What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-08-12 compared with 2026-05-11 · 111 added, 74 removed, 178 unchanged (51% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our interim financial statements and related notes appearing elsewhere in this Quarterly Report and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for fiscal year ended December 31, 2025, which was filed with the SEC on March 5, 2026 (Annual Report).

You should read the following discussion and analysis of our financial condition and results of operations together with our interim financial statements and related notes appearing elsewhere in this Quarterly Report and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 5, 2026 (Annual Report).

Some of the information contained in this discussion and analysis or set forth elsewhere, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties.

4 unchanged sentences

While not all of the information that we post on the Investor Relations section of our website is of a material nature, some information could be deemed to be material.

Accordingly, we encourage investors, the media, and others interested in us to review the information that we share on the Investors section of our website, https://ir.arrivent.com/ .

Accordingly, we encourage investors, the media, and others interested in us to review the information that we share on the Investor Relations section of our website, https://ir.arrivent.com/ .

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 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.

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

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.

We received Breakthrough Therapy Designation (“BTD”) 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 BTD 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 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.

5 unchanged sentences

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) 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.

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 PACC mutations, each a subtype of uncommon mutation.

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

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 (“ORR”) 68.2% (n=15 out of 22 1L patients at 240 mg) and DOR 14.6 months, and confirmed central nervous system responses with firmonertinib, including complete responses.

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.

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.

In May 2026 we announced clearance of a U.S.

investigational new drug (“IND”) application by the FDA for ARR-002, a potential first-in-class MUC16/NaPi2b dual-targeting tetravalent antibody-drug conjugate (“ADC”) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors.

We have initiated our Phase 1 trial with the first patient expected to be dosed in the second half of 2026.

We have entered into the Global Technology Transfer and License Agreement (the “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 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.

1 unchanged sentence

See “Business — Licenses, Partnerships and Collaborations —Allist Agreements” in our Annual Report.

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

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

(“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.

We are also obligated under the Lepu Biopharma Agreement to pay Lepu tiered royalties based on net sales of Licensed Products, as defined herein.

We are also obligated under the Lepu Biopharma Agreement to pay Lepu tiered royalties based on net sales of Licensed Products, as defined in the Lepu Biopharma Agreement.

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

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.

In March 2026, we dosed our 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, 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 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 $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 were $93.2 million and $95.8 million for the six months ended June 30, 2026 and 2025, respectively.

As of June 30, 2026, we had an accumulated deficit of $497.9 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.

21 unchanged sentences

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.

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.

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 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 patients in second or later line NSCLC patients with EGFR exon 20 insertion mutations and in April 2026 announced a February 27, 2027 Prescription Drug User Fee Act (“PDUFA”) target action date for the New Drug Application (“NDA”) filed for that indication.

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).

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.

In July 2026, AstraZeneca announced it had entered into an exclusive global license agreement for sunvozertinib and that a Supplemental NDA for the first line setting has been submitted to the FDA and China’s Center for Drug Evaluation.

Key Components of Our Results of Operations

16 unchanged sentences

We anticipate that we will make determinations as to which product candidates and development programs to pursue and how much funding to direct to each product candidate or program on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential.

In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

In addition, we cannot forecast which

product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Our future clinical development costs may vary significantly based on factors such as:

18 unchanged sentences

Interest and Investment Income

Interest and investment income consists of interest earned on our cash, cash equivalents and marketable securities and the accretion of premiums and amortization of discounts on marketable securities.

Interest and investment income consists of interest earned on our cash, cash equivalents and investments and the accretion of premiums and amortization of discounts on investments.

Results of Operations

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,

Comparison of the Three Months Ended June 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:

Three Months Ended June 30,

(in thousands)

7 unchanged sentences

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.

In the table below, Phase 3 trials includes costs incurred associated with the FURVENT and ALPACCA trials.

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 March 31, 2026 and 2025:

Three Months Ended March 31,

The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:

Three Months Ended June 30,

(in thousands)

Firmonertinib:

Phase 3 Trials

Other Firmonertinib costs

3 unchanged sentences

Total research and development expenses

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.

Research and development expenses were $42.3 million and $27.7 million for the three months ended June 30, 2026 and 2025, respectively.

The increase of $14.6 million was primarily due to a $9.8 million increase in costs related to early-stage programs, $3.4 million increase in personnel-related costs due to increased headcount, and a $1.5 million increase in total costs related to our lead product candidate, firmonertinib.

