Item 7. 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 our consolidated financial statements and related notes appearing elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. For a detailed discussion of our business environment, please read Item 1. Business, included in this Annual Report. As a result of many factors, including those factors set forth in Item 1A. Risk Factors of this Annual Report, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

Overview

We are a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. We leverage our team’s deep expertise in chemistry and structure-based drug design to develop innovative small molecules that are designed with the aim to overcome the limitations of existing therapies for clinically proven kinase targets.

Limitations faced by currently available kinase inhibitors can include (i) kinase resistance, or the emergence of new mutations in the kinase target that can enable resistance to existing therapies, (ii) kinase selectivity, or the potential for existing therapies to inhibit other structurally similar kinase targets and lead to off-target adverse events, and (iii) limited brain penetrance, or the ability for the therapy to treat disease that has spread or metastasized to the brain. By prioritizing target selectivity, we believe our drug candidates have the potential to overcome resistance, avoid dose-limiting off-target adverse events, address brain metastases, and drive more durable responses. This may result in the potential to drive deeper, more durable responses with minimal adverse events, and we believe these potential benefits may support opportunities for clinical utility earlier in the treatment paradigm.

Candidate Overview

Zidesamtinib (NVL-520)

Our first lead product candidate, zidesamtinib (NVL-520), is being developed for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). Zidesamtinib is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs). Zidesamtinib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of patients with locally advanced or metastatic (advanced) ROS1-positive NSCLC who have previously been treated with two or more prior ROS1 TKIs, and orphan drug designation for ROS1-positive NSCLC.

Our ARROS-1 clinical trial is a first-in-human global Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating zidesamtinib as an oral monotherapy in patients with advanced ROS1-positive NSCLC and other solid tumors. Dosing was initiated in the Phase 1 portion of the ARROS-1 clinical trial in January 2022. From January 2022 to August 2023, the Phase 1 portion of the ARROS-1 trial enrolled 104 patients (99 NSCLC, 5 other solid tumors).

In September 2023, we announced the initiation of the Phase 2 portion of the ARROS-1 clinical trial, following alignment with the FDA on a recommended Phase 2 dose (RP2D) of 100 mg once daily (QD). The Phase 2 portion of the ARROS-1 clinical trial is designed to evaluate the safety and activity of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors, examining several specific cohorts of patients based on the prior anti-cancer therapies that such patients have received. The Phase 2 cohorts have been designed to support potential registration in TKI-naïve and/or TKI pre-treated ROS1-positive NSCLC patients.

Between September 2023 and June 16, 2025, 435 patients were enrolled in the Phase 2 portion of the ARROS-1 clinical trial. In June 2025, we announced positive pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC from the global ARROS-1 Phase 1/2 clinical trial, and in September 2025, we presented the pivotal dataset at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer. The primary efficacy analysis population for this pivotal dataset consisted of 117 TKI pre-treated patients with advanced ROS1-positive NSCLC with measurable disease who received zidesamtinib at the RP2D by May 31, 2024, with duration of response (DOR) follow-up of at least 6 months available for nearly all responders.

In June 2025, we also shared preliminary data from the Phase 2 TKI-naïve cohort in the ARROS-1 clinical trial, in which enrollment is ongoing. Encouraging preliminary data were available for 35 TKI-naïve patients with advanced ROS1-positive NSCLC treated with zidesamtinib at RP2D as of August 31, 2024. As of June 16, 2025, a total of 104 patients had been enrolled in the ongoing TKI-naïve cohort of the ARROS-1 trial.

In November 2025, the FDA accepted for filing our New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act target action date of September 18, 2026. Additionally, we plan to submit data from the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 clinical trial to the FDA to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026.

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Neladalkib (NVL-655)

Our second lead product candidate, neladalkib (NVL-655), is being developed for patients with anaplastic lymphoma kinase (ALK)-positive NSCLC. Neladalkib is a brain-penetrant ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that may limit the use of first-generation (1G; crizotinib), second-generation (2G; ceritinib, alectinib, or brigatinib), and third-generation (3G; lorlatinib) ALK inhibitors. Neladalkib has received FDA Breakthrough Therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK TKIs, and orphan drug designation for ALK-positive NSCLC.

Our ALKOVE-1 clinical trial is a first-in-human global Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating neladalkib as an oral monotherapy in patients with advanced ALK-positive NSCLC and other solid tumors. Dosing was initiated in the Phase 1 portion of the ALKOVE-1 clinical trial in June 2022. From June 2022 to February 2024, the Phase 1 portion of the ALKOVE-1 clinical trial enrolled 133 patients (131 NSCLC, 2 other solid tumors).

In February 2024, we announced the initiation of the Phase 2 portion of the ALKOVE-1 clinical trial, following alignment with the FDA on a RP2D of 150 mg QD. The Phase 2 portion of the ALKOVE-1 clinical trial is designed to evaluate the safety and activity of neladalkib in several expansion cohorts of patients defined based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation for patients with ALK-positive NSCLC who are TKI-naïve.

In July 2025, we announced the initiation of the ALKAZAR Phase 3 clinical trial with registrational intent for TKI-naïve patients with advanced ALK-positive NSCLC. The ALKAZAR clinical trial is a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care. Patients are randomized 1:1 to receive neladalkib monotherapy or ALECENSA(alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. The ALKAZAR clinical trial is designed to enroll approximately 450 patients with TKI-naïve ALK-positive NSCLC. The primary endpoint is progression-free survival (PFS) based on Blinded Independent Central Review (BICR). Secondary endpoints include overall survival, PFS based on investigator’s assessment, time to intracranial response, and BICR assessment of intracranial objective response rate, intracranial duration of response, objective response rate, DOR, time to intracranial progression, and safety.

At the European Society for Medical Oncology Congress in October 2025, we presented preliminary data for neladalkib in patients with advanced ALK-positive solid tumors outside of NSCLC from the ongoing ALKOVE-1 clinical trial. Neladalkib demonstrated encouraging preliminary activity across a diverse set of ALK TKI-naïve and previously treated advanced ALK-positive solid tumors, and was considered generally safe and well-tolerated with a preliminary overall safety profile consistent with its ALK-selective, tropomyosin receptor kinase-sparing design, and with previously reported data.

In November 2025, we announced positive topline data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from the global ALKOVE-1 Phase 1/2 clinical trial. The primary analysis population for this topline dataset consisted of 253 TKI pre-treated patients with advanced ALK-positive NSCLC with measurable disease who received neladalkib at the RP2D by September 30, 2024, with DOR follow-up of at least 6 months available for nearly all responders.

In November 2025, we also shared preliminary data from the Phase 2 exploratory cohort for TKI-naïve patients with advanced ALK-positive NSCLC from the ALKOVE-1 study. Encouraging preliminary data were available for 44 TKI-naïve patients with advanced ALK-positive NSCLC treated with neladalkib at RP2D as of August 29, 2025.

We have completed our pre-NDA meeting with the FDA and plan to move forward with an NDA submission of the data for TKI pre-treated patients with advanced ALK-positive NSCLC from our ALKOVE-1 study of neladalkib in the first half of 2026. We plan to present detailed study results at a future medical meeting.

