Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

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:

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

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 transformative 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 incorporating a CD28 costimulatory domain that was designed for potency and tolerability and licensed from the National Institutes of Health, or the NIH, specifically for use in autoimmune diseases. 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.

In the over 100 patients treated, miv-cel has demonstrated a consistent, well-tolerated safety profile, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), and no cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). We believe miv-cel's positive benefit-risk profile and well-tolerated safety profile are attributed to its unique construct design as well as its well-established, validated manufacturing process.

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, and one-year follow-up data at MS Toronto 2026, the joint ACTRIMS-ECTRIMS meeting in October 2026. In the primary analysis, miv-cel achieved the primary and all secondary endpoints, demonstrating statistically significant, durable clinical benefit 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. In the one-year follow-up data, miv-cel demonstrated sustained clinical benefit across all primary and secondary endpoints, with nearly all patients remaining off chronic immunotherapies. In addition, miv-cel continued to be well-tolerated, with no high-grade

CRS, ICANS or IEC-HS. Data compare favorably to the results of a large, multicenter, retrospective natural history study we conducted to examine the impact of SPS on walking speed. The data, which were presented at AAN 2026, demonstrated that patients experienced no or minimal improvement in mobility and increased their use of walking aids and off-label immunotherapies over time.

We initiated the rolling BLA submission of miv-cel in SPS in the second quarter of 2026 and completed the submission in the fourth quarter of 2026, seeking priority review under the program's Regenerative Medicine Advanced Therapy, or RMAT, designation. In anticipation of a potential FDA approval and commercial launch in 2027, we are progressing launch readiness activities through targeted site activation engagements with CAR-T experts, neurologists and payers, and building an integrated patient support and reimbursement network to streamline the treatment journey. With experienced commercial leaders in place, we continue to hire field-based sales and medical specialists.

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. In October 2026, we reported positive longer-term, Phase 2 follow-up data in gMG demonstrating robust and durable effects sustained for up to 1.5 years across MG-ADL, QMG, and Myasthenia Gravis Composite scores, with the majority of patients maintaining minimal symptom expression (MSE) and remaining off chronic immunosuppressants. We continue to advance our FDA-aligned, Phase 3 registrational trial and expect to complete patient enrollment by mid-2027. Beyond SPS and gMG, our focused neurologic pipeline opportunities include expanding into progressive multiple sclerosis (PMS).

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. The RMAT designation was based on promising IIT data of miv-cel in PMS from Stanford University (Stanford) and the University of California, San Francisco (UCSF), where a single-dose of miv-cel has demonstrated robust CAR T-cell penetration in the central nervous system (CNS) and improved disability scores while removing the need for chronic immunotherapies. In addition, miv-cel demonstrated a consistent and well-tolerated safety profile with no high-grade CRS and no cases of ICANS or IEC-HS. In October 2026 at MS Toronto, Stanford presented updated Phase 1 clinical data of miv-cel in PMS, demonstrating sustained stable to improved expanded disability status scale scores (EDSS) in all five patients with available data as of last follow-up, with the majority showing sustained clinical benefit through one year. In addition, the first patient treated with miv-cel achieved sustained clinical benefit beyond two years. We expect to provide an update on our PMS development strategy by early 2027.

Additional pipeline opportunities include the potential to expand into broader autoimmune indications such as rheumatoid arthritis, or RA, where encouraging data have been generated in a Phase 1/2 IIT.

We are strengthening our CMC capabilities to support late-stage clinical development and anticipated commercialization. In July 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. In November 2026, we announced that we have deprioritized our KYV-102 manufacturing program to continue to focus on accelerating our late-stage neurologic indications with miv-cel.

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 and commercial readiness 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. As of September 30, 2026, we had an accumulated deficit of $544.8 million. Our net losses were $41.9 million and $120.0 million for the three and nine months ended September 30, 2026, respectively, compared with $36.8 million and $123.5 million for the three and nine months ended September 30, 2025, respectively. Our cash used in operations was $117.3 million and $120.2 million for the nine months ended September 30, 2026 and 2025, respectively. We have historically financed our operations primarily through issuances of redeemable convertible preferred stock and convertible notes, revenue from our collaboration agreement, sales of shares of our common stock, including through our ATM Facility (as defined below), and borrowings under our Loan Facility (as defined below). Management has determined that as of September 30, 2026, our cash and cash equivalents and available-for-sale marketable securities of $170.6 million, 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 the next 12 months 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:

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. 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.

Our pipeline and programs

Our focused neurologic autoimmune pipeline of product candidates 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, tensions between not only the U.S. and China, but also between the U.S. and other countries in the international community, 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, increasing inflationary pressures and volatility in the capital markets. 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; 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:

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, 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. General and administrative expenses also include costs associated with our commercial readiness and market access activities.

Our general and administrative expenses are expected to increase modestly as we continue to enhance corporate infrastructure and support commercial readiness activities for a potential approval of miv-cel in SPS while maintaining compliance with stock exchange listing and various regulatory requirements.

