What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-11 compared with 2025-11-10 · 75 added, 106 removed, 177 unchanged (51% of the section changed)

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We are a clinical-stage biopharmaceutical company dedicated to the identification, development and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers.

We seek to utilize our team’s deep drug development experience to maximize the potential of our lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors.

Firmonertinib is currently being evaluated in multiple clinical trials across a range of epidermal growth factor receptor mutant (EGFRm) in non-small cell lung cancer (NSCLC), including a pivotal Phase 3 clinical trial in treatment naïve, or first-line, patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations.

We received Breakthrough Therapy Designation for firmonertinib for this disease from the United States Food and Drug Administration (FDA) in October 2023, and Orphan Drug Designation for treatment of NSCLC with EGFRm or human epidermal growth factor receptor 2 mutations or human epidermal growth factor receptor 4 mutations in February 2024.

We seek to utilize our team’s deep drug development experience to maximize the potential of our lead product candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, including ARR 217 (MRG007) through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors.

Firmonertinib is currently being evaluated in multiple clinical trials across a range of epidermal growth factor receptor mutant (EGFRm) in non-small cell lung cancer (NSCLC).

We are conducting a pivotal Phase 3 clinical trial of firmonertinib in treatment naïve, or first-line, patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations and a pivotal Phase 3 clinical trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with PACC mutations.

We are also conducting a Phase 1 clinical trial of ARR-217 in patients with unresectable locally advanced or metastatic solid tumors.

We received Breakthrough Therapy Designation for firmonertinib for first line EGFRm NSCLC with exon 20 insertion from the United States Food and Drug Administration (FDA) in October 2023, and Orphan Drug Designation for treatment of NSCLC with EGFRm or human epidermal growth factor receptor 2 mutations or human epidermal growth factor receptor 4 mutations in February 2024.

A product candidate can receive Breakthrough Therapy Designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

For drugs that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development.

The receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process, review or approval compared to product candidates considered for approval under conventional FDA procedures and does not increase the likelihood that the product candidate will ultimately receive FDA approval for any indication.

For drugs that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development although BTD may not result in a faster development process, review or approval and does not increase the likelihood that the product candidate will ultimately receive FDA approval for any indication.

In 2021, we licensed from Allist the right to develop and commercialize firmonertinib worldwide, with the exception of greater China, which includes mainland China, Hong Kong, Macau and Taiwan.

Firmonertinib is an investigational, novel, epidermal growth factor receptor (EGFR) mutant-selective tyrosine kinase inhibitor (TKI) that we are developing for the treatment of NSCLC patients across a broader set of EGFRm than are currently served by approved EGFR TKIs.

Firmonertinib is currently only approved and commercially distributed by Shanghai Allist Pharmaceuticals Co.

(Allist) in China as a first-line therapy to treat classical EGFRm NSCLC.

Firmonertinib is currently approved and commercially distributed by Shanghai Allist Pharmaceuticals Co.

(Allist) in China as a first-line therapy to treat classical EGFRm NSCLC and Allist recently received accelerated approval in China for second-line therapy to treat EGFRm exon20 NSCLC.

The FDA has not approved firmonertinib for any use.

We selected firmonertinib for global development against nonclassical, or uncommon, mutations based on preliminary reductions in tumor size observed in seven out of ten patients in first-line treatment with EGFR exon 20 insertion mutations in the ongoing Phase 1b clinical trial, the FAVOUR trial, conducted by Allist in China, and preclinical activity in EGFR P-loop and-alpha-c-helix compressing (PACC) mutations, each a subtype of uncommon mutation.

If the future clinical trial results of the FAVOUR trial are unfavorable, our clinical development plans for firmonertinib, which include conducting our global, pivotal Phase 3 FURVENT clinical trial in

first-line non-squamous locally advanced or metastatic EGFRm NSCLC patients with exon 20 insertion mutations, may be adversely affected.

We selected firmonertinib for global development against nonclassical, or

uncommon, mutations based on preliminary reductions in tumor size observed in seven out of ten patients in first-line treatment with EGFR exon 20 insertion mutations treated with firmonertinib in the ongoing Phase 1b clinical trial, the FAVOUR trial, conducted by Allist in China, and preclinical activity in EGFR P-loop and-alpha-c-helix compressing (PACC) mutations, each a subtype of uncommon mutation.

