Core Insights - The biotechnology sector is witnessing significant innovation, particularly in advanced therapies for complex diseases, with a focus on autoimmune disorders and cell therapies [1] Company Overview - Kyverna Therapeutics Inc. is a small-cap biotechnology company specializing in cell therapies for autoimmune disorders [1] - The company has reported $211.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which is expected to fund operations into 2027 [4] Clinical Development - Kyverna's lead CAR T-cell therapy candidate, KYV-101, is in late-stage clinical development, with registrational trials for stiff person syndrome (SPS) and myasthenia gravis (MG), along with ongoing Phase 1/2 trials for lupus nephritis [2] - Topline data for the registrational Phase 2 trial of KYV-101 in SPS and BLA submission is anticipated in the first half of 2026 [2] - The Phase 3 trial for KYV-101 in MG will include approximately 60 patients, with enrollment expected to start by the end of 2025, and interim Phase 2 data is anticipated in Q4 2025 [3] Market Position and Analyst Insights - William Blair analyst Sami Corwin believes Kyverna is on track to potentially have the first FDA-approved CAR-T therapy for an autoimmune disease, which could establish the company as a leader in this field [5][6] - The upcoming Phase 3 data readout for KYV-101 is considered de-risked based on positive outcomes from compassionate use cases [5] - William Blair initiated coverage with an Outperform rating and a fair value estimate of $27, primarily driven by the potential of KYV-101 [7] - Kyverna Therapeutics shares increased by 4.85% to $3.46 at the time of publication [7]

PART I. FINANCIAL INFORMATION This section presents Kyverna Therapeutics' unaudited financial statements, management's analysis, market risk disclosures, and internal controls evaluation [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Kyverna Therapeutics, Inc.'s unaudited condensed financial statements, including the balance sheets, statements of operations and comprehensive income (loss), statements of stockholders' equity (deficit), and statements of cash flows, along with their accompanying notes, for the periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time | Metric (in thousands) | Dec 31, 2024 | Jun 30, 2025 | Change | | :-------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $96,621 | $53,440 | $(43,181) | | Available-for-sale marketable securities | $189,358 | $158,237 | $(31,121) | | Total current assets | $290,601 | $214,327 | $(76,274) | | Total assets | $304,645 | $226,508 | $(78,137) | | Total current liabilities | $33,756 | $39,789 | $6,033 | | Total liabilities | $38,058 | $42,131 | $4,073 | | Total stockholders' equity | $266,587 | $184,377 | $(82,210) | [Condensed Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This section outlines the company's financial performance, detailing revenues, expenses, and net loss over specific reporting periods | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | Change (%) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | Change (%) | | :-------------------- | :-------------------------- | :-------------------------- | :--------- | :-------------------------- | :-------------------------- | :--------- | | Research and development | $35,816 | $27,321 | 31% | $73,249 | $49,797 | 47% | | General and administrative | $8,594 | $6,114 | 41% | $18,569 | $12,996 | 43% | | Total operating expenses | $44,410 | $33,435 | 33% | $91,818 | $62,793 | 46% | | Net loss | $(42,081) | $(28,803) | 46% | $(86,716) | $(55,496) | 56% | | Net loss per share (basic and diluted) | $(0.97) | $(0.67) | 45% | $(2.01) | $(1.66) | 21% | [Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section details the changes in the company's equity, including additional paid-in capital and accumulated deficit, over time | Metric (in thousands) | Dec 31, 2024 | Mar 31, 2025 | Jun 30, 2025 | | :-------------------- | :----------- | :----------- | :----------- | | Additional paid-in capital | $530,002 | $532,162 | $534,633 | | Accumulated deficit | $(263,520) | $(308,155) | $(350,236) | | Total stockholders' equity | $266,587 | $224,010 | $184,377 | - Net loss for the three months ended June 30, 2025, was **$(42,081) thousand**, and for the six months ended June 30, 2025, was **$(86,716) thousand**, contributing to the **accumulated deficit**[13](index=13&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities over specific periods | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :----- | | Net cash used in operating activities | $(76,864) | $(49,700) | $(27,164) | | Net cash provided by (used in) investing activities | $34,745 | $(190,800) | $225,545 | | Net cash (used in) provided by financing activities | $(1,063) | $337,480 | $(338,543) | | Net (decrease) increase in cash and cash equivalents and restricted cash | $(43,182) | $96,980 | $(140,162) | | Cash, cash equivalents and restricted cash, at end of period | $53,991 | $132,192 | $(78,201) | - The significant increase in cash provided by investing activities in 2025 was primarily due to **$210.8 million in proceeds from maturities of available-for-sale marketable securities**, offsetting **$175.9 million in purchases**[151](index=151&type=chunk) - The substantial decrease in cash provided by financing activities in 2025 compared to 2024 is mainly due to the **absence of IPO proceeds**, which provided **$341.2 million in 2024**[154](index=154&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information supporting the unaudited condensed financial statements [1. Description of Business, Organization and Liquidity](index=7&type=section&id=1.%20Description%20of%20Business%2C%20Organization%20and%20Liquidity) This section describes the company's biopharmaceutical business, organizational structure, and current liquidity position - Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, with **KYV-101 as its lead product candidate**[18](index=18&type=chunk) - The company has an **accumulated deficit of $350.2 million** as of June 30, 2025, and reported **net losses of $86.7 million** for the six months ended June 30, 2025[19](index=19&type=chunk) - As of June 30, 2025, the company had **$211.7 million in cash, cash equivalents, and available-for-sale marketable securities**, which management estimates will fund operations for at least the **next 12 months**[20](index=20&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and policies used in preparing the financial statements - Financial statements are prepared under **U.S. GAAP for interim reporting**, with management making estimates and assumptions[21](index=21&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) - No material changes to accounting policies since December 31, 2024, 10-K filing[26](index=26&type=chunk) - Evaluating impact of **ASU No. 2023-09 (Income Taxes)** effective after December 15, 2024, and **ASU No. 2024-03 (Expense Disaggregation)** effective after December 15, 2026[27](index=27&type=chunk)[28](index=28&type=chunk) [3. Fair Value Measurements and Fair Value of Financial Instruments](index=8&type=section&id=3.