株探米国株
英語
エドガーで原本を確認する
0001994702false00019947022025-11-022025-11-02

 

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):

 

 

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 1.01 Entry into a Material Definitive Agreement.

On October 31, 2025, Kyverna Therapeutics, Inc. (the “Company”) entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Oxford Finance LLC, as collateral agent (in such capacity, the “Collateral Agent”), and certain lenders from time to time party thereto. The Loan and Security Agreement provides a non-dilutive term loan facility (the “Loan Facility”) up to an aggregate principal amount of up to $150.0 million in multiple tranches, subject to certain conditions.

 

The Loan Facility includes an initial tranche of $40.0 million and two additional tranches totaling $60.0 million, subject to the satisfaction of certain terms and conditions of the Loan and Security Agreement. A fourth tranche of $50.0 million may also be made available subject to the Collateral Agent’s discretion. The Company expects to draw $25.0 million from funds available from the first tranche on November 3, 2025. The Loan Facility matures on October 1, 2030.

 

The Loan Facility bears interest at a floating per annum rate equal to (a) the greater of (i) the 1-Month CME Term SOFR and (ii) 3.75% plus (b) 5.00%. The Company is required to make monthly payments of interest only until November 1, 2028 or, at the Company’s option subject to the achievement of certain milestones, until November 1, 2029, after which monthly payments of principal and interest will be due.

The Loan and Security Agreement includes events of default, which, if triggered, could result in, among other things, the acceleration of the Company’s repayment obligations. Pursuant to the Loan and Security Agreement, the Company granted the Collateral Agent a security interest in substantially all of its assets, including its intellectual property.

The foregoing description of the Loan and Security Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Loan and Security Agreement, which will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2025 and is incorporated herein by reference.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth under Item 1.01 of this Current Report on Form 8-K regarding the Loan and Security Agreement is incorporated by reference herein.

Item 7.01 Regulation FD Disclosure.

On November 3, 2025, the Company issued a press release announcing the closing of the Loan Facility pursuant to the Loan and Security Agreement and that the Company now expects to report topline registrational data for its Phase 2 trial for KYV-101 for stiff person syndrome in early 2026. 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.

 

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties, including, but not limited to, statements related to the expected timing for drawing on funds from the first tranche of the Loan Facility and the expected timing for reporting topline registrational data for the Company’s Phase 2 trial for KYV-101 for stiff person syndrome. Except for the factual statements made herein, information contained in this Current Report on Form 8-K consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that are difficult to predict. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. Reference is also made to other factors detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The forward-looking statements contained in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K and the Company assumes no obligation to publicly update any forward-looking statements to reflect changes in information, events or circumstances after the date of this Current Report on Form 8-K, unless required by law.

Item 9.01 Financial Statements and Exhibits.

d) Exhibits

Exhibit

Number

Description


99.1

Press Release issued by Kyverna Therapeutics, Inc., dated November 3, 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:

November 3, 2025

By:

/s/ Marc Grasso

 

 

 

Marc Grasso
Chief Financial Officer

 


EX-99.1 2 kytx-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

Kyverna Therapeutics Secures up to $150 Million in Non-Dilutive Financing from

Oxford Finance

Initial funding of $25 million from the first of four tranches

Facility strengthens Kyverna’s financial flexibility, further supporting advancement of its late-stage indications in generalized myasthenia gravis (gMG) and stiff person syndrome (SPS), while also accelerating pre-launch activities

Topline data readout of registrational Phase 2 SPS trial now expected in early 2026; narrowed from previous guidance of first half 2026

EMERYVILLE, Calif., November 3, 2025 - Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyverna”), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that, on October 31, 2025, it closed a loan facility with Oxford Finance LLC ("Oxford Finance") for up to $150 million in non-dilutive capital. The Company will initially be drawing $25 million under the facility on November 3, 2025, with additional tranches available based on the achievement of key clinical and commercial milestones aligned with Kyverna’s growth strategy and funding needs.

“We are pleased to partner with Oxford Finance on a strategic, non-dilutive financing agreement with attractive terms that strengthen our financial flexibility,” said Warner Biddle, Chief Executive Officer of Kyverna. “This facility further supports the rapid progress across our late-stage programs, including in myasthenia gravis, where we look forward to initiating enrollment in our Phase 3 registrational trial by the end of this year following positive interim Phase 2 trial data, and in stiff person syndrome, in which we are tracking ahead of schedule to report topline registrational results early next year.”

“Kyverna is uniquely positioned to potentially become the first company to deliver an approved CAR T-cell therapy for an autoimmune disease and we’re proud to be partnering with this outstanding team to advance that mission,” said Kirk Andrews, Managing Director of Oxford Finance. “This investment reflects Kyverna’s continued strong execution on their strategy and the promising potential of KYV-101, as consistently demonstrated in treated patients across multiple autoimmune indications, including most recently in generalized myasthenia gravis.”

The $150 million loan facility includes an initial tranche of $40 million and two additional tranches totaling $60 million, subject to the satisfaction of certain terms and conditions of the loan and security agreement. A fourth tranche of $50 million may also be made available subject to Oxford Finance’s discretion. Kyverna will be drawing $25 million from funds available from the first tranche on November 3, 2025. The facility matures on October 1, 2030.

At the closing of the loan facility, Kyverna continues to expect to have cash runway into 2027, supporting its BLA filing for SPS and its MG Phase 3 trial, while also accelerating pre-launch activities.


 

 

Anticipated Milestones

Kyverna has issued the following guidance on upcoming program milestones:

SPS:
o
Report topline registrational data in early 2026
o
BLA filing in 1H 2026
MG:
o
Initiate enrollment for registrational Phase 3 trial by year-end 2025
o
Report updated data for the Phase 2 portion of KYSA-6 Phase 2/3 trial data in 2026
Additional Indications:
o
Lupis Nephritis: Report Phase 1 data in a peer-reviewed publication in 2026
Future Pipeline:
o
File IND application in Q4 2025 for KYV-102, Kyverna's whole blood rapid manufacturing process

 

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 late-stage clinical development with registrational 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 other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com.

 

About Oxford Finance LLC

Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private companies operating in a variety of industries worldwide. For over 20 years, Oxford Finance has delivered flexible financing solutions to over 700 companies, allowing borrowers to maximize their equity by leveraging their assets. Since 2002, Oxford Finance has originated more than $14 billion in loans. Oxford Finance is headquartered in Alexandria, Virginia, with additional offices serving the greater San Diego, San Francisco, Boston and New York City metropolitan areas. For more information, visit https://oxfordfinance.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: the potential for Kyverna to draw down additional tranches under the loan facility and Kyverna’s ability to achieve clinical and commercial milestones and commercial revenue targets; the expected timing for drawing on an initial $25 million of funding under the loan facility; the estimated or anticipated future results and benefits of the loan facility and use of proceeds therefrom; Kyverna’s financial flexibility, funding needs and anticipated cash runway; Kyverna’s strategic priorities and focus and anticipation of continued momentum in the execution of its clinical and regulatory strategy; Kyverna’s progress across its programs, including in MG and SPS; the potential for Kyverna to be the first company to deliver an approved CAR T-cell therapy for an autoimmune disease and Kyverna's clinical trials, investigator initiated trials and named-patient access data and expected timing for reporting clinical data and commencing enrollment in its trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to general economic and market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; intellectual property rights; 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.

 

Contacts:

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