In a subsequent interim data readout from the FAVOUR trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations who were administered a 240 mg once-daily dose of firmonertinib, 79% of patients (n=22 out of 28 patients) were observed to experience a reduction in tumor size of at least 30%.

In a final analysis from the Phase 1b FURTHER trial of firmonertinib, which included a cohort of EGFRm NSCLC with PACC mutations, we observed 16.0 months median progression free survival with firmonertinib 240 mg in first-line, confirmed overall response rate 68.2% (n=15 out of 22 1L patients at 240 mg) and duration of response (DOR) 14.6 months, and confirmed central nervous system responses with firmonertinib including complete responses.

As one of the most prevalent cancers in the world, lung cancer imposes a significant global burden on human health, and EGFRm NSCLC represents a significant proportion of those affected.

Despite progress in the therapeutic landscape for EGFRm NSCLC, many patients, particularly those with uncommon mutations, such as exon 20 insertions or PACC mutations, are underserved by existing treatments.

In an interim data readout from the FAVOUR trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations, 79% of patients (n=22 out of 28 patients) were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by blinded independent central review utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, which measurement of reduction is the threshold in this trial for a partial response and for inclusion in determination of the overall response rate (ORR), which is the primary endpoint of this trial.

In the same interim data readout, those 79% of patients were observed to experience a 15.2-month median duration of response (DOR).

In September 2024, we announced positive interim proof-of-concept data from the FURTHER trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with PACC mutations.

In this interim readout, 64% of patients (n=14 out of 22 patients) were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by RECIST 1.1 criteria, which measurement of reduction is the threshold in this trial for a partial response and for inclusion in determination of the ORR, which is the primary endpoint of this trial.

Median DOR had not yet been reached, with 90.9% (n=20/22) of patients with confirmed responses remaining on study.

In June 2025, we announced plans to initiate ALPACCA (FURMO-006), the first randomized global Phase 3 study in first-line NSCLC in patients across PACC mutations.

Enrollment of the first patient in the ALPACCA trial is expected in the fourth quarter of 2025.

In September 2025, we announced our final data from the FURTHER trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with PACC mutations.

In this final readout, patients treated with 240 mg of firmonertinib were observed to experience 16.0 months median progression free survival and 14.6 months median duration of response.

Further, 68.2% of patients treated in first-line at 240 mg and 43.5% of patients treated in first-line at 160 mg were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by RECIST 1.1 criteria, which measurement of reduction is the threshold in this trial for determination of the ORR.

In addition, 47% (n=8/17) of patients with brain metastases at baseline were observed to experience a confirmed response utilizing modified RECIST 1.1 and 42.9% (n=6/14) of first line patients with brain metastases at baseline were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by RECIST 1.1 criteria.

Firmonertinib was generally well-tolerated with interim safety results.

We entered into the Global Technology Transfer and License Agreement (Allist License Agreement), pursuant to which, we have, among other things, secured an exclusive, royalty bearing and sublicensable license under certain intellectual property, including patents and know-how, owned or controlled by Allist to develop and commercialize any product containing firmonertinib or any of its salts or derivatives as an active ingredient of a product, which is led by a joint collaboration committee, comprising of representatives from both Allist and us.

In an interim data readout from the FAVOUR trial of firmonertinib in first-line patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations, 79% of patients (n=22 out of 28 patients) who were administered a 240 mg once daily dose of firmonertinib were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by blinded independent central review utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

This measurement of reduction is the threshold in this trial for a partial response and for inclusion in determination of the overall response rate (ORR), which is the primary endpoint of this trial.

In the same interim data readout, those 79% of patients were observed to experience a 15.2-month median DOR.

Interim results may not be indicative of final results;

however, we believe these interim clinical results underscore firmonertinib’s potential in patients whose tumors contain an uncommon EGFRm.

We have entered into the Global Technology Transfer and License Agreement (Allist License Agreement), pursuant to which, we have, among other things, secured an exclusive, royalty bearing and sublicensable license under certain intellectual property, including patents and know-how, owned or controlled by Allist to develop and commercialize any product containing firmonertinib or any of its salts or derivatives as an active ingredient of a product, which is led by a joint collaboration committee, comprising of representatives from both Allist and us.

Under the Allist License Agreement, we are obligated to pay Allist milestone payments up to an aggregate of $765.0 million upon the achievement of certain development, regulatory and sales milestone events as set forth in the Allist License Agreement.

During the nine months ended September 30, 2025 and 2024, no milestones were met or achieved.

