Kyverna Therapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 12, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 12, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277584
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219397
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 155 previous paragraphs and 174 current paragraphs.
91 unchanged; 44 reworded; 37 added; 17 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (37)
Current report
our ability to efficiently and cost-effectively conduct our current and future clinical trials;
Current report
our expected or anticipated financial performance;
Current report
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 report
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 report
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.
Current report
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 report
We are also strengthening our chemistry, manufacturing, and controls, or CMC, capabilities to support late-stage clinical development and anticipated commercialization. We have FDA-alignment on our CMC strategy and believe our manufacturing partnerships and ongoing process innovations position us to support both near-term commercial launch and longer-term pipeline growth.
Current report
Beyond SPS and gMG, our pipeline opportunities include expanding into other autoimmune indications as well as novel innovations to expand patient access.
Current report
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 report
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 report
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 report
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 report
†EU & US. ‡ Kyverna is also exploring miv-cel in progressive MS through IITs.
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License and Collaboration Agreements
Current report
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.
Current report
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.
Current report
Research and Development Expenses
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Research and development costs include:
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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;
Current report
consulting fees associated with our research and development activities;
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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;
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other costs associated with our research and development programs, including laboratory materials and supplies;
Current report
employee-related costs, including salaries, benefits, travel and meals expenses, and stock-based compensation expense for our research and development personnel; and
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allocated facilities and overhead costs, including software and other miscellaneous expenses incurred in connection with our research and development programs.
Current report
General and Administrative Expenses
Current report
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.
Current report
Interest Income
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Research and Development Expenses
Current report
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 report
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 report
General and Administrative Expenses
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Interest Income
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Shelf Registration Statement and the ATM Facility
Current report
Loan and Security Agreement
Current report
December 2025 Offering
Current report
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.
Current report
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.
Removed paragraphs (17)
Previous report
our financial performance;
Previous report
Our focused clinical development pipeline includes registrational trials for stiff person syndrome, or SPS, and generalized myasthenia gravis, or MG, and two multi-center Phase 1/2 trials for patients with lupus nephritis, or LN. We are also harnessing investigator-initiated trials, or IITs, and other Kyverna-sponsored clinical trials, or KYSA trials, including in multiple sclerosis, or MS, and rheumatoid arthritis, or RA, to inform the next priority indications to advance into late-stage development. Additionally, our pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using our proprietary whole blood rapid manufacturing process. We believe our cell therapy approach to treating autoimmune diseases may present a significant advantage over current standard-of-care therapies by aiming for deep B cell depletion, a holistic immune reset and durable drug-free, disease-free remission.
Previous report
Our current focus is to advance our first-in-class neuroimmunology CAR T franchise with SPS and MG. We have aligned with the U.S. Food and Drug Administration, or the FDA, on our KYSA-8 registrational Phase 2 trial design in SPS. We completed patient enrollment for the Phase 2 trial in SPS during the second quarter of 2025. We expect to report top line data from the Phase 2 trial in early 2026. We also continue to progress our chemistry, manufacturing and controls, or CMC, readiness efforts in a capital-efficient manner in support of our first anticipated biologics license application, or BLA, filing for SPS with the FDA in the first half of 2026.
Previous report
For our KYSA-1 and KYSA-3 Phase 1 trials for LN, patient enrollment has concluded and we expect to share data from these trials in a peer-reviewed publication in 2026.
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We also continue to expect to file an investigational new drug, or IND, application for KYV-102 in the fourth quarter of 2025.
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Note: Kyverna is also exploring KYV-101 in multiple sclerosis through IITs.
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The disruption and volatility in the global and domestic capital markets resulting from heightened inflation, potential tariffs, capital market volatility, interest rate and currency rate fluctuations, artificial intelligence, government agency changes under the new administration, any potential economic slowdown or recession, including trade wars or civil or political unrest (such as the ongoing war between Ukraine and Russia, conflict in the Middle East, and tension between China and Taiwan) may increase the cost of capital and limit our ability to access capital. These and similar adverse market conditions may negatively impact our business, financial position and results of operations.
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Research and development expenses increased by $1.3 million, or 4%, to $30.5 million for the three months ended September 30, 2025 from $29.2 million for the three months ended September 30, 2024.
