Kyverna Therapeutics, Inc.

Previous wording

We are a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Our mission is to liberate patients from autoimmune diseases through the curative potential of cell therapy. Our development strategy is supported by our breadth of experience in treating more than 100 autoimmune patients with our lead product candidate, mivocabtagene autoleucel, or miv-cel, also known as KYV-101, an anti-CD19 autologous CAR T with a differentiated CAR construct. 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, or IITs, 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 miv-cel through late-stage clinical development and commercialization across multiple autoimmune indications.

Current wording

We are a late-stage clinical immunology company pioneering differentiated therapies with curative potential for people living with neurologic autoimmune diseases. Our development strategy is supported by our breadth of experience in treating more than 100 autoimmune patients with our lead product candidate, mivocabtagene autoleucel, or miv-cel, also known as KYV-101, an anti-CD19 autologous CAR T with a differentiated CAR construct. 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, or IITs, 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 miv-cel through late-stage clinical development and commercialization across multiple autoimmune indications.

Previous wording

We are currently focused on advancing our neuroimmunology CAR T franchise, which includes evaluating miv-cel in stiff person syndrome, or SPS, and generalized myasthenia gravis, or gMG, both serious and highly debilitating autoimmune diseases with significant unmet medical need.

Current wording

We are currently focused on advancing our neuroimmunology CAR T franchise, starting with evaluating miv-cel in stiff person syndrome, or SPS, and generalized myasthenia gravis, or gMG, both serious and highly debilitating autoimmune diseases with significant unmet medical need. We received RMAT designations and Orphan Drug Designations, or ODD, from the FDA for both SPS and MG as well as Orphan Drug Designation from the European Medicines Agency in MG.

Previous wording

SPS is a rare and progressive neurologic autoimmune disease with no FDA-approved therapies. Patients with SPS have substantial disease burden, with symptoms characterized by muscle stiffness and painful muscle spasms, impacting mobility. 80% of patients lose mobility over time, and need walking aid assistance or a wheelchair. In addition, patients face risk of permanent disability and increased mortality. In SPS, we have completed a registrational 26-patient Phase 2 clinical trial (KYSA-8). We presented the positive primary analysis results from the KYSA-8 trial at the 2026 American Academy of Neurology, or AAN, Annual Meeting in April 2026. In the trial, miv-cel demonstrated statistically significant, durable clinical benefit across all primary and secondary endpoints at 16 weeks, with reversal of disability scores following a single dose of miv-cel. 100% of patients remained free of immunotherapies for SPS as of week 16. Further, miv-cel demonstrated a well-tolerated safety profile. We also presented outcomes from a large, multicenter, retrospective natural history study examining the impact of SPS on walking speed at AAN. We had a positive pre-BLA meeting with the FDA and gained alignment on our regulatory path for miv-cel in SPS, including a rolling BLA submission and all core components of the BLA package. In May 2026, we initiated the rolling BLA submission, seeking priority review under the program's Regenerative Medicine Advanced therapy (RMAT) designation, and anticipate completing the submission in the fourth quarter of 2026.

Current wording

SPS is a rare and progressive neurologic autoimmune disease with no therapies approved by the U.S. Food and Drug Administration, or the FDA. Patients with SPS have substantial disease burden, with symptoms characterized by muscle stiffness and painful muscle spasms, impacting mobility. 80% of patients lose mobility over time, and need walking aid assistance or a wheelchair. In addition, patients face risk of permanent disability and increased mortality. In SPS, we have completed a registrational 26-patient Phase 2 clinical trial (KYSA-8). We presented the positive primary analysis results from the KYSA-8 trial at the 2026 American Academy of Neurology, or AAN, Annual Meeting in April 2026. In the trial, miv-cel demonstrated statistically significant, durable clinical benefit across all primary and secondary endpoints at 16 weeks, with reversal of disability scores following a single dose of miv-cel. 100% of patients remained free of immunotherapies for SPS as of week 16. Further, miv-cel demonstrated a well-tolerated safety profile. We also presented outcomes from a large, multicenter, retrospective natural history study examining the impact of SPS on walking speed at AAN. During the second quarter of 2026, we held a positive pre-biologics license application, or BLA, meeting with the FDA and gained alignment on our regulatory path for miv-cel in SPS, including a rolling BLA submission and all core components of the BLA package. We then initiated the rolling BLA submission, seeking priority review under the program's Regenerative Medicine Advanced Therapy, or RMAT, designation. In July 2026, we submitted the Chemistry, Manufacturing, and Controls, or CMC, module, and anticipate completing the submission in the fourth quarter of 2026. We continue to advance activities to enable a successful launch upon approval. These efforts include hiring key commercial leadership roles, commercial site activation, entering into a commercial supply agreement, payer and patient advocacy engagement, and healthcare professional education. We plan to report 12-month topline data from KYSA-8 for miv-cel in patients with SPS in the third quarter of 2026.

