Kyverna Therapeutics, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Our goal is to liberate patients from autoimmune diseases through the curative potential of cell therapy. Our approach is supported by our breadth of experience treating patients with our lead product candidate, KYV-101, across more than 15 autoimmune disease indications. This has been documented through the scientific publication of multiple autoimmune case studies, our proprietary dataset of patients treated through named patient forms of compassionate use, our experience in ongoing investigator-initiated trials at leading academic institutions, as well as early clinical data from our ongoing company-sponsored trials illustrating the potential of these therapies to deeply deplete B cells with the aim of achieving durable treatment-free remission. This validation provides us with a clear path to continue advancing KYV-101 through late-stage clinical development and commercialization across two broad areas of autoimmune disease: neuroinflammation and rheumatology.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Our goal is to liberate patients from autoimmune diseases through the curative potential of cell therapy. Our approach is supported by our breadth of experience treating patients with our lead product candidate, KYV-101, across more than 15 autoimmune disease indications. This has been documented through the scientific publication of multiple autoimmune case studies, our proprietary dataset of patients treated through named patient forms of compassionate use, our experience in ongoing investigator-initiated trials at leading academic institutions, as well as early clinical data from our ongoing company-sponsored trials illustrating the potential of these therapies to deeply deplete B cells with the aim of achieving durable treatment-free remission. This validation provides us with a clear path to continue advancing KYV-101 through late-stage clinical development and commercialization across two broad areas of autoimmune disease: neuroimmunology and rheumatology.

Previous wording

Our lead program, KYV-101, is an autologous, fully human CD19 CAR T-cell product candidate incorporating highly potent CD28 co-stimulation. KYV-101 is made from an underlying chimeric antigen receptor, or CAR, licensed from the National Institutes of Health, or the NIH. We believe that this uniquely designed CAR in KYV-101 has the potential to deliver a differentiated therapeutic profile in autoimmune disease. In addition to a fully human scFv domain, the CAR in KYV-101 was also designed with a human CD8α hinge and transmembrane domain, a human CD28 costimulatory domain, and a human CD3ζ activation domain. This same underlying CAR in KYV-101 has completed a 20-patient Phase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported similar rates of durable antitumor responses while delivering improved tolerability in the clinic among adult oncology patients, as compared to the CAR used to create Yescarta®. We believe that these differentiated properties of the CAR in KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

Current wording

Our lead program, KYV-101, is a fully human, autologous CD19 CAR T-cell product candidate with CD28 co-stimulation, designed for potency and tolerability. KYV-101 is made from an underlying chimeric antigen receptor, or CAR, licensed from the National Institutes of Health, or the NIH. We believe that this uniquely designed CAR in KYV-101 has the potential to deliver a differentiated therapeutic profile in autoimmune disease. In addition to a fully human scFv domain, the CAR in KYV-101 was also designed with a human CD8α hinge and transmembrane domain, a human CD28 costimulatory domain, and a human CD3ζ activation domain. This same underlying CAR in KYV-101 has completed a 20-patient Phase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported similar rates of durable antitumor responses while delivering improved tolerability in the clinic among adult oncology patients, as compared to the CAR used to create Yescarta®. We believe that these differentiated properties of the CAR in KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

Previous wording

Our focused clinical development pipeline includes a pivotal Phase 2 trial of KYV-101 in stiff person syndrome, or SPS, a Phase 2 trial of KYV-101 in myasthenia gravis, or MG, and two multi-center Phase 1/2 trials for patients with lupus nephritis, or LN. We are also harnessing investigator-initiated trials and other Kyverna-sponsored clinical trials, or KYSA trials, including in multiple sclerosis and systemic sclerosis, to inform the next priority indications to advance into late-stage development. Additionally, our pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and increasing patient reach with KYV-102 using our proprietary whole blood rapid manufacturing process. We believe our cell therapy approach to autoimmune disease may present a significant advantage over current standard-of-care therapies by aiming for deep B cell depletion, an immune reset and long-term remission in autoimmune diseases.