We are also obligated under the Allist License Agreement to pay Allist tiered royalties based on net sales of Licensed Products (as defined in the Allist License Agreement).

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In January 2025, we entered into the Exclusive License Agreement (Lepu Biopharma Agreement) with Lepu Biopharma Co., Ltd.

to develop and commercialize any product containing ARR-217 or the antibody component of ARR-217.

(Lepu), pursuant to which we have, among other things, secured an exclusive, royalty bearing and sublicensable license under certain intellectual property, including patents and know-how, owned or controlled by Lepu to develop and commercialize any product containing ARR-217 or the antibody component of ARR-217.

Further, we are obligated to pay Lepu milestone payments up to an aggregate of approximately $1.17 billion upon the achievement of certain development, regulatory and sales milestone events as set forth in the Lepu Biopharma Agreement.

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See “Business — Licenses, Partnerships and Collaborations — Lepu Biopharma Agreement” in our Annual Report.

Since our inception in April 2021, we have devoted substantially all of our resources to organizing and staffing our company, acquiring the rights to develop firmonertinib, ARR-217, and clinical development of firmonertinib, business planning, raising capital, identifying potential product candidates, enhancing our intellectual property portfolio and undertaking research and clinical and preclinical studies for our development programs.

During the third quarter of 2025, Lepu dosed the first patient in the Phase 1 study for ARR-217 in patients with unresectable locally advanced or metastatic solid tumors.

In March 2026, ArriVent dosed its first patient in the ongoing Phase 1 study in partnership with Lepu.

Since our inception in April 2021, we have devoted substantially all of our resources to organizing and staffing our company, acquiring the rights to, and developing our product candidates, business planning, raising capital, identifying potential product candidates, enhancing our intellectual property portfolio and undertaking research and clinical and preclinical studies for our development programs.

We do not have any products approved for sale and have not generated any revenue from product sales or otherwise.

We have funded our operations to date primarily through the private placement of convertible preferred stock, our initial public offering in January 2024, our “at-the-market” offering, and our underwritten public offering of common stock and pre-funded warrants to purchase common stock in July 2025.

We have funded our operations to date primarily through the

private placement of convertible preferred stock, and through our initial public offering of common stock in January 2024, our “at-the-market” offering, and our underwritten public offering of common stock and pre-funded warrants to purchase common stock in July 2025.

We have incurred significant operating losses since our inception and have not yet generated any revenue.

Our net losses were $130.8 million and $59.9 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $369.1 million.

Our net losses were $43.3 million and $64.4 million for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, we had an accumulated deficit of $448.0 million.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, clinical trials and our expenditures on other research and development activities.

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We anticipate these losses will increase substantially as we:

● advance our lead product candidate, firmonertinib, as well as ARR-217, through clinical trials;

● advance our product candidates through clinical trials;

● acquire or in-license additional product candidates;

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Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

On July 4, 2025, the “One Big Beautiful Bill Act” (the “Act”) was enacted into law.

The Act contains changes to U.S.

tax law including provisions allowing accelerated tax deductions for qualified research and development expenditures.

We are continuing to evaluate the detailed provisions of the Act and their potential impact on our Consolidated Financial Statements.

We have evaluated the detailed provisions of the Act and have determined that there is no material impact on our Condensed Consolidated Financial Statements as of September 30, 2025.

We also face substantial competition from multiple sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions and governmental agencies and public and private research institutions.

Our competitors compete with us on the level of the technologies employed, or on the level of development of product candidates.

In addition, many small biotechnology companies have formed collaborations with large, established companies to (i) obtain support for their research, development and commercialization of products or (ii) combine several treatment approaches to develop longer lasting or more efficacious treatments that may potentially directly compete with our current or future product candidates.

We anticipate that we will continue to face increasing competition as new therapies and combinations thereof, technologies and data emerge within the field of oncology and, furthermore, within the treatment of NSCLC.

We believe that our current and future competition for resources and eventually for customers comes from companies that are commercializing or developing candidates targeting EGFRm-positive NSCLC, including, but not limited to,

AstraZeneca, Johnson & Johnson, Blossom Hill Therapeutics, Dizal Pharmaceutical, Oric Pharmaceuticals, Black Diamond Therapeutics, Inc., Cullinan Therapeutics, Inc., Taiho Pharmaceutical Co., Ltd., Boehringer Ingelheim, and Bayer AG.

