR Construct Rheumatology Hematology Neurology 15 Autoimmune Indications: 6 in rheumatology and 9 in neurology KYV-101 CAR Experience Across Multiple Indications (N=50) AAV, ANCA-associated vasculitis; AE, autoimmune encephalitis; ASyS, antisynthetase syndrome; BL, Burkitt lymphoma; CAR, chimeric antigen receptor; CIDP, chronic inflammatory demyelinating polyradiculoneuropathy; DLBCL, diffuse large B cell lymphoma; DE, DAGLA encephalitis; FL, follicular lymphoma; IgG4-RD, IgG4-related disease; LEMS, Lambert-Eaton myasthenic syndrome; LN, lupus nephritis; MCL, mantle cell lymphoma; MG, myasthenia gravis; MS, multiple sclerosis; RA, rheumatoid arthritis; SSc, systemic sclerosis; SPS, stiff person syndrome; KYV-101 CAR refers to both KYV-101 and NIH clinical experience with the underlying CAR used to create KYV-101.

P ≤ 0.001 P ≤ 0.0001 1000 2000 Concentration of each protein in culture supernatant (pg ml-1) Concentration of each protein in culture supernatant (pg ml-1) Hu19-CD828Z (N=20 patients) FMC63-28Z (N=22 patients) P ≤ 0.0001 P ≤ 0.0001 P ≤ 0.01 P ≤ 0.01 P > 0.05 P ≤ 0.01 P ≤ 0.01 P > 0.05 KYV-101 CAR Safety and Efficacy Experience From Hematology (N=20 NIH Phase 1) Reduced Neurologic Toxicity Observed Compared to YESCARTA® Construct Hu19-CD828Z FMC63-28Z FMC63-28Z P= 0.0017 P= 0.0005 Hu19-CD828Z Reduced Cytokine Production in Oncology Observed Compared to YESCARTA® Construct CAR, chimeric antigen receptor; GM-CSF, granulocyte-macrophage colony-stimulating factor; IFN, interferon; IL, interleukin; TNF, tumor necrosis factor; KYV-101 CAR refers to the underlying CAR used to create KYV-101. 1. Brudno JN et al. Nat Med. 2020;26:270-280. KYV-101 Key Lessons CAR demonstrated an improved safety profile in a 20-patient study without compromising efficacy Data supported dose-selection for autoimmune disease setting

KYV-101 CAR-Related Safety Data Shows No CRS or ICANS Grade ≥3 in First 30 Patients aReferences 3-6 are reported as neurological toxicities. bReported at 12% of 268 patients. cReported as 23% of 115 patients. dGrade 1 neurological AEs were not recorded in this trial. Three subjects had Grade 2 ICANS, and 16 patients had Grade <2 ICANS. These limited observations are derived from separate clinical settings, and with respect to the autoimmune data are based primarily on information from case reports rather than clinical trials. They do not represent head-to-head comparisons of CD19 CAR T-cell treatment in autoimmune indications as compared to oncology indications. Future clinical trials may not confirm the clinical safety observations discussed in these case reports and studies. BL, Burkitt lymphoma; CRS, cytokine release syndrome; DLBCL, diffuse large B cell lymphoma; FL, follicular lymphoma; ICANS, immune effector cell-associated neurotoxicity syndrome; IIM, idiopathic inflammatory myopathies; MCL, mantle cell lymphoma; Neuro, neurology; NR, not reported; Rheum, rheumatology; SLE, systemic lupus erythematosus; SSc, systemic sclerosis. 1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience with 28-day follow up as of June 04, 2024. 2. Müller F, et al. N Engl J Med. 2024;390(8):687-700. 3. Brudno JN, et al. Nat Med. 2020;26(2):270-280. 4. Neelapu SS, et al. N Engl J Med. 2017;377(26):2531-44. 5. BREYANZI® (lisocabtagene maraleucel) Prescribing Information 2024, Bristol-Myers Squibb. 6. KYMRIAH® (tisagenlecleucel) Prescribing Information 2022, Novartis Pharmaceuticals. CAR T-cell therapies are associated with class effects, including CRS and ICANS, which may be potentially serious or life-threatening, but generally resolve within the first month of treatment and are manageable with close monitoring by a treating physician Source Indication N Any Grade CRS Any Grade ICANSa CRS Grade ≥3 ICANS Grade ≥3 KYV-101 experience1 Rheum & Neuro 30 25 3 0 0 Schett Group case series2 SLE, IIM, SSc 15 9 1 0 0 Hu19-NIH Ph1 Lymphoma study3 DLBCL, FL, BL, MCL 20 18 NRd 2 1 ZUMA-1 (axi-cel)4 DLBCL 3L 101 94 65 13 28 TRANSCEND (liso-cel)5 DLBCL 3L 268 122 95 11 32b JULIET (tisa-cel)6 DLBCL 3L 115 85 69 26c 22

