# EDGAR Filing Document

**Accession Number:** 0001994702
**File Stem:** 0000950170-25-107300
**Filing Date:** 2025-8
**Character Count:** 20148
**Document Hash:** fa11868d36321f3c462d06ae3de7710a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-107300.hdr.sgml**: 20250812

**ACCESSION NUMBER**: 0000950170-25-107300

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250812

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250812

**DATE AS OF CHANGE**: 20250812

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kyverna Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001994702
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 831365441
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41947
- **FILM NUMBER:** 251206647

**BUSINESS ADDRESS:**
- **STREET 1:** 5980 HORTON STREET
- **STREET 2:** SUITE 550
- **CITY:** EMERYVILLE
- **STATE:** CA
- **ZIP:** 94608
- **BUSINESS PHONE:** 5106268331

**MAIL ADDRESS:**
- **STREET 1:** 5980 HORTON STREET
- **STREET 2:** SUITE 550
- **CITY:** EMERYVILLE
- **STATE:** CA
- **ZIP:** 94608

?xml version='1.0' encoding='ASCII'? 8-K

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

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## **FORM** 8-K

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**CURRENT REPORT**

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

**Date of Report (Date of earliest event reported):** August 12, 2025<br>

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Kyverna Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-41947 | 83-1365441 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 5980 Horton St., STE 550 |  |  |
| Emeryville**,** California |  | 94608 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (510) 925-2492<br>

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

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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:**

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

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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. ☐

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## **Item 2.02 Results of Operations and Financial Condition.** 
On August 12, 2025, Kyverna Therapeutics, Inc. (the "Company") issued a press release providing a business update and reporting financial results for the quarter ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the "Current Report").

In accordance with General Instructions B.2 of Form 8-K, the information in Item 2.02 of this Current Report and Exhibit 99.1 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 liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

## **Item 9.01 Financial Statements and Exhibits.** 
(d) Exhibits

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| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description** |
| 99.1 | [<u>Press Release issued by Kyverna Therapeutics, Inc. dated August 12, 2025.</u>](kytx-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | |
|:---|:---|:---|
|  | **KYVERNA THERAPEUTICS, INC.** | **KYVERNA THERAPEUTICS, INC.** |
| Date: August 12, 2025 | By: | /s/ Warner Biddle |
|  |  | Warner Biddle |
|  |  | Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Kyverna Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results**

*Topline data for registrational Phase 2 trial of KYV-101 in stiff person syndrome (SPS) and* 

*BLA submission anticipated in 1H 2026*

*Registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) to include ~60 patients with enrollment to initiate by year-end 2025; interim Phase 2 data expected in Q4 2025*

*Strong cash position to support upcoming milestones* 

**EMERYVILLE, Calif., August 12, 2025** – Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended June 30, 2025.

"The second quarter was marked by continued strong execution of our focused strategy, as we achieved key clinical and regulatory milestones to advance our potential first-in-class neuroimmunology CAR T franchise," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "We anticipate this momentum will continue in the second half of the year with the initiation of our Phase 3 registrational trial in MG. We believe this is an efficient and well-powered trial given the substantial clinical effect size that has been observed in this patient population treated with KYV-101. More broadly, we are well-positioned to deliver on multiple near-term value-creating milestones with our interim Phase 2 MG data readout expected in the fourth quarter of this year as well as anticipated topline registrational data for SPS and BLA filing in the first half of next year. We look forward to sharing more details on these programs at our upcoming KOL event, where we will highlight KYV-101's differentiated clinical profile, our Phase 3 trial design for MG and the market opportunity for our neuroimmunology franchise."

**Second Quarter 2025 Highlights and Recent Business Updates**

**KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Patient enrollment for the registrational trial was completed in the second quarter of 2025. Kyverna remains on track to report topline data from this study and submit its first BLA in the first half of 2026.

**KYSA-6 Registrational Phase 2/3 Trial for Myasthenia Gravis (MG)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Following a successful end-of-Phase 2 meeting with the FDA, Kyverna is expanding its existing KYSA-6 trial to include a Phase 3 portion, which the Company expects to begin enrolling by year-end 2025. The Phase 3 portion of the registrational trial will include approximately 60 patients; further details on the study design will be shared during the Company's virtual KOL event on August 28, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Kyverna has completed enrollment of the Phase 2 portion of the KYSA-6 trial and plans to report interim data in the fourth quarter of 2025.

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**KYSA-1 and KYSA-3 Trials for Lupus Nephritis (LN)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Kyverna has concluded enrollment for KYSA-1 and KYSA-3 and plans to share the full data set from its Phase 1 LN trials in a peer-reviewed publication in 2026 as the Company continues to prioritize accelerating its late-stage neuroimmunology indications.

**Additional Indications: Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Kyverna is efficiently exploring additional opportunities for KYV-101 through sponsored clinical trials and investigator-initiated trials (IITs) across several other autoimmune diseases, including MS and RA. Data from these efforts will inform the Company's indication expansion strategy.

o Phase 1 IIT data of KYV-101 in MS to be showcased at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September 2025, including an oral presentation on KYV-101 from Stanford University and a poster presentation from the University of California, San Francisco (UCSF).

o Phase 1/2 IIT data of KYV-101 in RA from Charité – University of Berlin to be highlighted at the American College of Rheumatology (ACR) Convergence 2025 meeting in October 2025.

**KYV-102**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Kyverna expects to file an investigational new drug (IND) application for KYV-102 in the fourth quarter of 2025. KYV-102 is produced with the Company's next-generation proprietary whole blood, rapid manufacturing process, incorporating the same construct as KYV-101. KYV-102 provides the opportunity to broaden access through the elimination of apheresis.