In March 2024 and October 2024, chemotherapy in combination with the anti-EGFR anti-mesenchymal epithelial transition factor receptor bispecific antibody amivantamab was approved in the United States and Europe, respectively, for first line EGFRm NSCLC patients with exon 20 insertion mutations.

In January 2025, Taiho Therapeutics and Cullinan Therapeutics announced that their study of the oral EGFR inhibitor zipalertinib met the primary endpoint in a phase 2b clinical trial of patents in second or later line NSCLC patients with EGFR exon 20 insertion mutations.

In July 2025, Dizal Pharmaceutical announced the FDA approval of sunvozertinib in second or later line NSCLC patients with EGFR exon 20 insertion mutations.

In March 2026, Dizal Pharmaceutical reported topline data from the study of sunvozertinib as first line treatment for NSCLC patients with EGFR exon 20 insertion mutations and its plans to engage with regulatory authorities regarding potential NDA(s).

Key Components of Our Results of Operations

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Research and Development Expenses

To date, our research and development expenses have been related primarily to the development of firmonertinib, preclinical studies and other clinical activities related to our portfolio.

To date, our research and development expenses have been related primarily to the development of our product candidates, preclinical studies and other clinical activities related to our portfolio.

Research and development costs are expensed as incurred and payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized when the goods or services are received.

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Our direct research and development expenses consist principally of external costs, such as fees paid to CROs and consultants in connection with our clinical trials for firmonertinib, preclinical and toxicology studies and costs related to manufacturing materials for clinical and preclinical studies.

Prior to our identification of potential product candidates in 2022, we did not track external costs by program.

Subsequent to the identification of potential product candidates, a significant majority of our direct research and development costs have been related to firmonertinib.

A significant majority of our direct research and development costs have been related to firmonertinib.

We deploy our personnel resources across all of our research and development activities.

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Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30,

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

(in thousands)

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We do not track internal research and development costs by product candidate.

The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30,

The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

(in thousands)

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Total research and development expenses

Research and development expenses were $32.2 million and $20.1 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $12.1 million was primarily due to an increase of $4.2 million related to expenditures on our lead product candidate, firmonertinib, $4.1 million in costs related to early-stage programs, and $3.8 million in personnel-related costs due to increased headcount.

Costs related to firmonertinib increased as a result of increased costs related to our FURVENT Phase 3 clinical trial of $4.9 million, along with $0.2 million in increased costs for our FAVOUR trial and our general firmonertinib costs, respectively.

Those increases were partially offset by a $1.0 million decrease in costs related to our FURTHER Phase 1 clinical trial.

Research and development expenses were $37.6 million and $61.3 million for the three months ended March 31, 2026 and 2025, respectively.

The decrease of $23.7 million was primarily due to a $28.6 million decrease in costs related to early-stage programs, offset by a $4.2 million increase in personnel-related costs due to increased headcount, and a $0.8 million increase in costs related to our lead product candidate, firmonertinib.

Costs related to firmonertinib increased as a result of increased costs of $1.6 million related to general firmonertinib programs, and increased costs of $0.3 million related to our FAVOUR trial, partially offset by a $0.9 million decrease in costs related to our FURTHER trial, and decreases in costs of $0.3 million related to our FURVENT Phase 3 clinical trial.

The decrease in early-stage program costs was due to a one-time $40 million up-front payment made to a collaboration partner during the three months ended March 31, 2025.

General and Administrative

General and administrative expenses were $6.1 million and $4.1 million for the three months ended September 30, 2025 and 2024, respectively.

General and administrative expenses were $8.5 million and $5.5 million for the three months ended March 31, 2026 and 2025, respectively.

The increase of $3.0 million was due primarily to increases in personnel-related costs.

Interest and Investment Income

Interest income was $3.3 million and $3.7 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease in interest income is due to decreased average invested balances.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Operating loss

Interest and investment income

Research and Development

We track outsourced clinical and preclinical costs and other external research and development costs associated with our lead product candidate, firmonertinib, and other early-stage programs.

We do not track internal research and development costs by product candidate.

The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

Firmonertinib:

Other Firmonertinib costs

Total Firmonertinib

Early-stage programs

Personnel-related and other internal costs

Total research and development expenses

Research and development expenses were $121.2 million and $58.9 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $62.3 million was primarily due to an increase of $42.1 million related to expenditures on early-stage programs, $10.8 million of expenditures on our lead product candidate, firmonertinib, and $9.5 million in personnel-related costs due to increased headcount.

