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Item 2 — Management's Discussion and Analysis
Kyverna Therapeutics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited financial statements and related notes thereto as of and for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in Part II of the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission, or the SEC, on March 26, 2026. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section below titled “Special Note Regarding Forward-Looking Statements.”
Throughout this Quarterly Report on Form 10-Q, unless the context otherwise requires, the terms “Kyverna,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Kyverna Therapeutics, Inc.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of preclinical studies and clinical trials, research and development plans and costs, plans for manufacturing, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, for example, but are not limited to, statements about:
•the initiation, timing, progress and results of our preclinical studies, clinical trials, and research and development programs for our product candidates;
•our ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo for our product candidates;
•our ability to successfully complete our clinical trials;
•our ability to quickly leverage our initial product candidates and to progress additional candidates;
•the prevalence of certain diseases and conditions we intend to treat and the size of the market opportunity for our product candidates;
•estimates of the number of patients with certain diseases and conditions we intend to treat and the number of patients that we will enroll in our clinical trials;
•the likelihood of our clinical trials demonstrating safety and efficacy of our product candidates;
•the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of our product candidates;
•the timing or likelihood of regulatory filings and approval for our product candidates;
•our ability to meet future regulatory standards with respect to our product candidates, if approved;
•our plans relating to the further development and manufacturing of our product candidates, including additional indications which we may pursue;
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•our ability to identify additional product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
•the rate and degree of market acceptance and therapeutic benefits of our product candidates, if approved, and any other product candidates we may develop;
•the implementation of our strategic plans for our business, product candidates, research programs and technologies;
•the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technologies;
•anticipated developments related to our competitors and our industry;
•our competitive position and ability to leverage the clinical, regulatory and manufacturing advancements to accelerate our clinical trials and regulatory approval of product candidates;
•the success of competing therapies that are or may become available;
•our ability to identify and enter into future license agreements and collaborations;
•the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with development, regulatory, manufacturing or commercialization expertise;
•our ability to prosecute, grow and defend our intellectual property portfolio against infringement claims;
•our ability to efficiently and cost-effectively conduct our current and future clinical trials;
•our reliance on third parties to conduct clinical trials of our product candidates;
•our reliance on third parties for the manufacture of our product candidates;
•our plans relating to sales strategy, manufacturing and commercializing our product candidates, if approved;
•our ability to attract and retain sales personnel, or to contract with a sales organization, if our product candidates are approved;
•anticipated regulatory and legal developments in the United States and foreign countries in which we may seek regulatory approval for our product candidates in the future;
•our ability to expand internationally;
•our ability to attract and retain key scientific and management personnel;
•our expected or anticipated financial performance;
•the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements;
•our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, or a smaller reporting company;
•estimates of our expenses, capital requirements and needs for additional financing; and
•potential unfavorable macroeconomic conditions or market volatility resulting from global economic conditions or geopolitical developments, including international tariffs, trade protection measures, economic sanctions, supply chain issues, inflationary pressures, economic slowdowns or recessions, acts of war and civil or political unrest.
We caution you that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in this Quarterly Report on Form 10-Q.
We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties 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, and involve a number of assumptions and limitations. Moreover, we operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to
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time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, other strategic transactions or investments we may make or enter into.
Overview
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.
Miv-cel, our lead program, is an autologous, fully human CD19-targeting CAR T-cell product candidate that is designed for potency and tolerability in autoimmune diseases. Miv-cel is made from an underlying chimeric antigen receptor, or CAR, licensed from the National Institutes of Health, or the NIH. In addition to a fully human scFv domain, the CAR in miv-cel was also designed with a human CD8α hinge and transmembrane domain, a highly potent human CD28 costimulatory domain, and a human CD3ζ activation domain. This same underlying CAR in miv-cel has completed a 20-patient Phase 1 clinical trial in oncology conducted by the NIH, and the results from this Phase 1 clinical 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 the unique miv-cel CAR construct has the potential to deliver a differentiated therapeutic profile in autoimmune disease over current standard-of-care therapies by addressing the underlying immune dysfunction – deeply depleting B cells with the goal of achieving an immune reset and durable, treatment-free remission.