%20Fair%20Value%20Measurements%20and%20Fair%20Value%20of%20Financial%20Instruments) This section details the methodology and categorization of fair value measurements for financial instruments - Fair value measurements are categorized into a **three-tier hierarchy**: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1 prices), and Level 3 (unobservable inputs)[29](index=29&type=chunk)[30](index=30&type=chunk) | Financial Instrument (in thousands) | Total Fair Value (Jun 30, 2025) | Level 1 | Level 2 | Level 3 | | :-------------------------------- | :------------------------------ | :------ | :------ | :------ | | Money market funds | $28,274 | $28,274 | $— | $— | | Corporate debt obligations | $14,194 | $— | $14,194 | $— | | U.S. Treasury bills (Cash equivalents) | $9,598 | $— | $9,598 | $— | | U.S. Treasury bills (Available-for-sale) | $158,236 | $— | $158,236 | $— | | Total fair value of assets | $210,302 | $28,274 | $182,028 | $— | [4. Available-for-Sale Marketable Securities](index=9&type=section&id=4.%20Available-for-Sale%20Marketable%20Securities) This section provides details on the company's available-for-sale marketable securities, including their cost and fair value | Security Type (in thousands) | Amortized Cost (Jun 30, 2025) | Unrealized Gains | Unrealized Losses | Estimated Fair Value (Jun 30, 2025) | | :--------------------------- | :---------------------------- | :--------------- | :---------------- | :---------------------------------- | | Money market funds | $28,274 | $— | $— | $28,274 | | U.S. Treasury bills | $167,852 | $4 | $(22) | $167,834 | | Corporate debt obligations | $14,195 | $— | $(1) | $14,194 | | Total | $210,321 | $4 | $(23) | $210,302 | - No significant creditworthiness deterioration or impairment losses were recognized for marketable securities during the three and six months ended June 30, 2025 and 2024[34](index=34&type=chunk) [5. Balance Sheet Components](index=10&type=section&id=5.%20Balance%20Sheet%20Components) This section provides a detailed breakdown of specific components within the balance sheet, such as property and accrued expenses | Property and Equipment (in thousands) | Dec 31, 2024 | Jun 30, 2025 | | :------------------------------------ | :----------- | :----------- | | Property and equipment, gross | $7,019 | $6,374 | | Less accumulated depreciation | $(3,672) | $(4,212) | | Property and equipment, net | $3,347 | $2,162 | - The company recognized **$0.6 million in impairment charges** related to capitalized software during the six months ended June 30, 2025[36](index=36&type=chunk) | Other Accrued Expenses (in thousands) | Dec 31, 2024 | Jun 30, 2025 | | :------------------------------------ | :----------- | :----------- | | Accrued R&D expenses - Contract Research Organizations | $5,669 | $9,534 | | Accrued R&D expenses - Contract Manufacturing Organizations | $5,487 | $4,309 | | Other accrued expenses | $2,903 | $1,232 | | Total | $14,059 | $15,075 | [6. License and Collaboration Agreements](index=11&type=section&id=6.%20License%20and%20Collaboration%20Agreements) This section outlines the company's significant licensing and collaboration agreements and their associated financial terms - Kyverna has exclusive, worldwide licenses from NIH for anti-CD19 CAR technology for autoimmune disease, requiring **minimum annual royalty payments of $0.2 million** and **cumulative benchmark royalties up to $7.4 million** for FDA approval[39](index=39&type=chunk)[40](index=40&type=chunk) - The Intellia Agreement grants an exclusive license for an allogeneic CD19-directed CAR cell therapy, with potential aggregate milestone payments up to **$64.5 million** and **low to mid-single-digit royalties on sales**[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - The Kite Agreement (related party) provides a co-exclusive license for SynNotch technology, with a **$6.3 million sublicensing fee** recorded as current accrued license expense as of June 30, 2025, and December 31, 2024[51](index=51&type=chunk)[54](index=54&type=chunk)[57](index=57&type=chunk) [7. Commitments and Contingent Liabilities](index=13&type=section&id=7.%20Commitments%20and%20Contingent%20Liabilities) This section details the company's contractual commitments and potential financial obligations from legal proceedings | Lease Type (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Operating lease cost | $850 | $854 | $1,700 | $1,543 | | Finance lease cost | $250 | $275 | $507 | $557 | | Total lease expense | $1,385 | $1,391 | $2,864 | $2,653 | - Total undiscounted lease obligations as of June 30, 2025, were **$6.0 million for operating leases** and **$0.3 million for finance leases**[59](index=59&type=chunk) - The company is a defendant in a shareholder class action and derivative lawsuits alleging material misstatements in its IPO registration statement, but believes it has **good defenses** and has **not accrued any loss**[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) [8. Stockholders' Equity](index=15&type=section&id=8.%20Stockholders'%20Equity) This section details changes in stockholders' equity, including shares reserved for future issuance and IPO proceeds | Shares Reserved for Future Issuance | Jun 30, 2025 | Dec 31, 2024 | | :---------------------------------- | :----------- | :----------- | | Outstanding stock option awards | 9,938,939 | 7,595,922 | | Unvested restricted stock units awards | 1,248,529 | 549,001 | | Shares available for future grants (2024 Equity Incentive Plan and 2024 Inducement Equity Incentive Plan) | 3,000,428 | 3,562,709 | | Shares available for future grants (Employee Stock Purchase Plan) | 844,000 | 422,000 | | Total shares reserved | 15,031,896 | 12,129,632 | - The company completed its IPO on February 12, 2024, issuing **16,675,000 shares of common stock at $22.00 per share**, resulting in **net proceeds of $336.2 million**[71](index=71&type=chunk) - A shelf registration statement (Form S-3) for up to **$250.0 million in securities**, including a **$50.0 million ATM Prospectus**, was declared effective on April 15, 2025[70](index=70&type=chunk) [9. Equity Incentive Plans](index=16&type=section&id=9.