KYTX Kyverna Therapeutics Inc

 

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): January 13, 2025

 

 

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

 

 

(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 January 13, 2025, Kyverna Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s strategic priorities for 2025 and certain anticipated milestones, which will be discussed during a presentation that will be made by the Company’s Chief Executive Officer, Warner Biddle, at the 43rd Annual J.P. Morgan Healthcare Conference (the “Conference”) at 5:15 p.m. Pacific Time on January 13, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the slides to be used in connection with the Company’s presentation at the Conference are furnished as Exhibit 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.

 

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 and Exhibit 99.2 attached hereto) shall not be deemed “filed” for 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release issued by Kyverna Therapeutics, Inc., dated January 13, 2025.
99.2		Kyverna Therapeutics, Inc. Presentation - Pioneering CAR T in Autoimmune Diseases, January 2025.
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: January 13, 2025	By:	/s/ Warner Biddle
		Name:	Warner Biddle
		Title:	Chief Executive Officer

 

 

Exhibit 99.1

 

Kyverna Therapeutics to Highlight Near-Term Strategic Priorities and Key Milestones at the

43^rd Annual J.P. Morgan Healthcare Conference

 

Extending Company’s leadership position in autoimmune CAR T with prioritized indication strategy; pivoting to late-stage development and commercialization

 

First-to-market opportunity with KYV-101 in stiff person syndrome; 40% enrolled in pivotal Phase 2 trial with first BLA filing targeted for 2026; fast-follow indications in

myasthenia gravis and lupus nephritis

 

Efficiently expanding into broader autoimmune indications and increasing patient reach with KYV-102 using whole blood rapid manufacturing

 

Cash runway into 2027 to deliver key milestones

 

EMERYVILLE, Calif., January 13, 2025 - Kyverna Therapeutics, Inc. (Kyverna, NASDAQ: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, announced it will present its 2025 strategic priorities and key milestones during a presentation that will be made by Chief Executive Officer, Warner Biddle, at the 43^rd Annual J.P. Morgan Healthcare Conference today, Monday, January 13, 2025.

 

“2025 will be a transformational year for Kyverna as we accelerate our next wave of growth and pivot to late-stage development and commercialization with our differentiated CD19 CAR T construct, KYV-101,” said Warner Biddle, Chief Executive Officer, Kyverna. “Building upon our leadership position, we have sharpened our focus and execution on a prioritized set of opportunities – stiff person syndrome, myasthenia gravis and lupus nephritis – each with a clear and rapid path to market, where we can deliver a profound patient impact. Importantly, these indications serve as a beachhead to other neuroinflammatory and rheumatologic diseases, which we will continue to pursue in a capital-efficient manner alongside next-generation innovations, starting with KYV-102, designed to broaden access to CAR T.”

 

Mr. Biddle added, “We are pleased with our clinical progress to date, having 40% of patients enrolled in KYSA-8, our pivotal KYV-101 Phase 2 trial in stiff person syndrome, which enables us to target a BLA filing in 2026 and puts us on track to deliver the first approved CAR T therapy in an autoimmune disease. Our fast-follow indication, myasthenia gravis, has already enrolled patients in a company-sponsored trial, KYSA-6, and we expect to report interim Phase 2 data in the second half of 2025.”

 

Strategic priorities for the upcoming year include:

 

●

Focused execution on company-sponsored KYSA studies evaluating KYV-101 in priority indications that offer a clear and rapid path to market. This includes advancing ongoing clinical studies in stiff person syndrome (KYSA-8), myasthenia gravis (KYSA-6), and lupus nephritis (KYSA-1 and KYSA-3).

 

 

●

Continue regulatory interactions leveraging the U.S. Food and Drug Administration’s Regenerative Medicine Advanced Therapy and Orphan Drug designations for stiff person syndrome and myasthenia gravis.

 

●

Evaluate additional opportunities in a capital-efficient manner, harnessing investigator-initiated trials (IITs) and other KYSA studies – including multiple sclerosis, systemic sclerosis, and others – to inform the next priority indications for the Company to advance into late-stage development.

 

●

Advance next-generation innovations, including KYV-102, incorporating the Company’s whole-blood rapid manufacturing approach, which aims to improve the CAR T patient experience, eliminate apheresis and ultimately broaden CAR T access.