Previous wording

In October 2025, we reported positive interim data from our registrational KYSA-6 (KYSA-6) Phase 2 clinical trial of miv-cel in gMG. In April 2026, we presented the positive longer-term follow-up data from the Phase 2 portion of the KYSA-6 trial at the 2026 AAN Annual Meeting. The updated data demonstrated durable clinical responses across all key clinical outcome measures with sustained benefit observed out to one year following a single dose of miv-cel. 100% of patients achieved clinically meaningful, rapid and robust reductions in Myasthenia Gravis Activities of Daily Living, or MG-ADL, and Quantitative Myasthenia Gravis, or QMG, scores from baseline (the co-primary endpoints of the Phase 3 portion of the trial), regardless of prior biologic exposure and at deeper levels observed compared to prior interim analysis. In addition, biomarker and mechanistic data further supported miv-cel’s differentiated clinical profile and miv-cel was well-tolerated. We began enrolling patients for our FDA-aligned, Phase 3 registrational trial in December 2025 and continue to enroll patients across 15 activated sites globally.

Current wording

In October 2025, we reported positive interim data from our registrational KYSA-6 Phase 2 clinical trial of miv-cel in gMG. In April 2026, we presented the positive longer-term follow-up data from the Phase 2 portion of the KYSA-6 trial at the 2026 AAN Annual Meeting. The updated data demonstrated durable clinical responses across all key clinical outcome measures with sustained benefit observed out to one year following a single dose of miv-cel. 100% of patients achieved clinically meaningful, rapid and robust reductions in Myasthenia Gravis Activities of Daily Living, or MG-ADL, and Quantitative Myasthenia Gravis, or QMG, scores from baseline (the co-primary endpoints of the Phase 3 portion of the trial), regardless of prior biologic exposure and at deeper levels observed compared to prior interim analysis. In addition, biomarker and mechanistic data further supported miv-cel’s differentiated clinical profile and miv-cel was well-tolerated. We continue to advance our FDA-aligned, Phase 3 registrational trial and expect to complete patient enrollment by mid-2027. We anticipate sharing longer term, follow-up Phase 2 topline data in gMG in the third quarter of 2026.

Previous wording

We are harnessing IITs and other Kyverna-sponsored clinical trials, or KYSA trials, including in progressive multiple sclerosis, or progressive MS, rheumatoid arthritis, or RA, lupus nephritis, or LN, and systemic sclerosis, or SSc, to inform our next priority indications to advance into late-stage development. In 2025, we shared encouraging data from a Phase 1 IIT in MS and a Phase 1/2 IIT in RA. In February 2026, the positive updated data of miv-cel in progressive multiple sclerosis from a Phase 1 IIT was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum.

Current wording

We are conducting IITs and other Kyverna-sponsored clinical trials, or KYSA trials, including in PMS, rheumatoid arthritis, or RA, lupus nephritis, or LN, and systemic sclerosis, or SSc. In 2025, encouraging data from a Phase 1 IIT in PMS and a Phase 1/2 IIT in RA were shared. In February 2026, the positive updated data of miv-cel in PMS from a Phase 1 IIT was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum. We expect to provide an update on our PMS development strategy by early 2027.

Previous wording

As part of our longer-term efforts to broaden patient access, we are exploring alternative lymphodepletion, or LD, and no LD regimens for miv-cel in addition to the potential for outpatient administration given miv-cel’s favorable safety profile. Additionally, our pipeline includes next-generation CAR T-cell technologies in order to efficiently expand into broader autoimmune indications and increase patient reach.