Previous report
External research and development expenses related to our KYV-101 program increased by $0.4 million, or 3%, for the three months ended September 30, 2025, compared to the same period a year ago, as we continued advancing our lead product candidate, KYV-101, through clinical development. The increase is mainly driven by a $2.0 million increase in CRO costs primarily due to accelerated enrollment in our KYSA trials, partially offset by a $1.3 million reduction in professional services costs and a $0.3 million reduction in other external research and development costs.
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Personnel-related expenses increased by $0.4 million, or 5%, for the three months ended September 30, 2025, compared to the same period a year ago, primarily due to higher severance and other employee costs 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 $0.2 million, or 3%, for the three months ended September 30, 2025, compared to the same period a year ago, primarily relates to a $0.6 million increase in professional services, partially offset by $0.3 million reduction in software licenses costs.
Previous report
General and administrative expenses decreased by $1.3 million, or 14%, for the three months ended September 30, 2025, compared to the same period a year ago. The decrease was primarily attributable to a $1.6 million decrease in professional services, partially offset by a $0.3 million increase in personnel-related costs, including stock-based compensation expense.
Previous report
Interest income decreased by $2.4 million, from $4.4 million for the three months ended September 30, 2024 to $2.0 million for the three months ended September 30, 2025 primarily due to lower cash, cash equivalents and short-term investment balances in 2025.
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Comparison of the Nine Months Ended September 30, 2025 and 2024
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Research and development expenses increased by $24.7 million, or 31%, to $103.7 million for the nine months ended September 30, 2025, from $79.0 million for the nine months ended September 30, 2024.
Previous report
External research and development expenses related to our KYV-101 program increased by $20.8 million, or 52%, for the nine months ended September 30, 2025, compared to the same period a year ago as we continued advancing our lead product candidate, KYV-101, through clinical development. The increase is mainly driven by a $19.4 million increase in strategic investment in CMO activities for SPS and MG, as well as a $8.4 million increase in CRO costs primarily due to accelerated enrollment in our KYSA trials. The increase in KYV-101 CMO and CRO costs was partially offset by a $3.2 million reduction in professional services costs.
Previous report
Other program expenses include research and development expenses for our KYV-201 and KYV-102 programs. Other program costs decreased by $1.4 million, or 37%, for the nine months ended September 30, 2025, compared to the same period a year ago due to a $3.0 million decrease in CMO costs. Costs related to the Ingenui-T rapid whole blood manufacturing process, which were classified as KYV-101 program costs in 2024 and are classified as other program costs in 2025, decreased to $2.6 million for the nine months ended September 30, 2025 from $3.5 million for the same period a year ago. Other program expenses for the nine months ended September 30, 2025 also included a $0.6 million credit received from a manufacturing vendor for our KYV-201 program.
Reworded paragraphs (44)
Previous wording
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, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials, research and development 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. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
Current wording
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:
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the initiation, timing, progress and results of our preclinical studies, clinical trials, and research programs for our product candidates;
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the initiation, timing, progress and results of our preclinical studies, clinical trials, and research and development programs for our product candidates;
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our plans relating to the further development and manufacturing of our product candidates, including additional indications for which we may pursue;
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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 products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
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our ability to identify additional product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
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the rate and degree of market acceptance and therapeutic benefits of our product candidates, if approved;
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the rate and degree of market acceptance and therapeutic benefits of our product candidates, if approved, and any other product candidates we may develop;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and genome-editing technology;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technologies;
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anticipated regulatory developments in the United States and foreign countries in which we may seek regulatory approval for our product candidates in the future;
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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;
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our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act or a smaller reporting company;
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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;
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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. Moreover, we operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to 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.
Current wording
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 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.
Previous wording
We are a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Our goal is to liberate patients from autoimmune diseases through the curative potential of cell therapy. Our approach is supported by our breadth of experience treating patients with our lead product candidate, KYV-101, across more than 15 autoimmune disease indications. This has been documented through the scientific publication of multiple autoimmune case studies, our proprietary dataset of patients treated through named patient forms of compassionate use, our experience in ongoing investigator-initiated trials at leading academic institutions, as well as clinical data from our ongoing company-sponsored trials illustrating the potential of KYV-101 to deeply deplete B cells with the aim of achieving durable treatment-free remission. This validation provides us with a clear path to continue advancing KYV-101 through late-stage clinical development and commercialization across two broad areas of autoimmune disease: neuroimmunology and rheumatology.
Current 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.
