Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Kyverna Therapeutics, Inc. due to a class action complaint alleging that the company made false and misleading statements regarding its IPO and clinical data [1][2] Group 1: Legal Investigation - The investigation is focused on whether Kyverna's board of directors breached their fiduciary duties to the company [1] - A class action complaint was filed on December 9, 2024, related to the company's IPO conducted on February 8, 2024 [1] Group 2: Allegations of Misleading Information - The complaint states that Kyverna possessed adverse data related to one of its ongoing trials, which was not disclosed [2] - The undisclosed adverse data negatively impacted the company's lead product, making the trends and results in the offering documents misleading [2] - The company's discussion of risk factors was inadequate, failing to describe the risks associated with withholding clinical data [2] Group 3: Investor Impact - Investors suffered damages when the market learned the truth about Kyverna's misleading public statements [2]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Kyverna Therapeutics reported a net loss for Q1 2025, significantly increased by higher operating expenses, while maintaining sufficient cash reserves post-IPO [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$260.7 million** as of March 31, 2025, primarily due to reduced cash, reflecting the quarter's net loss Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $56,865 | $96,621 | | Available-for-sale marketable securities | $185,784 | $189,358 | | **Total Assets** | **$260,655** | **$304,645** | | Total Current Liabilities | $33,292 | $33,756 | | **Total Liabilities** | **$36,645** | **$38,058** | | **Total Stockholders' Equity** | **$224,010** | **$266,587** | [Condensed Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The net loss for Q1 2025 increased to **$44.6 million**, primarily driven by significant increases in research and development and general and administrative expenses Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $37,433 | $22,476 | | General and administrative | $9,975 | $6,882 | | **Total operating expenses** | **$47,408** | **$29,358** | | **Loss from operations** | **($47,408)** | **($29,358)** | | **Net loss** | **($44,635)** | **($26,693)** | | Net loss per share, basic and diluted | ($1.03) | ($1.12) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$44.9 million** in Q1 2025, contrasting with a substantial IPO-driven cash inflow in Q1 2024 Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($44,915) | ($25,525) | | Net cash provided by (used in) investing activities | $5,578 | ($122,879) | | Net cash provided by (used in) financing activities | ($414) | $338,049 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's focus on cell therapies, its **$336.2 million** IPO proceeds, sufficient cash for 12 months, and an ongoing shareholder class action lawsuit - The company is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, with its lead product candidate being KYV-101[19](index=19&type=chunk) - On February 12, 2024, the company closed its IPO, issuing 16,675,000 shares of common stock and receiving net proceeds of **$336.2 million** after deducting underwriting commissions and other costs[20](index=20&type=chunk) - As of March 31, 2025, the company had cash, cash equivalents, and available-for-sale marketable securities of **$242.6 million**, which management believes is sufficient to fund operations for at least the next 12 months[22](index=22&type=chunk) - A shareholder class action complaint was filed in December 2024, alleging that the registration statement for the IPO contained material misstatements or omissions. The company intends to defend the lawsuit vigorously[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses KYV-101's clinical progress, a **67%** increase in Q1 2025 net loss due to R&D, strong liquidity of **$242.6 million** into 2027, and a **$250 million** shelf registration for future flexibility [Overview](index=21&type=section&id=Overview) Kyverna, a clinical-stage biopharmaceutical company, is advancing its lead cell therapy candidate, KYV-101, through pivotal trials for autoimmune diseases like SPS and MG, targeting a BLA filing in 2026 - The company's lead program, KYV-101, is an autologous, fully human CD19 CAR T-cell product candidate for autoimmune diseases[96](index=96&type=chunk) - Key clinical trials include a pivotal Phase 2 in stiff person syndrome (SPS), a Phase 2 in myasthenia gravis (MG), and two Phase 1/2 trials in lupus nephritis (LN)[97](index=97&type=chunk) - Enrollment is complete for the KYSA-8 pivotal Phase 2 trial in SPS, with an anticipated Biologics License Application (BLA) filing with the FDA in **2026**[98](index=98&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Total operating expenses increased **61%** to **$47.4 million** in Q1 2025, driven by a **67%** rise in R&D for KYV-101 and a **45%** increase in G&A expenses Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,433 | $22,476 | $14,957 | 67% | | General and administrative | $9,975 | $6,882 | $3,093 | 45% | | **Total operating expenses** | **$47,408** | **$29,358** | **$18,050** | **61%** | - The increase in KYV-101 program expenses was driven by an **$8.0 million** strategic investment in CMC readiness and a **$4.4 million** increase in CRO costs from accelerated trial enrollment[123](index=123&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$242.6 million** in cash and marketable securities, sufficient to fund operations into **2027**, supplemented by a **$250.0 million** shelf registration for future flexibility - As of March 31, 2025, the company had **$242.6 million** in cash, cash equivalents, and available-for-sale marketable securities[129](index=129&type=chunk) - Management anticipates that current cash reserves will be sufficient to fund operations into **2027**, covering key milestones like the BLA filing for KYV-101 in SPS[103](index=103&type=chunk) - In March 2025, the company filed a **$250.0 million** shelf registration statement on Form S-3, which includes a sales agreement for an at-the-market (ATM) offering of up to **$50.0 million**[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Kyverna Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide the information required under this item[155](index=155&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of March 31, 2025, due to material weaknesses in internal control over financial reporting, with remediation efforts underway - Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025, due to material weaknesses in internal control over financial reporting[157](index=157&type=chunk) - The identified material weaknesses relate to an insufficient number of qualified resources, ineffective risk assessment, and inadequate design of controls across substantially all financial statement areas[159](index=159&type=chunk)[160](index=160&type=chunk) - Remediation efforts are underway, including hiring a VP of Accounting/Corporate Controller and a Head of Information Technology, and engaging a third-party consulting firm to assist in designing and implementing internal controls[162](index=162&type=chunk)[165](index=165&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a shareholder class action lawsuit, filed in December 2024 and amended in May 2025, alleging material misstatements in its IPO