%20Equity%20Incentive%20Plans) This section describes the company's equity incentive plans and the associated stock-based compensation expenses - The company's 2024 Equity Incentive Plan superseded the 2019 Plan, with **3,571,058 awards granted** and **2,804,687 shares reserved for future issuance** as of June 30, 2025[72](index=72&type=chunk)[73](index=73&type=chunk) | Stock-Based Compensation Expense (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :-------------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $898 | $695 | $1,704 | $1,277 | | General and administrative | $1,620 | $589 | $2,975 | $2,285 | | Total stock-based compensation expense | $2,518 | $1,284 | $4,679 | $3,562 | - As of June 30, 2025, total unrecognized stock-based compensation expense was **$30.4 million** (expected over **3.1 years**) and for RSUs was **$3.9 million** (expected over **3.2 years**)[77](index=77&type=chunk)[79](index=79&type=chunk) [10. Net Loss Per Share Attributable to Common Stockholders](index=19&type=section&id=10.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This section details the calculation of net loss per share for common stockholders, including potential dilutive shares | Metric | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :------------------------------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss attributable to common stockholders (in thousands) | $(42,081) | $(28,803) | $(86,716) | $(55,496) | | Weighted average shares outstanding (basic and diluted) | 43,225,365 | 43,125,709 | 43,220,498 | 33,439,886 | | Net loss per share (basic and diluted) | $(0.97) | $(0.67) | $(2.01) | $(1.66) | | Potential Common Shares Excluded from Diluted EPS | As of Jun 30, 2025 | As of Jun 30, 2024 | | :------------------------------------------------ | :----------------- | :----------------- | | Options issued and outstanding | 9,938,939 | 4,169,964 | | Restricted stock units | 1,248,529 | 5,000 | | Total | 11,187,468 | 4,174,964 | [11. Income Taxes](index=20&type=section&id=11.%20Income%20Taxes) This section discusses the company's income tax position and the impact of recent tax legislation - The company is assessing the impact of the **One Big Beautiful Bill Act (OBBBA)**, enacted July 4, 2025, on its financial statements, particularly regarding R&D expense capitalization and accelerated fixed asset depreciation[85](index=85&type=chunk) [12. Related Party Transactions](index=20&type=section&id=12.%20Related%20Party%20Transactions) This section discloses transactions and arrangements involving the company and its related parties - A **$1.1 million promissory note** and accrued interest from the former CEO, related to early exercised options, was **forgiven on January 12, 2024**[86](index=86&type=chunk) - **$0.4 million in severance payments** to the former CEO was recorded as accrued expenses as of June 30, 2025, and December 31, 2024[87](index=87&type=chunk) [13. Segment Reporting](index=20&type=section&id=13.%20Segment%20Reporting) This section provides financial information about the company's operating segments, which is a single reportable segment - The company operates as a **single reportable segment** focused on developing therapies for autoimmune and inflammatory diseases[88](index=88&type=chunk) | Segment Expense (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | | :----------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | KYV-101 program | $22,541 | $13,326 | $44,661 | $24,323 | | Other programs | $986 | $512 | $1,498 | $3,140 | | Other R&D expenses | $12,289 | $13,483 | $27,090 | $22,334 | | General and administrative expenses | $8,594 | $6,114 | $18,569 | $12,996 | | Segment Loss and Net loss | $42,081 | $28,803 | $86,716 | $55,496 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Kyverna Therapeutics' financial condition and results of operations for the periods presented, highlighting key financial trends, operational activities, and future outlook. It includes an overview of the company's business, a breakdown of operating expenses, a comparison of financial results, and a discussion of liquidity and capital resources [SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=21&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions readers that the report contains forward-looking statements subject to significant risks and uncertainties - The report contains forward-looking statements regarding future operations, financial position, business strategy, and product candidates, subject to **substantial risks and uncertainties**[92](index=92&type=chunk)[94](index=94&type=chunk) - Actual results and timing of events could differ materially from forward-looking statements due to factors outlined in the **"Risk Factors" section**[90](index=90&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk) [Overview](index=23&type=section&id=Overview) This section provides a high-level summary of Kyverna's biopharmaceutical business, lead product candidate, and financial position - Kyverna is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, with **KYV-101 as its lead product candidate**[98](index=98&type=chunk) - Enrollment for the pivotal Phase 2 trial in Stiff Person Syndrome (SPS) (KYSA-8) was **completed in Q2 2025**, with data expected in **H1 2026**[101](index=101&type=chunk) - Enrollment for the Phase 2 trial in Generalized Myasthenia Gravis (MG) (KYSA-6) was completed, with **interim data expected in Q4 2025**, and a Phase 3 portion to begin by **end of 2025**[102](index=102&type=chunk) - The company had an **accumulated deficit of $350.2 million** as of June 30, 2025, and expects current cash and marketable securities (**$211.7 million**) to fund operations **into 2027**[106](index=106&type=chunk)[107](index=107&type=chunk) [Components of Operating Results](index=26&type=section&id=Components%20of%20Operating%20Results) This section breaks down the primary elements contributing to the company's operating expenses and other income/expense - Operating expenses are primarily composed of **research and development (R&D)** and **general and administrative (G&A) expenses**[115](index=115&type=chunk) - R&D expenses, which include costs for clinical studies, manufacturing, and licensing, are expected to **increase substantially** as product candidates advance[116](index=116&type=chunk)[118](index=118&type=chunk) - Interest income is derived from available-for-sale marketable securities and cash equivalents, while interest expense relates to laboratory equipment finance leases[120](index=120&type=chunk)[121](index=121&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance by comparing key metrics across different reporting periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=28&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial performance for the three-month periods ended June 30, 2025, and 2024 | Metric (in thousands) | 3 Months Ended Jun 30, 2025 | 3 Months Ended Jun 30, 2024 | Change ($) | Change (%) | | :-------------------- | :-------------------------- | :-------------------------- | :--------- | :--------- | | Research and development | $35,816 | $27,321 | $8,495 | 31% | | General and administrative | $8,594 | $6,114 | $2,480 | 41% | | Total operating expenses | $44,410 | $33,435 | $10,975 | 33% | | Interest income | $2,364 | $4,694 | $(2,330) | (50)% | | Net loss | $(42,081) | $(28,803) | $(13,278) | 46% | - KYV-101 program R&D expenses increased by **$9.2 million (69%)** due to a **$8.9 million increase in CMO costs** for CMC investment and a **$2.0 million increase in CRO costs** for accelerated trial enrollment[125](index=125&type=chunk) - General and administrative expenses increased by **$2.5 million (41%)** primarily due to a **$3.1 million increase in personnel-related costs**, including stock-based compensation[129](index=129&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=30&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial performance for the six-month periods ended June 30, 2025, and 2024 | Metric (in thousands) | 6 Months Ended Jun 30, 2025 | 6 Months Ended Jun 30, 2024 | Change ($) | Change (%) | | :-------------------- | :-------------------------- | :-------------------------- | :--------- | :--------- | | Research and development | $73,249 | $49,797 | $23,452 | 47% | | General and administrative | $18,569 | $12,996 | $5,573 | 43% | | Total operating expenses | $91,818 | $62,793 | $29,025 | 46% | | Interest income | $5,189 | $7,429 | $(2,240) | (30)% | | Net loss | $(86,716) | $(55,496) | $(31,220) | 56% | - KYV-101 program R&D expenses increased by **$20.3 million (84%)** due to a **$16.6 million increase in CMO costs** and a **$6.4 million increase in CRO costs**[133](index=133&type=chunk) - General and administrative expenses increased by **$5.6 million (43%)**, primarily due to a **$5.5 million increase in personnel-related costs**, including stock-based compensation[137](index=137&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and future capital requirements for operations - As of June 30, 2025, Kyverna had **$211.7 million in cash, cash equivalents, and available-for-sale marketable securities**, estimated to fund operations for at least **one year**[139](index=139&type=chunk)[142](index=142&type=chunk) - The company filed a shelf registration statement (Form S-3) for up to **$250.0 million in securities**, including a **$50.0 million ATM Prospectus**, declared effective on April 15, 2025[140](index=140&type=chunk) - Future funding requirements are substantial and depend on the progress of preclinical and clinical trials, regulatory approvals, manufacturing costs, and commercialization efforts[141](index=141&type=chunk)[144](index=144&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section addresses the impact of new accounting standards on the company's financial reporting - Refer to Note 2 for details on recently issued accounting pronouncements and their potential impact on financial statements[158](index=158&type=chunk) [Critical Accounting Estimates](index=35&type=section&id=Critical%20Accounting%20Estimates) This section highlights the significant accounting estimates and judgments made in preparing the financial statements - No material changes to significant accounting policies or critical accounting estimates during the six months ended June 30, 2025[159](index=159&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=35&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) This section explains the company's regulatory status and the associated disclosure and compliance implications - Kyverna is an **"emerging growth company"** and **"smaller reporting company,"** enabling it to use extended transition periods for new accounting standards and reduced disclosure requirements[160](index=160&type=chunk)[161](index=161&type=chunk) - This status may make the common stock less attractive to investors, potentially leading to a less active trading market and more volatile share price[160](index=160&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Kyverna Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Kyverna Therapeutics is **exempt from providing quantitative and qualitative disclosures about market risk**[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of Kyverna's disclosure controls and procedures, identifying material weaknesses in internal control over financial reporting. It outlines the remediation efforts undertaken and acknowledges the inherent limitations of control systems [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section assesses the effectiveness of the company's disclosure controls and procedures, noting identified material weaknesses - Management concluded that disclosure controls and procedures were **not effective** as of June 30, 2025, due to **material weaknesses in internal control over financial reporting**[164](index=164&type=chunk) - Material weaknesses include **insufficient qualified resources**, **ineffective risk identification**, and **insufficient evaluation of internal control components** across financial statement areas[166](index=166&type=chunk)[167](index=167&type=chunk) - Despite the material weaknesses, management believes the financial statements **fairly present** the company's financial position, results of operations, and cash flows[169](index=169&type=chunk) [Remediation Plans](index=36&type=section&id=Remediation%20Plans) This section outlines the company's strategies and actions to address and resolve identified material weaknesses in internal controls - Management has taken substantial measures to remediate material weaknesses, including **hiring additional accounting and IT personnel** and **completing annual risk assessments**[170](index=170&type=chunk)[175](index=175&type=chunk) - Entity-level controls and general controls over information systems have been designed and implemented, along with necessary management review controls[175](index=175&type=chunk) - As of June 30, 2025, controls have not operated for a sufficient period to fully conclude that material weaknesses have been remediated[172](index=172&type=chunk) [Changes in Internal Control Over Financial Reporting](index=37&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports on any material changes in the company's internal control over financial reporting during the quarter - No other material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, beyond the ongoing remediation efforts[173](index=173&type=chunk) [Limitations on the Effectiveness of Controls](index=37&type=section&id=Limitations%20on%20the%20Effectiveness%20of%20Controls) This section acknowledges the inherent limitations of internal control systems, which prevent absolute assurance against all risks - Inherent limitations