 

Anticipated Milestones:

 

Based on these strategic priorities, Kyverna has issued the following guidance on upcoming program milestones:

 

●

Stiff Person Syndrome:

 

o

Complete pivotal Phase 2 enrollment mid-2025

 

o

Report topline pivotal Phase 2 data 1H 2026

 

o

BLA filing in 2026

 

●

Myasthenia Gravis:

 

o

Confirm registrational path with regulators 1H 2025

 

o

Report interim Phase 2 data 2H 2025

 

●

Lupus Nephritis:

 

o

Report Phase 1 data 2H 2025

 

●

Future pipeline:

 

o

File KYV-102 investigational new drug application 2H 2025

 

The Company has a cash runway into 2027 to deliver on these key inflection points, with $321.6 million of cash, cash equivalents, and marketable securities as of September 30, 2024.

 

Presentation at the J.P. Morgan Healthcare Conference 

 

Warner Biddle will present a company overview at the 43^rd Annual J.P. Morgan Healthcare Conference today, January 13, 2025, at 5:15 PM PT. A live webcast of the presentation will be available on the Investors section of Kyverna’s website, www.kyvernatx.com. A replay of the webcast will be available on Kyverna’s website for approximately 30 days following the conference.

 

About KYV-101 

 

Uniquely designed, KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate with highly potent CD28 co-stimulation and designed for tolerability, which is under investigation for B-cell-driven autoimmune diseases. With KYV-101, Kyverna is pioneering a durable disease-clearing approach aiming for deep B cell depletion, an immune system reset, and long-term remission in autoimmune diseases.

 

It is currently being evaluated in company sponsored, open-label, Phase 2 trials in stiff person syndrome and myasthenia gravis and Phase 1/2 trials for lupus nephritis, as well as in investigator-initiated trials and company-sponsored trials for multiple indications. The clinical experience to date with KYV-101 highlights the potential for transformative clinical outcomes in autoimmune patients.  

 

 

About KYV-102

 

KYV-102 leverages the same fully human, clinically validated CD19 CAR-T construct as KYV-101.  It incorporates the Ingenui-T platform, a proprietary, next-generation process that utilizes whole blood with a rapid manufacturing approach. 

 

Kyverna intends to broaden CAR T patient access with KYV-102 by eliminating the need for apheresis starting material and reducing the manufacturing turnaround time from conventionally manufactured CAR T products.  

 

About Kyverna Therapeutics 

 

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna’s lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with Phase 2 trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing investigator-initiated trials and other KYSA studies, including in multiple sclerosis and systemic sclerosis, to inform the next priority indications for the Company to advance into late-stage development.  Its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.  For more information, please visit https://kyvernatx.com. 

 

Forward-Looking Statements  

 

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s strategic priorities and focus; the status of its Phase 2 trial in stiff person syndrome as a pivotal trial; the potential for KYV-101 to be the first-to-market in stiff person syndrome or the first approved CAR T therapy in autoimmune; the potential for KYV-102 to shorten the manufacturing process and increase patient reach and CAR T access; anticipated milestones and timing thereof, including anticipated timing for the first intended BLA submission for KYV-101 and timing for reporting data as well as expected completion of enrollments; Kyverna’s anticipated cash runway; and Kyverna’s clinical trials, investigator initiated trials and named-patient activities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that the FDA or other regulatory agencies may conclude that Kyverna’s Phase 2 trial in stiff person syndrome is not sufficient to be registration-enabling and may require additional trials or studies to support its intended BLA submission; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.  

 

Contact: 

 

Investors: InvestorRelations@kyvernatx.com 
Media: media@kyvernatx.com 

 

 

3

 

Exhibit 99.2

 

Cindy Patient warrior Pioneering CAR T in Autoimmune Diseases January 2025 Exhibit 99.2

2 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 conta ine d 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 an d financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies and named patient activities, ong oin g 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 futu re 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 rece nt 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 c ould differ materially and adversely from those anticipated or implied in the forward - looking statements. When evaluating Kyverna’s business and prospects, careful consideratio n 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 the se statements. This presentation also contains estimates made by independent parties relating to industry market size and other data. These est imates 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 an d 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 licenso r w ill 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 na mes, 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 trial s f or KYV - 101 and data from investigator - initiated trials and named patient activities are reported by the relevant investigators and physicians. Such data are not obtained using a single pr otocol 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 activities as the b asi s for approval in our applications for marketing approval to the U.S. Food and Drug Administration (FDA) or other foreign regulatory agencies, we believe that this strategy m ay provide additional clinical insights beyond highly focused clinical trials in specific geographies. ​ Throughout this presentation, the Company refers to its Phase 2 trial in stiff person syndrome as a pivotal trial; however, t he FDA or other regulatory agencies may conclude that the trial is not sufficient to be registration - enabling, and the Company may be required to conduct additional trials or studies to support a Biologics License Application. Disclaimer and Forward - Looking Statements

