Kyverna Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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Mar 31, 2025 · Filed May 13, 2025
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Notes to Unaudited Condensed Financial Statements
- Description of Business, Organization and Liquidity
Kyverna Therapeutics, Inc. (“Kyverna” or “the Company”) is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. The lead product candidate, KYV-101, is advancing through late-stage clinical development across two broad areas of autoimmune disease: neuroinflammation and rheumatology. The Company was incorporated on June 14, 2018, was initially named BAIT Therapeutics, Inc., changed its name to Kyverna Therapeutics, Inc. on October 1, 2019, and is headquartered in Emeryville, California.
Initial Public Offering
On February 7, 2024, the Company’s Registration Statement on Form S-1 for its initial public offering (the “IPO”) was declared effective, and on February 12, 2024, the Company closed the IPO and issued 16,675,000 shares of common stock at a price to the public of $22.00 per share, including 2,175,000 shares issued upon the exercise of underwriters’ option to purchase additional shares of common stock. The Company received gross proceeds of $366.9 million. Net proceeds were $336.2 million, after deducting underwriting commissions and other offering costs totaling $30.7 million. On February 8, 2024, the Company’s common stock began trading on the Nasdaq Global Select Market under the symbol “KYTX”. Immediately prior to the IPO closing, all of the outstanding shares of the Company’s redeemable convertible preferred stock converted into shares of the Company’s common stock on a 1-for-4.5511 basis.
Liquidity
The Company has incurred losses and negative cash flows from operations since inception. As of March 31, 2025, the Company has an accumulated deficit of $308.2 million. The Company had net losses of $44.6 million and $26.7 million for the three months ended March 31, 2025 and 2024, respectively.
The Company has historically financed its operations primarily through issuances of redeemable convertible preferred stock and convertible notes, revenue from its collaboration agreement and sale of shares of its common stock in the IPO. As of March 31, 2025, the Company had cash and cash equivalents and available-for-sale marketable securities of $242.6 million. The Company expects to continue to incur operating losses and negative cash flows from operations to support the development of its product candidates, to expand its product portfolio and to continue its research and development activities, including preclinical studies and clinical trials. The Company’s activities are subject to significant risks and uncertainties, including the completion of requisite clinical activities to support regulatory approvals, market acceptance of the Company’s product candidates, if approved, as well as the timing and extent of spending on research and development. There can be no assurance that the Company will ever earn revenue or achieve profitability, or if achieved, that the revenue or profitability will be sustained on a continuing basis. Unless and until it does, the Company will need to continue to raise additional capital. Based on its current operating plan, management estimates that its existing cash and cash equivalents and available-for-sale marketable securities balances will be sufficient to fund its operating plan and capital expenditure requirements for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed financial statements have been prepared on the same basis as the annual financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025.
In the opinion of the Company’s management, the information in these condensed financial statements reflects all adjustments, all of which are of a normal and recurring nature necessary for a fair statement of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development accrued expenses and stock-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the amount reported as revenue and expenses that are not readily apparent from other sources. Actual results may differ materially from those estimates.
Significant Accounting Policies
There have been no material changes to the accounting policies discussed in Note 2 to the financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025.
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments in this ASU should be applied prospectively; however, retrospective application is also permitted. The Company is currently evaluating the impact of the adoption of this standard on its financial statements.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU No. 2024-03 require a public business entity to disclose specific information about certain costs and expenses in the notes to its financial statements for interim and annual reporting periods. The objective of the disclosure requirements is to provide disaggregated information about a public business entity's expenses to help investors (i) better understand the entity's performance, (ii) better assess the entity's prospects for future cash flows, and (iii) compare an entity's performance over time and with that of other entities. ASU No. 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of the adoption of this standard on its financial statements.