registration statement - A shareholder class action complaint was filed in December 2024 against the company, certain officers and directors, and IPO underwriters[167](index=167&type=chunk) - The complaint alleges that the Form S-1 registration statement for the IPO contained material misstatements or omissions in violation of federal securities laws[167](index=167&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include limited operating history, substantial net losses, dependence on KYV-101's success, need for capital, material weaknesses in internal controls, and FDA investigation into CAR T-cell malignancies - The company has a limited operating history, has incurred substantial net losses (**$308.2 million** accumulated deficit as of March 31, 2025), and may never achieve profitability[169](index=169&type=chunk)[172](index=172&type=chunk) - The business is entirely dependent on the success of its product candidates, which require significant additional development and regulatory approval, and may never be commercialized[169](index=169&type=chunk)[181](index=181&type=chunk) - Material weaknesses in internal control over financial reporting have been identified, which could prevent accurate and timely financial reporting[169](index=169&type=chunk)[190](index=190&type=chunk) - The FDA is investigating the risk of T-cell malignancy following treatment with CD19-directed CAR T-cell immunotherapies like KYV-101, which could lead to additional regulatory scrutiny, approval delays, or stricter labeling requirements[170](index=170&type=chunk)[346](index=346&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=111&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred; **$336.2 million** net IPO proceeds were invested consistent with the prospectus, with no material change in planned use - The company's IPO in February 2024 generated net proceeds of **$336.2 million** after deducting underwriting discounts and offering costs[490](index=490&type=chunk) - There has been no material change in the planned use of IPO proceeds from what was described in the final prospectus[491](index=491&type=chunk) [Defaults Upon Senior Securities](index=111&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current reporting requirements [Mine Safety Disclosures](index=111&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations [Other Information](index=111&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans for company securities during the quarter ended March 31, 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading plan during the fiscal quarter[495](index=495&type=chunk) [Exhibits](index=112&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including certifications from key officers

[First Quarter 2025 Highlights and Recent Business Updates](index=1&type=section&id=First%20Quarter%202025%20Highlights%20and%20Recent%20Business%20Updates) Kyverna reported significant progress in Q1 2025, completing enrollment for its registrational Phase 2 trial of KYV-101 in Stiff Person Syndrome (SPS) and aligning with the FDA on a registrational path for both SPS and Myasthenia Gravis (MG) [KYV-101 Clinical Program](index=1&type=section&id=KYV-101%20Clinical%20Program) The KYV-101 program is advancing rapidly, with a primary focus on neuroinflammatory diseases, progressing to BLA filing for SPS and Phase 3 for MG, while informing future development priorities for LN and MS - Stiff Person Syndrome (SPS): Enrollment is complete in the pivotal Phase 2 trial (KYSA-8), with FDA alignment for registrational study and anticipated Biologics License Application (BLA) submission in the **first half of 2026**[1](index=1&type=chunk)[4](index=4&type=chunk) - Myasthenia Gravis (MG): Following a positive end-of-Phase 2 meeting, the FDA has provided written alignment for Kyverna to advance KYV-101 into a Phase 3 clinical trial, with interim data from the ongoing Phase 2 trial (KYSA-6) expected in the **second half of 2025**[1](index=1&type=chunk)[9](index=9&type=chunk) - Lupus Nephritis (LN): The company remains on track to report data from the KYSA-1 and KYSA-3 Phase 1 trials in LN in the **second half of 2025**[6](index=6&type=chunk) - Preliminary data from investigator-initiated trials in Multiple Sclerosis (MS) showed a potentially favorable benefit/risk profile for KYV-101, which will help inform the selection of future priority indications[9](index=9&type=chunk) [KYV-102 Program](index=2&type=section&id=KYV-102%20Program) Kyverna is developing KYV-102, a next-generation candidate featuring a proprietary whole-blood rapid manufacturing process, with an Investigational New Drug (IND) application planned for the second half of 2025 - Kyverna plans to file an Investigational New Drug (IND) application for its next-generation candidate, KYV-102, in the **second half of 2025**, aiming to improve patient experience and broaden CAR T access[7](index=7&type=chunk) [Corporate and Manufacturing Updates](index=2&type=section&id=Corporate%20and%20Manufacturing%20Updates) The company enhanced commercial readiness by gaining FDA confirmation on its CMC package for KYV-101 and initiating clinical manufacturing with a second partner, while implementing a workforce reduction to preserve capital - The FDA confirmed the planned Chemistry, Manufacturing, and Controls (CMC) package for KYV-101, and Kyverna initiated clinical manufacturing at its second partner, Elevate Bio, with the FDA accepting comparability data[10](index=10&type=chunk) - To support late-stage development and preserve cash runway into **2027**, the company reduced its workforce by approximately **16%** in the first quarter of 2025[10](index=10&type=chunk) [Anticipated Milestones](index=3&type=section&id=Anticipated%20Milestones) Kyverna has provided clear guidance on upcoming milestones, including the BLA filing for KYV-101 in SPS in the first half of 2026, interim Phase 2 data for MG and Phase 1 data for LN in the second half of 2025, and the IND application filing for KYV-102 in the second half of 2025 | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | **SPS** | Report Topline Pivotal Phase 2 Data | 1H 2026 | | | BLA filing | 1H 2026 (updated) | | **MG** | Report Interim Phase 2 Data | 2H 2025 | | **LN** | Report Phase 1 Data | 2H 2025 | | **Future Pipeline** | File KYV-102 IND application | 2H 2025 | [Financial Results for the Quarter Ended March 31, 2025](index=3&type=section&id=Financial%20Results%20for%20the%20Quarter%20Ended%20March%2031%2C%202025) Kyverna reported a strong financial position with **$242.6 million** in cash, equivalents, and securities, providing a runway into **2027**, with increased R&D and G&A expenses leading to a net loss of **$44.6 million** - The company holds **$242.6 million** in cash, cash equivalents, and marketable securities as of March 31, 2025, expected to fund operations into **2027**[12](index=12&type=chunk) | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $37.4 million | $22.5 million | | G&A Expenses | $10.0 million | $6.9 million | | Net Loss | $44.6 million | $26.7 million | | Net Loss Per Share | $1.03 | $1.12 | - Operating cash burn is expected to be higher in the first half of 2025 compared to the second half, due to one-time investments in CMC readiness and accelerated clinical trial enrollment[15](index=15&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section provides the detailed, unaudited financial statements for the period ended March 