Previous wording
Our lead program, KYV-101, is a fully human, autologous CD19 CAR T-cell product candidate with CD28 co-stimulation, designed for potency and tolerability. KYV-101 is made from an underlying chimeric antigen receptor, or CAR, licensed from the National Institutes of Health, or the NIH. We believe that this uniquely designed CAR in KYV-101 has the potential to deliver a differentiated therapeutic profile in autoimmune disease. In addition to a fully human scFv domain, the CAR in KYV-101 was also designed with a human CD8α hinge and transmembrane domain, a human CD28 costimulatory domain, and a human CD3ζ activation domain. This same underlying CAR in KYV-101 has completed a 20-patient Phase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported similar rates of durable antitumor responses while delivering improved tolerability in the clinic among adult oncology patients, as compared to the CAR used to create Yescarta®. We believe that these differentiated properties of the CAR in KYV-101 are critical for the potential success of CAR T-cell therapy in treating autoimmune diseases.
Current wording
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.
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The KYSA-6 Phase 2 trial in MG was amended into a registrational Phase 2/3 trial following an end-of-Phase 2 meeting with the FDA in early 2025. In October 2025, we presented positive interim data from the Phase 2 portion of the registrational KYSA-6 clinical trial of KYV-101 in MG at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting. We expect to initiate patient enrollment in the Phase 3 portion of this trial by the end of 2025 and share updated data on the Phase 2 portion of the trial in 2026. The Phase 3 portion of the trial is expected to include 60 patients. We previously received Regenerative Medicine Advanced Therapy, or RMAT, designations and Orphan Drug Designations from the FDA for both SPS and MG as well as Orphan Drug Designation from the European Medicines Association in MG.
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We previously received Regenerative Medicine Advanced Therapy, or 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 Association in MG. Through these designations, we continue to engage in consistent dialogue with the FDA across both programs.
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Since our inception in June 2018, we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, conducting clinical and regulatory activities, performing business planning, developing and establishing our intellectual property portfolio, raising capital and providing general and administrative support for these activities. We do not have any products approved for sale and have not generated any revenue from product sales.
Current wording
Since our inception in June 2018, we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, 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.
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September 30, 2025, we had an accumulated deficit of $387.0 million. Management has estimated that our cash and cash equivalents and available-for-sale marketable securities of $171.1 million as of September 30, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations. In particular, with the initial $25.0 million of funding under the loan and security agreement we entered into with Oxford Finance LLC in October 2025, we anticipate that our current cash, cash equivalents and available-for-sale marketable securities will be sufficient to fund our operations into 2027. We expect that our cash, cash equivalents and available-for-sale marketable securities will allow us to support our BLA filing for SPS and our registrational Phase 3 trial for MG, while accelerating our pre-launch activities. The amounts and timing of our actual expenditures will depend on numerous factors, including the progress of our research and development, the timing of patient enrollment in clinical trials and evolving regulatory requirements, the time and cost necessary to conduct our ongoing and planned preclinical studies and clinical trials, the results of our preclinical studies and clinical trials and other factors described in Part II, Item 1A of this Quarterly Report on Form 10-Q titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.
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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.
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continue to progress the development of our product candidates, including KYV-101 in multiple clinical trials in parallel;
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continue to progress the development of our product candidates, including miv-cel in multiple clinical trials in parallel;
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procure manufacturing of clinical supply and manufacturing operations for our product candidates;
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procure manufacturing of clinical supply and manufacturing operations for our clinical trials and commercial manufacturing, if any of our product candidates are approved;
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We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. Under the July 2023 development and manufacturing services agreement, or the Elevate Agreement, with ElevateBio Base Camp, Inc., or Elevate, Elevate provides us with cell manufacturing, release and testing services for our KYV-101 product candidate. Further, Elevate is undertaking process development services for the development of a rapid whole blood manufacturing process for our CAR T-cell products, including KYV-102. We expect to
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. 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.
Previous wording
Under the master services agreement with Minaris Advanced Therapies, Inc., or MAT, MAT’s facility in Philadelphia, Pennsylvania, is expected to provide us with certain customized cell manufacturing, release and testing services for our KYV-101 product candidate through March 2026. Pursuant to our license and supply agreement with Oxford Biomedica (UK) Limited, or Oxford, Oxford provides us with lentiviral vector process development services.