- Fair Value Measurements and Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements, as follows:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The Company’s fair value hierarchy for its financial instruments measured at fair value on a recurring basis as of March 31, 2025, was as follows (in thousands):
| Fair Value Measurements | ||||
|---|---|---|---|---|
| As of March 31, 2025 | Total | Level 1 | Level 2 | Level 3 |
| Cash equivalents | ||||
| Money market funds | $25,615 | $25,615 | $— | $— |
| Corporate debt obligations | 29,976 | — | 29,976 | — |
| Available-for-sale marketable securities | ||||
| U.S. Treasury bills | 185,784 | — | 185,784 | — |
| Total fair value of assets | $241,375 | $25,615 | $215,760 | $— |
The Company’s fair value hierarchy for its financial instruments measured at fair value on a recurring basis as of December 31, 2024, was as follows (in thousands):
| Fair Value Measurements | ||||
|---|---|---|---|---|
| As of December 31, 2024 | Total | Level 1 | Level 2 | Level 3 |
| Cash equivalents | ||||
| Money market funds | $36,745 | $36,745 | $— | $— |
| Corporate debt obligations | 33,910 | — | 33,910 | — |
| U.S. Treasury bills | 25,426 | — | 25,426 | — |
| Available-for-sale marketable securities | ||||
| U.S. Treasury bills | 189,358 | — | 189,358 | — |
| Total fair value of assets | $285,439 | $36,745 | $248,694 | $— |
Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and available-for-sale marketable securities. Cash equivalents consisted of money market funds, corporate debt obligations and U.S. Treasury bills, and available-for-sale marketable securities consisted of U.S. Treasury bills. The Company obtains pricing information from its investment manager and generally determines the fair value of available-for-sale marketable securities using standard observable inputs, including reported trades, broker/dealer quotes and bids and/or offers. The Company recognizes transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs.
- Available-for-Sale Marketable Securities
As of March 31, 2025, the Company’s available-for-sale marketable securities consisted of debt securities issued by the U.S. Treasury and corporate debt obligations with contractual maturities on various dates within the next 12 months.
The following table summarizes the amortized cost, unrealized gains and losses and fair value of the Company’s available-for-sale marketable securities as of March 31, 2025 (in thousands):
| Total | Total | Total | Total | |
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| As of March 31, 2025: | Cost | Gains | Losses | Fair Value |
| Money market funds (included in cash and cash equivalents) | $25,615 | $— | $— | $25,615 |
| U.S. Treasury bills | 185,782 | 5 | (3) | 185,784 |
| Corporate debt obligations (included in cash and cash equivalents) | 29,980 | — | (4) | 29,976 |
| Total available-for-sale marketable securities | $241,377 | $5 | $(7) | $241,375 |
As of March 31, 2025, $55.6 million was included in cash equivalents and $185.8 million was included in available-for-sale marketable securities.
The following table summarizes the amortized cost, unrealized gains and losses and fair value of the Company’s available-for-sale marketable securities as of December 31, 2024 (in thousands):
| Total | Total | Total | Total | |
|---|---|---|---|---|
| Amortized | Unrealized | Unrealized | Estimated | |
| As of December 31, 2024 | Cost | Gains | Losses | Fair Value |
| Money market funds (included in cash and cash equivalents) | $36,745 | $— | $— | $36,745 |
| U.S. Treasury obligations ($25,426 included in cash and cash equivalents) | 214,677 | 107 | — | 214,784 |
| Corporate debt obligations (included in cash and cash equivalents) | 33,912 | — | (2) | 33,910 |
| Total available for sale marketable securities | $285,334 | $107 | $(2) | $285,439 |
As of March 31, 2025 and December 31, 2024, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the Company’s marketable securities, and the Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. The Company considered the current and expected future economic and market conditions and determined that its investments were not significantly impacted by such conditions. For all securities with a fair value less than its amortized cost basis, the Company determined the decline in fair value below amortized cost basis to be immaterial and non-credit related, and therefore no allowance for losses has been recorded. During the three months ended March 31, 2025 and 2024, the Company didnot recognize any impairment losses on its investments.
As of each of March 31, 2025 and December 31, 2024, accrued interest receivable waszero. The Company’s accounting policy is to not measure an allowance for credit losses for accrued interest receivables and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which it considers to be in the period in which the Company determines the accrued interest will not be collected. During the three months ended March 31, 2025 and 2024, the Company didnot write off any accrued interest receivables.
- Balance Sheet Components
Property and Equipment, Net
Property and equipment, net, consists of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Laboratory equipment | $4,130 | $4,130 |
| Furniture and fixtures | 1,132 | 936 |
| Leasehold improvements | 936 | 821 |
| Computer equipment and software | 172 | 1,132 |
| Property and equipment, gross | 6,370 | 7,019 |
| Less accumulated depreciation | (3,934) | (3,672) |
| Property and equipment, net | $2,436 | $3,347 |
Depreciation and amortization expense related to property and equipment was $0.3 million for each of the three months ended March 31, 2025 and 2024. The Company recognized $0.6 million an impairment charge related to a capitalized software during the three months ended March 31, 2025.