31, 2025, including the Statements of Operations and Comprehensive Loss and the Condensed Balance Sheets [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, Kyverna reported a total operating expense of **$47.4 million** and a net loss of **$44.6 million**, compared to a total operating expense of **$29.4 million** and a net loss of **$26.7 million** for the same period in 2024 | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $37,433 | $22,476 | | General and administrative | $9,975 | $6,882 | | **Total operating expenses** | **$47,408** | **$29,358** | | Loss from operations | ($47,408) | ($29,358) | | Total other income, net | $2,773 | $2,665 | | **Net loss** | **($44,635)** | **($26,693)** | | Net loss per share, basic and diluted | ($1.03) | ($1.12) | | Weighted-average shares outstanding | 43,215,577 | 23,754,062 | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, Kyverna had total assets of **$260.7 million**, including **$242.6 million** in cash and marketable securities, with total liabilities of **$36.6 million** and total stockholders' equity of **$224.0 million** | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and marketable securities | $242,649 | $285,979 | | Total current assets | $247,651 | $290,601 | | **Total assets** | **$260,655** | **$304,645** | | **Liabilities and Stockholders' Equity** | | | | Current liabilities | $33,292 | $33,756 | | Non-current liabilities | $3,353 | $4,302 | | Stockholders' equity | $224,010 | $266,587 | | **Total liabilities and stockholders' equity** | **$260,655** | **$304,645** |

Core Insights - Kyverna Therapeutics has completed enrollment in the registrational Phase 2 trial for KYV-101 in stiff person syndrome (SPS) and is on track to report topline data in the first half of 2026, with a biologics license application (BLA) filing anticipated in the same timeframe [1][7][15] - The company is advancing into a registrational Phase 3 trial for KYV-101 in myasthenia gravis (MG) following a successful end-of-Phase 2 meeting with the FDA, with Phase 2 data expected in the second half of 2025 [1][2][15] - Kyverna reported a strong financial position with $242.6 million in cash and equivalents as of March 31, 2025, providing a cash runway into 2027 to support its BLA filing and ongoing clinical trials [11][22] Business Updates - The company is focused on developing KYV-101, an autologous, fully human CD19 CAR T-cell product candidate, for various B cell-mediated autoimmune diseases, prioritizing SPS, MG, and lupus nephritis [3][18] - Kyverna plans to host a KOL event in Q3 2025 to highlight its neuroinflammation franchise and the progress of KYV-101 [10] - The company is also exploring additional indications for KYV-101 through clinical trials in multiple sclerosis (MS) and expects to report interim data from ongoing trials in MG and lupus nephritis in the second half of 2025 [5][13][15] Financial Performance - For the quarter ended March 31, 2025, Kyverna reported a net loss of $44.6 million, or $1.03 per share, compared to a net loss of $26.7 million, or $1.12 per share, for the same period in 2024 [16][22] - Research and development expenses increased to $37.4 million from $22.5 million year-over-year, while general and administrative expenses rose to $10.0 million from $6.9 million [12][22] - The company’s total operating expenses for the quarter were $47.4 million, up from $29.4 million in the previous year [22] Milestones and Future Plans - Kyverna is on track to report topline data from the pivotal Phase 2 trial in SPS in the first half of 2026 and anticipates filing its first BLA in the same period [15] - The company plans to file an investigational new drug application for KYV-102 in the second half of 2025, which aims to improve the CAR T patient experience [8][15] - Kyverna is strategically investing in pre-launch activities for its therapies, particularly for SPS, which currently has no approved treatments [2][11]

Part I [Business](index=6&type=section&id=Item%201.%20Business) Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, with lead product KYV-101 in pivotal Phase 2 trials for SPS and MG [Overview and Pipeline](index=6&type=section&id=Overview%20and%20Pipeline) - Kyverna is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with the goal of achieving durable, treatment-free remission[23](index=23&type=chunk) - The lead product candidate, KYV-101, is an autologous, fully human CD19 CAR T-cell therapy licensed from the NIH, designed for an improved tolerability profile in autoimmune diseases[24](index=24&type=chunk) - The company has aligned with the FDA on a registrational Phase 2 trial for KYV-101 in Stiff Person Syndrome (SPS), with enrollment expected to complete in mid-2025 and a Biologics License Application (BLA) filing anticipated in 2026[26](index=26&type=chunk) Kyverna Therapeutics Clinical Pipeline | Indication | Candidate | Stage | Regulatory Milestone Achieved | | :--- | :--- | :--- | :--- | | **2025 Priorities** | | | | | Stiff Person Syndrome | KYV-101 | Phase 2 (Pivotal) | RMAT, ODD | | Myasthenia Gravis | KYV-101 | Phase 2 | RMAT, ODD, FTD | | Lupus Nephritis | KYV-101 | Phase 1/2 | FTD | | Rapid Whole Blood Process | KYV-102 | Preclinical | | [Our Solution and Clinical Development](index=8&type=section&id=Our%20Solution%20and%20Clinical%20Development) - KYV-101 is designed with a fully human CAR (Hu19-CD828Z) and potent CD28 costimulation, which aims to achieve deep B-cell depletion and immune reset with reduced cytokine release, potentially offering an improved therapeutic profile for autoimmune diseases[39](index=39&type=chunk)[41](index=41&type=chunk) - The company's clinical development strategy prioritizes three indications: Stiff Person Syndrome (SPS), Myasthenia Gravis (MG), and Lupus Nephritis (LN), based on experience from company-sponsored trials, investigator-initiated trials, and compassionate use cases[47](index=47&type=chunk)[49](index=49&type=chunk) - For Stiff Person Syndrome (SPS), a pivotal Phase 2 trial (KYSA-8) is underway with **70% of participants enrolled**. The primary endpoint is the change in the Timed 25-Foot Walk (T25FW) test at 16 weeks. Top-line results are expected in H1 2026[56](index=56&type=chunk)[57](index=57&type=chunk) - For Myasthenia Gravis (MG), the initial six-patient cohort in the Phase 2 KYSA-6 trial has completed enrollment, with interim data expected in H2 2025. The company plans to provide an update on the registrational path in H1 2025[27](index=27&type=chunk)[69](index=69&type=chunk) - For Lupus Nephritis (LN), two Phase 1/2 trials (KYSA-1 and KYSA-3) are advancing, with **9 patients enrolled** across both studies. Phase 1 data is expected in H2 2025[28](index=28&type=chunk)[84](index=84&type=chunk) - In a compassionate use dataset of 35 patients with at least 28 days of follow-up, **no high-grade Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed** following KYV-101 treatment, suggesting a potentially differentiated safety profile[93](index=93&type=chunk) - The company is developing Ingenui-T, a whole blood, rapid manufacturing process for its next-generation candidate KYV-102, aiming to improve patient access and reduce costs. An IND filing for KYV-102 is expected in H2 2025[97](index=97&type=chunk)[100](index=100&type=chunk) [Collaboration and License Agreements](index=19&type=section&id=Collaboration%20and%20License%20Agreements) - Kyverna has exclusive, worldwide licenses from the National Institutes of Health (NIH) for the fully human anti-CD19 CAR used in its product candidates. The agreements include upfront payments, annual royalties, and potential benchmark royalties totaling approximately **$7.4 million** for the first product approval across autologous and allogeneic licenses[102](index=102&type=chunk)[103](index=103&type=chunk) - The company has a collaboration with Intellia Therapeutics to develop KYV-201, an allogeneic CD19 CAR T-cell product. The agreement involves up to **$64.5 million** in potential development and regulatory milestone payments and **low to mid-single-digit royalties**. Intellia also has an option to co-develop and co-commercialize the product in the U.S.