Current wording

Our focused clinical development pipeline includes registrational trials for stiff person syndrome, or SPS, and generalized myasthenia gravis, or MG, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis, or LN. We are also harnessing investigator-initiated trials, or IITs, and other Kyverna-sponsored clinical trials, or KYSA trials, including in multiple sclerosis, or MS, and rheumatoid arthritis, or RA, to inform the next priority indications to advance into late-stage development. Additionally, our pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using our proprietary whole blood rapid manufacturing process. We believe our cell therapy approach to autoimmune disease may present a significant advantage over current standard-of-care therapies by aiming for deep B cell depletion, an immune reset and durable drug-free, disease-free remission in autoimmune diseases.

Previous wording

KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B-cell mediated autoimmune diseases with a prioritized focus in SPS, MG and LN. We have aligned with the U.S. Food and Drug Administration, or the FDA, on a registrational Phase 2 trial design in SPS, KYSA-8, including the 25-patient trial size and use of the timed 25-foot walk test (T25FW) as the primary endpoint. We have completed enrollment of study participants for this KYSA-8 pivotal Phase 2 trial in SPS. We also continue to progress our chemistry, manufacturing and controls, or CMC, readiness efforts in a capital-efficient manner in support of an anticipated biologics license application, or BLA, filing with the FDA in 2026.

Current wording

We have aligned with the U.S. Food and Drug Administration, or the FDA, on a registrational Phase 2 trial design in SPS, KYSA-8. We completed patient enrollment for this KYSA-8 pivotal Phase 2 trial in SPS during the second quarter of 2025. We expect to report Phase 2 data from this study in the first half of 2026. We also continue to progress our chemistry, manufacturing and controls, or CMC, readiness efforts in a capital-efficient manner in support of our first anticipated biologics license application, or BLA, filing for SPS with the FDA in the first half of 2026.

Previous wording

Our Phase 2 trial in MG, KYSA-6, has completed enrollment of patients in an initial six-patient cohort. Following a positive end-of-Phase 2 meeting with the FDA, we received written alignment confirming our plans to advance KYV-101 into a Phase 3 clinical trial. We continue to engage in positive dialogue with the FDA and expect to share details of the study design mid-year 2025, including trial size and endpoints. We plan to report interim data from the initial six-patient Phase 2 cohort in the second half of 2025. We received Regenerative Medicine Advanced Therapy, or RMAT, designations and Orphan Drug Designations from the FDA for both SPS and MG as well as Orphan Drug Designation from the European Medicines Association in MG.

Current wording

Patient enrollment in our Phase 2 trial in MG, KYSA-6, has been completed and we plan to report interim data in the fourth quarter of 2025. Following a successful end-of-Phase 2 meeting with the FDA, we are expanding our existing KYSA-6 trial to include a Phase 3 portion, for which we expect to initiate enrollment by the end of 2025. The Phase 3 portion of the trial is expected to include approximately 60 patients. We previously received Regenerative Medicine Advanced Therapy, or RMAT, designations and Orphan Drug Designations from the FDA for both SPS and MG as well as Orphan Drug Designation from the European Medicines Association in MG.

Previous wording

Since our inception in June 2018, we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, performing business planning, developing and establishing our intellectual property portfolio, raising capital and providing general and administrative support for these activities. We do not have any products approved for sale and have not generated any revenue from product sales.

Current wording

Since our inception in June 2018, we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, conducting clinical and regulatory activities, performing business planning, developing and establishing our intellectual property portfolio, raising capital and providing general and administrative support for these activities. We do not have any products approved for sale and have not generated any revenue from product sales.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering, or the IPO, in February 2024. Our net loss was $44.6 million for the three months ended March 31, 2025, compared with $26.7 million net loss for the three months ended March 31, 2024. As of March 31, 2025, we had an accumulated deficit of $308.2 million. Management has estimated that our cash and cash equivalents and available-for-sale marketable securities of $242.6 million as of March 31, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering, or the IPO, in February 2024. We may also seek to raise capital through debt financings, license agreements, collaborative agreements or other sources of financing. Our net losses were $42.1 million and $86.7 million for the three and six months ended June 30, 2025, respectively, compared with $28.8 million and $55.5 million net losses for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $350.2 million. Management has estimated that our cash and cash equivalents and available-for-sale marketable securities of $211.7 million as of June 30, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Previous wording