Other Accrued Expenses and Current Liabilities
Other accrued expenses and current liabilities consist of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Accrued research and development expenses - Contract Research Organizations | $6,423 | $5,669 |
| Accrued research and development expenses - Contract Manufacturing Organizations | 3,726 | 5,487 |
| Other accrued expenses | 1,757 | 2,903 |
| Total other accrued expenses and current liabilities | $11,906 | $14,059 |
- License and Collaboration Agreements
Patent License Agreements with the National Institutes of Health
In May 2021, the Company entered intotwo patent license agreements (the “NIH Agreements”) with the National Institutes of Health (the “NIH”), pursuant to which the Company obtained exclusive, worldwide licenses to certain patents to use an anti-CD19 CAR in the Company’s autologous and allogeneic CAR T-cell products for the treatment of patients with autoimmune disease. The Company paid $3.3 million for acquired licenses.
Under the NIH Agreements, commencing in January 2023 and subsequently on January 1 of each calendar year thereafter, the Company is also required to make minimum annual royalty payments of $0.2 million, which shall be credited against any earned royalties due based on a low single-digit percentage of net sales made in a respective year. In addition, benchmark royalties following the completion of certain regulatory-and clinical-related benchmarks are due to the NIH, with the minimum cumulative royalty due for a product reaching FDA approval or foreign-equivalent approval totaling $5.7 million for the autologous patent license agreement and $1.7 million for the allogeneic patent license agreement. Additional benchmark royalties would be payable for a subsequent indication under each NIH Agreement. If the Company enters into a sublicensing agreement, it will be required to pay the NIH a sublicense royalty payment as a percentage of the fair market value of any consideration received for each sublicense granted. The sublicensing percentage starts at a high teens to low twenties percentage if clinical trials for the product have not yet begun and decreases to a mid-single-digit percentage if the product has received FDA approval or foreign-equivalent approval.
Unless terminated sooner, the NIH Agreements remain in effect until the last licensed patent right granted pursuant to the respective agreement expires.
The acquisition of the licenses, including patent rights and know-how, was accounted for as an asset acquisition. As the acquired technology did not have an alternative use for accounting purposes, the consideration of $3.3 million was recorded as research and development expense in the statements of operations and comprehensive loss for the year ended December 31, 2021. The Company recognized $0.2 million as research and development expense related to minimum annual royalty payments for each of the three months ended March 31, 2025 and 2024. As of March 31, 2025 and December 31, 2024, the Company recorded zero and $0.6 million, respectively, related to benchmark royalties for regulatory approvals and patients’ dosing in clinical trials as accounts payable on the condensed balance sheet. No other benchmark royalties were probable or payable as of March 31, 2025 and December 31, 2024.
Intellia License and Collaboration Agreement
In December 2021, the Company entered into a License and Collaboration Agreement (the “Intellia Agreement”) with Intellia Therapeutics, Inc. (“Intellia”) to research and develop an allogeneic CD19-directed CAR cell therapy product (the “CRISPR Product”), suitable for validation through pre-clinical and clinical proof-of-concept clinical trials, including the performance of activities as agreed in the collaboration plan. Pursuant to the Intellia Agreement, Intellia granted to the Company an exclusive, worldwide, sublicensable in multiple tiers, royalty bearing license under certain of Intellia’s intellectual property to research, develop, sell and otherwise exploit the CRISPR Product. The Company is performing the majority of the work under the collaboration plan.
As consideration for the licenses granted to the Company pursuant to the Intellia Agreement, the Company issued to Intellia shares of its Series B Preferred Stock with the fair value of $7.0 million. The Company is also obligated to make aggregate milestone payments to Intellia of up to $64.5 million upon the achievement of specified development and regulatory milestones and is obligated to pay to Intellia low to mid-single-digit royalties as a percentage of annual worldwide sales, subject to certain adjustments, and additional potential royalties and milestones to Intellia’s licensors. The royalties are payable on a country-by-country basis, commencing upon the first commercial sale of the CRISPR Product in the applicable country and expiring upon the later of (i) 12 years after the first commercial sale or (ii) the expiration of the last-to-expire valid patent claim.