[101](index=101&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [Manufacturing, Competition, and Intellectual Property](index=21&type=section&id=Manufacturing%2C%20Competition%2C%20and%20Intellectual%20Property) - Kyverna does not own manufacturing facilities and relies on third-party CMOs, including ElevateBio and WuXi ATU, for the production of its product candidates for clinical trials[113](index=113&type=chunk)[114](index=114&type=chunk) - The company faces competition from large pharmaceutical companies developing biologics (e.g., Roche) and other organizations providing stem cell transplant therapies[119](index=119&type=chunk)[120](index=120&type=chunk) - The company's patent portfolio includes nine patent families. A key in-licensed family from the NIH, covering the CD19 CAR in KYV-101, KYV-102, and KYV-201, has a nominal expiration date of **2035**[123](index=123&type=chunk)[125](index=125&type=chunk) - Kyverna owns patent families directed to methods of treating autoimmune diseases like lupus nephritis, myasthenia gravis, and stiff person syndrome, with nominal expiration dates of **2043 and 2044**[126](index=126&type=chunk)[127](index=127&type=chunk) [Government Regulation](index=24&type=section&id=Government%20Regulation) - Kyverna's cell therapy products are regulated as biologics by the FDA and will require an approved Biologics License Application (BLA) for marketing in the U.S. The process involves extensive preclinical studies and clinical trials to establish safety and efficacy[134](index=134&type=chunk)[137](index=137&type=chunk) - The company has received several expedited program designations from the FDA, including Orphan Drug Designation for SPS, MG, and Systemic Sclerosis, and Regenerative Medicine Advanced Therapy (RMAT) designation for SPS and MG, which can facilitate development and expedite review[27](index=27&type=chunk)[165](index=165&type=chunk) - Sales of approved products will depend on coverage and reimbursement from third-party payors like Medicare, Medicaid, and private insurers. The company's operations are also subject to healthcare laws such as the Anti-Kickback Statute and the False Claims Act[180](index=180&type=chunk)[186](index=186&type=chunk) - The company is subject to international regulations, including the EU's General Data Protection Regulation (GDPR), due to its clinical trials and data processing activities involving individuals in the EU[216](index=216&type=chunk)[217](index=217&type=chunk) [Human Capital and Corporate Information](index=40&type=section&id=Human%20Capital%20and%20Corporate%20Information) - As of March 1, 2025, the company had **112 full-time employees**, with **84 engaged in research and development activities**[219](index=219&type=chunk) - The company strengthened its management team in 2024 and 2025 with key hires including a new CEO, Chief Medical and Development Officer, and Chief Business Officer[222](index=222&type=chunk) - The company's corporate headquarters are located in Emeryville, California, where it leases approximately **68,000 square feet** of office, manufacturing, and R&D space[223](index=223&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including limited operating history, significant losses, capital needs, and dependence on product candidate success and regulatory approval - The company has a limited operating history, has incurred substantial net losses (**$127.5 million** in 2024), and expects to continue incurring losses for the foreseeable future. It has no products approved for sale and has never generated product revenue[229](index=229&type=chunk)[231](index=231&type=chunk) - The business is entirely dependent on the success of its product candidates, which may never receive regulatory approval or be successfully commercialized. The development process is lengthy, expensive, and has an uncertain outcome[239](index=239&type=chunk) - Material weaknesses in internal control over financial reporting have been identified, relating to insufficient qualified resources, ineffective risk assessment, and inadequate design of controls. Failure to remediate these could adversely affect financial reporting and investor confidence[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk) - The FDA is investigating a serious risk of T-cell malignancy following treatment with BCMA-directed or CD19-directed CAR T-cell therapies, which could result in additional regulatory scrutiny, approval delays, or boxed warnings for Kyverna's product candidates[230](index=230&type=chunk)[402](index=402&type=chunk) - The company relies on third-party manufacturers (like WuXi and Elevate) and suppliers. The loss of these partners or their failure to comply with regulatory requirements could materially and adversely affect the business[228](index=228&type=chunk)[488](index=488&type=chunk) - The company depends on intellectual property licensed from third parties, such as the NIH. Termination of these licenses could result in the loss of significant rights and harm the ability to commercialize product candidates[230](index=230&type=chunk)[329](index=329&type=chunk) [Unresolved Staff Comments](index=112&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[539](index=539&type=chunk) [Cybersecurity](index=112&type=section&id=Item%201C.%20Cybersecurity) Cybersecurity risks are managed through an enterprise risk process overseen by the Audit Committee, with no material impact to date - Cyber risk management is overseen by the Audit Committee and directed by the Head of IT, who reports to the CFO[540](index=540&type=chunk)[542](index=542&type=chunk) - The company uses a managed security service provider and other third-party consultants to support its cyber risk management efforts, including periodic security testing[541](index=541&type=chunk) - The company states that risks from cybersecurity threats have not materially affected and are not reasonably likely to materially affect its business, results of operations, or financial condition[546](index=546&type=chunk) [Properties](index=113&type=section&id=Item%202.%20Properties) The company's corporate headquarters in Emeryville, California, comprises approximately 68,000 square feet of leased office, manufacturing, and R&D space - Kyverna leases approximately **68,000 square feet** for its headquarters in Emeryville, California. The leases expire in January and February **2027**[547](index=547&type=chunk) [Legal Proceedings](index=113&type=section&id=Item%203.