3 LIBERATING AUTOIM MUNE PATIENTS through the CURATIVE POTENTIAL OF CELL THERAPY Robert, Patient warrior Cindy, Patient warrior Roger, Patient warrior Bryce, Patient warrior

4 2025: Kyverna’s Transformative Year with Multiple Near - Term Catalysts Pivoting to Late - Stage Development and Commercialization FAST FOLLOW Accelerating MG and LN Phase 1 LN data and interim Phase 2 MG dat a expected in 2H 2025 FURTHER Expand into Broader Autoimmune Indications KYV - 102 IND filing targeted in 2H 2025 Deliver FIRST Autoimmune CAR T in Neuro SPS, Stiff Person Syndrome; MG, Myasthenia Gravis; LN, Lupus Nephritis BLA, Biologics License Application; IND, Investigational New Drug Application Cash runway into 2027 to deliver key inflection points 40% enrolled in pivotal Phase 2 SPS trial; BLA targeted in 2026

5 Manufacturing Excellence and Innovation Unique CAR T Construct RMAT, Regenerative Medicine Advanced Therapy; ODD, Orphan Drug Designation

6 Prioritized Portfolio Unlocks Significant Opportunities across Neuroinflammatory and Rheumatologic Diseases Stiff person Syndrome Myasthenia Gravis Lupus Nephritis SPS is the tip of the spear… Future Potential Indications 1) Published literature through GlobalData market analysis reports and internal data 2022 NMOSD, neuromyelitis optica spectrum disorder; CIDP, chronic inflammatory demyelinating polyradiculoneuropathy; ANCA, antineu tro phil cytoplasmic antibody Leveraging IITs and KYSA studies Systemic sclerosis Multiple sclerosis Rheumatoid arthritis NMOSD ANCA - associated vasculitis CIDP And others… ~8.3 Million Patients ESTIMATED TOTAL MARKET OPPORTUNITY 1

7 RMAT designation and potential for 1 st CAR T approved in autoimmune Pivotal Phase 2 is 40% enrolled with registrational intent No currently approved therapies High chronic cost burden Source for market size: Analysis of Komodo Health claims data; Yi J, et al. Neurol. Neuroimmunol. Neuroinflamm. (2022); Dalak as MC. Neurol. Neuroimmunol. Neuroinflamm. (2023) IVIG, Intravenous immunoglobulin therapy Stiff Person Syndrome: Deliver Pivotal Phase 2 Study, Prepare for BLA Filing Initial CAR T Addressable Market (US): On IVIG (off label) 1,500 – 2,500 IVIG Failure 400 – 700 Total Addressable Market (US): 2,000 – 6,000 Global Market (US, EU, Japan): 9,000

8 Previously presented at ECTRIMS KYV - 101 in SPS: Demonstrates Strong Clinical Activity and Potential for Deep Responses Kyverna Experience at Therapeutic Dose in Initial 3 Patients *Data on walking speed available for 2 of 3 patients . † Data shown for immunosuppressant and immunomodulatory agents only; does not include physiologic replacement steroids ≤7.5 mg/ day . Note: named patient data KYV - 101 therapeutic dose is 1 × 10 8 CAR T cells/ μ L. Data cutoff October 31, 2024. Reference: Updated from Kyverna Symposium at ECTRIMS, September 18, 2024. Copenhagen, Denmark. 0 1000 2000 3000 180 150 120 90 60 30 BL Anti - GAD65 (n=2) Anti - glycineR (n=1) 150 200 250 100 50 0 Elimination of Immunosuppressants † Improvement in Mobility* Reduction of Autoantibody Titers Days post - infusion Days post - infusion Mean anti - GAD65 titer, 1:x unit (SEM) Mean walking speed, m/s (SEM) Mean no. of immunosuppressants (SEM) Mean anti - glycineR titer, 1:x unit (SEM) 0 0.5 1.0 1.5 180 150 120 90 60 30 BL 0 6 0 8 After KYV - 101 Before KYV - 101 2 4