Under the Intellia Agreement, Intellia owns rights, title and interests in and to any intellectual property developed in the course of performance under the Intellia Agreement that is not specifically directed to the CRISPR Product. The Company granted to Intellia certain non-exclusive, royalty-free, fully paid-up, worldwide licenses under the Company’s intellectual property solely to perform the activities designated to Intellia under the collaboration, and to research, develop or otherwise exploit any human therapeutic product that is developed or commercialized by Intellia, utilizes or incorporates Intellia intellectual property and that is not the CRISPR Product or any product directed to CD19 or any other B-cell antigen.
In addition, the Company granted Intellia an exclusive option (the “Intellia Option”) to enter into a co-development and co-commercialization agreement with the Company for the CRISPR Product, (the “Co-Co Agreement”) for a fee payable to the Company. If Intellia exercises the Intellia Option, the Company and Intellia would share equally the regulatory and clinical development expenses associated with obtaining approval of the CRISPR Product in the U.S. and would also share equally all net profits and losses from commercialization of the CRISPR Product in the U.S. If Intellia exercises the Intellia Option, no milestone payments will be due and payable from that time forward and the Company will only pay royalties on sales outside of the U.S. In addition, upon exercise of the Intellia Option, following regulatory approval of the CRISPR Product, Intellia will have exclusive commercialization rights for the CRISPR Product for U.S. administration, subject to the Company’s rights to co-promote the CRISPR Product in the U.S., and the Company will retain the sole and exclusive rights to research, develop, or otherwise exploit the CRISPR Product for rest-of-world administration and shall have sole decision-making authority in relation thereto, subject to the parties’ obligations to cooperate regarding certain development, regulatory and commercialization strategies.
During the term of the Co-Co Agreement, subject to certain exceptions, neither party will clinically develop or commercialize a cell therapy product directed to CD19 other than the CRISPR Product for use in the treatment or prevention of certain indications set forth in the Intellia Agreement and any additional indication that the parties mutually agree to include (any such product, a “Competitive Product”); provided, however, that (i) any products for use in any indications that are the subject of a development program or third-party collaboration as of the effective date of the Co-Co Agreement shall not be considered Competitive Products and (ii) any products for use in any additional indications that are the subject of a development program or third-party collaboration as of the date that such additional indications are included in the global development plan shall not be considered Competitive Products.
The Intellia Agreement terminates on a country-by-country basis upon the expiration of the last valid claim within Intellia’s patent rights covering the CRISPR Product within such country, unless the agreement is earlier terminated in its entirety by either party for insolvency, by either party for material breach of contract, by Intellia if the Company participates in legal action or proceeding challenging the validity or enforceability of Intellia’s patents, or by the execution of the Co-Co Agreement. The Company may terminate the Intellia Agreement in its entirety, or on a country-by-country basis, by providing a written notice after the expiration or termination of the Intellia Option. Following the expiration of the term for a given country, the licenses granted to the Company in such country will automatically become fully paid-up, perpetual, irrevocable and royalty-free licenses.
No milestone payments were probable or payable as of March 31, 2025 and December 31, 2024.
Kite License Agreement (Related Party)
In January 2020, the Company entered into a License Agreement (the “Kite Agreement”) with Kite Pharma, Inc. (“Kite”), an affiliate of Gilead Sciences, Inc. (“Gilead”), a related party of the Company. In January 2020, the Company entered into a stock purchase agreement with Gilead, pursuant to which the Company issued to Gilead an aggregate of 6,890,744 shares of its Series A-2 redeemable convertible preferred stock, of which 4,042,066 shares were issued as consideration under the Kite Agreement.
Pursuant to the Kite Agreement, Kite granted to the Company a ten-year, co-exclusive license for the SynNotch technology primarily used in the Company’s own internal research and development programs for the treatment, diagnosis or prevention of autoimmune, inflammatory or allogeneic stem cell transplant inflammatory diseases (excluding post-transplant infectious diseases). Upon expiration of the ten-year co-exclusive license term, the license will become a non-exclusive license through expiration of the related patents.