%20Legal%20Proceedings) A shareholder class action complaint was filed in December 2024 alleging material misstatements in the IPO registration statement - A shareholder class action complaint was filed in December **2024**, alleging material misstatements or omissions in the company's IPO registration statement[548](index=548&type=chunk) [Mine Safety Disclosures](index=113&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[549](index=549&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=114&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock began trading on Nasdaq in February 2024, raising $336.2 million net from its IPO, with no plans for future cash dividends - Common stock began trading on Nasdaq under the symbol "KYTX" on February **8, 2024**[552](index=552&type=chunk) - The company closed its IPO on February **12, 2024**, raising aggregate net proceeds of **$336.2 million**[557](index=557&type=chunk)[559](index=559&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[555](index=555&type=chunk) [Reserved](index=114&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=115&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $127.5 million in 2024, driven by increased R&D and G&A expenses, with $286.0 million in cash to fund operations for at least one year [Results of Operations](index=121&type=section&id=Results%20of%20Operations) Comparison of Operations for Years Ended Dec 31, 2024 and 2023 | | 2024 | 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **(in thousands)** | | | | | | Research and development | $112,473 | $49,923 | $62,550 | 125% | | General and administrative | $30,131 | $12,483 | $17,648 | 141% | | **Total operating expenses** | **$142,604** | **$62,406** | **$80,198** | **129%** | | Loss from operations | ($142,604) | ($62,406) | ($80,198) | 129% | | Interest income | $15,359 | $2,282 | $13,077 | 573% | | **Net loss** | **($127,477)** | **($60,366)** | **($67,111)** | **111%** | - Research and development expenses increased by **125%** to **$112.5 million** in 2024, primarily driven by a **$46.2 million** increase in CRO, CMO, and clinical trial costs as the company advanced its lead product candidate, KYV-101[603](index=603&type=chunk) - General and administrative expenses increased by **141%** to **$30.1 million** in 2024, mainly due to a **$10.7 million** increase in salaries and benefits (including **$4.5 million** in stock-based compensation) and a **$4.7 million** increase in professional services costs[609](index=609&type=chunk) External R&D Costs by Program | | 2024 | 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **(in thousands)** | | | | | | KYV-101 | $61,884 | $18,267 | $43,617 | 239% | | KYV-201 | $3,947 | $4,509 | ($562) | (12)% | | Other R&D | $5,077 | $4,228 | $849 | 20% | | **Total** | **$70,908** | **$27,004** | **$43,904** | **163%** | [Liquidity and Capital Resources](index=124&type=section&id=Liquidity%20and%20Capital%20Resources) - As of December 31, 2024, the company had **$286.0 million** in cash, cash equivalents, and available-for-sale marketable securities. These funds are considered sufficient to fund planned operations for at least one year[611](index=611&type=chunk)[613](index=613&type=chunk) - Primary funding sources have been sales of redeemable convertible preferred stock (**$168.0 million**), convertible notes (**$2.0 million**), an upfront payment from Gilead (**$17.5 million**), and net proceeds from the IPO (**$336.2 million**)[611](index=611&type=chunk) Summary of Cash Flows | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | **(in thousands)** | | | | Net cash used in operating activities | ($114,250) | ($52,410) | | Net cash used in investing activities | ($160,902) | ($8,785) | | Net cash provided by financing activities | $337,113 | $58,118 | - Net cash used in operating activities more than doubled to **$114.3 million** in 2024 from **$52.4 million** in 2023, primarily due to the increased net loss[620](index=620&type=chunk) - Net cash provided by financing activities was **$337.1 million** in 2024, driven by the IPO proceeds, compared to **$58.1 million** in 2023 from the issuance of Series B Preferred Stock[625](index=625&type=chunk)[626](index=626&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=129&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate and foreign currency risks, but does not anticipate a material effect from a 10% change in rates or current exchange rate fluctuations - The primary market risk is interest rate risk on cash equivalents and marketable securities, but the company does not believe a hypothetical **10% change** in rates would have a material effect[642](index=642&type=chunk) - The company has foreign currency exchange risk from using R&D vendors outside the U.S., but to date, the impact has not been material[643](index=643&type=chunk) [Financial Statements and Supplementary Data](index=130&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section indicates the inclusion of the company's audited financial statements and supplementary data [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=130&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[646](index=646&type=chunk) [Controls and Procedures](index=130&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of December 31, 2024, due to material weaknesses in internal control over financial reporting, with remediation efforts underway - Management concluded that disclosure controls and procedures were not effective as of December **31, 2024**, due to material weaknesses in internal control over financial reporting[647](index=647&type=chunk) - Material weaknesses relate to an insufficient number of qualified resources, ineffective risk assessment, and inadequate design of controls over information systems and management reviews[650](index=650&type=chunk)[652](index=652&type=chunk) - Ongoing remediation efforts include hiring a VP of Accounting/Corporate Controller and Head of IT, engaging a third-party consulting firm, and implementing enhanced entity-level and general IT controls[653](index=653&type=chunk)[654](index=654&type=chunk) [Other Information](index=132&type=section&id=Item%209B.%20Other%20Information) The company implemented a Restated Non-Employee Director Compensation Program effective March 25, 2025, modifying equity awards for directors - The company implemented a Restated Non-Employee Director Compensation Program effective March **25, 2025**[659](index=659&type=chunk) - New directors will receive an initial equity grant valued at **$350,000**, split between options (**$262,500**) and RSUs (**$87,500**)[659](index=659&type=chunk) - Continuing directors will receive an annual equity grant valued at **$175,000**, split between options (**$131,250**) and RSUs (**$43,750**)[660](index=660&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=133&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - None[663](index=663&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=134&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's board comprises eight members across three staggered classes, with an executive team led by CEO Warner Biddle and an independent Audit Committee - The board of directors consists of **eight members**, divided into three staggered classes with three-year terms[666](index=666&type=chunk) - The executive officer team includes Warner Biddle (CEO), Ryan Jones (CFO), Karen Walker (CTO), and Naji H. Gehchan (Chief Medical and Development Officer)[686](index=686&type=chunk) - The company has an Audit Committee composed of independent directors Daniel K. Spiegelman (Chairperson), Mert Aktar, and Steve Liapis[695](index=695&type=chunk) [Executive Compensation](index=140&type=section&id=Item%2011.