In particular, we anticipate that our current cash, cash equivalents and available-for-sale marketable securities will be sufficient to fund our operations into 2027. We expect that our cash, cash equivalents and available-for-sale marketable securities will allow us to file a BLA for KYV-101 in SPS, advance a registration-enabling trial in MG, continue advancing our clinical trial program in LN, and identify our next priority indications to advance into late-stage development. Our operating cash burn can vary from quarter to quarter; for example, we made certain one-time investments in our CMC readiness in the first quarter of 2025, which we expect to continue through the first half of 2025 for an anticipated BLA in 2026. We have also accelerated enrollment in certain of our clinical trials and completed patient enrollment in our pivotal Phase 2 trial in SPS. For these reasons, we currently expect our operating cash burn in the first half of 2025 to be higher than our operating cash burn in the second half of 2025. The amounts and timing of our actual expenditures will depend on numerous factors, including the progress of our research and development, the timing of patient enrollment and evolving regulatory requirements, the time and cost necessary to conduct our ongoing and planned preclinical studies and clinical trials, the results of our preclinical studies and clinical trials and other factors described in Part II, Item 1A of this Quarterly Report on Form 10-Q titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.

Current wording

In particular, we anticipate that our current cash, cash equivalents and available-for-sale marketable securities will be sufficient to fund our operations into 2027. We expect that our cash, cash equivalents and available-for-sale marketable securities will allow us to support our first BLA filing for SPS, our registrational Phase 2/3 trial for MG and our pre-launch activities. The amounts and timing of our actual expenditures will depend on numerous factors, including the progress of our research and development, the timing of patient enrollment in clinical trials and evolving regulatory requirements, the time and cost necessary to conduct our ongoing and planned preclinical studies and clinical trials, the results of our preclinical studies and clinical trials and other factors described in Part II, Item 1A of this Quarterly Report on Form 10-Q titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. In March 2025 the FDA confirmed our planned CMC package to support commercial manufacturing of KYV-101 for SPS and MG as well as future indications, with extensive CMC experience in autoimmune disease from KYSA studies, IITs and compassionate-use cases supporting process characterization. We have supplied clinical product from two clinical manufacturing sites for which the FDA accepted comparability data between manufacturing sites in April 2025. Under our Development and Manufacturing Services Agreement, dated July 2023, or the Elevate Agreement, with ElevateBio Base Camp, Inc., or Elevate, we engaged Elevate in November 2024 to provide us with cell manufacturing, release and testing services for our KYV-101 product candidate. In March 2022, we entered into a master services agreement with Advanced Therapies, Inc., or Advanced Therapies. Advanced Therapies’ facility in Philadelphia, Pennsylvania, provides us with certain customized cell manufacturing, release and testing services for our KYV-101 product candidate. Pursuant to our License and Supply Agreement with Oxford Biomedica (UK) Limited, or Oxford, dated September 2023, we engaged Oxford to undertake lentiviral vector process development services, with the intention for Oxford to ultimately manufacture and supply to us lentiviral vectors for research and development purposes and for use in connection with our clinical trials.

Current wording

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. In March 2025 the FDA confirmed our planned CMC package to support commercial manufacturing of KYV-101 for SPS and MG as well as future indications, with extensive CMC experience in autoimmune disease from KYSA studies, IITs and compassionate-use cases supporting process characterization. We have supplied clinical product from two clinical manufacturing sites for which the FDA accepted comparability data between manufacturing sites in April 2025. Under our Development and Manufacturing Services Agreement, dated July 2023, or the Elevate Agreement, with ElevateBio Base Camp, Inc., or Elevate, we engaged Elevate in November 2024 to provide us with cell manufacturing, release and testing services for our KYV-101 product candidate. In March 2022, we entered into a master services agreement with Minaris Advanced Therapies, Inc., or MAT. MAT’s facility in Philadelphia, Pennsylvania, provides us with certain customized cell manufacturing, release and testing services for our KYV-101 product candidate. Pursuant to our License and Supply Agreement with Oxford Biomedica (UK) Limited, or Oxford, dated September 2023, we engaged Oxford to undertake lentiviral vector process development services, with the intention for Oxford to ultimately manufacture and supply to us lentiviral vectors for research and development purposes and for use in connection with our clinical trials.