Cost increases related to early-stage programs were largely due to a $40.0 million one-time up front payment pursuant to our collaboration with Lepu.

Costs related to firmonertinib increased as a result of increased costs related to our FURVENT Phase 3 clinical trial of $8.8 million, increases in general firmonertinib costs of $4.7 million, and $0.2 million in cost increases related to our FAVOUR trial.

These costs were partially offset by a decrease of $2.9 million in our FURTHER Phase 1 clinical trial.

General and Administrative

General and administrative expenses were $17.5 million and $11.8 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $5.8 million was due primarily to increases of $4.9 million in personnel-related costs and $0.7 million in accounting, legal, software, and other outside services.

Interest and Investment Income

Interest income was $7.9 million and $10.7 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease in interest income is due to decreased average invested balances.

Interest income was $2.8 million and $2.4 million for the three months ended March 31, 2026 and 2025, respectively.

The increase in interest income is due to increased average invested balances.

Liquidity and Capital Resources

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Additionally, in the first quarter of 2024, we completed our initial public offering of 11,180,555 shares of our common stock at a price to the public of $18.00 per share, including the exercise in full by the underwriters of their option to purchase 1,458,333 additional shares of our common stock, for aggregate proceeds of $183.2 million, net of underwriting discounts, commissions and other offering expenses.

As of September 30, 2025, we had cash and cash equivalents and marketable securities of $305.4 million.

As of March 31, 2026, we had cash and cash equivalents and marketable securities of $326.4 million.

On February 3, 2025, we filed an automatic shelf registration statement on Form S-3ASR (File No.

333-284661) with the SEC.

rights, and/or units to purchase any of such securities in one or more registered offerings, and (ii) a prospectus supplement pursuant to which we may offer and sell, from time to time, up to $250 million of shares of common stock in “at-the-market” offerings.

During the nine months ended September 30, 2025, we sold 3,973,190 shares of common stock pursuant to our Open Market Sale Agreement SM with Jefferies LLC (ATM Program) for total proceeds of $87.3 million, net of commissions and other expenses.

As of September 30, 2025, we have approximately $159.2 million remaining for future issuances of common stock pursuant to the ATM Program.

The shelf registration statement consists of (i) a base prospectus pursuant to which we may offer and sell, from time to time, shares of our common stock, shares of our preferred stock, various series of debt securities, warrants, rights, and/or units to purchase any of such securities in one or more registered offerings, and (ii) a prospectus supplement pursuant to which we may offer and sell, from time to time, up to $250 million of shares of common stock in “at-the-market” offerings.

During the three months ended March 31, 2026, we sold 2,425,495 shares of common stock pursuant to our Open Market Sale Agreement SM with Jefferies LLC (ATM Program) for total proceeds of $54.7 million, net of commissions.

As of March 31, 2026, we have approximately $66.9 million remaining for future issuances of common stock pursuant to the ATM Program.

There has been no material change in the planned use of proceeds as described in the shelf registration statement.

None of the offering expenses were paid or payable, directly, or indirectly, to our directors, officers, or persons owning 10% or more of any class of equity securities or to our affiliates.

In May 2025, we entered into a $75 million loan and security agreement with Silicon Valley Bank, a division of First Citizens Bank & Trust Company.

In May 2025, we entered into a $75 million loan and security agreement with Silicon Valley Bank, a division of First Citizens Bank & Trust Company, and amended the loan and security agreement in March 2026.

The credit facility provides the right, but not the obligation, to draw up to $75 million of capital, of which $50 million will be available if certain conditions and milestones are met.

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We cannot be assured that we will ever be profitable or generate positive cash flows from operating activities.

We believe that our existing cash and cash equivalents and marketable securities as of September 30, 2025 will be sufficient to meet our anticipated cash requirements through at least twelve months from the issuance date of these financial statements.

We believe that our existing cash and cash equivalents and marketable securities as of March 31, 2026 will be sufficient to meet our anticipated cash requirements through at least twelve months from the issuance date of these financial statements.

However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

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The following table summarizes our cash flows for the periods indicated:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Financing activities

Net increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Operating Activities

Net cash used in operating activities was $129.9 million for the nine months ended September 30, 2025 reflecting our net loss of $130.8 million and a $8.5 million decrease in our operating assets and liabilities attributable to the timing in which we pay our vendors for research and development activities.