%20Executive%20Compensation) Fiscal year 2024 executive compensation included new CEO Warner Biddle's $15.0 million package and former CEO Peter Maag's $1.48 million, with a clawback policy in effect 2024 Summary Compensation Table (Selected NEOs) | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Non-Equity Incentive Plan Comp ($) | All Other Comp ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Warner Biddle, CEO | 2024 | 182,292 | 650,000 | 13,760,605 | 375,000 | 25,000 | 14,992,896 | | Peter Maag, Ph.D., Former CEO | 2024 | 786,466 | - | - | - | 694,764 | 1,481,230 | | Karen Walker, CTO | 2024 | 440,000 | - | - | 151,360 | - | 591,360 | - Warner Biddle was appointed CEO in September **2024** with an annual base salary of **$625,000**, a target bonus of **60%**, a one-time sign-on bonus of **$650,000**, and a stock option to purchase **2,579,259 shares**[709](index=709&type=chunk)[714](index=714&type=chunk)[715](index=715&type=chunk) - Peter Maag resigned as CEO in September **2024** and entered into a separation agreement providing for severance, consulting fees, and continued vesting of equity awards for a specified period[704](index=704&type=chunk)[724](index=724&type=chunk) - The company adopted a Clawback Policy effective February **7, 2024**, allowing for the recovery of erroneously awarded incentive-based compensation in the event of a financial restatement[774](index=774&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=152&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of December 31, 2024, Vida Ventures, Westlake BioPartners, and Gilead Sciences were major beneficial owners, with executive officers and directors holding 21.9% of common stock Security Ownership of 5% and Greater Stockholders (as of Dec 31, 2024) | Name of Beneficial Owner | Percent of Shares Beneficially Owned | | :--- | :--- | | Entities affiliated with Vida Ventures, LLC | 11.1% | | Entities affiliated with Westlake BioPartners Fund I, L.P. | 10.5% | | Gilead Sciences, Inc. | 9.5% | | Entities affiliated with Northpond Ventures III, LP | 7.5% | | Bain Capital Life Sciences Opportunities III, LP | 7.3% | | JPMORGAN CHASE & CO. | 5.5% | - All executive officers and directors as a group beneficially owned **21.9%** of the company's common stock as of December **31, 2024**[785](index=785&type=chunk) - As of December **31, 2024**, there were **3,562,709 shares** remaining available for future issuance under the company's equity compensation plans[799](index=799&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=155&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company engaged in related party transactions, including a 2023 Series B financing and a $1.1 million note forgiveness for the former CEO, with a majority of independent directors - In **2023**, the company sold **$60.0 million** of Series B convertible preferred stock, with significant participation from major shareholders including Northpond Ventures, Westlake BioPartners, Vida Ventures, Gilead Sciences, and Bain Capital[803](index=803&type=chunk)[805](index=805&type=chunk)[806](index=806&type=chunk) - In January **2024**, the company forgave a **$1.1 million** promissory note, including principal and interest, that was issued to its former CEO in connection with an early exercise of stock options[815](index=815&type=chunk) - The board of directors has determined that Ian Clark, Fred E. Cohen, Christi Shaw, Mert Aktar, Steve Liapis, Beth Seidenberg, and Daniel K. Spiegelman are independent directors under Nasdaq rules[821](index=821&type=chunk) [Principal Accounting Fees and Services](index=159&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The company paid BDO USA, P.C. $909,285 in total fees for fiscal year 2024, primarily for audit services Fees Paid to Independent Registered Public Accounting Firm | | Fiscal Year 2024 | Fiscal Year 2023 | | :--- | :--- | :--- | | Audit Fees | $909,285 | $883,385 | | Tax Fees | $0 | $70,232 | | **Total Fees** | **$909,285** | **$953,617** | Part IV [Exhibits, Financial Statement Schedules](index=161&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section indexes financial statements and lists all exhibits filed as part of the Annual Report on Form 10-K [Form 10-K Summary](index=162&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[832](index=832&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=165&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) BDO USA, P.C. issued an unqualified opinion on the company's 2024 and 2023 financial statements, without auditing internal control over financial reporting - The independent auditor, BDO USA, P.C., issued an unqualified opinion on the financial statements for the years ended December **31, 2024 and 2023**[845](index=845&type=chunk) - The auditor was not engaged to perform, and did not express an opinion on, the effectiveness of the Company's internal control over financial reporting[847](index=847&type=chunk) [Financial Statements Tables](index=166&type=section&id=Financial%20Statements%20Tables) Financial statements show total assets increased to $304.6 million in 2024, net loss widened to $127.5 million, and operating cash outflow doubled Balance Sheets (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $96,621 | $34,647 | | Available-for-sale marketable securities | $189,358 | $22,896 | | **Total current assets** | **$290,601** | **$60,664** | | **Total assets** | **$304,645** | **$75,195** | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Total current liabilities | $33,756 | $19,859 | | **Total liabilities** | **$38,058** | **$26,018** | | Redeemable convertible preferred stock | $0 | $180,574 | | Total stockholders' equity (deficit) | $266,587 | ($131,397) | | **Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)** | **$304,645** | **$75,195** | Statements of Operations and Comprehensive Loss (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $112,473 | $49,923 | | General and administrative | $30,131 | $12,483 | | **Total operating expenses** | **$142,604** | **$62,406** | | **Loss from operations** | **($142,604)** | **($62,406)** | | **Net loss** | **($127,477)** | **($60,366)** | [Notes to Financial Statements](index=170&type=section&id=Notes%20to%20Financial%20Statements) Notes detail accounting policies, IPO impact, key license agreements, a terminated Gilead collaboration with outstanding fees, lease liabilities, and a full valuation allowance on deferred tax assets - On February **12, 2024**, the company closed its IPO, issuing **16,675,000 shares** and raising net proceeds of **$336.2 million**. All redeemable convertible preferred stock converted to common stock[862](index=862&type=chunk) - Under the NIH agreements, the company recognized **$0.6 million** in benchmark royalties as R&D expense in **2024**. Under the Intellia agreement, up to **$64.5 million** in future milestones are payable[915](index=915&type=chunk)[918](index=918&type=chunk) - A collaboration with Gilead was terminated effective January **22, 2024**. A related **$6.3 million** sublicensing fee payable to Kite (a Gilead affiliate) remains outstanding and its settlement has not yet been agreed upon[926](index=926&type=chunk)[932](index=932&type=chunk)[933](index=933&type=chunk) - As of December **31, 2024**, the company had total future lease payments of **$8.1 million** for operating leases and **$1.1 million** for finance leases[942](index=942&type=chunk) - The company maintains a full valuation allowance against its net deferred tax assets of **$65.6 million** as of December **31, 2024**, due to its history of cumulative losses[969](index=969&type=chunk)