9 Myasthenia Gravis: Fast Follow Indication, Significant Unmet Need RMAT designation with fast follow intent Phase 2 actively enrolling and dosing patients Synergistic commercial infrastructure to SPS Available therapies remain suboptimal with significant cost burden Source for market size: Analysis of Komodo Health claims data; GlobalData MG Forecast 2022; Bubuioc A, et al. J. Med. Life. ( 202 1); ICER MG Report 2021; Oosterhuis HJ. J. Neurol. Neurosurgeon. Psichiatry. (1989); ADAPT trial data Initial CAR - T Addressable Market (US): 30,000 – 40,000 Total Addressable Market (US): 80, 000 – 100, 000 Global Market (US, EU, Japan): 160,000

10 Previously presented at ECTRIMS KYV - 101 in MG: Has Demonstrated Rapid and Sustained Disease Control Kyverna Experience at Therapeutic Dose in Initial 3 Patients 0 2 4 6 180 150 120 90 60 30 BL *Data shown for immunosuppressant and immunomodulatory agents only; does not include physiologic replacement steroids ≤7.5 mg /da y. Note: named patient data. KYV - 101 therapeutic dose is 1 × 10 8 CAR T cells/ μ L. Data cutoff October 31, 2024. Reference: Updated from Kyverna Symposium at ECTRIMS, September 18, 2024. Copenhagen, Denmark. Elimination of Immunosuppressants* Improvement in Muscle Function Days post - infusion Days post - infusion Mean anti - AChr titer, nmol/L (SEM) Mean MG - ADL score (SEM) Mean no. of immunosuppressants (SEM) 0 2 6 8 180 150 120 90 60 30 BL 4 0 1 5 6 After KYV - 101 Before KYV - 101 2 4 3 0 Reduction of Autoantibody Titers

11 Lupus Nephritis: High Burden of Disease Progression Source for market size: GlobalData SLE Forecast 2021; Hocaoglu M, et al. Arthritis Rheumatol. (2023) (LUMEN Study); Helmick C G, et al. Arthritis & Rheumatism. (2008); Gasparotto M, et al. Rheumatology. (2020) Source for ESRD progression: Lateef A, Petri M. Arthritis Res Ther. 2012;14(Suppl 4):S4 Focused approach to address highest value patients in LN Provides path to Rheumatology Completion of Phase 1 enrollment expected 1H 202 5 High chronic cost of care with up to 30% of LN patients developing end stage renal disease Initial CAR - T Addressable Market (US): 15,000 – 40,000 Total Addressable Market (US): 70, 000 – 100, 000 Global Market (US, EU, Japan): 160,000

12 Previously presented at ACR Convergence KYV - 101 in LN: Redefining Clinical Success and Delivering First CAR T Rheumatology Indication Kyverna Experience at Therapeutic Dose in Initial 4 Patients Median anti - dsDNA titer, IU/mL (SE) *Data shown for immunosuppressant and immunomodulatory agents only; does not include physiologic replacement steroids ≤7.5 mg /da y; † Baseline is day 0 - 14 for UPCR. Note: named patient and KYSA study data; UPCR, urine protein creatinine ratio; EGFR, estimated glomerular filtration rate. KYV - 101 therapeutic dose is 1 × 10 8 CAR T cells/ μ L. Data cutoff October 31, 2024. Reference: Kyverna Symposium at ACR Convergence, November 18, 2024. Washington, DC. 0 100 200 180 150 120 90 60 30 BL Days post - infusion Median eGFR, mL/min/1.73 m 2 (SE) Days post - infusion Median no. of immunosuppressants (SE) 0 1 5 6 After KYV - 101 Before KYV - 101 2 4 3 0 Elimination of Immunosuppressants* Stabilization of Kidney Function Reduction of Autoantibody Titers Median UPCR (SE) 180 120 90 30 BL † 50 60 90 100 70 80 0 1 4 5 2 3 UPCR EGFR

13 KYV - 101: Driving Durable Remissions at Therapeutic Dose Note: named patient data. KYV - 101 therapeutic dose is 1 × 10 8 CAR T cells/ μ L. References: 1. Haghikia A, et al. Lancet Neurol. 2023;22:1104 - 5. 2. Unpublished data. 3. Faissner S, et al. PNAS. 2024;21:e24032 27121. 4. Kyverna Symposium. ACR Convergence. November 18, 2024. Washington, DC. Free of active disease and off immunosuppressants and glucocorticoids First MG patient > >19 months 1,2 First LN patient >12 months 2,4 First SPS patient >15 months 2,3

14 Uncontrollable Myasthenia Gravis Recurrent Flares Frequent Hospitalizations Intubations Tracheostomy Feeding Tube Denise, MG Warrior