NVL-330

Our third product candidate, NVL-330, is a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed with the aim to address the combined medical needs of treating tumors driven by HER2 mutations and alterations, including HER2 exon 20 insertion mutations (HER2ex20), treating brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type epidermal growth factor receptor (EGFR). Preclinical data have shown that NVL-330 inhibited a broad range of HER2 oncogenic alterations, including HER2ex20, in cell-based assays, was brain penetrant and was selective for HER2 oncogenic alterations over the structurally related wild-type EGFR. Additionally, new preclinical data were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2025, further supporting NVL-330’s potentially differentiated brain-penetrant profile. Compared to several currently available and investigational HER2 TKIs in the same preclinical assays, NVL-330 demonstrated a favorable efflux ratio and brain partitioning, metrics that are potentially positive predictors of brain exposure in humans. In preclinical models of intracranial activity, NVL-330 induced deep intracranial regression in mice. In the same models, the approved therapies Enhertu (T-DXd) and Hernexeos (zongertinib) did not induce intracranial regression at their clinically relevant doses. Additionally, NVL-330 induced intracranial tumor regression in mice that had progressed in the CNS on zongertinib.

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We are currently enrolling patients in the HEROEX-1 clinical trial, a global Phase 1a/1b, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-330 in pre-treated patients with advanced HER2-altered NSCLC, including those with HER2ex20 mutations. In July 2024, we announced that the first patient was dosed with NVL-330 in the HEROEX-1 trial. The HEROEX-1 trial is evaluating the overall safety and tolerability of NVL-330. Additional objectives include determination of the RP2D, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Discovery Programs

We have prioritized a number of additional small molecule research programs following an assessment of medical need. Research for these programs is ongoing, and we plan to disclose a new development candidate by year-end 2026.

Financial Overview

Since commencing significant operations in 2018, we have focused substantially all of our efforts and financial resources on research and development activities for our programs, including zidesamtinib, neladalkib and NVL-330, establishing and maintaining our intellectual property portfolio, organizing and staffing our Company, business planning, raising capital, preparing for potential commercialization and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated revenue from product sales or any other source.

We have incurred significant net losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development of, receipt of marketing approval from regulatory authorities for, and eventual commercialization of our product candidates. We reported net losses of $425.4 million, $260.8 million and $126.2 million for the years ended December 31, 2025, 2024 and 2023, respectively. As of December 31, 2025, we had an accumulated deficit of $972.4 million. We expect to incur significant expenses for the foreseeable future in connection with ongoing activities, particularly if and as we:

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continue to advance zidesamtinib, neladalkib and NVL-330 in clinical development;

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advance the development of our discovery programs;

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expand our pipeline of product candidates through our product discovery and development efforts;

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seek regulatory approvals for our product candidates;

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continue to build a sales, marketing and distribution infrastructure to commercialize any approved product candidates and incur related commercial manufacturing costs;

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implement operational, financial and management systems;

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attract, hire and retain additional clinical, scientific, management, sales and marketing and administrative personnel;

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maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know-how;

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acquire or in-license other product candidates and technologies; and

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operate as a public company.

We will not generate revenue from product sales unless and until we successfully complete clinical development of, obtain regulatory approval for and successfully commercialize one or more of our product candidates. As a result, we may need additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. Our ability to raise additional funds may be adversely impacted by general economic conditions, both inside and outside the U.S., including disruptions to, and instability and volatility in, the credit and financial markets in the U.S. and worldwide, including heightened inflation, interest rate and currency rate fluctuations, and economic slowdown or recession as well as concerns related to public health emergencies, natural disasters or geopolitical events, including actual or threatened tariffs or other changes in trade policy, civil or political unrest or military conflicts. In addition, market instability and volatility, high levels of inflation and interest rate fluctuations may increase our cost of financing or restrict our access to potential sources of future liquidity. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce or eliminate our product development or commercialization efforts. Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts.

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Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, 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 be forced to reduce or terminate our operations.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $1.4 billion. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2029. Our existing cash, cash equivalents and marketable securities may not be sufficient to fund all of our product candidates through regulatory approval, and we may need to raise additional capital to complete the development and commercialization of our product candidates. See “—Liquidity and Capital Resources.”

Components of Our Results of Operations

Operating expenses

Our operating expenses are comprised of research and development expenses and general and administrative expenses.

Research and development expenses

Research and development expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel engaged in research and development functions; costs incurred in connection with the advancement of our discovery programs and product candidates in preclinical and clinical studies, including under agreements with contract research organizations (CROs); and the cost of developing and scaling our manufacturing process, including under agreements with contract manufacturing organizations (CMOs), to manufacture drug substance and drug product for use in our research and preclinical and clinical studies and manufacture commercial-scale validation batches in preparation for the commercial launch of our product candidates that obtain regulatory approval.

We track our direct external research and development expenses on a program-by-program basis, including costs incurred with our CROs and CMOs, in connection with our preclinical, clinical and manufacturing activities. Costs incurred prior to nominating a development candidate are included in discovery programs. We do not allocate employee costs or other indirect costs to specific product development programs because these costs are deployed across multiple programs and, as such, are not separately classified.

We expect to incur substantial research and development expenses as we continue to advance zidesamtinib, neladalkib and NVL-330 in clinical development, and expand our discovery, research and preclinical activities in the near term and in the future. Although the ALKAZAR Phase 3 clinical trial, the Phase 2 portions of our ARROS-1 and ALKOVE-1 clinical trials and the HEROEX-1 Phase 1 clinical trial are ongoing, at this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any product candidates we may develop. A change in the outcome of any number of variables with respect to product candidates we may develop could significantly change the costs and timing associated with the development of that product candidate. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:

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the timing and progress of development activities relating to zidesamtinib, neladalkib, NVL-330 and any future product candidates from our discovery programs, including any additional costs that may result from delays in enrollment or other factors;

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the number and scope of preclinical and clinical programs we decide to pursue;

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our ability to maintain our current research and development programs and to establish new ones;

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successful patient enrollment in, and the initiation and completion of, clinical trials;

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the number of trials required for regulatory approval;

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the countries in which the trials are conducted;

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the length of time required to enroll eligible subjects and initiate clinical trials;

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the number of subjects that participate in the trials and per subject trial costs;

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potential additional safety monitoring requested by regulatory authorities;

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the duration of subject participation in the trials and follow-up;

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the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities;

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the receipt of approvals from applicable regulatory authorities;

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the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;

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the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party;

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establishing commercial manufacturing capabilities including making arrangements with CMOs; and

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development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch.

Any changes in the outcome of any of these factors could significantly impact the costs, timing and viability associated with the development of our product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

General and administrative expenses

General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance, commercial and administrative functions. General and administrative expenses also include professional fees for legal, patent, consulting, investor and public relations and accounting and audit services, as well as expenses relating to commercialization preparation activities. We anticipate that our general and administrative expenses will increase over time as we increase our headcount to support the growth of our organization as well as prepare for the commercial launch of our product candidates that obtain regulatory approval.

Other income (expense)

Change in fair value of related party revenue share liability

We have a revenue sharing agreement with Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (collectively, Deerfield), each an investor in the Company, to pay Deerfield a fixed low single-digit percentage rate of net sales of certain commercial products. We account for the liability to Deerfield at fair value with changes recognized in the consolidated statements of operations and comprehensive loss.

Interest income and other income (expense), net

Interest income and other income (expense), net consists of interest income earned on our cash, cash equivalents and marketable securities and other income (expense) unrelated to our core operations.

Results of Operations

The following discussion and analysis of our results of operations includes a comparison of the year ended December 31, 2025 to the year ended December 31, 2024. For the discussion and analysis of our results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023, refer to Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on February 27, 2025 (the 2024 Form 10-K), which is incorporated herein by reference.