Kite had licensed certain of the SynNotch technology included in the Kite Agreement pursuant to that certain Amended and Restated Exclusive License Agreement, between The Regents of the University of California and Kite (as successor to Cell Design Labs, Inc.) (the "UCSF License Agreement"). The Company is responsible for all costs and payments arising under the UCSF License Agreement and as a result of activities under the Kite Agreement, including earned royalties based on a low single-digit percentage of net sales, milestone payments in an aggregate amount of up to $10.8 million and accrued interest payables.
Pursuant to the Kite Agreement, the Company is also obligated to pay mid-teen-and mid-single-digit percentages of annual maintenance fees, minimum annual royalties and patent prosecution costs payable under the UCSF License Agreement during the co-exclusive term and non-exclusive term, respectively. The Company was also obligated to pay a $6.3 million sublicensing fee under the UCSF License Agreement, which the Company agreed to offset with future milestone payments payable by Gilead under a Collaboration, Option and License Agreement that the Company entered into with Gilead in January 2020 (the “Gilead Agreement”).
Unless terminated earlier, the Kite Agreement will expire upon the expiration of all licensed patents and Kite improvement patents therein. The Company has the right to terminate the Kite Agreement at will, in the Company’s sole discretion, in its entirety upon 90 days’ written notice to Kite. In addition, either party may terminate the Kite Agreement for uncured material breach by the other party, or upon the occurrence of insolvency-related events of the other party.
The acquisition of the co-exclusive license under the Kite Agreement, including patent rights and know-how, was accounted for as an asset acquisition. As the acquired technology did not have an alternative use for accounting purposes, the license consideration of $3.5 million and the sublicensing fee of $6.3 million was recorded as a research and development expense in the statements of operations and comprehensive loss for the year ended December 31, 2020.
As of each of March 31, 2025 and December 31, 2024, the Company had the total sublicensing fee of $6.3 million as current accrued license expense - related party. There are no future milestones payable to offset the sublicensing fee due to the termination of the Gilead Agreement.
The annual maintenance fee, patent prosecution costs and minimal annual royalties are expensed as incurred and were minimal for each of the three months ended March 31, 2025 and 2024.
- Commitments and Contingent Liabilities
Leases
As of March 31, 2025, the Company leases office and laboratory space in Emeryville, California under operating leases which have terms through February 2027, and certain of these leases include options to extend for an additional 36 months. In addition to the base rent, which includes escalating payments over the lease term, the Company pays variable costs related to operating expenses and taxes, which are recognized as incurred. The Company also has multiple leases for laboratory equipment with terms of 36 months that are accounted for as finance leases. Total operating lease cost for the three months ended March 31, 2025 and 2024, was $0.9 million and $0.7 million, respectively. Total finance lease cost for each of the three months ended March 31, 2025 and 2024 was $0.3 million. Total variable lease cost for each of the three months ended March 31, 2025 and 2024 was $0.3 million. Total undiscounted lease obligations under the Company’s operating and finance leases were $6.9 million and $0.6 million, respectively, as of March 31, 2025.
License Agreements
The Company entered into license agreements with the NIH, Intellia and Kite, pursuant to which the Company is required to pay certain milestone payments contingent upon the achievement of specific development and regulatory events, and royalties on sales of products developed under these agreements (See Note 6).
Contractual Obligations and Commitments
The Company enters into contracts in the normal course of business with clinical research organizations (“CROs”) for clinical trials, with clinical manufacturing organizations (“CMOs”) for clinical supplies manufacturing and with other vendors for preclinical studies, supplies and other products and services for operating purposes. These agreements generally provide for termination at the request of either party generally with less than one-year notice. The Company did not expect any of these agreements to be terminated and did not have any non-cancellable obligations under these agreements as of March 31, 2025.
Legal Contingencies
From time to time, the Company may become involved in legal proceedings arising from the ordinary course of business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount.
