Kyverna Therapeutics (NASDAQ: KYTX) reports Phase 2 KYSA-8 CAR T data

Rhea-AI Filing Summary

Kyverna Therapeutics reported positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel, formerly KYV-101), a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome.

The company also stated it will host a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the results, and made a detailed press release available describing the KYSA-8 data and its implications for the miv-cel program.

Positive

• Positive topline data from KYSA-8, a registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel) in stiff person syndrome, was announced.

Negative

• None.

Insights

Biotech clinical-stage analyst

Positive registrational Phase 2 topline data marks an important milestone for Kyverna’s miv-cel CAR T program in stiff person syndrome.

Kyverna Therapeutics disclosed positive topline data from KYSA-8, described as a registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel) in stiff person syndrome. The therapy is characterized as a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation, highlighting a differentiated cell therapy approach for this indication.

Calling KYSA-8 a registrational Phase 2 study suggests the company views these results as central to potential future regulatory interactions for miv-cel. While specific efficacy or safety metrics are not detailed in this disclosure, the phrase “positive topline data” indicates that key predefined outcomes were met in a way the company considers favorable.

Kyverna plans a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the KYSA-8 results, alongside a full press release dated December 15, 2025. Further details from that release will clarify the magnitude of benefit, safety profile, and how the company intends to use these data in future development and regulatory plans for miv-cel.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

false 0001994702 0001994702 2025-12-15 2025-12-15

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): December 15, 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., Suite 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 December 15, 2025, Kyverna Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel, formerly KYV-101), a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome. The Company will host a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the results. 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.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 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 December 15, 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: December 15, 2025				By:		/s/ Marc Grasso, M.D.
						Marc Grasso, M.D. Chief Financial Officer

FAQ

What did Kyverna Therapeutics (KYTX) announce about the KYSA-8 trial?

Kyverna Therapeutics announced positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel, formerly KYV-101), in stiff person syndrome.

What is mivocabtagene autoleucel (miv-cel) in Kyverna Therapeutics' KYSA-8 study?

Mivocabtagene autoleucel (miv-cel, formerly KYV-101) is described as a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation being studied in the KYSA-8 Phase 2 trial.

Which condition is targeted in Kyverna Therapeutics' KYSA-8 Phase 2 trial?

The KYSA-8 registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel) targets stiff person syndrome.

When will Kyverna Therapeutics discuss the KYSA-8 topline results?

Kyverna Therapeutics plans to review the KYSA-8 results on a conference call at 8:00 a.m. Eastern Time on December 15, 2025.

Where can investors find more details on Kyverna Therapeutics' KYSA-8 data?

More details are provided in a press release dated December 15, 2025, identified as Exhibit 99.1, which discusses the positive topline data from the KYSA-8 trial.

How does Kyverna describe the development stage of KYSA-8?

Kyverna describes KYSA-8 as a registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel), indicating its importance within the development program.