Current wording

As part of our longer-term efforts to broaden patient access, we continue to explore miv-cel with alternative or preconditioning regimens and the potential for outpatient administration supported by miv-cel’s favorable safety profile.

Previous wording

In January 2026, the Investigational New Drug, or IND, application for KYV-102, our proprietary whole blood, rapid manufacturing process, was accepted by the U.S. FDA.

Current wording

In January 2026, the Investigational New Drug, or IND, application for KYV-102, our proprietary whole blood, rapid manufacturing process, was accepted by the FDA.

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., or Gilead, which terminated effective as of January 22, 2024; from the sale of shares of our common stock in our initial public offering in February 2024, or the IPO, through our ATM Facility (as defined below) and other underwritten public offerings; and cash received from our Loan Facility (as defined below) entered in October 2025. Our net loss was $39.7 million for the three months ended March 31, 2026, compared with $44.6 million net loss for the three months ended March 31, 2025. As of March 31, 2026, we had an accumulated deficit of $464.6 million. Management has determined that our cash and cash equivalents and available-for-sale marketable securities of $236.4 million as of March 31, 2026 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 and 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., or Gilead, which terminated effective as of January 22, 2024; from the sale of shares of our common stock in our initial public offering in February 2024, or the IPO, through our ATM Facility (as defined below) and other underwritten public offerings; and cash received from our Loan Facility (as defined below) entered in October 2025. Our net losses were $38.3 million and $78.0 million for the three and six months ended June 30, 2026, respectively, compared with $42.1 million and $86.7 million net loss for the three and six months ended June 30, 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $502.9 million. Management has determined that our cash and cash equivalents and available-for-sale marketable securities of $199.4 million as of June 30, 2026, net proceeds from the sale of shares under the ATM Facility and the term loans available under the Loan Facility with Oxford Finance 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 and 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

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our product candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. Under the July 2023 development and manufacturing services agreement, or the Elevate Agreement, with ElevateBio BaseCamp, Inc., or Elevate, Elevate provides us with cell manufacturing, release and testing services for our miv-cel product candidate.

Current wording

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our product candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. The Elevate CCSA replaced the July 2023 development and manufacturing services agreement with Elevate under which Elevate provided us with cell manufacturing, release and testing services for our miv-cel product candidate. Under the 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 miv-cel product candidate. Pursuant to our license and supply agreement with Oxford Biomedica (UK) Limited, or Oxford, Oxford provides us with lentiviral vector process development services.

Previous wording

Fast Track Designation, or FTD, does not ensure that we will experience a faster development process, regulatory review or regulatory approval process compared to conventional FDA procedures. *Phase 3 may not be required if Phase 2 is registrational.

Current wording

Fast track designation does not assure that we will experience a faster development process, regulatory review or regulatory approval

Previous wording

†EU & US. ‡ Kyverna is also exploring miv-cel in progressive MS through IITs.

Current wording

†EU & US. ‡Kyverna is also exploring miv-cel in progressive multiple sclerosis through IITs from Stanford University and the University of California, San Francisco.

Previous wording

The largest component of our total operating expenses since inception has been research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for research and development employees, including stock-based compensation; expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct preclinical and clinical studies; costs of acquiring and manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other outside services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.

Current wording

expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct preclinical and clinical studies; costs of acquiring and manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other outside services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.

Previous wording

We expect our research and development expenses to increase substantially for the foreseeable future as we advance our product candidates into and through preclinical studies and clinical trials, pursue regulatory approval of our product candidates and expand our pipeline of product candidates. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors, including the safety and efficacy of our product candidates, early clinical data, investment in our clinical programs, competition, manufacturing capability and commercial viability. We may never receive regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if approved.

Current wording

The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors, including the safety and efficacy of our product candidates, early clinical data, investment in our clinical programs, competition, manufacturing capability and commercial viability. We may never receive regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if approved.

Previous wording

Interest expense consists primarily of interest expense related to our Loan Facility and laboratory equipment finance leases. The Loan Facility interest expense was $0.6 million for the three months ended March 31, 2026 and we expect that it will increase in the future as we will incur interest on the outstanding borrowings under the Loan Facility.