Comparison of the Years Ended December 31, 2025 and 2024

The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

Operating expenses

Other income (expense)

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Research and development expenses

The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

Direct external research and development expenses by program:

Unallocated research and development expenses:

Research and development expenses were $307.0 million for the year ended December 31, 2025, compared to $217.8 million for the year ended December 31, 2024. The increase in direct external research and development expenses related to neladalkib of $37.7 million was primarily due to costs related to the ongoing Phase 2 portion of the ALKOVE-1 clinical trial and the Phase 3 ALKAZAR clinical trial, which was initiated in July 2025, and professional services. The increase in direct external research and development expenses related to NVL-330 of $13.5 million was primarily due to costs related to the ongoing HEROEX-1 Phase 1 clinical trial and manufacturing costs. The increase in personnel-related expenses of $33.4 million was primarily due to an increase of $16.7 million in stock-based compensation expense and an increase in headcount. For the years ended December 31, 2025 and 2024, stock-based compensation expense was $48.1 million and $31.4 million, respectively.

General and administrative expenses

The following table summarizes our general and administrative expenses for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

General and administrative expenses were $107.3 million for the year ended December 31, 2025, compared to $62.6 million for the year ended December 31, 2024. The increase in personnel-related expenses of $21.6 million was primarily due to an increase in headcount and an increase of $9.2 million in stock-based compensation expense. For the years ended December 31, 2025 and 2024, stock-based compensation expense was $38.4 million and $29.2 million, respectively. The increase in commercial preparation and other expenses of $19.0 million was primarily due to costs incurred in preparation for the potential commercial launch of our product candidates.

Other income (expense)

Change in fair value of related party revenue share liability

The change in fair value of the related party revenue share liability was $55.2 million and $17.9 million for the years ended December 31, 2025 and 2024, respectively. For the years ended December 31, 2025 and 2024, the change in fair value of the related party revenue share liability was due to changes in certain assumptions in the model used to calculate fair value such as the probability and timing of obtaining regulatory approval due to the progression of our product candidates in clinical development towards potential commercialization, and estimated future product revenues.

Interest income and other income (expense), net

Interest income and other income (expense), net for the years ended December 31, 2025 and 2024, consisted primarily of interest income of $44.8 million and $38.4 million, respectively. The increase in interest income was primarily due to an increase in cash, cash equivalents and marketable securities.

Liquidity and Capital Resources

Since our inception, we have incurred significant net losses. We have not yet commercialized any of our product candidates and our ability to generate revenue from product sales will depend heavily on the successful clinical development of, receipt of marketing

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approval from regulatory authorities for, and eventual commercialization of one or more of our product candidates. Through December 31, 2025, we have funded our operations primarily with proceeds from the sales of convertible preferred stock, the issuance of convertible notes, debt financing from stockholders and proceeds from the sale of common stock in our public offerings. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $1.4 billion and accounts payable and accrued expenses and other current liabilities of $91.2 million.

In November 2025, we issued and sold 4,950,496 shares of our Class A common stock in an underwritten public offering at a public offering price of $101.00 per share. We received net proceeds of $471.8 million, after deducting equity issuance costs and underwriting discounts and commissions.

The following discussion and analysis of a summary of our cash flows includes a comparison of the year ended December 31, 2025 to the year ended December 31, 2024. For the discussion and analysis that compares our summary of cash flows for the year ended December 31, 2024 to the year ended December 31, 2023, refer to Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2024 Form 10-K, which is incorporated herein by reference.

Cash Flows

The following table summarizes our cash flows for each of the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

Net cash used in operating activities $ (275,209 ) $ (185,064 )

Net increase (decrease) in cash and cash equivalents $ 116,054 $ (189,696 )

Operating activities

During the year ended December 31, 2025, operating activities used $275.2 million of cash, resulting from our net loss of $425.4 million adjusted for non-cash items, primarily stock-based compensation expense of $86.5 million, change in fair value of related party revenue share liability of $55.2 million and net accretion on marketable securities of $11.1 million, and net cash provided by changes in our operating assets and liabilities of $19.2 million. Our net loss was primarily due to clinical trial and manufacturing costs to support the development of our product candidates, personnel-related expenses due to the growth of our Company, costs related to professional services and costs incurred in preparation for the potential commercial launch of our product candidates, partially offset by interest income due to our cash, cash equivalents and marketable securities. Net cash provided by changes in our operating assets and liabilities was primarily due to increases in accounts payable and accrued expenses and other liabilities of $36.1 million, partially offset by increases in other assets and prepaid expenses and other current assets of $16.9 million.

During the year ended December 31, 2024, operating activities used $185.1 million of cash, resulting from our net loss of $260.8 million adjusted for non-cash items, including stock-based compensation expense of $60.6 million, change in fair value of related

party revenue share liability of $17.9 million and net accretion on marketable securities of $14.7 million, and net cash provided by changes in our operating assets and liabilities of $11.8 million. Net cash provided by changes in our operating assets and liabilities was due to an increase in accrued expenses and other current liabilities of $26.9 million, partially offset by an increase in prepaid expenses and other current assets of $7.6 million, a decrease in accounts payable of $4.0 million, and an increase in other assets of $3.4 million.

Changes in prepaid expenses and other current assets, other assets, accounts payable, and accrued expenses and other liabilities were generally due to growth in our business, the advancement of our research and development programs and the timing of vendor invoicing and payments.

Investing activities

During the year ended December 31, 2025, net cash used in investing activities was $124.1 million, primarily due to purchases of marketable securities of $1.1 billion, partially offset by proceeds from maturities of marketable securities of $932.8 million.

During the year ended December 31, 2024, net cash used in investing activities was $573.5 million, primarily due to purchases of marketable securities of $1.0 billion, partially offset by proceeds from maturities of marketable securities of $450.5 million.

Financing activities

During the year ended December 31, 2025, net cash provided by financing activities was $515.3 million, primarily due to proceeds from an underwritten public offering of $472.5 million, net of underwriting discounts and commissions, and proceeds from the exercise of options to purchase common stock of $42.0 million.

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During the year ended December 31, 2024, net cash provided by financing activities was $568.9 million, primarily due to proceeds from an underwritten public offering of $540.5 million, net of underwriting discounts and commissions, and proceeds from the exercise of options to purchase common stock of $28.8 million.

Funding Requirements

We expect to incur significant expenses in connection with our ongoing activities, particularly as we advance our preclinical, clinical, and commercialization preparation activities for our product candidates in development and any future product candidates. The timing and amount of our operating expenditures will depend largely on:

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the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our discovery programs and product candidates, including the advancement of zidesamtinib, neladalkib and NVL-330 throughout clinical development;

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the clinical development plans we establish for our product candidates, including zidesamtinib, neladalkib and NVL-330;

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the number and characteristics of product candidates that we discover and develop through our product discovery and research efforts;

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the terms of any collaboration agreements we may choose to pursue;

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the outcome, timing and cost of meeting regulatory requirements established by the FDA, the European Medicines Agency and other comparable foreign regulatory authorities;

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the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

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the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us;

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the effect of competing technological and market developments;

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the cost and timing of completion of commercial-scale outsourced manufacturing activities; and

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the cost of continuing to build sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $1.4 billion. We expect that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2029. Our existing cash, cash equivalents and marketable securities may not be sufficient to fund all of our product candidates through regulatory approval, and we may need to raise additional capital to complete the development and commercialization of our product candidates. Our estimate as to how long we expect our existing cash, cash equivalents and marketable securities to fund our operations does not include potential product revenue and is based on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including those listed above.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our common stockholders will 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 preferred 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 acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Other Commitments

We have an obligation under a revenue sharing agreement with Deerfield to pay Deerfield a fixed low single-digit percentage rate of net sales of certain commercial products. We are also party to a revenue sharing agreement with our scientific founder, Matthew Shair, Ph.D., pursuant to which we were obligated to pay Dr. Shair 1.5% of net sales of certain commercial products. In December 2025, Dr. Shair assigned the revenue sharing agreement to Royalty Pharma plc (Royalty Pharma) and, as a result, any payments we are obligated to make under this agreement will be made to Royalty Pharma. See Note 10 in the notes to the consolidated financial statements included elsewhere in this Annual Report for additional information regarding our obligations under the revenue sharing agreements.