On December 9, 2024, a shareholder class action complaint was filed in the United States District Court for the Northern District of California against the Company, certain of its current and former officers and directors, and the underwriters of the IPO. Per a stipulated schedule, an amended complaint was filed on May 2, 2025. The amended complaint alleges that the registration statement on Form S-1 filed in connection with the IPO and the prospectus contained therein contained material misstatements or omissions in violation of federal securities laws. The Company intends to defend the claims in this lawsuit vigorously and believes it has good and substantial defenses to the claims in the amended complaint, but there is no guarantee that the Company will be successful in these efforts. Given the complexity of the issues in the lawsuit, the fact that the lawsuit was recently filed and is in its early stages, and the inherent uncertainty of litigation, the Company is unable to make any predictions about the ultimate outcome of this matter. As a result, the Company is unable to determine whether any loss ultimately will occur or to estimate the range of such loss. No amount of loss has been accrued in the accompanying condensed financial statements as of and for the three months ended March 31, 2025. The Company did not have any accruals for the matter described herein on its condensed balance sheets as of March 31, 2025 and December 31, 2024.
Guarantees and Indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of March 31, 2025 and December 31, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible.
- Common Stock
As of March 31, 2025 and December 31, 2024, common stock reserved for future issuance was as follows:
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Outstanding stock option awards | 7,979,810 | 7,595,922 |
| Unvested restricted stock units awards | 635,167 | 549,001 |
| Shares available for future options grants under the 2024 Equity Incentive Plan and Equity Inducement Plan | 5,598,976 | 3,562,709 |
| Shares available for future grants under the Employee Stock Purchase Plan | 844,000 | 422,000 |
| Total shares reserved for future issuance | 15,057,953 | 12,129,632 |
Early Exercise of Options for a Promissory Note
In December 2022, the Company’s former chief executive officer (the “Former CEO”), a then-related party, early exercised options for 349,321 shares of common stock in exchange for a partial recourse promissory note receivable with the principal amount of $1.1 million. The note bore interest at 4.27% per annum and was to be due in December 2027. For accounting purposes, the promissory note was determined to be non-recourse and, as such, the issuance of the promissory note and subsequent early exercise of stock options were considered not substantive. While the issued shares were not considered outstanding for accounting purposes, they were legally issued and had voting and dividend rights. The shares were included in common stock on the statement of redeemable convertible preferred stock and stockholders’ deficit as of December 31, 2023.
On January 12, 2024, the Company and the Former CEO entered into a note forgiveness letter, pursuant to which the promissory note and all accrued interest thereon in an aggregate amount of $1.1 million were forgiven. As the shares subject to the options that were early exercised were vested as of the date of the forgiveness of the note, these are included in the calculation of net loss per share attributable to common stockholders from the date of the note’s forgiveness. The Company concluded that the note forgiveness was effectively a repricing of options and is a modification. Therefore, the incremental stock-based compensation expense was recognized for the vested shares at the modification date (see Note 9).
Shelf Registration Statement
On March 27, 2025, the Company filed a shelf registration statement on Form S-3 (the “Registration Statement”), covering the offer and sale from time to time of up to $250.0 million in aggregate offering price of shares of its common stock, shares of its preferred stock, debt securities, warrants, rights, units and/or depositary shares. The Registration Statement was declared effective by the SEC on April 15, 2025. The terms of any offering under the Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Registration Statement filed with the SEC prior to the completion of any such offering. The Registration Statement included a sales agreement prospectus (the “ATM Prospectus”), covering the offer and sale from time to time through or to Jefferies, LLC (“Jefferies”), as sales agent, of up to $50.0 million in aggregate offering price of shares of the Company’s common stock under an Open Market Sale Agreement SM entered into with Jefferies on March 27, 2025. As of March 31, 2025, $50.0 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the Registration Statement.
- Equity Incentive Plans
In January 2024, the Company’s board of directors adopted, and stockholders approved, the Company’s 2024 Equity Incentive Plan (the “2024 Plan”), which became effective on February 6, 2024. The 2024 Plan superseded the Company’s 2019 Equity Incentive Plan (the “2019 Plan”). No share awards can be granted under the 2019 Plan from the effective date of the 2024 Plan. Shares subject to outstanding equity awards granted under the 2019 Plan may be added to the 2024 Plan as such shares become available from time to time if awards terminate, expire, or lapse for any reason without the delivery of shares, or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price.
As of March 31, 2025, incentive stock options, nonstatutory stock options and restricted stock units had been granted under the 2024 Plan. As of March 31, 2025,4,953,253 shares of the Company’s common stock were reserved for issuance under the 2024 Plan.
In January 2024, the Company’s board of directors and stockholders adopted the Company’s 2024 Employee Stock Purchase Plan (the “ESPP”), which became effective on February 6, 2024. As of March 31, 2025,844,000 shares of common stock were reserved for future issuance under the ESPP.