Current wording

Interest expense consists primarily of amounts related to our Loan Facility and laboratory equipment finance leases. We expect that it will increase in the future as we will incur interest on the outstanding borrowings under the Loan Facility.

Previous wording

Research and development expenses decreased by $7.4 million, or 20%, from $37.4 million for the three months ended March 31, 2025 to $30.1 million for the three months ended March 31, 2026.

Current wording

Research and development expenses decreased by $11.0 million, or 31%, from $35.8 million for the three months ended June 30, 2025, to $24.8 million for the three months ended June 30, 2026.

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 $0.4 million, or 63%, in 2026 mainly due to a $0.2 million decrease in CMO costs.

Current wording

Other program expenses include research and development expenses, mainly for our KYV-201 and KYV-102 programs. Other program costs decreased year-over-year by $1.0 million, or 98%, in 2026, mainly due to a decrease in CMO and CRO costs.

Previous wording

Personnel-related expenses increased by $1.2 million, or 14%, from $8.5 million for the three months ended March 31, 2025 to $9.7 million for the three months ended March 31, 2026 primarily due to growth in the number of employees in our research and development organization.

Current wording

Personnel-related expenses increased by $0.5 million, or 7%, from $8.3 million for the three months ended June 30, 2025 to $8.8 million for the three months ended June 30, 2026, primarily due to growth in the number of employees in our research and development organization.

Previous wording

Other research and development expenses primarily consist of unallocated research and development costs, professional services, facilities, depreciation and overhead costs. The decrease of $1.3 million, or 21%, for the three months ended March 31, 2026, compared to the same period a year ago, is mainly due to a one-time $0.6 million impairment charge related to a capitalized software recorded during the three months ended March 31, 2025 and lower allocated overhead expenses.

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 $0.5 million, or 14%, for the three months ended June 30, 2026, compared to the same period a year ago, is mainly due to a $0.6 million increase in professional services and higher allocated overhead expenses.

Previous wording

General and administrative expenses increased by $1.3 million, or 13%, for the three months ended March 31, 2026, compared to the same period a year ago. The increase primarily relates to a $0.7 million increase in personnel-related expenses and a $0.5 million increase in professional services. Stock-based compensation expense, included in personnel-related costs, increased from $1.4 million for the three months ended March 31, 2025, to $2.3 million for the three months ended March 31, 2026.

Current wording

General and administrative expenses increased by $6.2 million, or 72%, for the three months ended June 30, 2026, compared to the same period a year ago. The increase primarily relates to a $3.3 million increase in personnel-related expenses, including a $0.8 million increase in stock-based compensation expense and a $3.1 million increase in professional services. The increase in professional consulting costs is mainly due to an increase in information technology consulting as well as commercial and market access preparations.

Previous wording

Interest income decreased by $0.5 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, primarily due to lower effective interest yield during the three months ended March 31, 2026 as compared to the same period a year ago.

Current wording

Interest income decreased by $0.4 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to lower effective interest yield on our marketable securities during the three months ended June 30, 2026 as compared to the same period a year ago.

Previous wording

External research and development expenses related to our miv-cel program decreased by $6.9 million, or 31%, for the three months ended March 31, 2026 compared to 2025 mainly driven by a decrease in costs incurred for CMO activities of $8.3 million. We incurred higher CMO costs during the three months ended March 31, 2025 to support significant BLA readiness efforts. CRO costs decreased slightly in the three months ended March 31, 2026, compared to the three months ended March 31, 2025, mainly due to lower costs incurred for our KYSA-8 trial. The decrease in miv-cel CMO and CRO costs was partially offset by a $0.8 million increase in professional services and a benchmark royalty expense of $1.0 million, which became payable to the National Institutes of Health in accordance with a patent license agreement, during the three months ended March 31, 2026.