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We lease office space for our corporate headquarters, which is located in Cambridge, Massachusetts. We enter into contracts in the normal course of business with our CMOs, CROs and other third parties to support research and development, commercial preparation, and other business activities. These contracts are generally terminable by us for convenience or for breach after reasonable cure periods.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements as defined in the rules and regulations of the SEC.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Related party revenue share liability

We account for the related party revenue share liability with Deerfield at fair value. The revenue sharing agreement with Deerfield obligates us to pay a fixed low single-digit percentage rate of net sales of certain commercial products. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, Financial Instruments, we elected the fair value option. Each reporting period, we remeasure the liability to estimated fair value using a discounted cash flow model based on the most recent assumptions such as the probability and timing of product approval, future product revenues and discount rate. These assumptions are estimates and can change based on factors such as the progression of our product candidates in clinical development and potential commercialization, current market conditions, competition, estimated clinical benefit and pricing. Changes to these assumptions can result in a material impact to our consolidated financial statements. Changes in fair value in each reporting period are recognized as a component of other income (expense) in the consolidated statements of operations and comprehensive loss. The estimated fair value as of December 31, 2025 and 2024 was determined to be $73.2 million and $17.9 million, respectively. We have not recorded any net sales and, as a result, have not paid any amounts under this obligation.

Accrued research and development expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of services performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of actual costs. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include activities with vendors in connection with preclinical and clinical development activities, CROs in connection with preclinical and clinical studies and testing, and CMOs in connection with the process development and scale up activities and the production of materials.

We base the expense recorded related to contract research, manufacturing, or other vendors on our estimates of the services received and efforts expended pursuant to the terms of the individual agreements with the CROs, CMOs, or other vendors that conduct services and supply materials. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. While the majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met, some require advance payments. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. We record these as prepaid expenses and other current assets and other assets on our consolidated balance sheets.

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Stock-based compensation

We account for our stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation — Stock Compensation (ASC 718). We have granted stock options and restricted stock units (RSUs), both of which are subject to service-based vesting conditions, and RSUs with performance-based vesting conditions (PSUs). In accordance with ASC 718, we recognize stock-based compensation expense in the consolidated statements of operations and comprehensive loss based on a stock-based award’s grant-date fair value.

We use the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs and PSUs, the fair value is equal to the market price of a share of our Class A common stock on the grant date. We recognize forfeitures as they occur. Stock-based compensation expense for stock awards with service-based vesting conditions is recognized on a straight-line basis based on the grant-date fair value over the associated service period of the award, which is generally the vesting period. Stock awards with service-based vesting conditions generally vest over three- or four-year service periods and stock options expire after ten years. Stock-based compensation expense for stock awards with performance-based vesting conditions is recognized on a straight-line basis over the requisite service period for each separately vesting portion of the underlying stock award when the performance-based vesting condition is deemed probable to occur. We reassess the probability of vesting at each reporting period and adjust stock-based compensation expense, if applicable, based on our probability assessment.

We record stock-based compensation expense to research and development expense or general and administrative expense based on the underlying function of the individual that was granted the stock-based compensation award. Shares issued upon stock option exercise and RSU and PSU vesting are newly-issued shares.

The assumptions used in our Black-Scholes option-pricing model for stock options are as follows:

Expected Term — As we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, we utilize the “simplified” method, as prescribed in the SEC’s Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetical average of the vesting term and the original contractual term of the stock option.

Expected Volatility — The expected volatility is based on our historical volatility and that of similar entities within our industry for periods corresponding with the expected term of the grant.

Risk-Free Interest Rate — The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant for a period that corresponds with the expected term of the grant.

Expected Dividends — The expected dividend yield is 0% as we have not historically paid, and do not expect for the foreseeable future to pay, a dividend on our common stock.

The assumptions used in our Black-Scholes option-pricing model are inherently subjective and represent management’s best estimates. These assumptions involve a number of variables, uncertainties and the application of management’s judgment. If any assumptions change, our stock-based compensation expense could be materially different in the future.

Stock-based compensation expense for stock awards with service-based vesting conditions was $86.5 million, $60.6 million and $25.6 million for the years ended December 31, 2025, 2024 and 2023, respectively. The performance-based vesting conditions under the PSUs have not been deemed probable to occur, and accordingly, no stock-based compensation expense has been recognized.

As of December 31, 2025, total unrecognized compensation cost, excluding unrecognized compensation costs related to PSUs, was $170.4 million, which is expected to be recognized over a weighted-average period of 2.3 years. As of December 31, 2025, total unrecognized compensation cost related to PSUs was $11.1 million, which will be recognized when the performance-based vesting conditions are deemed probable to occur.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements included in this Annual Report.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities related to our cash, cash equivalents and marketable securities. As of December 31, 2025, we had $261.7 million in cash and cash equivalents and $1.1 billion in marketable securities classified as available-for-sale securities. We invest our excess cash in money market funds, commercial paper, corporate bonds, government and agency securities and U.S. treasury bills. We mitigate credit risk by maintaining a diversified portfolio, placing our cash with high credit quality financial institutions and limiting the amount of investment exposure as to maturity and investment type according to our investment policy. We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure.

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Interest income is sensitive to changes in the general level of interest rates; however, due to the short-term maturities and low risk profiles of our investments, we do not anticipate a significant exposure to interest rate risk. A 10% change in market interest rates would not be expected to have a material impact on our financial condition or results of operations.

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Item 8. Financial Statements and Supplementary Data.

NUVALENT, INC.

Index to Consolidated Financial Statements

Page

Report of Independent Registered Public Accounting Firm (PCAOB ID: 185) 107

Consolidated Balance Sheets 109

Consolidated Statements of Operations and Comprehensive Loss 110

Consolidated Statements of Stockholders’ Equity 111

Consolidated Statements of Cash Flows 112

Notes to Consolidated Financial Statements 113

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Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors

Nuvalent, Inc.:

Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting

We have audited the accompanying consolidated balance sheets of Nuvalent, Inc. and subsidiary (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2025, and the related notes (collectively, the consolidated financial statements). We also have audited the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025 based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are

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material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Valuation of the related party revenue share liability

As discussed in Note 4 to the consolidated financial statements, the Company’s related party revenue share liability balance as of December 31, 2025 was $73.2 million. As discussed in Note 2, the revenue share liability is remeasured at the end of each reporting period using a discounted cash flow model to calculate the estimated payments that could become due following commercialization. Assumptions in the model include but are not limited to probability and timing of product approval, future product revenues and discount rate.

We identified the assessment of the valuation of the related party revenue share liability as a critical audit matter. Subjective and challenging auditor judgment and specialized skills and knowledge were required to evaluate certain assumptions used to determine the fair value of the liability. These assumptions included probability and timing of product approval, future product revenues, and discount rate. The assessment of these assumptions was challenging because they were derived from unobservable inputs. Additionally, changes to probability and timing of product approval or future product revenues could have had a significant impact on the determination of the fair value.