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.

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 September 30, 2026 and 2025

The following table summarizes our results of operations for the periods presented:

* Not meaningful.

Research and Development Expenses

The following table summarizes our research and development expenses for the periods presented:

Research and development expenses decreased by $3.4 million, or 11%, during the three months ended September 30, 2026, compared to the same period in the prior year.

External research and development expenses related to our miv-cel program decreased by $3.9 million, or 24%, during the three months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $4.7 million decrease in CMO costs, partially offset by a $0.4 million increase in manufacturing supplies. We incurred higher CMO costs during the three months ended September 30, 2025 to support significant BLA readiness efforts.

Other program expenses include research and development expenses, primarily for our KYV-201, KYV-102 and other programs. Other program costs increased by $0.1 million, or 15%, during the three months ended September 30, 2026, compared to the same period in the prior year, primarily driven by $1.0 million in license costs, partially offset by a $0.7 million decrease in CMO costs.

Personnel-related expenses increased by $0.8 million, or 9%, during the three months ended September 30, 2026, compared to the same period in the prior year, due to increased headcount to support the development of miv-cel and our other programs.

Other research and development expenses decreased by $0.5 million, or 10%, during the three months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $0.8 million decrease in rent and allocated overhead expenses, partially offset by a $0.6 million increase in outside services.

General and Administrative Expenses

General and administrative expenses increased by $7.6 million, or 92%, during the three months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $3.4 million increase in personnel-related expenses, including a $0.9 million increase in stock-based compensation expense due to increased headcount. Professional services and overhead expenses increased by $2.4 million and $1.3 million, respectively, to continue supporting commercial readiness and market access activities. Other general and administrative expenses increased by $0.5 million due to an asset impairment charge recorded during the three months ended September 30, 2026.

Other Income, Net

Interest income decreased by $0.3 million during the three months ended September 30, 2026, compared to the same period in the prior year, primarily driven by lower effective interest yield on our cash equivalents and available-for-sale marketable securities.

Interest expense increased by $0.7 million during the three months ended September 30, 2026, compared to the same period in the prior year, due to the Loan Facility entered into in the fourth quarter of 2025.

Comparison of the Nine Months Ended September 30, 2026 and 2025

The following table summarizes our results of operations for the periods presented:

* Not meaningful.

Research and Development Expenses

The following table summarizes our research and development expenses for the periods presented:

Research and development expenses decreased by $21.8 million, or 21%, during the nine months ended September 30, 2026, compared to the same period in the prior year.

External research and development expenses related to our miv-cel program decreased by $22.0 million, or 36%, during the nine months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $23.2 million decrease in CMO costs and a $1.6 million decrease in CRO costs due to lower costs incurred for our clinical trials, partially offset by a $1.2 million increase in outside services and a $1.2 million increase in royalty and other payments under our license agreements. We incurred higher CMO costs during the nine months ended September 30, 2025 to support significant BLA readiness efforts, related to our SPS product candidate.

Other program expenses include research and development expenses, primarily for our KYV-201, KYV-102 and other programs. Other program costs decreased by $1.1 million, or 48%, during the nine months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $1.9 million decrease in CMO and CRO costs, partially offset by higher license costs.

Personnel-related expenses increased by $2.6 million, or 10%, during the nine months ended September 30, 2026, compared to the same period in the prior year, due to increased headcount to support the clinical development of miv-cel and our other programs.

Other research and development expenses decreased by $1.3 million, or 9%, during the nine months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $1.8 million decrease in rent and allocated overhead expenses and a $0.6 million asset impairment charge incurred in the same period in the prior year, partially offset by a $1.5 million increase in outside services related to the BLA readiness activities and regulatory submission.

General and Administrative Expenses

General and administrative expenses increased by $15.1 million, or 56%, during the nine months ended September 30, 2026, compared to the same period in the prior year, primarily driven by a $7.5 million increase in personnel-related costs, including a $2.6 million increase in stock-based compensation expense, due to increased headcount. Professional services and overhead expenses increased by $5.2 million and $1.2 million, respectively, to continue supporting commercial readiness and market access activities. Other general and administrative expenses increased by $1.2 million, primarily due to a $0.5 million asset impairment charge recorded during the three months ended September 30, 2026.

Other Income, Net

Interest income decreased by $1.3 million during the nine months ended September 30, 2026, compared to the same period in the prior year, primarily driven by lower effective interest yield on our cash equivalents and available-for-sale marketable securities.

Interest expense increased $2.0 million during the nine months ended September 30, 2026, compared to the same period in the prior year, due to the Loan Facility entered into in the fourth quarter of 2025.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred significant losses and negative cash flows from operations since our inception. We have historically financed our operations primarily through issuances of redeemable convertible preferred stock and convertible notes, revenue from our collaboration agreement, sales of shares of our common stock, including through our ATM Facility, and borrowings 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.