Current wording

External research and development expenses related to our miv-cel program decreased by $18.0 million, or 40%, for the six months ended June 30, 2026, compared to the same period a year ago, mainly driven by a decrease in costs incurred for CMO activities of $18.5 million. We incurred higher CMO costs during the six months ended June 30, 2025 to support significant BLA readiness efforts, related to our SPS product candidate. CRO costs decreased by $1.7 million in the six months ended June 30, 2026, compared to the six months ended June 30, 2025, mainly due to lower costs incurred for our KYSA-8 SPS trial, partially offset by higher costs for our KYSA-6 MG trials. The decrease in miv-cel CMO and CRO costs was partially offset by a benchmark royalty expense of $1.0 million, as we reached a milestone and it became payable in accordance with a patent license agreement during the six months ended June 30, 2026 and $1.0 million of higher professional consulting services costs.

Previous wording

On March 27, 2025, we filed a shelf registration statement on Form S-3, or the Prior 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 Prior Registration Statement was declared effective by the SEC on April 15, 2025. The Prior Registration Statement included a sales agreement prospectus, or the Prior 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, or the ATM Agreement. In November 2025, we sold 2,477,100 shares under the Prior ATM Prospectus for net proceeds of $16.4 million after deducting the placement agent’s fees. As of March 31, 2026, and December 31, 2025, $32.5 million of shares of common stock remained available for sale under the Prior ATM Prospectus.

Current wording

On March 27, 2025, we filed a shelf registration statement on Form S-3, or the Prior 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 Prior Registration Statement was declared effective by the SEC on April 15, 2025. The Prior Registration Statement included a sales agreement prospectus, or the Prior 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, or the ATM Agreement. In November 2025, we sold 2,477,100 shares under the Prior ATM Prospectus for net proceeds of $16.4 million after deducting the sales agent’s fees.

Previous wording

On March 26, 2026, we filed a new shelf registration statement on Form S-3, or the 2026 Registration Statement, covering the offer and sale from time to time of up to $300.0 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 2026 Registration Statement was declared effective by the SEC on April 2, 2026, and the Prior Registration Statement, including the Prior ATM Prospectus, ceased to be available for further utilization at that time. The terms of any offering under the 2026 Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the 2026 Registration Statement filed with the SEC prior to the completion of any such offering. The 2026 Registration Statement included a sales agreement prospectus, or the 2026 ATM Prospectus, covering the offer and sale from time to time through or to Jefferies, as sales agent, of up to $100.0 million in aggregate offering price of shares of our common stock under the ATM Agreement. As of May 1, 2026, $100.0 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the 2026 Shelf Registration Statement.

Current wording

On March 26, 2026, we filed a new shelf registration statement on Form S-3, or the 2026 Registration Statement, covering the offer and sale from time to time of up to $300.0 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 2026 Registration Statement was declared effective by the SEC on April 2, 2026, and the Prior Registration Statement, including the Prior ATM Prospectus, ceased to be available for further utilization at that time. The terms of any offering under the 2026 Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the 2026 Registration Statement filed with the SEC prior to the completion of any such offering. The 2026 Registration Statement included a sales agreement prospectus, or the 2026 ATM Prospectus, covering the offer and sale from time to time through or to Jefferies, as sales agent, of up to $100.0 million in aggregate offering price of shares of our common stock under the ATM Agreement, or the ATM Facility. In June 2026, we sold 426,038 shares under the 2026 ATM Prospectus for net proceeds of $3.6 million, after deducting the sales agent’s fees. As of June 30, 2026, $96.3 million remains allocated and available under the 2026 ATM Prospectus and $200.0 million remains available and allocated under the 2026 Registration Statement.