Costs related to firmonertinib increased as a result of increased costs of $5.0 million related to our Phase 3 trials, primarily related to the ongoing ALPACCA clinical trial, partially offset by a $1.2 million decrease in costs related to our FURTHER trial, and decreases in costs of $2.3 million related to other firmonertinib costs due to the timing of costs incurred with outside service providers and consultants.

General and Administrative

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.

General and administrative expenses were $10.4 million and $5.9 million for the three months ended June 30, 2026 and 2025, respectively.

The increase of $4.4 million was due primarily to increases in personnel-related costs, including increases in headcount, and consultant costs to support the growth in the overall business.

Interest and Investment Income

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.

Interest income was $2.8 million and $2.2 million for the three months ended June 30, 2026 and 2025, respectively.

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

Comparison of the Six Months Ended June 30, 2026 and 2025

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Six Months Ended June 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.

In the table below, Phase 3 trials includes costs incurred associated with the FURVENT and ALPACCA trials.

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

The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:

Six Months Ended June 30,

(in thousands)

Firmonertinib:

Phase 3 Trials

Other Firmonertinib costs

Total Firmonertinib

Early-stage programs

Personnel-related and other internal costs

Total research and development expenses

Research and development expenses were $80.0 million and $89.0 million for the six months ended June 30, 2026 and 2025, respectively.

The decrease of $9.1 million was primarily due to an $18.9 million decrease in costs related to early-stage programs, offset by a $7.6 million increase in personnel-related costs due to increased headcount, and a $2.3 million increase in total costs related to our lead product candidate, firmonertinib.

Costs related to firmonertinib increased as a result of increased costs of $4.7 million related to our Phase 3 trials, primarily related to the ongoing ALPACCA clinical trial, partially offset by a decrease in costs related to our FURVENT clinical trial due primarily to completion of enrollment of patients in the trial as well as decreases in costs of $0.7 million related to other firmonertinib costs.

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 six months ended June 30, 2025.

General and Administrative

General and administrative expenses were $18.8 million and $11.4 million for the six months ended June 30, 2026 and 2025, respectively.

The increase of $7.5 million was due primarily to increases in personnel-related costs, including increases in headcount, and consultant costs to support the growth in the overall business.

Interest and Investment Income

Interest income was $5.6 million and $4.6 million for the six months ended June 30, 2026 and 2025, respectively.

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

Liquidity and Capital Resources

Sources of Liquidity

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

To date, we have raised gross proceeds of $305.0 million from the issuance of convertible preferred stock.

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

To date, we have financed our operations primarily through public and private equity financings, including our initial public offering of common stock in the first quarter of 2024, from which we received aggregate net proceeds of $183.2 million, our "at-the-market" offering, and our underwritten public offering of common stock and pre-funded warrants in July 2025.

Prior to becoming a public company, we raised $305.0 million in gross proceeds from the sale of our convertible preferred stock.

As of June 30, 2026, we had cash and cash equivalents and short-term investments of $373.1 million.

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

333-284661) with the SEC.

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.

The shelf registration statement consists of (i) a base prospectus pursuant to which we may offer and sell, from time to time, any combination of shares of our common stock, shares of our preferred stock, various series of debt securities, warrants, rights, and units to purchase any of such securities in one or more registered offerings, and (ii) a prospectus supplement (the “2025 Prospectus Supplement”) pursuant to which we may offer and sell, from time to time, up to $250.0 million of shares of common stock in "at-the-market" offerings through Jefferies LLC (“Jefferies”) as our sales agent (the “ATM Program”).

On May 11, 2026, we filed a prospectus supplement (the “2026 Prospectus Supplement”) to the shelf registration with respect to our ATM program.

Pursuant to the 2026 Prospectus Supplement, we may offer and sell shares of our common stock having an aggregate offering price of up to an additional $250.0 million, through Jefferies acting as our sales agent.

During the six months ended June 30, 2026, we sold 5,358,318 shares of common stock pursuant to the ATM Program for total net proceeds of $140.0 million, net of commissions and offering costs.

As of June 30, 2026, we have approximately $229.1 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.

3 unchanged sentences

No amounts have been drawn on this facility at the date of this Quarterly Report.