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 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. During the nine months ended September 30, 2026, we sold 1,159,170 shares of our common stock under the ATM Facility for net proceeds of $8.7 million after deducting the sales agent's fees and issuance costs of $0.6 million. As of September 30, 2026, $200.0 million remains available and unallocated under the 2026 Registration Statement and $90.7 million remains available and allocated for sale under the ATM Facility.

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 September 30, 2026, the term loan balance was $25.0 million, which reflects the $25.0 million borrowed under the Term A Loans net of de minimis unamortized debt discount and debt issuance costs.

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 September 30, 2026, we had $170.6 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 administrative expenditures to support our operations. 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 September 30, 2026, we had an accumulated deficit of $544.8 million. Based on the current cash forecast, management estimates that its existing cash and cash equivalents and available-for-sale marketable securities balances 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 the next twelve months from the issuance date of the condensed financial statements included in this Quarterly Report on Form 10-Q. There can be no assurance that we will ever earn revenue or achieve profitability, or if achieved, that the revenue or profitability will be sustained on a continuing basis. Unless and until it does, we will need to continue to raise additional capital. We may seek to raise capital through equity financings, debt financings, license, and/or collaboration agreements, or other sources of financing. There is no assurance, however, that any additional financing or any revenue-generating license or collaboration will be available when needed or that we will be able to obtain financing or enter into a license or collaboration on terms acceptable to us, or at all. The condensed financial statements do not reflect any adjustments relating to the outcome of this uncertainty. 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:

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 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:

Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2026, was $117.3 million and primarily consisted of a net loss of $120.0 million and a $9.6 million net change in operating assets and liabilities, partially offset by non-cash charges of $12.3 million. The non-cash charges primarily consisted of $10.3 million of stock-based compensation expense, $1.3 million of non-cash lease expense, $1.1 million of depreciation and amortization expense and $0.5 million of asset impairment, partially offset by $1.1 million of income related to the accretion of discounts on available-for-sale marketable securities. The net change in operating assets and liabilities was primarily due to a $4.2 million decrease in other accrued expenses and current liabilities, a $2.6 million decrease in accrued compensation, a $1.9 million decrease in accounts

payable, a $1.8 million decrease in operating lease liability, and a $0.2 million increase in prepaid expense and other current assets, partially offset by a $1.0 million decrease in other non-current assets.

Net cash used in operating activities for the nine months ended September 30, 2025, was $120.2 million and primarily consisted of a net loss of $123.5 million and a $2.8 million net change in operating assets and liabilities, partially offset by non-cash charges of $6.1 million. The non-cash charges primarily consisted of $7.4 million of stock-based compensation expense, $2.2 million of non-cash lease expense, $1.4 million of depreciation and amortization expense and $0.6 million of asset impairment, partially offset by $5.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in net operating assets and liabilities was primarily due to a $2.5 million decrease in operating lease liability, a $1.6 million decrease in accounts payable, a $1.5 million increase in other non-current assets and a $0.2 million decrease in other accrued expenses and current liabilities, partially offset by a $2.1 million increase in accrued compensation and a $0.8 million decrease in prepaid expense and other current assets.

Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2026, was $14.5 million and primarily consisted of $209.5 million in proceeds from maturities of available-for-sale marketable securities, partially offset by $194.0 million of purchases of available-for-sale marketable securities, $0.6 million of capitalized internal-use software development costs, and $0.5 million of purchases of property and equipment.

Net cash provided by investing activities for the nine months ended September 30, 2025, was $57.3 million and primarily consisted of $306.5 million in proceeds from maturities of available-for-sale marketable securities and $0.1 million in proceeds from the sale of property and equipment, partially offset by $248.7 million of purchases of available-for-sale marketable securities and $0.6 million of capitalized internal-use-software development costs.

Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2026, was $10.5 million and primarily consisted of $8.7 million in proceeds from issuance of common stock shares under the ATM Facility, net of sales agent's fees and issuance costs, and $2.6 million in proceeds from exercise of common stock options, partially offset by $0.4 million in taxes paid related to net share settlement upon vesting of restricted stock units, and $0.3 million in principal paid on finance lease liabilities.

Net cash provided by financing activities for the nine months ended September 30, 2025, was $0.4 million and primarily consisted of $1.7 million in proceeds from exercises of common stock options, partially offset by $0.7 million in principal paid on finance lease liabilities, $0.4 million in payments for offering costs related to the filing of the Prior Registration Statement, and $0.1 million in taxes paid related to net share settlement upon vesting of restricted stock units.

Contractual Obligations and Commitments

We enter into contracts in the normal course of business with CROs for clinical trials, with CMOs for clinical and commercial supply 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 September 30, 2026. As of September 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 September 30, 2026, we lease 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.

As of September 30, 2026, our non-cancellable operating lease obligation was $9.9 million, of which $2.4 million is due within the next 12 months. As of September 30, 2026, our non-cancellable finance lease obligation was de minimis.

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 nine months ended September 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 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.