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s valuation process for the related party revenue share liability, including certain controls related to management’s determination of the probability and timing of product approval, future product revenues and discount rate. We evaluated the Company’s probability and timing of product approval and future product revenues by comparing these assumptions to externally available publications and scientific studies for comparable products. We involved valuation professionals with specialized skills and knowledge, who assisted in evaluating the discount rate used by the Company by comparing the Company’s inputs to the discount rate to publicly available data for comparable entities and assessing the resulting discount rate.

/s/ KPMG LLP

We have served as the Company’s auditor since 2020.

Boston, Massachusetts

February 26, 2026

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NUVALENT, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

December 31,

Assets

Current assets

Prepaid expenses and other current assets 20,474 14,146

Liabilities and Stockholders’ Equity

Current liabilities

Accrued expenses and other current liabilities 61,013 48,795

Related party revenue share liability 73,160 17,940

Other liabilities 35 —

Commitments and contingencies (Note 10)

Stockholders’ equity

Accumulated other comprehensive income (loss) 2,353 (59 )

The accompanying notes are an integral part of these consolidated financial statements.

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NUVALENT, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

Year Ended December 31,

Operating expenses

Other income (expense)

Comprehensive loss

Other comprehensive income (loss)

Unrealized gains (losses) on marketable securities 2,412 (90 ) 525

The accompanying notes are an integral part of these consolidated financial statements.

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NUVALENT, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

Class A Class B Additional Accumulated Other Total

Common Stock Common Stock Paid-in Comprehensive Accumulated Stockholders'

Shares Amount Shares Amount Capital Income (Loss) Deficit Equity

Unrealized gains on marketable securities — — — — — 525 — 525

Stock-based compensation expense — — — — 25,563 — — 25,563

Unrealized losses on marketable securities — — — — — (90 ) — (90 )

Stock-based compensation expense — — — — 60,579 — — 60,579

Unrealized gains on marketable securities — — — — — 2,412 — 2,412

Stock-based compensation expense — — — — 86,502 — — 86,502

The accompanying notes are an integral part of these consolidated financial statements.

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NUVALENT, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

Year Ended December 31,

Cash flows from operating activities

Adjustments to reconcile net loss to net cash used in operating activities

Change in fair value of related party revenue share liability 55,220 17,940 —

Other non-cash 345 — —

Changes in operating assets and liabilities

Prepaid expenses and other current assets (6,342 ) (7,563 ) 644

Cash flows from investing activities

Cash flows from financing activities

Payments of equity issuance costs (382 ) (483 ) (856 )

Payments of insurance costs financed by a third-party — (622 ) (777 )

Supplemental disclosure of noncash investing and financing information:

Operating lease right-of-use asset $ 798 $ — $ —

Equity issuance costs $ 336 $ 6 $ —

Insurance premium financed by a third-party $ — $ — $ 1,399

The accompanying notes are an integral part of these consolidated financial statements.

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NUVALENT, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Nature of Business

Nuvalent, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. The Company was founded in January 2017 as a Delaware corporation. The Company is headquartered in Cambridge, Massachusetts.

The Company is subject to risks similar to those of other pre-commercial stage companies in the biopharmaceutical industry, including dependence on key individuals, the need to develop commercially viable products, competition from other companies, many of which are larger and better capitalized, the need for adequate financing to fund the development of its product candidates, the need to obtain and maintain adequate protection for the Company’s intellectual property, and the impact of geopolitical events on the Company’s business. There can be no assurance that the Company’s research and development will be successful, that adequate protection for the Company’s intellectual property will be obtained and maintained, that any product candidates will receive required regulatory approval, or that approved products, if any, will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from the sale of its products.

The Company has incurred recurring losses since inception, including net losses of $425.4 million, $260.8 million and $126.2 million for the years ended December 31, 2025, 2024 and 2023, respectively. As of December 31, 2025, the Company had an accumulated deficit of $972.4 million. The Company expects to continue to generate net losses for the foreseeable future. The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date of issuance of these consolidated financial statements.

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of presentation and consolidation

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and under the rules and regulations of the United States Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Nuvalent Securities Corporation. All intercompany balances and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified to conform with current period presentation.

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the fair value of the related party revenue share liability, the accounting for research and development contracts, including clinical trial accruals, and valuation of equity instruments. The Company bases its estimates, assumptions, and judgments on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions.

Concentrations of credit risk and of significant suppliers

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company’s cash, cash equivalents and marketable securities may be held in accounts at financial institutions that may exceed federally insured limits. However, the Company mitigates credit risk by maintaining a diversified portfolio, placing its cash with high credit quality financial institutions and limiting the amount of investment exposure as to maturity and investment type according to its investment policy. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships.

The Company is dependent on third-party vendors for the manufacturing of its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture materials and components required for the production of its product candidates. These programs could be adversely affected by a significant interruption in the manufacturing process.

Cash and cash equivalents

The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents may include money market funds and marketable securities. The Company records interest income received on cash, cash equivalents, and marketable securities to other income (expense) in the consolidated statements of operations

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and comprehensive loss. The Company invests its excess cash in money market funds, commercial paper, corporate bonds, government and agency securities and U.S. treasury bills.

Fair value measurements

The Company follows the provision of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements (“ASC 820”), which defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

Level 1 — quoted prices for identical assets or liabilities in active markets.

Level 2 — quoted prices for similar assets or liabilities in active markets or inputs that are observable.

Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions).

The Company’s cash equivalents, marketable securities, and related party revenue share liability are carried at fair value, determined according to the fair value hierarchy described above (see Note 4).

Marketable securities

The Company accounts for marketable securities in accordance with FASB ASC Topic 320, Investments - Debt and Equity Securities. The Company’s marketable securities are classified as available-for-sale debt securities and recorded at fair value based on inputs that are observable, either directly or indirectly, such as quoted prices for identical securities in active markets (Level 1) or quoted prices for similar securities in active markets or inputs that are observable (Level 2). At the time of purchase, the Company classifies marketable securities with maturities of three months or less as cash equivalents on the consolidated balance sheets. The Company’s available-for-sale securities are classified as current assets as they are readily available to be converted to cash and for use in the Company’s current operations.

Unrealized gains and losses are included as a component of accumulated other comprehensive income (loss) in the consolidated statements of stockholders’ equity. Realized gains and losses are recorded to other income (expense) in the consolidated statements of operations and comprehensive loss.

When the fair value is below the amortized cost of an available-for-sale security, the Company must determine if the decline in fair value below the amortized cost basis has resulted from a credit loss or other factors. If the Company determines that the decline in fair value below the amortized cost basis is due to credit-related factors, the Company measures the credit loss and recognizes an allowance for credit losses in the consolidated balance sheet and the credit-related impairment in the consolidated statements of operations and comprehensive loss. The allowance for credit losses is measured as the amount by which the amortized cost basis exceeds the present value of expected cash flows, limited to the difference between the amortized cost basis and the security’s fair value. The Company subsequently assesses whether the measurement of credit losses has increased or decreased and adjusts the allowance for credit losses with corresponding gains or losses recognized in the consolidated statements of operations and comprehensive loss. Impairments not relating to credit losses are recorded to other comprehensive income (loss).

If the Company intends to sell the available for sale security or it is more likely than not that the Company will be required to sell the security prior to the recovery of its amortized cost basis, then the allowance for the credit losses is written off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations and comprehensive loss.