Previous wording

General and administrative expenses consist primarily of payroll and personnel-related expenses, including: salaries, employee benefit costs and stock-based compensation expense; professional fees for legal, consulting, accounting and tax services; allocated overheads, including rent, equipment, information technology costs and utilities; and other general operating expenses not otherwise classified as research and development expenses.

Current wording

General and administrative expenses consist primarily of payroll and personnel-related expenses, including: salaries, employee benefit costs and stock-based compensation expense; professional fees for legal, consulting, accounting and tax services; allocated overheads, including rent, facilities and information technology costs; and other general operating expenses not otherwise classified as research and development expenses.

Previous wording

Personnel-related research and development expenses increased by $2.0 million, or 30%, from $6.6 million for the three months ended March 31, 2024 to $8.5 million for the three months ended March 31, 2025 primarily due to growth in the number of employees in our research and development organization. The year-over-year increase in personnel-related costs also reflects an increase of $0.2 million in stock-based compensation expense.

Current wording

Personnel-related expenses increased by $0.6 million, or 7%, for the three months ended June 30, 2025, compared to the same period a year ago, primarily due to the growth in the number of employees in our research and development organization as well as higher stock-based compensation expense.

Previous wording

External research and development expenses related to our KYV-101 program increased by $11.1 million or 101% from $11.0 million in 2024 to $22.1 million in 2025 as we continued advancing our lead product candidate, KYV-101, through clinical development. This increase is mainly driven by $8.0 million of strategic investment in CMC readiness to support commercial readiness for SPS and MG, as well as a $4.4 million increase in CRO costs primarily due to accelerated enrollment in our KYSA trials. The increase in KYV-101 CMO and CRO costs was partially offset by a $0.7 million reduction in professional services.

Current wording

External research and development expenses related to our KYV-101 program increased by $20.3 million or 84% for the six months ended June 30, 2025, compared to the same period a year ago as we continued advancing our lead product candidate, KYV-101, through clinical development. The increase is mainly driven by a $16.6 million increase in strategic investment in CMO costs for SPS and MG, as well as a $6.4 million increase in CRO costs primarily due to accelerated enrollment in our KYSA trials. The increase in KYV-101 CMO and CRO costs was partially offset by a $2.0 million reduction in professional services costs.

Previous wording

Other program expenses include research and development expenses for our KYV-201 and KYV-102 programs. Other program costs decreased year-over-year by $2.1 million, or 80%, in 2025 due to a $0.5 million decrease in CMC costs. Costs related to the Ingenui-T rapid whole blood manufacturing process, which were classified as KYV-101 program costs in 2024 and are classified as KYV-102 program costs in 2025, decreased from $1.5 million for the three months ended March 31, 2024 to $1.0 million for the three months ended March 31, 2025. Other program expenses for 2025 also included a $0.6 million credit received from a manufacturing vendor for our KYV-201 program.

Current wording

Other program expenses include research and development expenses for our KYV-201 and KYV-102 programs. Other program costs decreased by $1.6 million, or 52%, for the six months ended June 30, 2025, compared to the same period a year ago due to a $1.4 million decrease in CMO costs. Costs related to the Ingenui-T rapid whole blood manufacturing process, which were classified as KYV-101 program costs in 2024 and are classified as other program costs in 2025, decreased to $1.8 million for the six months ended June 30, 2025 from $2.3 million for the same period a year ago. Other program expenses for the six months ended June 30, 2025 also included a $0.6 million credit received from a manufacturing vendor for our KYV-201 program.

Previous wording

Other research and development expenses primarily consist of facilities, depreciation and overhead costs. The year-over-year increase of $3.9 million, or 172%, in 2025 is mainly due to higher facilities and overhead costs, a $0.9 million increase in professional services, a $0.6 impairment charge related to a capitalized software, a $0.9 million increase in allocated overhead expenses and a $0.3 million increase in rent expense.

Current wording

Other research and development expenses primarily consist of unallocated research and development costs, professional services, facilities, depreciation and overhead costs. The increase of $2.2 million, or 28%, for the six months ended June 30, 2025, compared to the same period a year ago, is mainly due to higher facilities and overhead costs, a $1.2 million increase in professional services and a $0.6 million impairment charge related to a capitalized software.