KYV-101 Effects in 30 Patients With Autoimmune Diseases Number of Patients Treated <90 days CAR T Expansiona B-Cell Depletion Autoantibody Reduction/Otherb KYV-101 Demonstrates Promising Outcomes Across Multiple Indications (N=30) aNo CAR T expansion defined as Cmax < 6 cells/μL and area under curve 56 <100. bOther refers to impact on OCBs (MS patients) or reduced IgG4 levels (IgG4-RD patients). CDemonstration of reduced clinical and biological activity. dDurable response defined as no immunomodulator use for ≥3 preceding months at the time of data cut through June 4, 2024. 1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. Observations are derived from separate clinical settings and are based in part on information from case reports rather than clinical trials. Future clinical trials may not confirm the observations discussed in these case reports and studies. CAR, chimeric antigen receptor; IgG4-RD, Immunoglobulin G 4-related disease; MS, multiple sclerosis. Disease Impactc Durable Immunomodulator-Free Response (DIFR)d

Note: Red triangles indicate median time to CAR T-cell peak expansion for all patients (left) and median time to CD19 B-cell reconstitution for patients whose B cells have returned (right). ABS, absolute; CAR, chimeric antigen receptor. 1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience as of May 24, 2024. Trailblazing in Autoimmune Disease With 30 Patients Experience Pharmacodynamic Activity and Return of B Cells CAR Expansion Consistent With Oncology Experience Days Post-Infusion CD19 B-Cell Count Cells/µL Days Post-Infusion CAR T-Cell Count Cells/µL KYV-101 CAR T Cells/µL CD19 ABS, Trucount

Myasthenia Gravis Named Patient #1 – Lancet NeurologyWithin 60 Days of Infusion, Observed Improved Symptoms and Mobility IgG titer day CAR T-cells▼ CAR T-cells▼ 10 20 30 40 50 60 Mar-23 Jul-22 Nov-21 Mar-21 day QMG Score Walking distance(m) Arm holding time [sec] Observed dramatic reduction in AChR-ab serum levels, while maintaining antibody titers After 5 ICU admissions in 18 months, improvement in QMG score and mobility observed 0 62 Note. Named patient data. AChR-ab, acetylcholine receptor antibody; CAR, chimeric antigen receptor; ICU, intensive care unit; IgG, immunoglobulin G; QMG, quantitative myasthenia gravis; VZV, varicella-zoster virus. 1. Haghikia A, et al. Lancet Neurol. 2023;22:1104-1105

Denise – 1 Year Anniversary First KYV-101 autoimmune patient at 1 year Disease free No adverse events No background immunosuppressants or glucocorticoids B cells repopulated as of day 132 For detailed case description, see: Haghikia et al., Anti-CD19 CAR T Cells for Refractory Myasthenia Gravis, The Lancet J. of Neurology (Vol. 22 Dec. 2023) and Haghikia et al, “World’s First Successful Treatment of the Autoimmune Disease Myasthenia Gravis,” The Medical University Hospital Magdeburg A.o.R. (Nov. 2023).