in control systems mean **absolute assurance against all control issues or fraud cannot be provided**[174](index=174&type=chunk) - Controls can be circumvented by individual acts, collusion, or management override, and their effectiveness may deteriorate over time[174](index=174&type=chunk) PART II. OTHER INFORMATION This section provides additional information including legal proceedings, comprehensive risk factors, equity sales, and required exhibits [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) Kyverna is involved in a shareholder class action and consolidated derivative lawsuits alleging material misstatements in its IPO registration statement. Motions to dismiss have been filed, and derivative actions are stayed pending the class action's disposition. The company believes it has strong defenses and has not accrued any loss, but litigation could adversely impact the business - A shareholder class action and consolidated derivative lawsuits were filed in December 2024 and May 2025, respectively, alleging **material misstatements in the IPO registration statement**[177](index=177&type=chunk)[178](index=178&type=chunk) - Defendants filed a motion to dismiss the amended class action complaint on June 26, 2025, and derivative actions are **stayed pending its disposition**[177](index=177&type=chunk)[178](index=178&type=chunk) - Kyverna believes it has **good defenses** and has **not accrued any loss**, but acknowledges litigation can have an adverse impact due to costs, diversion of resources, and reputational harm[179](index=179&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Investing in Kyverna's common stock involves a high degree of risk, including the company's limited operating history, substantial net losses, need for additional capital, dependence on product candidate success, material weaknesses in internal controls, and intense competition. The section details risks related to business operations, R&D, intellectual property, government regulation, data privacy, and reliance on third parties - Investing in Kyverna's common stock involves a **high degree of risk** due to its **limited operating history**, **substantial net losses**, and **need for additional capital**[181](index=181&type=chunk)[183](index=183&type=chunk)[188](index=188&type=chunk) - Key risks include **dependence on product candidate success**, **material weaknesses in internal control over financial reporting**, and **intense competition** from established pharmaceutical and biotechnology companies[181](index=181&type=chunk)[193](index=193&type=chunk)[200](index=200&type=chunk)[256](index=256&type=chunk) - The company faces risks related to lengthy and expensive preclinical/clinical development, potential side effects, intellectual property protection, evolving government regulations, data privacy and security, and reliance on third-party manufacturers and CROs[181](index=181&type=chunk)[239](index=239&type=chunk)[263](index=263&type=chunk)[286](index=286&type=chunk)[353](index=353&type=chunk)[420](index=420&type=chunk)[443](index=443&type=chunk) [Risk Factor Summary](index=38&type=section&id=Risk%20Factor%20Summary) This section provides a concise overview of the most significant risks associated with investing in the company's common stock - Kyverna has a **limited operating history**, **substantial net losses**, and requires **significant additional capital**, with no products approved for commercial sale[181](index=181&type=chunk) - The business depends entirely on the **successful development, regulatory approval, and commercialization of its product candidates**, which is a lengthy, expensive, and uncertain process[181](index=181&type=chunk) - **Material weaknesses in internal control over financial reporting**, intense competition, potential side effects, reliance on third-party manufacturers and CROs, and intellectual property challenges are significant risks[181](index=181&type=chunk) [Risks Related to Our Business, Limited Operating History and Financial Position](index=40&type=section&id=Risks%20Related%20to%20Our%20Business%2C%20Limited%20Operating%20History%20and%20Financial%20Position) This section details risks stemming from the company's nascent operations, historical financial losses, and capital requirements - Kyverna has a **limited operating history**, no approved products, and an **accumulated deficit of $350.2 million** as of June 30, 2025, with expected continued losses[183](index=183&type=chunk) - **Substantial additional capital is required** to finance operations, and failure to raise it could delay or eliminate R&D programs or commercialization efforts[188](index=188&type=chunk)[192](index=192&type=chunk) - **Material weaknesses in internal control over financial reporting** persist as of June 30, 2025, potentially affecting accurate financial reporting and investor confidence[200](index=200&type=chunk)[203](index=203&type=chunk)[207](index=207&type=chunk) - The company is subject to **securities litigation**, including a class action and derivative lawsuits, which are expensive and divert management attention[229](index=229&type=chunk)[230](index=230&type=chunk) [Risks Related to Research, Development and Commercialization](index=51&type=section&id=Risks%20Related%20to%20Research%2C%20Development%20and%20Commercialization) This section outlines risks inherent in the lengthy, expensive, and uncertain process of developing and commercializing product candidates - The company has not completed large-scale clinical trials, and product candidates face a **high risk of failure** due to the lengthy, expensive, and uncertain development process[231](index=231&type=chunk)[239](index=239&type=chunk) - Results from investigator-initiated trials or named patient activities are **not representative of controlled clinical trials** and cannot be used for regulatory approval, potentially identifying concerns that impact clinical development[233](index=233&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Reliance on third-party CROs and CMOs for clinical trials and manufacturing exposes the company to risks of **delays, increased costs, and non-compliance** with regulatory requirements (e.g., cGMPs)[241](index=241&type=chunk)[281](index=281&type=chunk)[285](index=285&type=chunk) - Undesirable side effects or unexpected characteristics of product candidates could lead to **trial suspensions, abandonment, or restrictive labeling**, severely harming business[263](index=263&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) [Risks Related to Intellectual Property](index=65&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section addresses risks concerning the company's ability to obtain, maintain, and defend its intellectual property rights - Kyverna