Previous wording

General and administrative expenses increased by $3.1 million, or 45%, for the three months ended March 31, 2025, compared to the same period a year ago. The increase was primarily attributable to a $2.4 million increase in personnel-related costs and a $1.4 million increase in outside services, partially offset by a $0.7 million decrease in facilities and overhead costs. The increase was offset by a $0.3 million decrease in stock-based compensation as we recognized a $1.1 million incremental stock-based compensation expense in connection with the former CEO note forgiveness for the three months ended March 31, 2024. See Note 8 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for more information.

Current wording

General and administrative expenses increased by $5.6 million, or 43%, for the six months ended June 30, 2025, compared to the same period a year ago. The increase primarily relates to a $5.5 million increase in personnel-related costs, including stock-based compensation expense, and a $1.5 million increase in professional services, partially offset by a $1.4 million decrease in facilities and overhead costs. The six months ended June 30, 2024 included a $1.1 million incremental stock-based compensation expense in connection with the former CEO note forgiveness.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through March 31, 2025, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock of $168.0 million, issuances of convertible notes of $2.0 million, an upfront payment of $17.5 million under the Gilead Agreement and net proceeds from the IPO of $336.2 million. As of March 31, 2025, we had $242.6 million in cash, cash equivalents and available-for-sale marketable securities.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through June 30, 2025, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock, issuances of convertible notes, an upfront payment under the Gilead Agreement and net proceeds from the IPO. As of June 30, 2025, we had $211.7 million in cash, cash equivalents and available-for-sale marketable securities.

Previous wording

On March 27, 2025, we filed a shelf registration statement on Form S-3, or 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 our common stock, shares of our 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, or the ATM Prospectus, covering the offer and sale from time to time through or to Jefferies, LLC, or Jefferies, as sales agent, of up to $50.0 million in aggregate offering price of shares of our common stock under an Open Market Sale Agreement SM entered into with Jefferies on March 27, 2025.

Current wording

On March 27, 2025, we filed a shelf registration statement on Form S-3, or 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 our common stock, shares of our 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, or the ATM Prospectus, covering the offer and sale from time to time through or to Jefferies, LLC, or Jefferies, as sales agent, of up to $50.0 million in aggregate offering price of shares of our common stock under an Open Market Sale Agreement SM entered into with Jefferies on March 27, 2025. As of June 30, 2025, $50.0 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the Registration Statement.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. As of March 31, 2025, we had an accumulated deficit of $308.2 million. Based on the current cash forecast, management has determined that our cash, cash equivalents and available-for-sale marketable securities of $242.6 million as of March 31, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2025, we had an accumulated deficit of $350.2 million. Based on the current cash forecast, management has determined that our cash, cash equivalents and available-for-sale marketable securities of $211.7 million as of June 30, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Previous wording

Net cash used in operating activities was $44.9 million and $25.5 million for the three months ended March 31, 2025 and 2024, respectively.

Current wording

Net cash used in operating activities was $76.9 million and $49.7 million for the six months ended June 30, 2025 and 2024, respectively.

Previous wording

Cash used in operating activities for the three months ended March 31, 2025, was primarily due to our net loss of $44.6 million, decreased by non-cash charges of $1.9 million and increased by $2.2 million for changes in our net operating assets and liabilities. The non-cash charges primarily consisted of a $2.2 million stock-based compensation expense, a $0.7 million non-cash lease expense, a $0.6 million impairment charge of a capitalized software and a $0.5 million depreciation and amortization expense, partially offset by $2.1 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in other current liabilities of $2.3 million, a decrease in accrued compensation of $1.8 million, a decrease in operating lease liability of $1.0 million, an increase in other non-current assets of $0.5 million and an increase in prepaid expense and other current assets of $0.4 million offset by an increase in accounts payable of $3.8 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2025, was primarily due to our net loss of $86.7 million, decreased by non-cash charges of $3.8 million and by $6.0 million for changes in our net operating assets and liabilities. The non-cash charges primarily consisted of a $4.7 million stock-based compensation expense, a $1.4 million non-cash lease expense, a $1.0 million depreciation and amortization expense and a $0.6 million impairment charge of a capitalized software, partially offset by $4.0 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable of $5.2 million, a decrease in prepaid expense and other current assets of $2.0 million, an increase in other accrued expenses and current liabilities of $1.0 million, and an increase in accrued compensation of $0.1 million, partially offset by a decrease in operating lease liability of $1.7 million and an increase in other non-current assets of $0.5 million.