In September 2024, the Company adopted the 2024 Inducement Equity Incentive Plan (the “Inducement Plan”). As of March 31, 2025,3,354,579 shares were granted and 645,741 shares were available for future grant under the Inducement Plan.
Stock Options
Stock options issued under the 2019 Plan, 2024 Plan and the Inducement Plan generally vest over afour-year period and expireten years from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the individual award agreements and the Company’s severance policies.
A summary of option activity under the 2019 Plan, 2024 Plan and the Inducement Plan is as follows:
| Number ofOptions | Weighted-AverageExercisePrice PerShare | Weighted-AverageRemainingContractualTerm (inyears) | AggregateIntrinsicValue (inthousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 7,595,922 | $5.83 | 7.58 | $760 |
| Options granted | 687,679 | $3.08 | ||
| Options exercised | (3,955) | $0.73 | ||
| Options forfeited | (250,766) | $5.77 | ||
| Options expired | (49,070) | $4.64 | ||
| Outstanding at March 31, 2025 | 7,979,810 | $5.60 | 7.44 | $30 |
| Exercisable at March 31, 2025* | 1,813,209 | $4.54 | 4.46 | $30 |
| Vested and expected to vest at March 31, 2025 | 7,979,810 | $5.60 | 7.44 | $30 |
- Includes 186,769 shares of unvested stock options for which the holders have the right to early exercise such options as of March 31, 2025.
Aggregate intrinsic value represents the difference between the fair value of the underlying common stock and the exercise price. The weighted-average grant date fair value of options granted for the three months ended March 31, 2025 and 2024 was $2.44 and $17.52, respectively. The total fair value of options that vested during the three months ended March 31, 2025 and 2024 was $2.9 million and $0.5 million, respectively. The intrinsic value of options exercised during the three months ended March 31, 2025 and 2024 was less than $0.1 million and $3.1 million, respectively, and is calculated as the difference between the exercise price and the fair value of common stock as of the exercise date. As of March 31, 2025, total unrecognized stock-based compensation expense was $27.9 million, which is expected to be recognized over a weighted-average period of 3.1 years.
Restricted Stock Units
During the three months ended March 31, 2025, the Company granted Restricted Stock Units (“RSUs”) for 112,000 shares with a weighted-average grant date fair value per share of $2.70. RSU shares vest over a four-year period. The fair value of the RSUs equals the fair value of the Company's common stock as of the grant date. The estimated fair value of RSUs granted was $0.3 million. As of March 31, 2025, total unrecognized compensation expense for RSUs was $2.8 million, which is expected to be recognized over weighted-average period of 3.2 years.
| Number of RSUs | Weighted-AverageGrant Rate Fair Value | |
|---|---|---|
| Unvested at December 31, 2024 | 549,001 | $7.19 |
| Granted - RSUs | 112,000 | 2.70 |
| Forfeited - RSUs | (25,834) | 6.88 |
| Unvested at March 31, 2025 | 635,167 | $6.41 |
During the year ended December 31, 2024, the Company granted performance RSUs for 100,000 shares with a weighted-average grant date fair value per share of $8.05. There was no activity for performance RSUs during the three months ended March 31, 2025. Performance RSU shares vest in full upon the Company receiving certain regulatory approvals within 36 months from the grant date. The fair value of the performance RSUs equals the fair value of the Company's common stock as of the grant date. The estimated fair value of performance RSUs granted was $0.8 million. As of March 31, 2025, total unrecognized compensation expense for performance RSUs was $0.8 million. Compensation expense of $0.8 million for performance RSUs is expected to be recognized when it is probable that the performance criteria will be achieved over the remaining vesting term. As of March 31, 2025, the performance criteria was not probable and no expense was recognized.
Stock-Based Compensation Expense
The Black-Scholes option pricing model, used to estimate fair value of the option awards, requires the use of the following assumptions:
Fair value of common stock. Prior to the IPO, the fair market value of common stock was determined by the Board of Directors with assistance from management and external valuation experts. The approach to estimating the fair market value of common stock was consistent with the methods outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Subsequent to the IPO, the fair value of common stock is the Company’s closing price per share on the Nasdaq Global Select Market at the grant date.