is dependent on intellectual property licensed from third parties (e.g., NIH for KYV-101), and **termination of these licenses could result in loss of significant rights**[286](index=286&type=chunk)[290](index=290&type=chunk) - Obtaining and maintaining sufficient patent protection is expensive, time-consuming, and uncertain, with risks of patents being **challenged, invalidated, or infringed by competitors**[291](index=291&type=chunk)[292](index=292&type=chunk)[295](index=295&type=chunk)[298](index=298&type=chunk) - The company faces risks of **infringing third-party patents**, leading to costly lawsuits, injunctions, or royalty payments, which could prevent or delay commercialization[319](index=319&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk) - Changes in patent law (e.g., Leahy-Smith Act, UPC in Europe) and the difficulty of protecting trade secrets could diminish the value of intellectual property and competitive position[338](index=338&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) [Risks Related to Government Regulation](index=78&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section details risks associated with regulatory approvals, compliance, and evolving healthcare laws and policies - The company is subject to numerous environmental, health, and safety laws, and **non-compliance could lead to fines, penalties, or operational disruptions**[348](index=348&type=chunk)[349](index=349&type=chunk) - Regulatory approval processes (FDA, foreign authorities) are **lengthy, unpredictable, and costly**, with no assurance of success or broad indications[353](index=353&type=chunk)[354](index=354&type=chunk)[358](index=358&type=chunk) - The FDA's investigation into T-cell malignancy risk with CAR T-cell therapies (like KYV-101) could **delay approval, require boxed warnings, or lead to a different risk-benefit assessment** for autoimmune indications[360](index=360&type=chunk) - Commercialization faces challenges from **unfavorable pricing regulations, limited third-party reimbursement**, and increasing healthcare cost-containment initiatives (e.g., IRA, state drug pricing laws)[363](index=363&type=chunk)[365](index=365&type=chunk)[368](index=368&type=chunk)[370](index=370&type=chunk) - Relationships with healthcare providers are subject to **anti-kickback, fraud, and abuse laws**, with potential for criminal sanctions, civil penalties, and reputational harm[375](index=375&type=chunk)[376](index=376&type=chunk) - Disruptions at government agencies (FDA, SEC) due to funding changes or shutdowns could hinder timely review and approval of product candidates[416](index=416&type=chunk)[417](index=417&type=chunk) [Risks Related to Data and Privacy](index=96&type=section&id=Risks%20Related%20to%20Data%20and%20Privacy) This section outlines risks related to cybersecurity threats, data breaches, and compliance with complex data privacy regulations - Internal IT systems and those of third-party partners are vulnerable to **cyberattacks, malware, and other security incidents**, risking operational disruption, data loss, and reputational harm[422](index=422&type=chunk)[423](index=423&type=chunk)[428](index=428&type=chunk)[429](index=429&type=chunk) - Compliance with federal and state data privacy laws (e.g., HIPAA, CCPA, CPRA) is complex and costly, with potential for **significant civil/criminal penalties and private litigation** for non-compliance[432](index=432&type=chunk)[435](index=435&type=chunk)[436](index=436&type=chunk) - Foreign data protection laws, including GDPR and the UK GDPR, impose stringent requirements and **substantial fines (up to €20 million or 4% of global revenue)** for breaches[437](index=437&type=chunk) - The NIS 2 Directive in Europe imposes new cybersecurity obligations and potential fines for in-scope organizations, including those in R&D of medicinal products[439](index=439&type=chunk) - Artificial intelligence tools pose new security risks to confidential information and personal data, and their use by vendors may not meet evolving regulatory standards[442](index=442&type=chunk) [Risks Related to Our Reliance on Third Parties](index=100&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section details risks arising from the company's dependence on third parties for research, development, manufacturing, and supply - Kyverna relies on third-party CROs, clinical investigators, and data management organizations for preclinical studies and clinical trials, reducing control over timing and quality[443](index=443&type=chunk)[444](index=444&type=chunk)[447](index=447&type=chunk) - Reliance on third-party CMOs for manufacturing exposes the company to risks of **supply limitations, quality issues, non-compliance with cGMPs**, and potential delays or increased costs if manufacturers fail to perform or are replaced[452](index=452&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk)[457](index=457&type=chunk) - Dependence on limited source suppliers for critical materials poses risks of **supply disruptions, increased costs, and delays** in clinical trials if long-term contracts are not secured or suppliers fail[459](index=459&type=chunk)[462](index=462&type=chunk)[463](index=463&type=chunk) - Future collaborations are crucial but complex, with risks that partners may not commit sufficient resources, pursue competing products, or terminate agreements, impacting funding and development[465](index=465&type=chunk)[468](index=468&type=chunk)[469](index=469&type=chunk) [Risks Related to Ownership of Our Common Stock](index=107&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section addresses risks concerning the volatility of common stock, potential dilution, and corporate governance provisions - The market price of Kyverna's common stock is **highly volatile**, influenced by clinical trial results, competitor announcements, and general economic conditions[473](index=473&type=chunk)[474](index=474&type=chunk) - Quarterly and annual operating results are expected to fluctuate, and failure to meet expectations could cause the **stock price to decline**[476](index=476&type=chunk)[479](index=479&type=chunk) - Future issuances of equity or convertible debt, including shares from equity incentive plans and the shelf registration statement, would **dilute existing stockholders' ownership**[482](index=482&type=chunk)[486](index=486&type=chunk)[492](index=492&type=chunk)[493](index=493&type=chunk) - Anti-takeover provisions in charter documents and Delaware law, along with exclusive forum provisions, could **delay acquisitions** and limit stockholders' ability to influence corporate actions or obtain favorable judicial forums[502](index=502&type=chunk)[503](index=503&type=chunk)[504](index=504&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=117&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Kyverna