Fair value option for related party revenue share liability

The Company has a revenue sharing agreement with Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (collectively, “Deerfield”), each an investor in the Company, to pay a fixed low single-digit percentage rate of net sales of certain commercial products, which represents a freestanding financial instrument. In accordance with FASB ASC Topic 825, Financial Instruments, the Company elected the fair value option. Accordingly, the related party revenue share liability was measured at fair value upon issuance and is remeasured at the end of each reporting period with changes in fair value recognized as a component of other income (expense) in the consolidated statements of operations and comprehensive loss. The fair value of the related party revenue share liability is estimated using a discounted cash flow model to calculate the estimated payments that could become due following commercialization. Assumptions in the model include but are not limited to the following: probability and timing of product approval, future product revenues and discount rate. The fair value measurement is based on significant inputs that are not observable in the market and thus represents a Level 3 measurement.

Research and development and clinical trial accruals

Research and development costs are expensed as incurred. These consist primarily of salaries and related costs, including stock-based compensation, for personnel engaged in research and development functions; costs incurred in connection with the advancement of the Company’s discovery programs and product candidates in preclinical and clinical studies, including under agreements with contract

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research organizations (“CROs”); and the cost of developing and scaling the Company’s manufacturing process, including under agreements with contract manufacturing organizations, to manufacture drug substance and drug product for use in the Company’s research and preclinical and clinical studies and manufacture commercial-scale validation batches in preparation for the commercial launch of the Company’s product candidates that obtain regulatory approval.

Payments for such activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and may be reflected in the consolidated balance sheets as prepaid or accrued expenses. Determining the prepaid and accrued expenses balances at the end of any reporting period incorporates certain judgments and estimates by management that are based on information available to the Company including information provided by employees and vendors regarding the progress to completion of specific tasks or costs incurred.

Patent costs

All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.

Stock-based compensation

The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation — Stock Compensation (“ASC 718”). The Company has granted stock options and restricted stock units (“RSUs”), both of which are subject to service-based vesting conditions, and RSUs with performance-based vesting conditions (“PSUs”). In accordance with ASC 718, the Company recognizes stock-based compensation expense in the consolidated statements of operations and comprehensive loss based on a stock award’s grant-date fair value.

The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs and PSUs, the fair value is equal to the market price of a share of the Company’s Class A common stock on the grant date. The Company recognizes forfeitures as they occur. Stock-based compensation expense for stock awards with service-based vesting conditions is recognized on a straight-line basis based on the grant-date fair value over the associated service period of the award, which is generally the vesting period. Stock awards with service-based vesting conditions generally vest over three- or four-year service periods and stock options expire after ten years. Stock-based compensation expense for stock awards with performance-based vesting conditions is recognized on a straight-line basis over the requisite service period foreach separately vesting portion of the underlying stock award when the performance-based vesting condition is deemed probable to occur. The Company reassesses the probability of vesting at each reporting period and adjusts stock-based compensation expense, if applicable, based on its probability assessment.

The Company records stock-based compensation expense to research and development expense or general and administrative expense based on the underlying function of the individual that was granted the award. Shares issued upon stock option exercise and RSU and PSU vesting are newly-issued shares.

The assumptions used in the Company’s Black-Scholes option-pricing model for stock options are as follows:

Expected Term — As the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, the Company utilizes the “simplified” method, as prescribed in the SEC’s Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetical average of the vesting term and the original contractual term of the stock option.

Expected Volatility — The expected volatility is based on the historical volatility of the Company and that of similar entities within the Company’s industry for periods corresponding with the expected term of the grant.

Expected Dividends — The expected dividend yield is 0% as the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.

The assumptions used in the Company’s Black-Scholes option-pricing model are inherently subjective and represent management’s best estimates. These assumptions involve a number of variables, uncertainties and the application of management’s judgment. If any assumptions change, the Company’s stock-based compensation expense could be materially different in the future.

Net income (loss) per share

Basic net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potentially dilutive common shares. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

Income taxes

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The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to the provision for income taxes.

The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. Any resulting unrecognized tax benefits are recorded within the provision for income taxes.

Recently adopted accounting pronouncements

Effective January 1, 2025, the Company prospectively adopted Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) on an annual basis, which requires public entities to provide disclosure of specific categories in their income tax rate reconciliations, as well as disclosure of income taxes paid disaggregated by jurisdiction.

Recently issued accounting pronouncements

In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities, at annual and interim reporting periods, to disclose in a tabular format additional information about specific expense categories in the notes to the consolidated financial statements. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company does not expect the impact of the adoption of this standard to be material to its consolidated financial statements or disclosures.

In September 2025, the FASB issued ASU 2025-06, Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which modernizes the accounting for internal use software. The standard removes references to project stages and clarifies the criteria for capitalizing software costs. ASU 2025-06 is effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods, with early adoption permitted. The Company does not expect the impact of the adoption of this standard to be material to its consolidated financial statements or disclosures.

3. Marketable Securities

The following tables provide the amortized cost and fair value of the Company’s available-for-sale securities by security type (in thousands):

AmortizedCost GrossUnrealizedGains GrossUnrealizedLosses Fair Value

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The following table summarizes the amortized cost and fair value of the Company’s available-for-sale securities by contractual maturity (in thousands):

Amortized Cost Fair Value

There were no credit losses recorded during the years ended December 31, 2025, 2024 and 2023. Interest income for the years ended December 31, 2025, 2024 and 2023 was $44.8 million, $38.4 million and $23.3 million, respectively.

4. Fair Value Measurements

The following tables present the Company’s fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands):

Fair Value Measurements at December 31, 2025

Level 1 Level 2 Level 3 Total

Assets:

Marketable securities:

Liabilities:

Related party revenue share liability $ — $ — $ 73,160 $ 73,160

Fair Value Measurements at December 31, 2024

Level 1 Level 2 Level 3 Total

Assets:

Marketable securities:

Liabilities:

Related party revenue share liability $ — $ — $ 17,940 $ 17,940

Cash equivalents were valued by the Company based on quoted market prices for identical securities, which represent a Level 1 measurement within the fair value hierarchy. Commercial paper, corporate bonds, government and agency securities, and U.S. treasury bills were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. During the periods presented, there were no transfers in or out of Level 3. The carrying values of the Company’s accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these liabilities.

The following table sets forth the changes in estimated fair value of the Company’s related party revenue share liability for the year ended December 31, 2025, which represents a Level 3 measurement within the fair value hierarchy (in thousands):

Change in fair value 55,220

The fair value of the related party revenue share liability was estimated using a discounted cash flow model to calculate the estimated payments that could become due following commercialization. Assumptions in the model include but are not limited to the following: probability and timing of product approval, future product revenues and discount rate. Changes in fair value each reporting period are recognized as a component of other income (expense) in the consolidated statements of operations and comprehensive loss. See Note 10 for additional information regarding the revenue sharing agreement with Deerfield.

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5. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

December 31,

Accrued clinical and other research and development $ 30,235 $ 25,555

Accrued employee compensation and benefits 16,935 10,452

Accrued other and other current liabilities 2,867 1,277

6. Equity

In November 2025, the Company issued and sold 4,950,496 shares of its Class A common stock in an underwritten public offering at a public offering price of $101.00 per share (the “2025 Public Offering”). Upon the closing of the 2025 Public Offering, the Company received net proceeds of $471.8 million, after deducting equity issuance costs of $0.7 million in addition to underwriting discounts and commissions. In addition, the underwriters exercised their option in full to purchase an additional 742,574 shares of the Company’s Class A common stock (the “Additional Shares”) from Deerfield. The Company did not receive any proceeds from the sale of the Additional Shares by Deerfield.