Current wording
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
Given our stage of development, we do not yet have a marketing or sales organization or commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our product candidates, we also expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Current wording
Given our stage of development, we have not yet established a marketing or sales organization or commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our product candidates, we also expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
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 expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct preclinical and clinical studies; manufacturing process development activities and 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; compensation and benefits for research and development employees, including stock-based compensation; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred. Our internal research and development employees are shared across multiple programs and are not solely dedicated to individual programs. Other research and development expenses primarily include license fees, professional services, unallocated CRO and CMO costs and allocated overhead and facilities expenses.
Current 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.
Previous wording
General and administrative expenses consist primarily of payroll and personnel-related expenses, including: salaries, employee benefit costs and stock-based compensation expense; professional fees for legal, consulting, accounting and tax services; allocated overheads, including rent, facilities and information technology costs; and other general operating expenses not otherwise classified as research and development expenses.
Current wording
General and administrative expenses consist primarily of payroll and personnel-related expenses, including: salaries, employee benefit costs and stock-based compensation expense; professional fees for legal, consulting, accounting and tax services; allocated overheads, including rent, equipment, information technology costs and utilities; and other general operating expenses not otherwise classified as research and development expenses.
Previous wording
Interest expense consists primarily of interest expense related to our laboratory equipment finance leases.
Current 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.
Previous wording
Other program expenses include research and development expenses for our KYV-201 and KYV-102 programs. Other program costs increased by $0.2 million, or 40%, for the three months ended September 30, 2025, compared to the same period a year ago.
Current 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.
Previous wording
Personnel-related expenses increased by $2.9 million, or 13%, to $25.5 million for the nine months ended September 30, 2025 from $22.6 million for the same period a year ago primarily due to the growth in the number of employees in our research and development organization.
Current 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.
Previous wording
Other research and development expenses primarily consist of unallocated research and development costs, professional services, facilities, depreciation and overhead costs. The increase of $2.4 million, or 19%, for the nine months ended September 30, 2025, compared to the same period a year ago, is mainly due to higher facilities and overhead costs, including rent, a $1.8 million increase in professional services and a $0.6 million impairment charge related to a capitalized software, partially offset by a $0.7 million reduction in personnel-related expenses and a $0.4 million reduction in software license costs.
Current 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.
Previous wording
General and administrative expenses increased by $4.3 million, or 19%, for the nine months ended September 30, 2025, compared to the same period a year ago. The increase primarily relates to a $5.8 million increase in personnel-related costs, including stock-based compensation expense, partially offset by a $1.6 million decrease in facilities and overhead costs. The nine months ended September 30, 2024 included a $1.1 million incremental stock-based compensation expense in connection with the former CEO note forgiveness.
Current 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.
Previous wording
Interest income decreased by $4.6 million for the nine months ended September 30, 2025, compared to the same period a year ago, primarily due to lower cash, cash equivalents and short-term investment balances in 2025.
Current 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.
Previous wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through September 30, 2025, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock, issuances of convertible notes, an upfront payment under the Gilead Agreement and net proceeds from the IPO. As of September 30, 2025, we had $171.1 million in cash, cash equivalents and available-for-sale marketable securities.
Current wording
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through March 31, 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.
Previous wording
On March 27, 2025, we filed a shelf registration statement on Form S-3, or the Registration Statement, covering the offer and sale from time to time of up to $250.0 million in aggregate offering price of shares of our common stock, shares of our preferred stock, debt securities, warrants, rights, units and/or depositary shares. The Registration Statement was declared effective by the SEC on April 15, 2025. The terms of any offering under the Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Registration Statement filed with the SEC prior to the completion of any such offering. The Registration Statement included a sales agreement prospectus, or the ATM Prospectus, covering the offer and sale from time to time through or to Jefferies, LLC, or Jefferies, as sales agent, of up to $50.0 million in aggregate offering price of shares of our common stock under an Open Market Sale Agreement SM entered into with Jefferies on March 27, 2025. As of September 30, 2025, $50.0 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the Registration Statement.
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. 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.
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. The Loan and Security Agreement provides a non-dilutive term loan facility, or the Loan Facility, up to an aggregate principal amount of $150.0 million. The Loan Facility includes an initial tranche 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 $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 tranche. The Loan Facility matures on October 1, 2030.
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, 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.
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 drug 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, 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.