had no unregistered sales of equity securities. The company closed its IPO on February 12, 2024, issuing 16,675,000 common shares at $22.00 per share, generating $336.2 million in net proceeds. These proceeds have been invested in money market funds and fixed-income securities, with no material change in planned use - No unregistered sales of equity securities occurred[511](index=511&type=chunk) - The IPO closed on February 12, 2024, issuing **16,675,000 common shares at $22.00 per share**, yielding **$336.2 million in net proceeds**[512](index=512&type=chunk) - IPO net proceeds are invested in money market funds and high-quality, fixed-income securities, with no material change in planned use[513](index=513&type=chunk) [Item 3. Defaults Upon Senior Securities](index=117&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to Kyverna Therapeutics - This item is not applicable[515](index=515&type=chunk) [Item 4. Mine Safety Disclosures](index=117&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Kyverna Therapeutics - This item is not applicable[516](index=516&type=chunk) [Item 5. Other Information](index=117&type=section&id=Item%205.%20Other%20Information) During the fiscal quarter ended June 30, 2025, none of Kyverna's directors or officers adopted or terminated any Rule 10b5-1 trading arrangements - No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[517](index=517&type=chunk) [Item 6. Exhibits](index=118&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Certificate of Incorporation and Bylaws, employment offer letters, and certifications of principal executive and financial officers - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, employment offer letters for key personnel, and certifications of principal executive and financial officers[518](index=518&type=chunk)

[Kyverna Therapeutics Business Update and Second Quarter 2025 Financial Results](index=1&type=section&id=Kyverna%20Therapeutics%20Business%20Update%20and%20Second%20Quarter%202025%20Financial%20Results) [Business Highlights and Clinical Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Clinical%20Pipeline%20Update) Kyverna executed its Q2 2025 clinical strategy, completing enrollment for the registrational Phase 2 SPS trial and advancing the MG trial to Phase 3, while preparing for KYV-102 IND filing [KYV-101 Program Updates](index=1&type=section&id=KYV-101%20Program%20Updates) KYV-101 achieved full enrollment for the registrational SPS trial, with a BLA target in 1H 2026, and the MG trial progressed to a registrational Phase 3, while LN trials concluded to prioritize neuroimmunology - Completed patient enrollment for the registrational Phase 2 trial (KYSA-8) for Stiff Person Syndrome (SPS) in Q2 2025[4](index=4&type=chunk) - Expanded the Myasthenia Gravis (MG) trial (KYSA-6) to include a registrational Phase 3 portion following a successful end-of-Phase 2 meeting with the FDA[5](index=5&type=chunk) - Concluded enrollment for Lupus Nephritis (LN) trials (KYSA-1 and KYSA-3) to prioritize accelerating late-stage neuroimmunology indications[6](index=6&type=chunk) - Data from investigator-initiated trials (IITs) in Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA) will be presented in Q3 and Q4 2025, respectively, to inform indication expansion strategy[7](index=7&type=chunk)[8](index=8&type=chunk) [Future Pipeline: KYV-102](index=2&type=section&id=Future%20Pipeline%3A%20KYV-102) Kyverna plans to file an IND for KYV-102 in Q4 2025, leveraging a proprietary whole blood, rapid manufacturing process to enhance patient access by eliminating apheresis - The company expects to file an Investigational New Drug (IND) application for KYV-102 in the fourth quarter of 2025[9](index=9&type=chunk) - KYV-102 is produced with a next-generation proprietary whole blood, rapid manufacturing process, which eliminates the need for apheresis and has the potential to broaden patient access[9](index=9&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Kyverna appointed Marc Grasso as CFO in June 2025 and will host a virtual KOL event on August 28, 2025, to discuss its neuroimmunology CAR T franchise - Appointed Marc Grasso, M.D., as Chief Financial Officer in June 2025, bringing over 25 years of public company and investment banking experience[12](index=12&type=chunk) - A virtual KOL event titled "A Spotlight on Kyverna's Neuroimmunology CAR T Franchise" is scheduled for August 28, 2025[12](index=12&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) Key upcoming milestones include interim Phase 2 MG data and Phase 3 enrollment by year-end 2025, SPS topline data and BLA filing in 1H 2026, and a KYV-102 IND application in Q4 2025 Anticipated Milestones Table | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | **Myasthenia Gravis (MG)** | Report interim Phase 2 data | Q4 2025 | | | Initiate enrollment for registrational Phase 3 trial | By year-end 2025 | | **Stiff Person Syndrome (SPS)** | Report topline registrational Phase 2 data | 1H 2026 | | | BLA filing | 1H 2026 | | **Lupus Nephritis (LN)** | Report Phase 1 data in peer-reviewed publication | 2026 | | **Multiple Sclerosis (MS)** | Report Phase 1 IIT data | Q3 2025 | | **Rheumatoid Arthritis (RA)** | Report Phase 1/2 IIT data | Q4 2025 | | **Future Pipeline (KYV-102)** | File IND application | Q4 2025 | [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Kyverna reported a Q2 2025 net loss of **$42.1 million** ($0.97 per share) with **$211.7 million** cash, extending its runway into 2027, primarily due to increased R&D expenses [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) As of June 30, 2025, Kyverna held **$211.7 million** in cash, providing a runway into 2027, with increased R&D and G&A expenses leading to a **$42.1 million** net loss for Q2 2025 - Cash, cash equivalents, and marketable securities totaled **$211.7 million** as of June 30, 2025, which is expected to provide a cash runway into 2027[14](index=14&type=chunk) Financial Metric (Q2 2025 vs Q2 2024) | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | **$35.8 M** | **$27.3 M** | | G&A Expenses | **$8.6 M** | **$6.1 M** | | Net Loss | **$42.1 M** | **$28.8 M** | | Net Loss per Share | **$0.97** | **$0.67** | [Financial Statements](index=5&type=section&id=Financial%20Statements) Unaudited financial statements show Q2 2025 total operating expenses of **$44.4 million** and a net loss of **$42.1 million**, with total assets of **$226.5 million** and stockholders' equity of **$184.4 million** as of June 30, 2025 Statement of Operations Highlights (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | **$35,816** | **$27,321** | | General and administrative | **$8,594** | **$6,114** | | **Total operating expenses** | **$44,410** | **$33,435** | | **Net loss** | **$(42,081)** | **$(28,803)** | Condensed Balance Sheet Highlights | (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, marketable securities | **$211,677** | **$285,979** | | Total assets | **$226,508** | **$304,645** | | Total stockholders' equity | **$184,377** | **$266,587** |