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.
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,
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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.
Myasthenia gravis, or MG, is a B-cell and antibody-mediated neuromuscular autoimmune disease that causes fluctuating muscle weakness and fatigue. The disease includes gMG, which impacts muscles beyond the eyes and may involve bulbar, limb, and respiratory muscles. Most patients develop gMG within two years after MG diagnosis. Symptoms are highly disruptive to quality of life and can include muscle weakness and fatigue, difficulty chewing and swallowing, trouble with speech, and in severe cases, respiratory failure, which can be life-threatening. Despite available treatment options, including immunosuppressants and biologics, patients still struggle with symptom control and require chronic and costly treatment options in addition to background therapies.
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.
Beyond SPS and gMG, our pipeline opportunities include expanding into other autoimmune indications as well as novel innovations to expand patient access.
In August 2026, the FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis, or naSPMS, which provides the opportunity for increased FDA engagement and eligibility for priority and rolling reviews, as well as accelerated approval pathways.
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.
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.
We are strengthening our CMC capabilities to support late-stage clinical development and anticipated commercialization. On July 23, 2026, we entered into a clinical and commercial supply agreement, or the Elevate CCSA, with ElevateBio BaseCamp, Inc., or Elevate, for both U.S commercial and global clinical supply of miv-cel. The new manufacturing agreement provides us with flexible and scalable supply of miv-cel, supporting our potential launches in SPS and gMG, as well as other ongoing clinical studies.
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.
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.
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
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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.
We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon the successful development, approval and commercialization of our product candidates and upon the receipt of sufficient revenues to support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need to continue to raise additional capital.
We expect our expenses will increase substantially in connection with our ongoing and planned activities, as we:
•continue to progress the development of our product candidates, including miv-cel in multiple clinical trials in parallel;
•explore additional indications for our existing product candidates;
•procure manufacturing of clinical supply and manufacturing operations for our clinical trials and commercial manufacturing, if any of our product candidates are approved;
•acquire, discover, validate and develop additional product candidates;
•attract, hire and retain additional personnel;
•implement operational, financial and management systems;
•pursue regulatory approval for any product candidates that successfully complete clinical trials;
•establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval and related commercial manufacturing build-out;
•obtain, maintain, expand and protect our portfolio of intellectual property rights; and
•operate as a public company.
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.
We continue to advance our product-launch readiness activities. However, we have not yet established a fully operational commercial infrastructure. We expect to continue investing in our commercial capabilities as appropriate. Accordingly, if we obtain regulatory approval for any of our product candidates, we expect to incur additional expenses to expand our infrastructure to support product sales, marketing, market access, distribution and other commercial activities.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability, if at all. Even if we are able to generate revenue from the sale of our product candidates, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
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Our pipeline and programs
Our portfolio of product candidates for the treatment of autoimmune diseases is summarized in the figure below:
RMAT, Regenerative Medicine Advanced Therapy; ODD, Orphan Drug Designation; FTD, Fast Track Designation, IIT, investigator-
initiated trial; naSPMS, non-active secondary progressive multiple sclerosis;
Fast track designation does not assure that we will experience a faster development process, regulatory review or regulatory approval
process compared to conventional US Food and Drug Administration procedures; *Phase 3 may not be required if Phase 2 is registrational.
†EU & US. ‡ Kyverna is also exploring miv-cel in progressive multiple sclerosis through IITs from Stanford University and the University of California, San Francisco.
License and Collaboration Agreements
Information regarding our license and collaboration agreements is included in Note 6, “License and Collaboration Agreements,” to the condensed financial statements included in this Quarterly Report on Form 10-Q.