**Corporate Updates**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In June 2025, Kyverna Therapeutics announced the appointment of Marc Grasso, M.D., as Chief Financial Officer. Dr. Grasso brings over 25 years of public company, capital markets and investment banking experience. His appointment marks a strategic addition to Kyverna's executive team as the company advances its late-stage clinical and commercial efforts in autoimmune cell therapy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Kyverna will host a virtual KOL event, "A Spotlight on Kyverna's Neuroimmunology CAR T Franchise," on Thursday, August 28, 2025, from 11:00 am – 1:30 pm ET. The event will be webcast live and those who intend to join can pre-register for the webcast **<u>here</u>**.

**Anticipated Milestones**

Kyverna has issued the following guidance on upcoming program milestones:

**SPS:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Report topline registrational Phase 2 data in 1H 2026

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•BLA filing in 1H 2026

**MG:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Report interim Phase 2 data in Q4 2025

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Initiate enrollment for registrational Phase 3 trial by year-end 2025 **(New)**

**LN:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Report Phase 1 data in a peer-reviewed publication in 2026

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**Additional Indications:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•MS: Report Phase 1 IIT data in Q3 2025 **(New)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•RA: Report Phase 1/2 IIT data in Q4 2025 **(New)**

**Future Pipeline:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•File KYV-102 IND application in Q4 2025

**Financial Results for the Quarter Ended June 30, 2025**

Kyverna reported $211.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which the Company expects will provide a cash runway into 2027, supporting its first BLA filing for SPS, its MG Phase 3 trial and pre-launch activities.

Research and Development (R&D) expenses were $35.8 million for the quarter ended June 30, 2025, compared to $27.3 million for the quarter ended June 30, 2024, which included $0.9 million and $0.7 million of non-cash stock-based compensation expenses, respectively.

General and Administrative (G&A) expenses were $8.6 million for the quarter ended June 30, 2025, compared to $6.1 million for the quarter ended June 30, 2024, which included $1.6 million and $0.6 million of non-cash stock-based compensation expenses respectively.

For the quarter ended June 30, 2025, the Company reported a net loss of $42.1 million, or a net loss per common share of $0.97, compared to a net loss of $28.8 million, or a net loss per common share of $0.67, for the same period in 2024.

**About KYV-101** 

KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, KYV-101 has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases.

**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 <u>https://kyvernatx.com</u>.

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**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 and anticipation of continued momentum in the execution of its clinical and regulatory strategy; the expected timing for releasing topline data for its registrational Phase 2 trial in stiff person syndrome; the potential for KYV-101 to be a first-in-class neuroimmunology CAR T franchise; the anticipated number of patients to be enrolled in the registrational Phase 2/3 trial in MG; Kyverna's anticipated milestones and timing thereof, including the anticipated timing for a BLA submission, the anticipated timing for initiating the registrational Phase 2/3 trial in MG, and the anticipated timing for reporting data from clinical trials and IITs; KVY-101's differentiated clinical profile; Kyverna's anticipated cash runway; Kyverna's upcoming KOL event and the topics anticipated to be discussed at such event, including the trial design for the registrational Phase 3 trial in MG; Kyverna's indication expansion strategy and exploration of additional opportunities for KYV-101 in other autoimmune diseases, including in MS and RA; and Kyverna's clinical trials, IITs 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 require additional trials or studies to support its intended BLA submission; 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.

**<u>For more information, please contact:</u>**

**Investors:** InvestorRelations@kyvernatx.com

**Media:** <u>Media@kyvernatx.com</u>

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**Kyverna Therapeutics, Inc.**

**Statements of Operations and Comprehensive Loss**

**(in thousands, except share and per share data)**

**(Unaudited)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended June 30,** | **Six Months Ended June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Operating expenses |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | $35816 | $27321 | $73249 | $49797 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 8594 | 6114 | 18569 | 12996 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 44410 | 33435 | 91818 | 62793 |
| Loss from operations | (44410) | (33435) | (91818) | (62793) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income | 2364 | 4694 | 5189 | 7429 |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (14) | (39) | (38) | (83) |
| &nbsp;&nbsp;&nbsp;&nbsp;Other expense, net | (21) | (23) | (49) | (49) |
| Total other income, net | 2329 | 4632 | 5102 | 7297 |
| Net loss | (42081) | (28803) | (86716) | (55496) |
| Other comprehensive loss |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Unrealized loss on available-for-sale marketable securities, net | (19) | (36) | (125) | (41) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other comprehensive loss | (19) | (36) | (125) | (41) |
| Net loss and other comprehensive loss | $(42100) | $(28839) | $(86841) | $(55537) |
| Net loss per share attributable to common stockholders, basic and diluted | $(0.97) | $(0.67) | $(2.01) | $(1.66) |
| Weighted-average shares of common stock outstanding, basic and diluted | 43225365 | 43125709 | 43220498 | 33439886 |

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**Kyverna Therapeutics, Inc.**

**Condensed Balance Sheets**

**(in thousands)**

**(Unaudited)**

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| | | |
|:---|:---|:---|
|  | **June 30,** | **December 31,** |
|  | **2025** | **2024** |
| **Assets** |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents and available-for-sale marketable securities | $211677 | $285979 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 2650 | 4622 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 214327 | 290601 |
| Restricted cash | 551 | 552 |
| Property and equipment, net | 2162 | 3347 |
| Operating lease right-of-use assets | 5049 | 6468 |
| Finance lease right-of-use assets | 366 | 841 |
| Other non-current assets | 4053 | 2836 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $226508 | $304645 |
| **Liabilities and stockholders' equity** |  |  |
| Current liabilities | $39789 | $33756 |
| Non-current liabilities | 2342 | 4302 |
| Stockholders' equity | 184377 | 266587 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $226508 | $304645 |

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