Our Pipeline of CAR T-Cell Therapies for Autoimmune Diseases Technology Candidates Target Indication Discovery /Validation Preclinical ClinicalPhase 1 ClinicalPhase 2 Clinical Phase 3 Partnership /Commercial Rights Key Milestone Achieved CAR T KYV-101Rheumatology CD19 Lupus nephritis KYSA-1: IND cleared 11/22 Fast Track 05/23 KYSA-3: CTA cleared 06/23 Systemic sclerosis IND cleared 10/23 KYV-101Neurology CD19 Myasthenia gravis IND cleared 11/23 Fast Track 12/23 ODD 04/24 Multiple sclerosis IND cleared 12/23 Fast Track 01/24 CRISPR / Cas9Allogeneic KYV-201 CD19 Multiple indications CAR T & OtherApproaches Multiple Multiple IBD & other indications Phase 1/2 (US) Phase 1/2 (EU) Phase 1/2 (US) Phase 2 (US) Phase 2 (US) Note: IBD includes Crohn’s disease and ulcerative colitis. Note: Fast track designation does not assure that we will experience a faster development process, regulatory review or regulatory approval process compared to conventional FDA procedures. CAR, chimeric antigen receptor; CRISPR, clustered regularly interspaced short palindromic repeats; CTA, clinical trial application; FDA, Food and Drug Administration; IBD, inflammatory bowel disease; IND, investigational new drug; ODD, orphan drug designation.

Demonstrating the Transformative Impact of KYV-101 on Lupus Nephritis Disease Control Months Post Infusion KYV-101 infusion aPatient order based on time from CAR T infusion. bData Cutoff: May 24, 2024. Pred dose post-infusion listed as last reported dose after taper. 1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. Observations are derived from separate clinical settings and interim results. Future clinical trials may not confirm the observations discussed in these case reports and studies. Ani, anifrolomab; AZA, azathioprine; Bel, belimumab; CYC, cyclophosphamide; GC, glucocorticoids; HCQ, hydroxychloroquine; HCT, hydrocortisone; IS, immunosuppressive agent; Lef, leflunomide; M, million; MMF, mycophenolate mofetil; MTX, methotrexate; Obi, obinutuzumab; Pred, predniso(lo)ne; RTX, rituximab; Sir, sirolimus; Sol, solumedrol; Tac, tacrolimus; Voc, voclosporin. 0 3 9 No IS or GC No IS; Pred 10mg/d MMF -> BID, HCQ Pred 50mg/d No IS; Pred 5mg/d No IS or GC No IS; Pred 2.5mg/d No IS; Pred 5mg/d No IS; Pred 17.5mg/d Post KYV-101 Infusionb Patienta Prior IS CAR T-Cell Dose KYSA-1 Pt 1 RTX, AZA, CYC, Tac, MTX, Sir, Bel, MMF, Pred, HCQ 50 M KYSA-1 Pt 2 Sol, AZA, CYC, Bel, Voc, MMF, Pred, HCQ 50 M KYSA-3 Pt 4 CYC, Bel, MMF, Pred, HCQ 100 M KYSA-3 Pt 5 AZA, CYC, Bel, Ani, RTX, MTX, MMF, Pred, HCQ 100 M KYSA-1 Pt 3 CYC, Bel, Voc, Tac, RTX, Sol MMF, Pred, HCQ 50 M Named Pt 6 CYC, Bel, Ani, HCT, Lef, MMF, Pred 100 M Named Pt 7 MMF/Tac, RTX, Bel, Obi, GC 100 M 6

1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. ABS, absolute; CAR, chimeric antigen receptor. Early Lupus Nephritis Patient Data: Pharmacokinetics and B-Cell Count Days Post-Infusion Pharmacodynamic Activity and Return of B Cells Urine Protein Creatinine Ratio (UPCR) 200 Days Post-Infusion CAR Expansion Consistent With Oncology KYSA-1 Pt #1 (Colorado) KYSA-1 Pt #2 (Northwell) KYSA-3 Pt #1 (Erlangen) KYSA-1 Pt #3 (UPenn) 1 KYSA-3 Pt #2 (Erlangen)1 150 60 40 20 0 0 25 75 300 CAR T-Cell Count Cells/µL CD19 B-Cell Count Cells/µL 400 200 100 0 0 100 1000 1500 200 CD19 ABS, Trucount KYSA-1 Pt#1 KYSA-1 Pt#2 KYSA-1 Pt#3 KYSA-3 Pt#4 KYSA-3 Pt#5 Named Pt#6 Named Pt#7 KYV-101 CAR T Cells/µL KYSA-1 Pt#1 KYSA-1 Pt#2 KYSA-1 Pt#3 KYSA-3 Pt#4 KYSA-3 Pt#5 Named Pt#6 Named Pt#7 50