15 Dosed with KYV - 101

16

17 Reimagining the Next Generation of CAR T Patient Delivery with KYV - 102 No Apheresis, Reduces Costs, Improves Patient Access KYV - 102 KYV - 101 Begins with apheresis Begins with whole blood – no need for apheresis 7 - 10 day culture time <3 - day culture time TARGETED BENEFITS • Improve patient accessibility • Reduce manufacturing turnaround time and costs • Unlock system capacity • Support expansion into new indications and patient populations • Proprietary process Ingenui - T Process Unlocking Additional Patient Value with KYV - 102

18 Regulatory Milestone Phase 3* Phase 2 Phase 1 Preclinical Candidate Indication RMAT, ODD KYV - 101 Stiff person syndrome RMAT, ODD**, FTD KYV - 101 Myasthenia gravis FTD KYV - 101 Lupus nephritis KYV - 102 Whole Blood Next - Gen Process *Phase 3 may not be required if Phase 2 is registrational Fast track designation does not assure that we will experience a faster development process, regulatory review or regulatory app roval process compared to conventional FDA procedures. ODD, orphan drug designation; FTD, Fast Track Designation **EU & US KYSA - 8 KYSA - 6 KYSA - 1 & KYSA - 3 Focused 2025 Pipeline Priorities Opportunities to Expand into Additional Indications 2025 Priorities FTD KYV - 101 Multiple Sclerosis ODD KYV - 101 Systemic Sclerosis KYV - 101 Multiple Indications KYV - 201 Allogeneic KYSA - 7, IITs KYSA - 5 IITs Future Opportunities RMAT, Regenerative Medicine Advanced Therapy; ODD, Orphan Drug Designation; FTD, Fast Track Designation

19 KYV - 101: Uniquely Designed for Autoimmune Diseases KYV - 101 Fully Human Design Anti - CD19 scFv CD8 α TM CD28 Costim CD3 ζ C D8 α Hinge Designed for POTENCY • Differentiated CD19 with highly potent CD28 costimulation • Deep B - cell depletion and immune reset Delivering TRANSFORMATIVE CLINICAL OUTCOMES • “One and Done” • Potential for outpatient administration Engineered for SAFETY • Fully human design • No high - grade CRS or ICANS observed

20 KYV - 101 is a Fundamentally Different Approach Goals of KYV - 101 DEEP B CELL DEPLETION and IMMUNE RESET ELIMINATION of chronic therapy % SINGLE administration 1 Transformative outcomes with CURATIVE POTENTIAL Disease Modification Aim to slow or stop progression Aim for long - term remission with curative potential Time

21 Near - Term Milestones to Drive Value Creation Milestones Program Complete Pivotal Phase 2 Enrollment mid - 2025 Report Topline Pivotal Phase 2 Data 1H 2026 BLA filing in 2026 Stiff Person Syndrome RMAT Designation Confirm Registrational Path with Regulators 1H 2025 Report Interim Phase 2 Data 2H 2025 Myasthenia Gravis RMAT Designation Report Phase 1 Data 2H 2025 Lupus Nephritis File KYV - 102 IND application 2H 2025 Future Pipeline Cash Runway into 2027 Enables Achievement of Key Inflection Points

22 2025 Priorities to Rapidly Deliver KYV - 101 to Market Transformative year to support late - stage development and commercialization of KYV - 101 On track to deliver the FIRS T autoimmune CAR T approved in neuroinflammatory disease with SPS BLA filing targeted for 2026 FAST - follow indications in MG and LN Broaden patient access and FURTHER unlock larger opportunities through next - generation approaches, including KYV - 102 Cash runway into 2027 to deliver key milestones

Roger Patient warrior Appendix

24 Anti - CD19 CAR T therapy deeply depletes B cells in blood and tissues and disrupts B cell follicular architecture, with the aim of triggering an immune reset Tur C, et al. Ann Rheum Dis. 2024 Sep 11;0:1 – 8:ard - 2024 - 226142. Before Treatment CD19+ Significant Reduction in B Cell Architecture using CD - 19 CAR - 2 Untreated After CD19 CAR T 0 2 4 6 8 10 B - Compartment Architecture Score (0 - 9) After Rituximab P = 0.007 H&E Rituximab ( α CD20) Treatment Incomplete Tissue Depletion of B - cells Many B - cells are in the Tissues Targeting the Underlying Mechanism of Disease with CAR T CD19 CAR T - Cell Treatment Deep Tissue Depletion of B - cells