Macroeconomic Trends
We may be affected by worldwide economic conditions and challenges, such as the effects of the ongoing geopolitical conflicts in Ukraine, war in Iran and other conflicts and instability in the Middle East, instability in Venezuela, tensions between not only the U.S. and China, but also between the U.S. and other countries in the international community, disruptions in the banking industry and inflationary trends, and the imposition, or threatened imposition, of tariffs and potential retaliatory trade restrictions. The past several years have been marked by significant market uncertainty and increasing inflationary pressures. These market dynamics continue and similar adverse market conditions may negatively impact our business, financial position and results of operations. For further discussion of the potential impacts of macroeconomic events on us, refer to the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q.
Components of Operating Results
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research and Development Expenses
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;
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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.
Research and development costs include:
•costs incurred under agreements with third-party CROs, CMOs and other third parties that conduct preclinical and clinical activities on our behalf and manufacture our product candidates;
•consulting fees associated with our research and development activities;
•costs associated with acquiring technology and intellectual property licenses that have no alternative future uses, milestone payments and annual license maintenance fees under our licensing agreements;
•other costs associated with our research and development programs, including laboratory materials and supplies;
•employee-related costs, including salaries, benefits, travel and meals expenses, and stock-based compensation expense for our research and development personnel; and
•allocated facilities and overhead costs, including software and other miscellaneous expenses incurred in connection with our research and development programs.
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.
General and Administrative Expenses
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.
Our general and administrative expenses have increased, and are expected to continue to increase primarily due to increased personnel costs, including salaries, benefits and stock-based compensation expense, expanded infrastructure and increased consulting and professional services associated with maintaining compliance with stock exchange listing and requirements of the SEC, investor relations costs and director and officer insurance premiums.
Interest Income
Interest income consists primarily of interest and accretion of premiums and discounts on our investments in available-for-sale marketable securities and cash equivalents.
Interest Expense
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.
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Other Expense, Net
Other expense, net primarily consists of settlement and revaluation of transactions and accounts payable in foreign currency.
Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods presented:
Three Months Ended June 30, Change
2026 2025 $ %
(in thousands, except percentages)
Operating expenses
Research and development $ 24,788 $ 35,816 $ (11,028 ) (31 )%
General and administrative 14,768 8,594 6,174 72 %
Total operating expenses 39,556 44,410 (4,854 ) (11 )%
Loss from operations (39,556 ) (44,410 ) 4,854 (11 )%
Interest income 1,929 2,364 (435 ) (18 )%
Interest expense (674 ) (14 ) (660 ) 4,714 %
Other expense, net (18 ) (21 ) 3 (14 )%
Total other income, net 1,237 2,329 (1,092 ) (47 )%
Net loss $ (38,319 ) $ (42,081 ) $ 3,762 (9 )%
Research and Development Expenses
The following table summarizes our research and development expenses for the periods presented:
Three Months Ended June 30, Change
2026 2025 $ %
(in thousands, except percentages)
Miv-cel $ 11,386 $ 22,541 $ (11,155 ) (49 )%
Other programs 24 986 (962 ) (98 )%
Personnel-related expenses 8,814 8,272 542 7 %
Other research and development expenses 4,564 4,017 547 14 %
Total research and development expenses $ 24,788 $ 35,816 $ (11,028 ) (31 )%
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.
External research and development expenses related to our miv-cel program decreased by $11.2 million, or 49%, for the three months ended June 30, 2026 compared to 2025, mainly driven by a decrease in costs incurred for CMO activities of $10.2 million. We incurred higher CMO costs during the three months ended June 30, 2025 to support significant BLA readiness efforts and higher clinical supply costs. CRO costs decreased by $1.2 million in the three months ended June 30, 2026, compared to the three months ended June 30, 2025, mainly due to lower costs incurred for our KYSA-8 trial, partially offset by higher costs for our KYSA-6 trial.
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.
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.
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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.
General and Administrative Expenses
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.
Other Income, Net
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.