In September 2024, the Company issued and sold 5,750,000 shares of its Class A common stock in an underwritten public offering, including the exercise in full by the underwriters of their option to purchase an additional 750,000 shares of the Company’s Class A common stock, at a public offering price of $100.00 per share (the “2024 Public Offering”). Upon the closing of the 2024 Public Offering, the Company received net proceeds of $540.0 million, after deducting equity issuance costs of $0.5 million in addition to underwriting discounts and commissions.

In October 2023, the Company issued and sold 6,160,714 shares of its Class A common stock in an underwritten public offering, including the exercise in full by the underwriters of their option to purchase an additional 803,571 shares of the Company’s Class A common stock, at a public offering price of $56.00 per share (the “2023 Public Offering”). Upon the closing of the 2023 Public Offering, the Company received net proceeds of $323.5 million, after deducting equity issuance costs of $0.8 million in addition to underwriting discounts and commissions.

7. Stock-Based Compensation

The Company recorded stock-based compensation expense within its consolidated statements of operations and comprehensive loss as follows (in thousands):

Year Ended December 31,

Under the 2021 Plan (as defined below), the Company has granted stock options, RSUs and PSUs. As of December 31, 2025, total unrecognized compensation cost, excluding unrecognized compensation cost related to PSUs, was $170.4 million, which is expected to be recognized over a weighted-average period of2.3 years. Stock-based compensation expense for PSUs is recognized on a straight-line basis over the requisite service period for each separately vesting portion of the PSUs when the performance-based vesting condition is deemed probable to occur. The performance-based vesting conditions under the PSUs have not been deemed probable to occur, and accordingly, no stock-based compensation expense has been recognized. As of December 31, 2025, total unrecognized compensation cost related to PSUs was $11.1 million, which will be recognized when the performance-based vesting conditions are deemed probable to occur.

2021 equity incentive plan

In July 2021, the Company adopted the 2021 Stock Option and Incentive Plan (the “2021 Plan”). The 2021 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, RSUs (including PSUs), unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of shares of Class A common stock reserved for issuance under the 2021 Plan is subject to increase on each January 1 thereafter by 5.0% of the number of shares of the Company’s Class A and Class B common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The shares of Class A common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expired or are otherwise

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terminated (other than by exercise) under the 2021 Plan will be added back to the shares of Class A common stock available under the 2021 Plan. As of December 31, 2025, 8,244,716 shares of Class A common stock remained available for future issuance under the 2021 Plan.

2021 employee stock purchase plan

In July 2021, the Company adopted the 2021 Employee Stock Purchase Plan (as amended and restated, the “ESPP”). The ESPP permits eligible employees to purchase shares of Class A common stock at a discount in accordance with the terms of the offering and consists of consecutive, overlapping 12-month offering periods, each consisting of two six-month purchase periods. As of December 31, 2025, 2,322,110 shares remained available for issuance and sale under the ESPP.

Stock options

The following table presents the range of assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted:

Year Ended December 31,

Weighted average expected option term (years) 6.0 6.0 6.0

Range of expected stock price volatility 70% — 71% 72% — 76% 76% — 82%

Weighted average expected stock price volatility 71% 75% 80%

Range of risk-free interest rate 3.7% — 4.4% 3.5% — 4.6% 3.4% — 4.7%

Expected dividend rate 0% 0% 0%

The following table summarizes the Company’s stock option activity since December 31, 2024:

Weighted

Average

Weighted Remaining Aggregate

Average Contractual Intrinsic

Number Exercise Term Value

of Shares Price (in years) (in thousands)

The aggregate intrinsic value of stock options exercised during the years ended December 31, 2025, 2024 and 2023 was $107.6 million, $102.3 million and $52.3 million, respectively. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock on the date of exercise.

The weighted average grant-date fair value of stock options granted during the years ended December 31, 2025, 2024 and 2023 was $51.94 per share, $53.07 per share and $23.01 per share, respectively.

RSUs

The following table summarizes the Company’s RSU activity since December 31, 2024:

Number of Shares Weighted Average Grant-Date Fair Value

The RSU activity above includes 141,935 of outstanding PSUs. The total fair value of RSUs vested during the year ended December 31, 2025 was $19.0 million. No RSUs vested during the years ended December 31, 2024 and 2023.

8. Net Loss Per Share

The Company has two classes of common stock outstanding: Class A common stock and Class B common stock. The rights of the holders of Class A common stock and Class B common stock are substantially identical, except with respect to voting and conversion.

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Each share of Class A common stock is entitled to one vote. Class B common stock is nonvoting, and each share of Class B common stock is convertible into one share of Class A common stock at the option of the holder at any time, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. The Company allocates undistributed earnings attributable to common stock between the common stock classes on a one-to-one basis when computing net loss per share. As a result, basic and diluted net loss per share of Class A common stock and per share of Class B common stock are equivalent.

The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

As of December 31,

9. Income Taxes

All of the Company’s net losses have been generated in the United States. The Company recognized income tax provisions of $0.6 million and $0.8 million during the years ended December 31, 2025 and 2024, respectively, as a result of investment income earned in Nuvalent Securities Corporation. The Company recognized no income tax provision during the year ended December 31, 2023.

Reconciliation of federal statutory income tax rate to effective income tax rate

The Company has elected to prospectively adopt the guidance in ASU 2023-09. The following tables present reconciliations of the U.S. federal statutory income tax rate of 21% to the Company’s effective income tax rate for the years ended December 31, 2025, 2024 and 2023 (dollar values in thousands):

U.S. federal statutory income tax rate $ (89,206 ) 21.0 %

Foreign tax effects — — %

Effect of changes in tax laws or rates enacted in the current period — — %

Effect of cross-border tax laws — — %

Tax credits

Changes in valuation allowances 114,819 (27.0 )%

Nontaxable or nondeductible items

Stock-based compensation (12,413 ) 2.9 %

Permanent adjustments 113 — %

Changes in unrecognized tax benefits — — %

Other adjustments 447 (0.1 )%

Effective income tax rate $ 585 (0.1 )%

Year Ended December 31,

U.S. federal statutory income tax rate 21.0 % 21.0 %

State income taxes, net of federal benefit 6.7 % 8.3 %

Tax credits generated 14.3 % 5.7 %

Change in deferred tax asset valuation allowance (45.8 )% (38.7 )%

Stock-based compensation 3.6 % 3.5 %

Effective income tax rate (0.3 )% — %

During the years ended December 31, 2025, 2024 and 2023, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items.

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Net deferred tax assets

Net deferred tax assets consisted of the following (in thousands):

December 31,

Deferred tax assets:

Research and development tax credit carryforwards 82,361 52,117

Change in fair value of related party revenue share liability 19,284 4,785

Total net deferred tax assets 270 —

Deferred tax liabilities:

Total gross deferred tax liabilities (270 ) —

Net deferred tax assets $ — $ —

As of December 31, 2025, the Company had U.S. federal and state net operating loss carryforwards of $503.2 million and $531.1 million, respectively, which may be available to offset future taxable income. The federal net operating losses include $1.2 million which expire in 2037 and $502.0 million which carryforward indefinitely, but may only be used to offset 80% of annual taxable income. The state net operating losses expire at various dates beginning in 2037. As of December 31, 2025, the Company also had federal and state research and development tax credit carryforwards of $14.6 million and $14.1 million, respectively, and federal orphan drug credits of $56.5 million, which may be available to offset future tax liabilities. The federal and state research and development tax credit carryforwards and the federal orphan drug credits expire at various dates beginning in 2033.