[Business Update and Financial Results Overview](index=1&type=section&id=Business%20Update%20and%20Financial%20Results%20Overview) Kyverna reported full-year 2024 financial results and business highlights, emphasizing its leadership in CAR T-cell therapies for autoimmune diseases and a strong balance sheet - Kyverna reported its full-year 2024 financial results and business highlights, emphasizing its leadership in developing CAR T-cell therapies for autoimmune diseases[1](index=1&type=chunk)[2](index=2&type=chunk) - The company is accelerating the clinical path for its lead candidate, KYV-101, in three priority indications: stiff person syndrome (SPS), myasthenia gravis (MG), and lupus nephritis (LN)[1](index=1&type=chunk)[2](index=2&type=chunk) - A strong balance sheet is expected to extend the company's cash runway into **2027**, funding operations through key clinical and regulatory milestones[1](index=1&type=chunk)[12](index=12&type=chunk) [Clinical Pipeline and Program Updates](index=1&type=section&id=Clinical%20Pipeline%20and%20Program%20Updates) The company provided updates on its clinical pipeline, including progress for lead candidate KYV-101 in multiple indications and the development of next-generation KYV-102 [KYV-101 Program](index=1&type=section&id=KYV-101%20Program) The company's lead candidate, KYV-101, an autologous, fully human CD19 CAR T-cell therapy, is being prioritized for development in Stiff Person Syndrome, Myasthenia Gravis, and Lupus Nephritis, with significant clinical trial progress and regulatory alignment achieved [Stiff Person Syndrome (SPS)](index=1&type=section&id=Stiff%20Person%20Syndrome%20(SPS)) The KYV-101 program for Stiff Person Syndrome is advancing with a registrational Phase 2 trial, targeting BLA filing in 2026, and has received multiple FDA designations - Kyverna has aligned with the FDA on a registrational Phase 2 trial design for KYSA-8 in SPS, which is currently **70% enrolled**[1](index=1&type=chunk)[6](index=6&type=chunk) - Key upcoming milestones for the SPS program include completing enrollment by **mid-2025**, reporting topline data in the **first half of 2026**, and targeting a Biologics License Application (BLA) filing in **2026**[1](index=1&type=chunk)[6](index=6&type=chunk) - The program has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the FDA[6](index=6&type=chunk) [Myasthenia Gravis (MG)](index=1&type=section&id=Myasthenia%20Gravis%20(MG)) The KYV-101 program for Myasthenia Gravis has completed initial enrollment for its Phase 2 trial, with interim data expected in late 2025, and holds multiple FDA and EMA designations - The Phase 2 trial in MG, KYSA-6, has completed enrollment for its initial **6-patient cohort**[5](index=5&type=chunk) - Interim data from this cohort is expected to be reported in the **second half of 2025**[5](index=5&type=chunk) - The program has received RMAT, Fast Track, and Orphan Drug designations from the FDA, as well as Orphan Drug Designation from the European Medicines Agency[7](index=7&type=chunk) [Lupus Nephritis (LN)](index=2&type=section&id=Lupus%20Nephritis%20(LN)) The KYV-101 program for Lupus Nephritis is advancing two Phase 1/2 trials, with Phase 1 data expected in late 2025, and has received Fast Track Designation from the FDA - Kyverna is advancing two Phase 1/2 trials (KYSA-1 and KYSA-3) and expects to report Phase 1 data from both in the **second half of 2025**[10](index=10&type=chunk) - The company has received Fast Track Designation from the FDA for this program[10](index=10&type=chunk) - Positive clinical data presented in **November 2024** showed sustained efficacy and durability at over **6-month follow-up** in patients with severe LN treated with KYV-101[10](index=10&type=chunk) [Additional Indications](index=2&type=section&id=Additional%20Indications) Kyverna is exploring additional opportunities for KYV-101 through sponsored and investigator-initiated trials in other autoimmune diseases - Kyverna is exploring additional opportunities for KYV-101 through sponsored and investigator-initiated trials in diseases such as systemic sclerosis and multiple sclerosis[9](index=9&type=chunk) [KYV-102 Program](index=2&type=section&id=KYV-102%20Program) KYV-102 is a next-generation candidate utilizing the same CD19 CAR T as KYV-101 but incorporates a proprietary whole-blood rapid manufacturing process. This approach aims to improve the patient experience and broaden access to CAR T therapy by eliminating the need for apheresis - Kyverna plans to file an investigational new drug (IND) application for KYV-102 in the **second half of 2025**[9](index=9&type=chunk) [Corporate Updates and Anticipated Milestones](index=2&type=section&id=Corporate%20Updates%20and%20Anticipated%20Milestones) The company announced key leadership appointments and outlined anticipated clinical and regulatory milestones for its pipeline programs [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company strengthened its leadership by appointing a new CEO, Warner Biddle, and making several other key additions to the management team. The Board of Directors was also enhanced with the appointment of Christi Shaw and Mert Aktar, who bring extensive industry and manufacturing expertise - Strengthened management team with key hires including a new CEO, Chief Medical and Development Officer, and Chief Business Officer[11](index=11&type=chunk) - Appointed Christi Shaw and Mert Aktar to the Board of Directors, adding significant corporate strategy and cell therapy manufacturing expertise[11](index=11&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) Kyverna has provided clear guidance on its upcoming clinical and regulatory milestones through 2026, focusing on completing enrollments, reporting trial data for its three priority indications, and filing its first BLA for KYV-101 Upcoming Program Milestones | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | **SPS** | Complete Pivotal Phase 2 Enrollment | mid-2025 | | | Report Topline Pivotal Phase 2 Data | 1H 2026 | | | BLA filing | 2026 | | **MG** | Confirm Registrational Path with Regulators | 1H 2025 | | | Report Interim Phase 2 Data | 2H 2025 | | **LN** | Report Phase 1 Data | 2H 2025 | | **Future Pipeline** | File KYV-102 IND application | 2H 2025 | [Financial Results](index=4&type=section&id=Financial%20Results) Kyverna reported its full-year 2024 financial performance, including a significant increase in cash position and operating expenses, leading to a wider net loss [Financial Highlights for Full Year 2024](index=4&type=section&id=Financial%20Highlights%20for%20Full%20Year%202024) For the year ended December 31, 2024, Kyverna reported a strong cash position of $286.0 million, providing a cash runway into 2027. The company's net loss increased to $127.5 million from $60.4 million in the prior year, driven by higher operating expenses Key Financial Metrics (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash, Cash Equivalents, and Marketable Securities | $286.0 million | $57.5 million | | Net Loss | $127.5 million | $60.4 million | | Net Loss Per Common Share | $3.33 | $89.61 | | Net Cash Used in Operating Activities | $114.3 million | $52.4 million | - The company expects its cash, cash