Improvement at 3 Months in Biomarkers and Overall Disease Activity Rapid decrease in anti-dsDNA antibodies in all subjects Normalization of complement components (C3/C4) Overall improvement in clinical disease activity Reduction in Autoantibodies (RIA) Days Post-Infusion Baseline Month 3 Complement C4 mg/dL Days Post-Infusion Complement C3 mg/dL Baseline Month 3 Complement C3 (mg/dL) KYSA-1 Pt#1 KYSA-1 Pt#2 KYSA-1 Pt#3 KYSA-3 Pt#4 KYSA-3 Pt#5 Complement C4 (mg/dL) Days Post-Infusion Baseline Month 3 KYSA-1 Pt#1 KYSA-1 Pt#2 KYSA-1 Pt#3 KYSA-3 Pt#4 KYSA-3 Pt#5 Named Pt#6 Named Pt#7 Anti-dsDNA IU/mL Normalization of Complement Anti-dsDNA (IU) 1. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. dsDNA, double-stranded deoxyribonucleic acid; IU, international units.

Wang et al.2 (iCell) Proteinuria Clinical Trial Experience and Case Reports High variability observed in the short term Months Post-Infusion Protein:Creatinine Ratio Urinary Protein Excretion Müller et al.1 (Erlangen) Days Post-Infusion Urine Protein Creatinine Ratio z Urine Protein Creatinine Ratio Urine Protein Creatinine Ratio Urine Protein Creatinine Ratio 10.0 5.0 2.5 0.5 0 100 200 Days Post-Infusion 7.5 KYV-101 1. Muller et al. N Engl J Med. 2024;390:687-700. 2. Wang et al. Ann Rheum Dis. 2024 May 30:ard-2024-225785. 3. Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. KYSA-1 Pt#1 KYSA-1 Pt#2 KYSA-1 Pt#3 KYSA-3 Pt#4 KYSA-3 Pt#5 Named Pt#6 Named Pt#7

Short-Term Disease Control in One Patient With Lupus Nephritis Promising safety profile Initial disease response Disease recurrence after 5 months Patient with high BMI and treated with 50M cells Low CAR exposure associated with initial response but disease recurrence Low CAR expansion at 50M cells Initial improvements in biomarkers and disease activity followed by recurrence of disease after 5 months Days Post-Infusion CAR T Cells/µL Number of CAR T Cells in Blood (/µL) Days Post-Infusion CAR T Cells/µL Early return of B cells at 50M cells CD19 ABS, Trucount Complement C3 mg/dL Days Post-Infusion Complement C3 (mg/dL) Complement C4 (mg/dL) Anti-dsDNA IU/mL Days Post-Infusion Days Post-Infusion Anti-dsDNA (IU) ELISA Complement C4 mg/dL KYSA-1 Pt1 BMI, body mass index; CAR, chimeric antigen receptor; ITP, immunothrombocytopenia.

Safety: CAR T Cell-Related Safety Events, If Encountered, Are Readily ManageableNo ≥ Grade 3 CRS or ICANS Observed aAdverse events report pending. Note: Time from infusion as of May 29, 2024 (days). Internal data from KYSA-1, KYSA-3, and investigator-reported named patient experience. AAV, ANCA-associated vasculitis; AE, autoimmune encephalitis; ASyS, antisynthetase syndrome; CIDP, chronic inflammatory demyelinating polyradiculoneuropathy; CRS, cytokine release syndrome; DE, DAGLA encephalitis; ICANS, immune effector cell-associated neurotoxicity syndrome; IgG4-RD, immunoglobulin G4-related disease; LEMS, Lambert-Eaton myasthenic syndrome; LN, lupus nephritis; MG, myasthenia gravis; MS, multiple sclerosis; RA, rheumatoid arthritis; SSc, systemic sclerosis; SPS, stiff person syndrome.