Previous wording
We have incurred significant losses and negative cash flows from operations since our inception. As of September 30, 2025, we had an accumulated deficit of $387.0 million. Based on the current cash forecast, management has determined that our cash, cash equivalents and available-for-sale marketable securities of $171.1 million as of September 30, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.
Current 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.
Previous wording
Net cash used in operating activities was $120.2 million and $77.2 million for the nine months ended September 30, 2025 and 2024, respectively.
Current 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.
Previous wording
Cash used in operating activities for the nine months ended September 30, 2024, was primarily due to our net loss of $90.0 million, decreased by non-cash charges of $5.0 million and decreased by a net reduction of $7.8 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $7.0 million stock-based compensation expense, a $1.9 million non-cash lease expense and a $1.6 million depreciation and amortization expense, partially offset by $5.4 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 $6.0 million, an increase in other current liabilities of $3.3 million and an increase in accrued compensation of $1.6 million, partially offset by a decrease in operating lease liability of $1.8 million, an increase in in other non-current assets of $0.9 million and an increase in prepaid expense and other current assets of $0.7 million.
Current 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.
Previous wording
Cash used in operating activities for the nine months ended September 30, 2025, was primarily due to our net loss of $123.5 million, decreased by non-cash charges of $6.1 million and by $2.8 million for changes in our net operating assets and liabilities. The non-cash charges primarily consisted of a $7.4 million stock-based compensation expense, a $2.2 million non-cash lease expense, a $1.4 million depreciation and amortization expense and a $0.6 million impairment charge of a capitalized software, partially offset by $5.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in operating lease liability of $2.5 million, a decrease in accounts payable of $1.6 million, an increase in other non-current assets of $1.5 million, a decrease in other accrued expenses and current liabilities of $0.2 million, partially offset by an increase in accrued compensation of $2.1 million, a decrease in prepaid expense and other current assets of $0.8 million.
Current 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.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2024, was $190.1 million, which consisted of $362.8 million of purchases of available-for-sale marketable securities and $1.7 million of purchases of property and equipment, offset by $174.3 million in proceeds from maturities of available-for-sale marketable securities.
Current 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.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2025, was $57.3 million, which consisted of $306.5 million in proceeds from maturities of available-for-sale marketable securities and $0.1 million in proceeds from sale of property and equipment, offset by $248.7 million of purchases of available-for-sale marketable securities and $0.6 million of capitalized internal-use-software costs.
Current 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.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024, was $337.3 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and $0.2 million of proceeds from exercises of stock options, partially offset by $3.4 million payments for deferred offering costs and a payment of $0.7 million related to finance lease obligations.
Current 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.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025, was $0.4 million, which consisted of $1.7 million of proceeds from exercises of stock options, partially offset by $0.7 million related to finance lease obligations, $0.4 million related to deferred offering costs paid in connection with the filing of the Registration Statement and $0.1 million related to shares withheld for tax obligations payments in connection with RSUs vested during the nine months ended September 30, 2025.
Current 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.
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 September 30, 2025. As of September 30, 2025, and December 31, 2024, we recognized a sublicensing fee of $6.3 million in our condensed balance sheets related to the fee due under our Kite Agreement as discussed in Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q. On October 24, 2025, we, Kite and Gilead entered into a letter agreement with respect to the Gilead Agreement and the Kite Agreement, or the Letter Agreement. Under the Letter Agreement, we agreed to pay $2.5 million in cash within 30 days of the signing of the Letter Agreement. We also agreed to pay the remaining balance of $3.8 million by no later than December 31, 2026 in the form of, at our sole discretion (i) a one-time equity issuance of common stock, (ii) a one-time cash payment, or (iii) any combination of cash and common stock. The parties also agreed to terminate the Kite Agreement on October 24, 2025 and mutually released one another from any further obligations, except for certain surviving provisions.
Current 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.
Showing the first 40 of 44 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
As of March 31, 2026, we had $236.4 million in cash, cash equivalents and available-for-sale marketable securities.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering, or the IPO, in February 2024. We may also seek to raise capital through debt financings, license agreements, collaborative agreements or other sources of financing. Our net losses were $36.8 million and $123.5 million for the three and nine months ended September 30, 2025, respectively, compared with $34.5 million and $90.0 million net losses for the three and nine months ended September 30, 2024, respectively. As of
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the periods presented:
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the periods presented: