Kyverna Therapeutics (NASDAQ: KYTX) reports positive KYSA-8 topline data

Rhea-AI Filing Summary

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

The company is hosting a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the results and has provided an investor slide presentation as Exhibit 99.1, which is furnished rather than filed under federal securities law provisions.

Positive

• Positive topline results from KYSA-8, a registrational Phase 2 trial of mivocabtagene autoleucel in stiff person syndrome, advancing Kyvernas CD19 CAR T-cell therapy program.

Negative

• None.

Insights

Biotech equity analyst

Positive topline registrational Phase 2 data is a key clinical milestone for Kyvernas CAR T program.

Kyverna Therapeutics reports positive topline data from KYSA-8, described as a registrational Phase 2 trial of mivocabtagene autoleucel in stiff person syndrome. As an autologous CD19 CAR T-cell therapy with CD28 co-stimulation, miv-cel targets B-cell biology using a modality that has been important in other hematologic settings.

For a development-stage biotech, positive topline data from a registrational trial can materially influence perceptions of a programs potential and the companys value proposition, even though detailed efficacy and safety metrics are not included here. The accompanying press release and Exhibit 99.1 presentation, referenced for the December 15, 2025 conference call, will provide the granular results that determine how strong this dataset appears relative to clinical expectations.

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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 (the “Conference Call”). A copy of the slides to be used in connection with the Conference Call 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		Kyverna Therapeutics, Inc. Presentation - Topline Data -KYSA-8 Registrational Phase 2 Trial of Miv-Cel (KYV-101) in Stiff Person Syndrome (SPS), 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 on December 15, 2025?

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 the KYSA-8 trial mentioned by Kyverna Therapeutics (KYTX)?

KYSA-8 is described as a registrational Phase 2 trial evaluating mivocabtagene autoleucel, a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome.

When is Kyverna Therapeutics conference call to discuss the KYSA-8 topline data?

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

What materials about the KYSA-8 results did Kyverna Therapeutics provide to investors?

Kyverna furnished an investor slide deck as Exhibit 99.1, titled "Presentation - Topline Data - KYSA-8 Registrational Phase 2 Trial of Miv-Cel (KYV-101) in Stiff Person Syndrome (SPS), December 15, 2025."

Is the KYSA-8 topline data information considered fixed or filed under U.S. securities laws?

The company states that the information in Item 7.01, including Exhibit 99.1, is furnished and not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, and is not incorporated into other filings unless specifically referenced.