Published Case Reports – NeuronKYV-101 in Myasthenia Gravis AChR, acetylcholine receptor; CAR, chimeric antigen receptor; LEMS, Lambert-Eaton myasthenic syndrome; MG, myasthenia gravis; MG-ADL, MG activities of daily living scale. 1. Motte J, et al. Neuron 2024;112:1–7. Impact on Autoantibodies and MG-ADL disease score Activities of Daily Living (MG-ADL) Days After CAR T-cell Infusion Days Before Infusion Days After CAR T-cell Infusion AChR Antibody Titer

CAR, chimeric antigen receptor; CSF, cerebrospinal fluid; ICANS, immune effector cell-associated neurotoxicity syndrome; MS, multiple sclerosis; OCB, oligoclonal band. 1. Fischbach F, et al. Med. 2024;22:S2666-6340(24)00114-4. Published Case Reports – MED KYV-101 in Multiple Sclerosis Evidence of Biologic Activity by Demonstrated Decrease in OCBs Day 0 14 64

CAR T-Cell Therapy May Allow Complete Disease Control in a Treatment-Free Setting (Immune Reset) Moderate/Limited Chronic administration. (e.g. cycle Q24 weeks) Yes Concurrent Immunomodulation (e.g. MTX, GC) Improved in treatment-refractory patients Two cycles, on background MTX Continuous immunomodulation from week 16 onward (MTX/abatacept) Sustained over months Single infusion None Background immunosuppressants Dose Efficacy DEPTH B-Cell Depletion TIME Note: Bispecific antibody experience in autoimmunity and anti-CD19 CAR T in autoimmunity based on published case reports rather than clinical trials. CAR, chimeric antigen receptor; GC, glucocorticoids; MTX, methotrexate, Q24, every 24.1. RITUXAN® (rituximab) USPI, Biogen and Genentech USA, Inc. 2021. 2. Bucci L, et al. Nat Med. 2024;Apr 26. 3. Müller F, et al. N Engl J Med. 2024;390:687-700. Monoclonal antibodies Bispecificantibody case reports Anti-CD19CAR T case reports Ref: 3 Ref: 2 Ref: 1

Monoclonal antibodies Bispecificantibody case reports TREATMENT-FREE Anti-CD19CAR T case reports HOSPITALIZATION HOSPITALIZATION WEEKS 1 4 8 12 16 20 24 28 32 36 42 LD Conceptual Considerations for Various B-Cell Targeting Approaches Favor CAR T-Cell Therapy (Immune Reset) Dosing Short-term risk Long-term risk HOSPITALIZATION Background immunosuppression (IM) Note: Bispecific antibody experience in autoimmunity and anti-CD19 CAR T in autoimmunity based on published case reports rather than clinical trials; bispecific antibody experience adapted from Bucci L, et al. Nat Med. 2024;Apr 26.; anti-CD19 CAR T LD and hospitalization estimated from unpublished KYSA study protocols and internal data. Anti-CD19 CAR T treatment-free duration experience adapted from published case reports, including Müller F, et al. N Engl J Med. 2024;390:687-700. Monoclonal experience modeled on intravenous BENLYSTA (belimumab) Prescribing Information 2024. GlaxoSmithKline. CAR, chimeric antigen receptor; LD, lymphodepletion.

Over 50 patients have received the KYV-101 CAR construct The 30-patient experience in autoimmune diseases shows a promising safety profile, expected CAR T-cell expansion, and effective B-cell depletion There is reduction in autoantibodies and overall improvement of disease activity in the setting of immunosuppressant withdrawal The first patient treated has DIFR after 1 year These data support advancing a broad clinical trial program across a range of rheumatic and neurologic autoimmune diseases Conclusions CAR, chimeric antigen receptor; DIFR, durable immunomodulator-free response; LN, lupus nephritis.

Document And Entity Information	Jun. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 14, 2024
Entity Registrant Name	Kyverna Therapeutics, Inc.
Entity Central Index Key	0001994702
Entity Emerging Growth Company	true
Entity File Number	001-41947
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	83-1365441
Entity Address, Address Line One	5980 Horton St., STE 550
Entity Address, City or Town	Emeryville
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94608
City Area Code	(510)
Local Phone Number	925-2492
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.00001 per share
Trading Symbol	KYTX
Security Exchange Name	NASDAQ