Previous wording

Cash used in operating activities for the three months ended March 31, 2024, was primarily due to our net loss of $26.7 million, decreased by other non-cash charges of $3.0 million and increased by a net reduction of $1.8 million in our net operating assets and liabilities. Non-cash changes primarily consisted of a $2.3 million stock-based compensation expense, a $0.5 million depreciation and amortization expense and a $0.5 million non-cash lease expense, partially offset by a $0.3 million accretion of discount on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in prepaid other current assets of $2.6 million, a $1.4 million decrease in accrued compensation, a decrease in operating lease liabilities of $0.5 million, an increase in other non-current assets of $0.3 million and a $0.1 million decrease in other accrued expenses and current liabilities, offset by an increase in accounts payable of $3.1 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2024, was primarily due to our net loss of $55.5 million, decreased by non-cash charges of $3.2 million and increased by a net reduction of $2.6 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $3.6 million stock-based compensation expense, a $1.2 million non-cash lease expense and a $1.0 million depreciation and amortization expense, partially offset by $2.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in operating lease liability of $1.1 million, a decrease in other non-current assets of $0.3 million and a decrease in accrued compensation of $0.1 million, offset by an increase in other accrued expenses and current liabilities of $2.6 million, an increase in accounts payable by $1.0 million and an increase in prepaid expense and other current assets of $0.5 million.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025, was $5.6 million, which consisted of $86.7 million in proceeds from maturities of available-for-sale marketable securities, offset by $81.1 million of purchases of available-for-sale marketable securities.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025, was $34.7 million, which consisted of $210.8 million in proceeds from maturities of available-for-sale marketable securities, offset by $175.9 million of purchases of available-for-sale marketable securities and $0.2 million of capitalized internal-use-software costs.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2024, was $122.9 million, which consisted of $145.3 million of purchases of available-for-sale marketable securities and $0.5 million of purchases of property and equipment, offset by $23.0 million in proceeds from maturities of available-for-sale marketable securities.

Current wording

Net cash used in investing activities for the six months ended June 30, 2024, was $190.8 million, which consisted of $225.2 million of purchases of available-for-sale marketable securities and $1.6 million of purchases of property and equipment, offset by $36.0 million in proceeds from maturities of available-for-sale marketable securities.

Previous wording

Net cash used in financing activities for the three months ended March 31, 2025, was $0.4 million, which consisted of $0.3 million related to finance lease obligations and $0.1 million payments for deferred offering costs related to the filing of the Registration Statement.

Current wording

Net cash used in financing activities for the six months ended June 30, 2025, was $1.1 million, which consisted of $0.6 million related to finance lease obligations, $0.4 million related to deferred offering costs paid in connection with the filing of the Registration Statement and less than $0.1 million related to shares withheld for tax obligations payments in connection with RSUs vested during the six months ended June 30, 2025.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024, was $338.0 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and less than $0.1 million of proceeds from exercises of stock options, partially offset by $3.0 million payments for deferred offering costs and a payment of $0.2 million related to finance lease obligations.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024, was $337.5 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and less than $0.1 million of proceeds from exercises of stock options, partially offset by $3.4 million payments for deferred offering costs and a payment of $0.5 million related to finance lease obligations.

Previous wording

As of March 31, 2025, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of March 31, 2025, our non-cancellable lease obligations were $6.9 million and $0.6 million under operating and finance leases, respectively, of which $3.4 million and $0.5 million related to operating and finance leases, respectively, are due within the next 12 months.

Current wording

As of June 30, 2025, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of June 30, 2025, our non-cancellable lease obligations were $6.0 million and $0.3 million under operating and finance leases, respectively, of which $3.8 million and $0.3 million related to operating and finance leases, respectively, are due within the next 12 months.

Previous wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2024 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025. There have been no material changes to our significant accounting policies or critical accounting estimates during the three months ended March 31, 2025.

Current wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2024 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025. There have been no material changes to our significant accounting policies or critical accounting estimates during the six months ended June 30, 2025.