Previous wording

On October 31, 2025, we entered into a Loan and Security Agreement, or the Loan and Security Agreement, with Oxford Finance LLC, or Oxford Finance, as collateral agent, and certain lenders from time to time party thereto. The Loan and Security Agreement provides a non-dilutive term loan facility, or the Loan Facility, up to an aggregate principal amount of up to $150.0 million senior secured credit facilities, subject to certain conditions. The Loan Facility includes an initial tranche of the term loan of $40.0 million and two additional tranches totaling $60.0 million, subject to the satisfaction of certain terms and conditions of the Loan and Security Agreement. A fourth tranche of the term loan of $50.0 million may also be made available subject to Oxford Finance’s discretion. On November 3, 2025, we drew $25.0 million from funds available from the first term loan. The Loan Facility matures on October 1, 2030, and bears interest at a floating per annum rate equal to (a) the greater of (i) the 1-Month CME Term Secured Overnight Financing Rate, or SOFR, administered by CME Group Benchmark Administrator Limited and (ii) 3.75% plus (b) 5.00%. We are required to make monthly payments of interest only until November 1, 2028 or, at our option subject to the achievement of certain milestones, until November 1, 2029, after which monthly payments of principal and interest will be due. The Loan and Security Agreement includes events of default, which, if triggered, could result in, among other things, the acceleration of our repayment obligations. Additionally, pursuant to the Loan and Security Agreement, we granted Oxford Finance a security interest in substantially all of our assets, including our intellectual property.

Current wording

On October 31, 2025, we entered into a Loan and Security Agreement, or the Loan and Security Agreement, with Oxford Finance LLC, or Oxford Finance, as collateral agent, or the Collateral Agent, and certain lenders from time to time party thereto, or the Lenders. The Loan and Security Agreement provides a term loan facility, or the Loan Facility, of up to an aggregate principal amount of $150.0 million in senior secured credit facilities.

Previous wording

As of March 31, 2026, we had $236.4 million in cash, cash equivalents and available-for-sale marketable securities.

Current wording

As of June 30, 2026, we had $199.4 million in cash, cash equivalents and available-for-sale marketable securities.

Previous wording

Our primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs and, to a lesser extent, general and administrative expenditures. We anticipate that we will continue to incur significant and increasing expenses for the foreseeable future as we continue to advance our product candidates, expand our corporate infrastructure, including the costs associated with being a public company, further our research and development initiatives for our product candidates and incur costs associated with the potential commercialization of our product candidates, if approved. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Current wording

Our primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs and, to a lesser extent, general and administrative expenditures. We anticipate that we will continue to incur significant and increasing expenses for the foreseeable future as we continue to advance our product candidates, expand our corporate infrastructure, further our research and development initiatives for our product candidates and incur costs associated with the potential commercialization of our product candidates, if approved. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. As of March 31, 2026, we had an accumulated deficit of $464.6 million. Based on the current cash forecast, management has determined that our cash, cash equivalents and available-for-sale marketable securities of $236.4 million as of March 31, 2026 will be sufficient to fund our planned operations for at least one year from the filing date of this Quarterly Report on Form 10-Q. The 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

Form 10-Q) and the term loans available under the Loan Facility with Oxford Finance will be sufficient to fund our operating plan and capital expenditure requirements for at least one year from the filing date of this Quarterly Report on Form 10-Q. The 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

Furthermore, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures.

Current wording

Furthermore, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials, product launch-readiness activities and other research and development expenditures.

Previous wording

Net cash used in operating activities was $41.6 million and $44.9 million for the three months ended March 31, 2026 and 2025, respectively.

Current wording

Net cash used in operating activities was $81.9 million and $76.9 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

Cash used in operating activities for the three months ended March 31, 2026, was primarily due to our net loss of $39.7 million, decreased by non-cash charges of $3.5 million and increased by a net change in our net operating assets and liabilities of $5.4 million. The non-cash charges primarily consisted of a $3.2 million stock-based compensation expense, $0.6 million non-cash lease expense, $0.4 million depreciation and amortization expense and a $0.1 million non-cash interest expense, partially offset by $0.7 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 accrued compensation of $6.9 million, a decrease in other current liabilities of $4.4 million, a decrease in operating lease liability of $0.5 million and an increase in prepaid expense and other current assets of $0.1 million, partially offset by a $6.3 million increase in accounts payable.

Current wording

Cash used in operating activities for the six months ended June 30, 2026, was primarily due to our net loss of $78.0 million, decreased by non-cash charges of $7.7 million but increased by $11.6 million for changes in our net operating assets and liabilities. The non-cash charges primarily consisted of a $6.7 million stock-based compensation expense, a $1.0 million non-cash lease expense and a $0.8 million depreciation and amortization expense, partially offset by $0.9 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 accrued compensation of $4.5 million, a decrease in other current liabilities of $4.4 million, a decrease in accounts payable of $2.4 million, a decrease in operating lease liability of $1.2 million, and an increase in prepaid expense and other current assets of $0.5 million, partially offset by a decrease in other non-current assets of $1.5 million.