Interest expense increased $0.7 million for the three months ended June 30, 2026, compared to the same period a year ago, due to the Loan Facility entered into in the fourth quarter of 2025.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods presented:
Six Months Ended June 30, Change
2026 2025 $ %
(in thousands, except percentages)
Operating expenses
Research and development $ 54,861 $ 73,249 $ (18,388 ) (25 )%
General and administrative 26,062 18,569 7,493 40 %
Total operating expenses 80,923 91,818 (10,895 ) (12 )%
Loss from operations (80,923 ) (91,818 ) 10,895 (12 )%
Interest income 4,256 5,189 (933 ) (18 )%
Interest expense (1,341 ) (38 ) (1,303 ) 3,429 %
Other expense, net (39 ) (49 ) 10 (20 )%
Total other income, net 2,876 5,102 (2,226 ) (44 )%
Net loss $ (78,047 ) $ (86,716 ) $ 8,669 (10 )%
Research and Development Expenses
The following table summarizes our research and development expenses for the periods presented:
Six Months Ended June 30, Change
2026 2025 $ %
(in thousands, except percentages)
Miv-cel $ 26,616 $ 44,661 $ (18,045 ) (40 )%
Other programs 230 1,498 (1,268 ) (85 )%
Personnel-related expenses 18,534 16,791 1,743 10 %
Other research and development expenses 9,481 10,299 (818 ) (8 )%
Total research and development expenses $ 54,861 $ 73,249 $ (18,388 ) (25 )%
Research and development expenses decreased by approximately $18.3 million, or 25%, to $54.9 million for the six months ended June 30, 2026, from $73.2 million for the six months ended June 30, 2025.
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
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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.
Other program expenses include research and development expenses, mainly for our KYV-201 and KYV-102 programs. Other program costs decreased by $1.3 million, or 85%, for the six months ended June 30, 2026, compared to the same period a year ago due to a $1.1 million decrease in CMO and CRO costs. Costs related to the Ingenui-T rapid whole blood manufacturing process decreased to $0.2 million for the six months ended June 30, 2026, from $1.8 million for the same period a year ago.
Personnel-related expenses increased by $1.7 million, or 10%, to $18.5 million for the six months ended June 30, 2026 from $16.8 million for the same period a year ago primarily due to the growth in the number of employees in our research and development organization.
Other research and development expenses primarily consist of unallocated research and development costs, professional services, facilities, depreciation and overhead costs. The decrease of $0.8 million, or 8%, for the six months ended June 30, 2026, compared to the same period a year ago, is mainly due to lower rent, depreciation and amortization and unallocated CMO costs, partially offset by higher professional services costs and higher facilities and overhead costs. The six months ended June 30, 2025 included a $0.6 million impairment charge related to a capitalized software.
General and Administrative Expenses
General and administrative expenses increased by $7.4 million, or 40%, for the six months ended June 30, 2026, compared to the same period a year ago. The increase primarily relates to a $4.1 million increase in personnel-related costs, including a $1.7 million increase in stock-based compensation expense and a $3.8 million increase in professional services, partially offset by a $0.5 million decrease in facilities and overhead costs. The increase in professional consulting costs is mainly due to an increase in information technology consulting as well as commercial and market access preparations.
Other Income, Net
Interest income decreased by $0.9 million for the six months ended June 30, 2026, compared to the same period a year ago, primarily due to lower effective interest yield on our marketable securities in 2026.
Interest expense increased $1.3 million for the six months ended June 30, 2026, compared to the same period a year ago, due to the Loan Facility entered into in the fourth quarter of 2025.
Liquidity and Capital Resources
Sources of Liquidity
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, 2026, 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, net proceeds from the IPO, net proceeds from the ATM Facility, net proceeds from the underwritten public offering of our common stock as well as the borrowing under our Loan Facility.
Shelf Registration Statement and the ATM Facility
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 AgreementSM 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.
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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.
Loan and Security Agreement
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.
On July 8, 2026, we, the Collateral Agent, and the Lenders entered into an amendment to the Loan and Security Agreement, or the Amendment, pursuant to which the parties agreed, among other things, to extend the availability of the remaining $15.0 million of Term A Loans through December 31, 2026, in exchange for us paying an upfront cash fee of $187,500. In addition, if we do not draw the full remaining $15.0 million of Term A Loans by December 31, 2026, we will pay the Lenders a non-utilization fee equal to 1.0% of the aggregate undrawn amount of the Term A Loans.