25 KYSA Trials Position KYV - 101 on Rapid Path to Market in Priority Indications Lupus Nephritis Myasthenia Gravis Stiff Person Syndrome KYSA - 1 & KYSA - 3 KYSA - 6 KYSA - 8 Study Name US & EU US & EU US Location Phase 1 Phase 2 Phase 2 Study Phase NCT05938725 & NCT 06342960 NCT06193889 NCT06588491 NCT 9 Patients 20 Patients 25 Patients Anticipated Enrollment Safety and tolerability MG - ADL at 24 weeks Change in T25FW at 16 weeks Primary Endpoints Evaluate efficacy PK/PD of KYV - 101 QMG score, MGC composite score Stiffness index at 16 weeks, Hauser ambulation index 2nd Endpoints

26 Kyverna’s Leading Patient Experience with KYV - 101 Across diverse indications treated with KYV - 101 1 50+ Autoimmune Patients 15+ Autoimmune Indications • Stiff person syndrome • Myasthenia gravis • Multiple sclerosis • NMOSD • CIDP • Rheumatoid arthritis • Systemic sclerosis • Lupus nephritis • ANCA - associated vasculitis • And others 1) as of October 31, 2024. Broad indication experience builds market opportunity with KYV - 101

27 Initially Focused on Three Indications with High Unmet Need; Potential for KYV - 101 to Deliver Differentiated Benefit Significant area of Unmet need Transformative outcomes in established market Lead indication, establishes commercial infrastructure 70,000 – 100,000 80,000 – 100,000 2,000 - 6,000 Total addressable US market 15,000 – 40,000 30,000 – 40,000 1,500 - 2,500 (IVIG treated) or 400 - 700 (IVIG failure) Initial CAR T addressable US market • Focused approach to address highest value patients in LN • Provides path to Rheumatology • RMAT designation with fast - follow intent • Synergistic commercial infrastructure to SPS • RMAT designation • Potential for 1 st CAR T approved in autoimmune Strategic rationale RMAT RMAT MG SPS LN SPS market size source: Analysis of Komodo Health claims data; Yi J, et al. Neurol. Neuroimmunol. Neuroinflamm. (2022); Dalak as MC. Neurol. Neuroimmunol. Neuroinflamm. (2023) MG market size source: Analysis of Komodo Health claims data; GlobalData MG Forecast 2022; Bubuioc A, et al. J. Med. Life. (2 021 ); ICER MG Report 2021; Oosterhuis HJ. J. Neurol. Neurosurgeon. Psichiatry. (1989); ADAPT trial data LN market size source: GlobalData SLE Forecast 2021; Hocaoglu M, et al. Arthritis Rheumatol. (2023) (LUMEN Study); Helmick CG , e t al. Arthritis & Rheumatism. (2008); Gasparotto M, et al. Rheumatology. (2020)

28 Cara Bauer Chief Human Resources Officer Proven Leadership Team with Significant CAR T and Autoimmune Experience Dominic Borie, MD, PhD President, Research and Development Karen Walker Chief Technology Officer Ryan Jones, MBA Chief Financial Officer Tom Van Blarcom, PhD Senior Vice President and Head of Research Benjamin Dewees, RAC Vice President of Global Regulatory Affairs Warner Biddle Chief Executive Officer Sham Dholakia, MD Chief Product Officer Dan Maziasz Chief Business Officer Tracy Rossin Senior Vice President, Corporate Affairs, Communications and Investor Relations Board of Directors Leadership Team Ian Clark Chairperson and Independent Director Mert Aktar Independent Director Warner Biddle Chief Executive Officer Fred Cohen, MD Independent Director Steve Liapis, PhD Independent Director Beth Seidenberg, MD Independent Director Christi Shaw Independent Director Dan Spiegelman Independent Director

29 Strong Financial Position to Deliver Key Milestones Cash, cash equivalents and marketable securities (as of Sep 30, 2024) ~43M Shares Outstanding (as of Oct 31, 2024) ~$ 321.6M ~$24.6M Q3 Operating Cash Burn (3 months ended Sep 30, 2024)

v3.24.4

Cover	Jan. 13, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 13, 2025
Entity File Number	001-41947
Entity Registrant Name	Kyverna Therapeutics, Inc.
Entity Central Index Key	0001994702
Entity Tax Identification Number	83-1365441
Entity Incorporation, State or Country Code	DE
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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.00001 per share
Trading Symbol	KYTX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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