Utilization of the U.S. federal and state net operating loss carryforwards, as well as the research and development tax credit carryforwards and federal orphan drug credits may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 (“IRC”), and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards, research and development tax credit carryforwards or the federal orphan drug credits would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the net operating loss carryforwards, research and development tax credit carryforwards or the federal orphan drug credits before utilization. Further, until a study is completed by the Company and any limitation is known, no amounts are being presented as an uncertain tax position.

Valuation allowance

The Company has evaluated the positive and negative evidence bearing upon its ability to realize the net deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and that the Company has yet to commercialize any of its product candidates to generate revenue from product sales and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2025 and 2024. Management reevaluates the positive and negative evidence at each reporting period.

The valuation allowance increased by $142.5 million, $119.1 million and $48.8 million during the years ended December 31, 2025, 2024 and 2023, respectively, primarily as a result of increases in net operating loss carryforwards, research and development tax credit carryforwards, the change in fair value of related party revenue share liability and research and development costs capitalized under Section 174 of the IRC.

Unrecognized tax benefits and tax examinations

As of December 31, 2025 and 2024, the Company had not recorded any amounts for unrecognized tax benefits. The Company files income tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The Company is open to future tax examination under statute from 2022 to the present.

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10. Commitments and Contingencies

Revenue sharing agreements

The Company has a revenue sharing agreement with Deerfield pursuant to which the Company is obligated to pay Deerfield a fixed low single-digit percentage rate of net sales of certain commercial products (the “Deerfield Revenue Sharing Agreement”). The Company is also party to a revenue sharing agreement with its scientific founder pursuant to which the Company was obligated to pay the scientific founder 1.5% of net sales of certain commercial products (the “Scientific Founder Revenue Sharing Agreement” and together with the Deerfield Revenue Sharing Agreement, the “Revenue Sharing Agreements”). In December 2025, the scientific founder assigned the Scientific Founder Revenue Sharing Agreement to Royalty Pharma plc (“Royalty Pharma”) and, as a result, any payments the Company is obligated to make under the Scientific Founder Revenue Sharing Agreement will be made to Royalty Pharma.

Under the Revenue Sharing Agreements, the payment obligation in respect of such products expires on the later of 12 years from the first commercial sale in a country or the expiration of the last-to-expire patent in that country. The Company accounts for the liability with Deerfield at fair value with changes recognized in the consolidated statements of operations and comprehensive loss (see Note 4). The Company accounts for the obligation to Royalty Pharma as a contingent liability and has not accrued any liability as of December 31, 2025 or 2024. The Company has not recorded any net sales and, as a result, has not paid any amounts under the Revenue Sharing Agreements.

Indemnification agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, CROs, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnifications and is not currently aware of any indemnification claims.

11. Segment Information

The Company is a clinical-stage biopharmaceutical company and has not generated any revenue since commencing significant operations in 2018. The Company’s operations are organized and reported as one reportable segment, which includes all activities related to the discovery, development, and commercialization of precisely targeted therapies for patients with cancer. This presentation is consistent with how the Company’s chief operating decision maker (“CODM”), its Chief Executive Officer, assesses the performance of the Company and makes operating decisions on a consolidated basis. The accounting policies of the consolidated segment are the same as those described in the summary of significant accounting policies (see Note 2). The CODM assesses performance and decides how to allocate resources based on consolidated net loss as reported on the consolidated statements of operations and comprehensive loss. The CODM uses consolidated net loss to monitor budget versus actual results, assess cash runway, and benchmark against the Company’s competitors. The measure of segment assets is reported on the consolidated balance sheets as total assets. The Company’s assets are held in the United States.

The following table sets forth the Company’s segment information (in thousands):

Year Ended December 31,

Direct external expenses by program:

General and administrative professional and consultant fees 15,033 10,854 6,423

Change in fair value of related party revenue share liability 55,220 17,940 —

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(1)Other segment items included in consolidated net loss include expenses for commercialization preparation activities, research and development consulting services, information technology, insurance, employee recruitment and other miscellaneous activities.

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Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

None.

Item 9A. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our President and Chief Executive Officer and our Chief Financial Officer (our principal executive officer and principal financial and accounting officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our President and Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management’s Annual Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2025, our internal control over financial reporting was effective.

Our independent registered public accounting firm, KPMG LLP, which audited the consolidated financial statements included in this Annual Report, has issued an attestation report on our internal control over financial reporting, which is included herein.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Item 9B. Other Information.

Director and Officer Trading Arrangements

The following table describes for the quarterly period ended December 31, 2025, each trading arrangement for the sale or purchase of Company securities adopted or terminated by our directors and officers that is either (1) a contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (a Rule 10b5-1 trading arrangement) or (2) a “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K):

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Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.

Not applicable.

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PART III

Item 10. Directors, Executive Officers and Corporate Governance.

The information concerning our executive officers is set forth under the heading “Information about our Executive Officers” in Item 1 of this Annual Report on Form 10-K. The remaining information required by this Item 10 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 11. Executive Compensation.

The information required by this Item 11 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders, which, for the avoidance of doubt, does not include the information required by Item 402(v) of Regulation S-K, and is incorporated herein by reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this Item 12 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item 13 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 14. Principal Accountant Fees and Services.

The information required by this Item 14 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference.

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PART IV

Item 15. Exhibits and Financial Statement Schedules.

(a)The financial statements, financial statement schedules, and exhibits filed as part of this Annual Report are as follows:

1. Financial Statements

See “Index to Consolidated Financial Statements” beginning on page 106 of this Annual Report.

2. Financial Statement Schedules

Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated financial statements or the notes thereto.

3. Exhibits

The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report are listed in the Exhibit Index immediately preceding the signature page of this Annual Report. The exhibits listed in the Exhibit Index are incorporated by reference herein.

Item 16. Form 10-K Summary.

Not applicable.

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Exhibit Index.

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19.1 Amended and Restated Insider Trading Policy X

23.1 Consent of KPMG LLP, independent registered public accounting firm X

101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Document

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

NUVALENT, INC.

Date: February 26, 2026 By: /s/ James R. Porter

James R. Porter, Ph.D.

President and Chief Executive Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature Title Date

James R. Porter, Ph.D. (Principal Executive Officer)

/s/ Alexandra Balcom Chief Financial Officer February 26, 2026

Alexandra Balcom (Principal Financial Officer and Principal Accounting Officer)

/s/ Grant Bogle Director February 26, 2026

Grant Bogle

/s/ Michael L. Meyers Director February 26, 2026

Michael L. Meyers, M.D., Ph.D.

/s/ Christy Oliger Director February 26, 2026

Christy Oliger

NUVL US Equity

NUVL · 10-K · period ended 2025-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Item 8. Financial Statements and Supplementary Data.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

Item 9A. Controls and Procedures.

Item 9B. Other Information.

Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.

Item 10. Directors, Executive Officers and Corporate Governance.

Item 11. Executive Compensation.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

Item 14. Principal Accountant Fees and Services.

Item 15. Exhibits and Financial Statement Schedules.

Item 16. Form 10-K Summary.

NUVL US Equity☆

NUVL · 10-K · period ended 2025-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Item 8. Financial Statements and Supplementary Data.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

Item 9A. Controls and Procedures.

Item 9B. Other Information.

Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.

Item 10. Directors, Executive Officers and Corporate Governance.

Item 11. Executive Compensation.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

Item 14. Principal Accountant Fees and Services.

Item 15. Exhibits and Financial Statement Schedules.

Item 16. Form 10-K Summary.

NUVL US Equity