equivalents, and marketable securities of **$286.0 million** to provide a cash runway into **2027**[12](index=12&type=chunk) [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) The company's operating expenses more than doubled in 2024, primarily due to a significant increase in research and development costs from $49.9 million to $112.5 million. This led to a wider loss from operations and a net loss of $127.5 million for the year Statements of Operations (in thousands) | Line Item | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $112,473 | $49,923 | | General and administrative | $30,131 | $12,483 | | **Total operating expenses** | **$142,604** | **$62,406** | | Loss from operations | ($142,604) | ($62,406) | | Total other income, net | $15,127 | $2,040 | | **Net loss** | **($127,477)** | **($60,366)** | [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of December 31, 2024, Kyverna's balance sheet showed significant growth, with total assets increasing to $304.6 million from $75.2 million in 2023. This was primarily driven by a substantial rise in cash and marketable securities. Stockholders' equity turned positive to $266.6 million from a deficit of $131.4 million, reflecting financing activities during the year Condensed Balance Sheets (in thousands) | Line Item | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $285,979 | $57,543 | | **Total assets** | **$304,645** | **$75,195** | | Total liabilities | $38,058 | $26,018 | | **Stockholders' equity (deficit)** | **$266,587** | **($131,397)** | [About Kyverna and its Products](index=4&type=section&id=About%20Kyverna%20and%20its%20Products) This section provides an overview of Kyverna Therapeutics, its lead product candidates KYV-101 and KYV-102, and their therapeutic potential [About KYV-101](index=4&type=section&id=About%20KYV-101) KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate designed for tolerability with a potent CD28 co-stimulation domain. It is being investigated for its potential to achieve deep B cell depletion and long-term remission in various B-cell-driven autoimmune diseases - KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate designed for B-cell-driven autoimmune diseases[14](index=14&type=chunk) - It is currently being evaluated in a pivotal Phase 2 trial for stiff person syndrome, a Phase 2 trial for myasthenia gravis, and Phase 1/2 trials for lupus nephritis[15](index=15&type=chunk) [About KYV-102](index=4&type=section&id=About%20KYV-102) KYV-102 is a next-generation therapy that uses the same clinically validated CD19 CAR-T construct as KYV-101. It incorporates the proprietary Ingenui-T platform, which enables a rapid manufacturing process using whole blood, aiming to eliminate the need for apheresis and broaden patient access - KYV-102 leverages the same CAR-T construct as KYV-101 but incorporates the Ingenui-T platform, a proprietary, next-generation process[16](index=16&type=chunk) - The platform utilizes whole blood with a rapid manufacturing approach, aiming to eliminate the need for apheresis and reduce manufacturing turnaround time[16](index=16&type=chunk) [About Kyverna Therapeutics](index=4&type=section&id=About%20Kyverna%20Therapeutics) Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on the curative potential of cell therapy for patients with autoimmune diseases. Its lead candidate, KYV-101, is advancing through multiple clinical trials, and its pipeline includes next-generation autologous and allogeneic CAR T-cell therapies - Kyverna is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases[17](index=17&type=chunk) - The company's lead candidate, KYV-101, is in Phase 2 trials for stiff person syndrome and myasthenia gravis, and Phase 1/2 trials for lupus nephritis[17](index=17&type=chunk)

Core Insights - Kyverna Therapeutics is advancing its clinical programs for KYV-101, targeting stiff person syndrome, myasthenia gravis, and lupus nephritis, with a clear path to commercialization [2][7][17] - The company has aligned with the FDA on a registrational Phase 2 trial design for KYSA-8 in stiff person syndrome, with 70% enrollment completed and topline data expected in the first half of 2026 [7][11] - Financially, Kyverna reported $286 million in cash and equivalents as of December 31, 2024, providing a cash runway into 2027 [11][21] Clinical Development - KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate, currently in pivotal Phase 2 trials for stiff person syndrome and myasthenia gravis, and Phase 1/2 trials for lupus nephritis [3][15] - The company expects to report interim data from the Phase 2 trial in myasthenia gravis in the second half of 2025, and Phase 1 data from lupus nephritis trials in the same timeframe [6][7] - Kyverna is also exploring additional indications for KYV-101 through investigator-initiated trials across various autoimmune diseases [9][17] Financial Performance - For the year ended December 31, 2024, Kyverna reported a net loss of $127.5 million, or $3.33 per share, compared to a net loss of $60.4 million, or $89.61 per share, in 2023 [12][20] - Operating expenses increased significantly, with research and development costs rising to $112.5 million from $49.9 million in the previous year [20] - The company’s total assets as of December 31, 2024, were $304.6 million, a substantial increase from $75.2 million in 2023 [21] Strategic Initiatives - Kyverna has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for its programs [7][8] - The company is strengthening its management team to support its growth strategy, with key appointments in executive roles [13] - Future plans include filing an investigational new drug application for KYV-102 in the second half of 2025, which aims to improve patient access to CAR T therapies [9][16]

Core Insights - Kyverana Therapeutics (NASDAQ: KYTX) is preparing for multiple catalysts in the coming years, aiming to be among the first to potentially receive regulatory approval for a CAR-T therapy [2] Group 1 - The company is focused on developing CAR-T therapies, which are a type of immunotherapy used to treat certain types of cancer [2] - Kyverana Therapeutics is part of a broader trend in the biotech industry, where companies are increasingly investing in innovative therapies to address unmet medical needs [2]

Core Viewpoint - Kyverna Therapeutics, Inc. (KYTX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Kyverna Therapeutics indicates an expected loss of -$3.29 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 96.3% [9]. - Over the past three months, analysts have raised their earnings estimates for Kyverna Therapeutics by 7.9% [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is crucial for stock price movements [2][3]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Kyverna Therapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased common stock of Kyverna Therapeutics, Inc. during its IPO on February 8, 2024, about the lead plaintiff deadline of February 7, 2025, for a class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased Kyverna common stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by February 7, 2025 [3]. - The lawsuit claims that Kyverna's IPO registration statement and prospectus misrepresented facts regarding the clinical trial results of its lead product candidate, KYV-101, leading to investor damages when the true information was revealed [5]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].