On July 3, 2025, we closed an underwritten public offering (the July 2025 Offering) in which we issued and sold an aggregate of 3,059,615 shares of our common stock, including the exercise in full of the underwriters’ option to purchase 576,923 additional shares of common stock, at a public offering price of $19.50 per share, and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to 1,363,469 shares of common stock at a public offering price of $19.4999 per pre-funded warrant, which represents the per share public offering price for the shares less the $0.0001 per share exercise price for each pre-funded warrant.

On July 3, 2025, we closed an underwritten public offering in which we issued and sold an aggregate of 3,059,615 shares of our common stock, including the exercise in full of the underwriters’ option to purchase 576,923 additional shares of common stock, at a public offering price of $19.50 per share, and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to 1,363,469 shares of common stock at a public offering price of $19.4999 per pre-funded warrant, which represents the per share public offering price for the shares less the $0.0001 per share exercise price for each pre-funded warrant.

The proceeds to us, net of underwriting discounts, commissions, and other expenses, were $80.5 million.

4 unchanged sentences

This could have an adverse impact on our ability to achieve certain of our planned objectives, and thus, materially harm our business.

Our ability to successfully transition to profitability will depend upon obtaining additional financing and achieving a level of product sales adequate to support our cost structure.

Our ability to successfully transition to

profitability will depend upon obtaining additional financing and achieving a level of product sales adequate to support our cost structure.

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 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.

We believe that our existing cash and cash equivalents and short-term investments as of June 30, 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.

4 unchanged sentences

● the outcome, timing and costs of seeking regulatory approvals;

● the cost of manufacturing firmonertinib, if approved, and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;

● the cost of manufacturing firmonertinib, if approved, and our other current or future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;

● the costs of any third-party products used in our combination clinical trials that are not covered by such third party or other sources;

1 unchanged sentence

● the receipt of marketing approval and revenue received from any potential commercial sales of firmonertinib or other product candidates;

● the cost of commercialization activities for firmonertinib and future product candidates we develop if we receive marketing approval, including marketing, sales and distribution costs;

● the cost of commercialization activities for firmonertinib and our other current or future product candidates we develop if we receive marketing approval, including marketing, sales and distribution costs;

● the emergence of competing therapies and other adverse market developments;

7 unchanged sentences

If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit,

reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

3 unchanged sentences

Financing activities

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Operating 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.

Net cash used in operating activities was $81.5 million for the six months ended June 30, 2026 reflecting our net loss of $93.2 million and $1.1 million in accretion of bond discounts.

These decreases were partially offset by $12.2 million in stock-based compensation and a change of $0.7 million in our operating assets and liabilities primarily attributable to the timing in which we pay our vendors for research and development activities.

Net cash used in operating activities was $94.1 million for the six months ended June 30, 2025 reflecting our net loss of $95.8 million and a $3.9 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 $5.6 million in stock-based compensation.

1 unchanged sentence

Investing Activities

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.

Net cash provided by investing activities for the six months ended June 30, 2026 was $49.7 million, and included $78.4 million of purchases of investments, offset by $128.0 million of maturities of investments.

Net cash of $50.7 million was provided by investing activities for the six months ended June 30, 2025, and included $31.4 million of purchases of investments, offset by $82.1 million of maturities of investments.

Financing Activities

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 $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.

Net cash provided by financing activities was $141.0 million for the six months ended June 30, 2026.

This was due to $140.0 million of proceeds from sales of common stock, net of expenses, and $1.0 million of stock option exercises.

Net cash provided by financing activities was $81.9 million for the six months ended June 30, 2025.

This was due to $81.9 million of proceeds from sales of common stock, net of expenses, and $0.4 million of stock option exercises, offset by payments of deferred financing costs.

Contractual Obligations and Commitments

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.

As of June 30, 2026, except for an operating lease, we did not have any long-term obligations, capital lease obligations, purchase obligations 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.

These contracts generally provide for termination after a notice period, and, therefore, are cancelable contracts.

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, Alphamab, Aarvik, and Lepu.

Amounts related to contingent milestone payments under our license and collaboration agreements are not yet considered contractual obligations 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 collaboration partners.

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.

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.

With the exception of $11.0 million in total developmental milestones payable, because the achievement of other milestones and royalties is not probable as of June 30, 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.

4 unchanged sentences

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.

9 unchanged sentences

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