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

Net cash used in investing activities for the three months ended March 31, 2026, was $50.2 million, which consisted of $115.9 million of purchases of available-for-sale marketable securities, partially offset by $65.7 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, 2026, was $14.1 million, which consisted of $147.8 million of purchases of available-for-sale marketable securities, $0.3 million of purchases of property and equipment and $0.3 million of capitalization of internal-use software costs, partially offset by $134.3 million in proceeds from maturities of available-for-sale marketable securities.

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 financing activities for the three months ended March 31, 2026, was $0.1 million, which consisted of $0.2 million in proceeds from the exercise of common stock options, offset by $0.1 million related to finance lease obligations and $0.1 million payments for deferred offering costs related to the filing of the 2026 ATM Prospectus and $0.2 million of taxes paid related to net share settlement of RSUs.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026, was $3.7 million, which consisted of $2.5 million in proceeds from issuance of common stock shares under the ATM Facility, net of the sales agent's fees and $1.9 million in proceeds from the exercise of stock options, partially offset by $0.4 million related to payment of tax withholding obligations for the net settlement of restricted stock units that vested during the six months ended June 30, 2026, $0.2 million related to finance lease obligations and $0.1 million of payments for offering costs related to the filing of the 2026 Registration Statement.

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 2026 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 Prior Registration Statement and less than $0.1 million related to shares withheld to satisfy tax withholding obligations in connection with restricted stock units that vested during the six months ended June 30, 2025.

Previous wording

We have milestone, royalty and other payments due to third parties under our existing license and collaboration agreements. Refer to Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q for additional details. We cannot estimate when such payments will be due and none of these events were probable to occur as of March 31, 2026. As of March 31, 2026, and December 31, 2025, we recognized a sublicensing fee of $3.8 million in our condensed balance sheets payable to Kite Therapeutics, Inc. by December 31, 2026 as discussed in Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q.

Current wording

We have milestone, royalty and other payments due to third parties under our existing license and collaboration agreements. Refer to Note 6, "License and Collaboration Agreements" to the condensed financial statements included in this Quarterly Report on Form 10-Q for additional details. We cannot estimate when such payments will be due and none of these events were probable to occur as of June 30, 2026. As of June 30, 2026, and December 31, 2025, we recognized a sublicensing fee of $3.8 million in our condensed balance sheets payable to Kite Therapeutics, Inc. by December 31, 2026 as discussed in Note 6 to the condensed financial statements included in this Quarterly Report on Form 10-Q.

Previous wording

As of March 31, 2026, we leased office and laboratory space in Emeryville, California under operating leases, or the Emeryville Lease. On February 27, 2026, we entered into a lease amendment to reduce total office and lab space and add new office space in the same building commencing around July 1, 2026. The term of the Emeryville Lease has been extended through August 31, 2030.

Current wording

As of June 30, 2026, we leased office and laboratory space in Emeryville, California under operating leases, or the Emeryville Lease. On February 27, 2026, we entered into a lease amendment to reduce total office and lab space and added new office space in the same building commencing on July 2, 2026. The term of the Emeryville Lease is through August 31, 2030.

Previous wording

We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of March 31, 2026, our non-cancellable lease obligations were $11.5 million and $0.2 million under operating and finance leases, respectively, of which $2.8 million and $0.2 million related to operating and finance leases, respectively, are due within the next 12 months.

Current wording

We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of June 30, 2026, our non-cancellable lease obligations were $10.5 million and $0.1 million under operating and finance leases, respectively, of which $2.4 million and $0.1 million related to operating and finance leases, respectively, are due within the next 12 months.

Previous wording

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2, “Summary of Significant Accounting Policies”, to the condensed financial statements included in this Quarterly Report on Form 10-Q.

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, 2025 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026. There have been no material changes to our significant accounting policies or critical accounting estimates during the three months ended March 31, 2026.

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, 2025 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026. There have been no material changes to our significant accounting policies or critical accounting estimates during the six months ended June 30, 2026.