As of June 30, 2026, the term loan balance was $24.9 million, which reflects the $25.0 million borrowed under the Term A Loans net of unamortized debt discount and debt issuance costs of $0.1 million.
Refer to Note 8, "Term Loan" to the condensed financial statements included in this Quarterly Report on Form 10-Q for additional details regarding the Loan and Security Agreement, as amended by the Amendment.
December 2025 Offering
On December 17, 2025, we entered into an underwriting agreement, or the Underwriting Agreement, with several underwriters named therein, or the Underwriters, relating to the issuance and sale of our common stock in an underwritten public offering pursuant to the Prior Registration Statement. On December 18, 2025, we closed the offering and issued an aggregate of 13,333,333 shares of our common stock for net proceeds of $93.7 million. Additionally, under the terms of the Underwriting Agreement, the Underwriters had an option to purchase up to an additional 1,999,999 shares of common stock, which the Underwriters exercised on December 24, 2025 and purchased 704,499 shares of our common stock for net proceeds of $5.0 million to us.
As of June 30, 2026, we had $199.4 million in cash, cash equivalents and available-for-sale marketable securities.
Future Funding Requirements
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.
We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2026, we had an accumulated deficit of $502.9 million. Based on the current cash forecast, management estimates that its existing cash and cash equivalents and available-for-sale marketable securities balances, net proceeds from the sale of shares under the ATM Facility (see Note 9, “Common Stock”, to the condensed financial statements included in this Quarterly Report on
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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.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Our future funding requirements will depend on many factors, including, but not limited to, the following:
•the timing, scope, progress and results of our preclinical studies and clinical trials for our current and future product candidates;
•the number, scope and duration of clinical trials required for regulatory approval of our current and future product candidates;
•the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities for our product candidates, including any requirement to conduct more studies or generate additional data beyond that which we currently expect would be required to support a Biologic License Application;
•the cost of manufacturing clinical and commercial supplies, as well as scale-up of our current and future product candidates;
•the potential increase in the number of our employees and expansion of our physical facilities to support growth initiatives;
•our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
•litigation expenses we incur to defend against any claims, including the cost of filing and prosecuting our patent applications, and maintaining and enforcing our patents and other intellectual property rights;
•the extent to which we acquire or in-license other product candidates and technologies;
•the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against our product candidates;
•the effect of competing technological and market developments;
•the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
•the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
•our implementation of various computerized informational systems and efforts to enhance operational systems;
•the costs associated with being a public company; and
•the impact of inflation, as well as other factors, including economic uncertainty and geopolitical tensions, which may exacerbate the magnitude of the factors discussed above.
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.
Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, or potentially other capital sources, such as collaboration or licensing arrangements with third parties or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans when needed on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital
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expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates, or we may have to grant licenses on terms that may not be favorable to us. If we are unable to raise capital as and when needed or on attractive terms, we may have to significantly delay, reduce or discontinue the development and commercialization of our product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.
Cash Flows
The following table summarizes our primary sources and uses of cash for the periods presented:
Six Months Ended June 30,
2026 2025
(in thousands)
Net cash used in operating activities $ (81,903 ) $ (76,864 )
Net cash (used in) provided by investing activities (14,071 ) 34,745
Net cash provided by (used in) financing activities 3,687 (1,063 )
Net decrease in cash, cash equivalents and restricted cash $ (92,287 ) $ (43,182 )
Operating Activities
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.
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.
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.
Investing Activities
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.
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.
Financing Activities
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
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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.
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.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with CROs for clinical trials, with 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 and, therefore, we believe that our non-cancellable obligations under these agreements are not material.
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.
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.
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.
Recently Issued Accounting Pronouncements
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.
Critical Accounting Estimates
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.
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (a) are no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our condensed financial statements may not be comparable to those of companies that comply with the new or revised accounting pronouncements as of public company effective dates. We may
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choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
We are also a “smaller reporting company.” If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.