Core Insights - Kyverna Therapeutics is advancing its clinical programs with a focus on KYV-101 for autoimmune diseases, specifically targeting stiff person syndrome (SPS) and myasthenia gravis (MG) [2][15] - The company has a strong cash position of $211.7 million, expected to support operations into 2027, including the first BLA filing for SPS and the Phase 3 trial for MG [11][12] - Upcoming milestones include topline data for the Phase 2 trial in SPS and interim data for the Phase 2 trial in MG, both anticipated in 2026 [3][11] Clinical Trials and Development - The registrational Phase 2 trial for SPS has completed patient enrollment, with topline data expected in the first half of 2026 and BLA submission anticipated in the same timeframe [3][11] - The Phase 3 registrational trial for MG is set to include approximately 60 patients, with enrollment expected to begin by the end of 2025, and interim Phase 2 data is anticipated in Q4 2025 [2][7] - Kyverna is also exploring additional indications for KYV-101 in multiple sclerosis (MS) and rheumatoid arthritis (RA) through investigator-initiated trials, with data presentations scheduled for upcoming conferences [8][15] Financial Performance - For the quarter ended June 30, 2025, Kyverna reported a net loss of $42.1 million, compared to a net loss of $28.8 million for the same period in 2024, reflecting increased R&D and G&A expenses [12][13] - Research and development expenses were $35.8 million for Q2 2025, up from $27.3 million in Q2 2024, indicating a focus on advancing clinical trials [12][19] - General and administrative expenses also increased to $8.6 million in Q2 2025 from $6.1 million in Q2 2024, contributing to the overall net loss [13][19] Future Pipeline and Strategy - Kyverna plans to file an investigational new drug (IND) application for KYV-102 in Q4 2025, which utilizes a next-generation manufacturing process aimed at broadening patient access [9][15] - The company is strategically positioned to deliver multiple near-term milestones, including data readouts and trial initiations, which are expected to create value for stakeholders [2][11] - Kyverna's leadership changes, including the appointment of a new CFO, are aimed at strengthening the executive team as the company advances its late-stage clinical and commercial efforts [15]

Core Insights - Kyverna Therapeutics, Inc. is hosting a webcast event on August 28, 2025, to discuss its neuroimmunology franchise, focusing on KYV-101 and its potential applications in myasthenia gravis (MG) and stiff person syndrome (SPS) [1][2] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company specializing in cell therapies for autoimmune diseases, with its lead candidate, KYV-101, advancing through late-stage clinical development [4] - The company is conducting registrational trials for KYV-101 in MG and SPS, along with ongoing Phase 1/2 trials for lupus nephritis [4] - Kyverna is also exploring next-generation CAR T-cell therapies and has plans to expand into broader autoimmune indications with KYV-102, utilizing a proprietary whole blood rapid manufacturing process [4] Webcast Details - The webcast will feature presentations from the management team and renowned Key Opinion Leaders (KOLs), followed by a Q&A session [2][3] - The event aims to provide an in-depth look at KYV-101's differentiation and its potential for durable drug-free, disease-free remission, as well as a high-level overview of Kyverna's commercial strategy [6]

Summary of Qiverna Therapeutics Conference Call Company Overview - **Company**: Qiverna Therapeutics - **Focus**: Development of CAR T cell therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS), Myasthenia Gravis (MG), and Lupus Nephritis [1][2] Core Points and Arguments Clinical Development Progress - **KYV-101**: Lead CAR T cell therapy candidate is advancing through late-stage clinical development with pivotal trials for SPS and MG, and ongoing trials for Lupus Nephritis [3][4] - **SPS Trial**: Fully enrolled pivotal Phase II trial with results expected in the first half of 2026; BLA filing also anticipated in the first half of 2026 [3][8] - **MG Trial**: Initial six patients enrolled in Phase II trial, with results expected in the second half of 2023; FDA has approved a pivot to a pivotal Phase III trial design [3][20] - **Lupus Nephritis**: Ongoing studies with results expected in the second half of 2023 [8][23] Unique Therapy Design - **KYV-101 Design**: Features a CD28 co-stimulatory domain, providing deep B cell depletion and an immune reset, which is believed to enhance efficacy and safety compared to competitors [4][5] - **Safety Profile**: No high-grade CRS (Cytokine Release Syndrome) or ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) observed in over 70 treated patients [5][6] Market Opportunity - **SPS Market**: Estimated 4,500 patients currently known, with potential to identify 2,000 to 6,000 more as awareness increases; first mover advantage anticipated [17][18] - **MG Market**: Addressable market for second-line plus patients estimated at 30,000 to 40,000, significantly larger than SPS [21] Competitive Differentiation - **Efficacy**: KYV-101 shows significant reductions in MG ADL scores, with some patients achieving scores of zero, which is not seen with existing therapies [19][22] - **Transformational Impact**: Patients treated with KYV-101 have reported improved mobility and quality of life, with many able to discontinue background immunosuppressants [10][16] Future Developments - **Next Generation Product**: KYV-102, a whole blood rapid manufacturing construct, aims to simplify the patient journey and reduce costs; IND filing expected in the second half of 2023 [9][24] - **Pipeline Expansion**: Plans to explore additional indications beyond current focus areas, leveraging existing clinical studies [9][25] Important but Overlooked Content - **Compassionate Use Program**: Data from over 40 patients treated under this program shows no high-grade CRS or ICANS, reinforcing the safety profile of KYV-101 [6][14] - **Neuroinflammation Franchise**: Establishing a franchise around neuroinflammation diseases, leveraging synergies between SPS and MG treatment centers [11][12] Financial Position - **Cash Runway**: Sufficient funding to support operations and clinical milestones through 2027 [26]

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]