Expected Term. The expected term of options granted represents the period of time that the options are expected to be outstanding. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined by calculating the midpoint of the contractual term of the options and the weighted-average vesting period.
Expected Volatility. The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company did not have any trading history for the common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the common stock becomes available.
Risk-Free Interest Rate. The risk-free interest rate assumption is based on the U.S. Treasury instrument whose term was consistent with the expected term of the Company’s stock options.
Dividends. The Company has not paid any cash dividends on common stock since inception and does not anticipate paying any dividends in the foreseeable future. Consequently, an expected dividend yield of zero was used.
The fair value of options granted was estimated using the Black-Scholes valuation model using the following assumptions for the three months ended March 31, 2025 and 2024, respectively:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Expected volatility | 96.0% - 97.1% | 93.0% |
| Expected dividend yield | 0% | 0% |
| Expected term (in years) | 5.35 - 6.08 | 6.07 - 6.08 |
| Risk-free interest rate | 4.0% - 4.5% | 4.1% - 4.2% |
The following table presents the classification of stock-based compensation expense related to stock options granted (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development | $806 | $581 |
| General and administrative | 1,355 | 1,697 |
| Total stock-based compensation expense | $2,161 | $2,278 |
In January 2024, in connection with the Former CEO note forgiveness (see Note 8), the Company recognized stock-based compensation expense of $1.1 million in general and administrative expenses in the statement of operations and comprehensive loss for the three months ended March 31, 2024.
- Net Loss Per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Numerator: | ||
| Net loss attributable to common stockholders | $(44,635) | $(26,693) |
| Denominator: | ||
| Weighted average shares used in computing basic and diluted net loss per share | 43,215,577 | 23,754,062 |
| Net loss per share attributable to common stockholders, basic and diluted: | $(1.03) | $(1.12) |
The potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have had an antidilutive effect were as follows:
| As of March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options issued and outstanding | 7,979,810 | 4,228,705 |
| Unvested early exercised common stock options | 635,167 | — |
| 8,614,977 | 4,228,705 | |
- Related Party Transactions
For the three months ended March 31, 2024, the Company recorded less than $0.1 million to deferred offering costs related to an advisory services agreement with one of its board members. The services agreement ended in February 2024.
On January 12, 2024, the Company and the Former CEO entered into a note forgiveness letter, pursuant to which the promissory note and all accrued interest thereon in an aggregate amount of $1.1 million were forgiven. The promissory note was issued by the Former CEO in December 2022 in connection with early exercised options (see Note 8).
The Company had $0.6 million and $0.4 million in other accrued expenses and current liabilities on the condensed balance sheet as of March 31, 2025 and December 31, 2024, respectively, related to severance payments for the Former CEO.
- Segment Reporting
The Company operates and manages its business asone reportable and operating segment, which is the business of developing therapies for autoimmune and inflammatory diseases. Thechief executive officer, who is the chief operating decision maker (“CODM”), reviews financial information on an aggregate basis for purposes of allocating resources, assessing performance and monitoring budget versus actuals. The CODM assesses performance based on net loss as reported on the statement of operations and comprehensive loss. Further, segment depreciation expense and segment asset additions are consistent with amounts reported within the statement of cash flows given the Company's operations are aggregated within a single reportable segment. All of the Company’s long-lived assets are located in the United States. Asset and other balance sheet information is not reported to the CODM.
The following table sets forth the Company’s summary of segment loss, including significant segment expenses for the three months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended March 31, | ||||
|---|---|---|---|---|
| 2025 · 2024 | ||||
| Research and development expenses: | ||||
| KYV-101 program | $ | 22,120 | $ | 10,997 |
| Other programs | 559 | 2,628 | ||
| Other research and development expenses(a) | 14,754 | 8,851 | ||
| General and administrative expenses(b) | 9,975 | 6,882 | ||
| Interest income | (2,825) | (2,735) | ||
| Other expense, net | 52 | 70 | ||
| Segment Loss and Net loss | $ | 44,635 | $ | 26,693 |
(a) Primarily includes personnel costs, R&D professional services, unallocated CRO and CMO costs and allocated overhead and facilities expenses
(b) Primarily includes personnel costs, allocated overhead and facilities expenses, legal, IT, accounting and general and administrative expenses
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.