Net cash used in operating activities was $41.9 million for the three months ended March 31, 2026 reflecting our net loss of $43.3 million, $0.6 million in amortization of bond discounts, and a $3.5 million decrease in our operating assets

and liabilities attributable to the timing in which we pay our vendors for research and development activities.

These decreases were partially offset by $5.5 million in stock-based compensation.

Net cash used in operating activities was $68.0 million for the three months ended March 31, 2025 reflecting our net loss of $64.4 million and a $5.9 million decrease in our operating assets and liabilities attributable to the timing in which we pay our vendors for research and development activities.

These decreases were partially offset by $2.3 million in stock-based compensation.

Included in the net loss is a $40.0 million upfront payment made in conjunction with our collaboration with Lepu.

Net cash used in operating activities was $54.0 million for the nine months ended September 30, 2024 reflecting our net loss of $59.9 million, offset by a $3.5 million net decrease in our operating assets and liabilities attributable to the timing in which we pay our vendors for research and development activities, and $2.3 million in stock-based compensation.

Investing Activities

Net cash used by investing activities for each of the nine months ended September 30, 2025 and 2024 were less than $0.1 million .

Net cash provided by investing activities for the three months ended March 31, 2026 was $3.6 million, and included $64.4 million of purchases of short and long-term investments, offset by $68.0 million of maturities of short-term investments.

Net cash of $36.8 million was provided by investing activities for the three months ended March 31, 2025.

This was attributable to maturities of marketable securities.

Financing Activities

Net cash provided by financing activities was $168.3 million for the nine months ended September 30, 2025.

This was due to $87.3 million of proceeds from sales under the ATM Program and $80.6 million from the July 2025 Offering, both net of expenses.

Net cash provided by financing activities was $54.9 million for the three months ended March 31, 2026.

This was due to $54.7 million of proceeds from sales under the ATM Program, net of expenses.

In addition, $0.1 million was provided by stock option exercises.

Net cash provided by financing activities was $186.5 million for the nine months ended September 30, 2024, primarily due to the net proceeds from our initial public offering.

Net cash provided by financing activities was $6.7 million for the three months ended March 31, 2025.

This was due to $6.5 million of sales under the ATM Program and $0.3 million of stock option exercises.

Contractual Obligations and Commitments

As of September 30, 2025, except for the operating lease, we did not have any long-term obligations, capital lease obligations, purchase obligation or long-term liabilities.

As of March 31, 2026, except for the operating lease, we did not have any long-term obligations, capital lease obligations, purchase obligation or long-term liabilities.

We enter into contracts in the normal course of business with third-party CROs and clinical trial sites for our clinical trials, and with supply vendors for other services and products for operating purposes.

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Amounts related to contingent milestone payments under our license and collaboration agreements are not yet considered contractual obligations, and not included in the table above, as they are contingent on the successful achievement of certain clinical, regulatory and commercial milestones.

We also have commitments for obligations under our agreements with Allist, Jiangsu Alphamab Biopharmaceuticals Co., Ltd., Aarvik Pharmaceuticals, Inc., and Lepu.

We also have commitments for obligations under our agreements with Allist, Alphamab, Aarvik, and Lepu.

Under these agreements we are required to make milestone payments upon successful completion of certain clinical, regulatory, development, sales and commercial milestones.

Additionally, we are required to make royalty payments in connection with the sale of products developed under these agreements.

Because the achievement of these milestones and royalties is not probable and payment is not required as of September 30, 2025, such contingencies have not been recorded in our financial statements.

With the exception of a $6.0 million developmental milestone payable under the Lepu Biopharma Agreement, because the achievement of other milestones and royalties is not probable and payment is not required as of March 31, 2026, such contingencies have not been recorded in our financial statements.

For additional information regarding our agreements, see Note 8 to our accompanying financial statements in Part I, Item 1 of this Quarterly Report.

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On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued research and development and stock-based compensation expenses.

We base our estimates on historical experience, known trends and events, and various other factors that are believed to be 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 base our estimates on historical experience, known trends and events, and

various other factors that are believed to be 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.

Actual results may differ from these estimates under different assumptions or conditions.

6 unchanged sentences

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the consummation of our initial public offering, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the day on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (Exchange Act) or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a smaller reporting company as defined in the Exchange Act.

We may continue to be a smaller reporting company even after we are no longer an emerging growth company.

We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Recent Accounting Pronouncements

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis