What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-07 · 89 added, 80 removed, 311 unchanged (35% of the section changed)

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KIMMTRAK is now approved in 39 countries for the treatment of unresectable or mUM.

We have commercially launched KIMMTRAK in 28 countries globally including the United States, Germany and France through June 30, 2025, with further commercial launches planned in additional territories where KIMMTRAK is approved.

We have commercially launched KIMMTRAK in 28 countries globally including the United States, Germany and France through September 30, 2025, with further commercial launches planned in additional territories where KIMMTRAK is approved.

KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM.

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We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future.

We had net losses of $10.3 million and $5.3 million for the three and six months ended June 30, 2025, respectively, and net losses of $11.6 million and $36.1 million for the three and six months ended June 30, 2024, respectively.

As of June 30, 2025, our accumulated deficit was $801.0 million.

We had net losses of $0.2 million and $5.5 million for the three and nine months ended September 30, 2025, respectively, and net income of $8.7 million and net loss of $27.3 million for the three and nine months ended September 30, 2024, respectively.

As of September 30, 2025, our accumulated deficit was $801.2 million.

We expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the SEC, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company.

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Recent Developments

In June 2025, we signed a distribution and commercialization agreement with Er-Kim for KIMMTRAK, in relation to the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, in Turkey, the Middle East, North Africa, the Caucasus and the Commonwealth of Independent States regions.

We have now activated over 150 clinical trial sites around the world, enrolling patients in our PRISM-MEL-301, the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.

We have announced that we will present data from the single ascending dose portion of the Phase 1 trial of IMC-I109V for people living with HBV or HBV-positive hepatocellular carcinoma at the 2025 American Association for the Study of Liver Diseases’ Meeting in November 2025.

The Independent Data Monitoring Committee ("IDMC") has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, our registrational Phase 3 trial in first-line, advanced cutaneous melanoma.

The IDMC made the decision following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial.

Patients treated with the dose of 160 mcg will be included in the intent-to-treat analysis for the primary endpoint.

Patients who are receiving 40 mcg have the option to dose-escalate to 160 mcg, but will not be included in the intent-to-treat analysis for the primary endpoint.

We will now continue with a 1:1 randomization of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.

We will present a poster, entitled "IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study" (Poster 1185), at the 2025 American Association for the Study of Liver Diseases’ Meeting on November 7, 2025.

Components of Results of Operations

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Cost of revenue from sale of therapies may also include costs related to manufacturing losses and excess or obsolete inventory costs.

For example, in June 2025, we initiated a global Class III voluntary recall for one batch of KIMMTRAK (tebentafusp) relating to an unexpected result in routine stability testing.

For example, in June 2025, we initiated a global recall for one batch of KIMMTRAK (tebentafusp) relating to an unexpected result in routine stability testing.

As of the date of this Quarterly Report, based on all available data to date, we do not expect there will be a material impact on KIMMTRAK or our financial statements.

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R&D tax regime.

For the periods ending June 30, 2025 and 2024, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.

For the periods ending September 30, 2025 and 2024, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.

Under the RDEC program, tax credits for qualifying R&D expenses incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenses.

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Other income, net consists primarily of unrealized gains (losses) resulting from the change in fair value of our marketable securities and also includes loan and borrowing costs and other items.

Income tax expense

Income tax (expense) benefit

We are subject to corporate taxation in the United Kingdom and our wholly-owned subsidiaries are subject to corporate taxation in the United States, Ireland and Switzerland.

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Unsurrendered tax losses are carried forward to be offset against future taxable profits.

After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $280.4 million as of June 30, 2025.

After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom of $275.7 million as of September 30, 2025.

A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom because future profits are not sufficiently certain.

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The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%.

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

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

The following table summarizes our total revenue (in thousands):

Three Months Ended June 30,

Three Months Ended September 30,

2025 2024 Increase /

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$ 103,693 $ 80,248 $ 23,445 29.2 %

Collaboration revenue

— 53 (53) (100.0) %

Total revenue

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Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands):

Three Months Ended June 30,

Three Months Ended September 30,

2025 2024 Increase /

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$ 103,693 $ 80,248 $ 23,445 29.2 %

For the three months ended June 30, 2025, we generated net revenue from sale of therapies of $98.0 million due to the sale of KIMMTRAK, of which $64.1 million was in the United States, $33.0 million in Europe and $0.8 million in International.

Revenue from sale of therapies, net increased in the three months ended June 30, 2025 compared to the three months ended June 30, 2024, due primarily to increased sales volume in the United States and Europe as well as global country expansion.

This was partially offset by fewer shipments in international regions, primarily due to timing of orders.

For the three months ended September 30, 2025, we generated net revenue from sale of therapies of $103.7 million due to the sale of KIMMTRAK, of which $67.3 million was in the United States, $33.5 million in Europe and $2.9 million in International.

Revenue from sale of therapies, net increased in the three months ended September 30, 2025 compared to the three months ended September 30, 2024, due primarily to increased sales volume in the United States and Europe as well as global country expansion.

The following table summarizes our R&D expenses (in thousands):

Three Months Ended June 30,

Three Months Ended September 30,

2025 2024 Increase /

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Total R&D expenses $ 70,572 $ 52,770 $ 17,802 33.7 %

For the three months ended June 30, 2025, our R&D expenses were $69.0 million, compared to $51.1 million for the three months ended June 30, 2024.

For the three months ended June 30, 2025, our external R&D expenses increased by $15.3 million primarily due to an increase in all other external clinical and preclinical costs of $10.8 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations.

In addition, there was an increase of $5.9 million in expenses incurred for our tebentafusp programs as a result of the advanced cutaneous melanoma ("TEBE-AM") Phase 3 trial, including purchases of drug consumables.

For the three months ended June 30, 2025, our internal R&D expenses increased by $2.6 million primarily due to an increase in all other internal R&D costs due to the growth of our clinical and preclinical programs.

For the three months ended September 30, 2025, our R&D expenses were $70.6 million, compared to $52.8 million for the three months ended September 30, 2024.

For the three months ended September 30, 2025, our external R&D expenses increased by $16.1 million due to an increase in all other external clinical and preclinical costs of $9.2 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations.

In addition, there was an increase of $3.5 million in expenses incurred for our PRAME programs due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial and an increase of $3.5 million in expenses incurred for our tebentafusp programs as a result of the advanced cutaneous melanoma ("TEBE-AM") and ATOM Phase 3 trials.

For the three months ended September 30, 2025, our internal R&D expenses increased by $1.7 million primarily due to an increase in all other internal R&D costs due to the growth of our clinical and preclinical programs.

We expect our R&D expenses to increase in future periods as we advance our trials and further develop our clinical and preclinical pipeline.

SG&A Expenses

For the three months ended June 30, 2025, our SG&A expenses were $42.8 million, compared to $38.6 for the three months ended June 30, 2024, an increase of $4.2 million.

The increase was due to higher costs related to commercial and business support functions to support our growing pipeline and global commercial expansion during the three months ended June 30, 2025.

For the three months ended September 30, 2025, our SG&A expenses were $39.8 million, compared to $35.5 for the three months ended September 30, 2024, an increase of $4.2 million.

The increase was due to higher costs related to commercial and business support functions to support our growing pipeline and global commercial expansion.

Interest Income and Interest Expense

For the three months ended June 30, 2025, interest income was $4.3 million compared to $6.2 million for the three months ended June 30, 2024.

This decrease of $1.9 million was due to reduced cash and cash equivalents balances related to purchases of marketable securities of $350.0 million in the second quarter of 2024.

For the three months ended June 30, 2025, interest expense was $3.0 million compared to $4.3 million for the three months ended June 30, 2024 and the decrease was primarily related to interest on the Pharmakon loan in 2024, which was repaid in November 2024.

For the three months ended September 30, 2025, interest income was $4.1 million compared to $6.0 million for the three months ended September 30, 2024.

This decrease of $1.9 million was due to lower interest rates earned on our money market funds.

For the three months ended September 30, 2025, interest expense was $3.0 million compared to $4.3 million for the three months ended September 30, 2024 and the decrease was related to interest on the Pharmakon loan in 2024, which was repaid in November 2024.

Foreign Currency Gain

For the three months ended September 30, 2025, foreign currency gain was $1.3 million compared to $4.0 million for the three months ended September 30, 2024.

This decrease of $2.7 million reflects less favorable exchange rate movements mainly due to the strengthening of the U.S.

dollar against the pound sterling and the euro in the three months ended September 30, 2025.

Other Income, Net

For the three months ended June 30, 2025, other income, net was $4.7 million compared to $4.4 million for the three months ended June 30, 2024.

The change was primarily related to income on our marketable securities purchased in the second quarter of 2024, including the unrealized gains resulting from the change in fair value.

Income Tax Expense

For the three months ended June 30, 2025, the income tax expense was $0.6 million compared to $1.5 million for the three months ended June 30, 2024.

This decrease was related to a favorable discrete item in the second quarter of 2025 related to share-based compensation.

Comparison of the Six Months Ended June 30, 2025 and 2024

For the three months ended September 30, 2025, other income, net was $5.1 million compared to $9.0 million for the three months ended September 30, 2024.

This decrease was due to higher unrealized gains resulting from the change in fair value of our marketable securities in the three months ended September 30, 2024 related to more favorable interest rate movement.

Income Tax (Expense) Benefit

For the three months ended September 30, 2025, the income tax expense was $0.5 million compared to an income tax benefit of $2.6 million for the three months ended September 30, 2024.

This change was due to a favorable discrete item in the three months ended September 30, 2024 related to U.S.

research tax credits claimed on our 2023 U.S.

income tax return.

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

The following table summarizes our total revenue (in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Increase /

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Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands).

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Increase /

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$ 295,538 $ 225,937 $ 69,601 30.8 %

For the six months ended June 30, 2025, we generated revenue from sale of therapies, net of $191.8 million, due to the sale of KIMMTRAK, of which $120.7 million was in the United States, $65.8 million in Europe (including the impact of a net decrease in estimated reserves related to prior periods of $6.0 million) and $5.3 million in International.

Revenue from sale of therapies, net increased in the six months ended June 30, 2025 compared to the six months ended June 30, 2024, due primarily to increased volume in the United States and Europe as well as global country expansion.

This was partially offset by fewer shipments in international regions, primarily due to timing of orders.

For the nine months ended September 30, 2025, we generated revenue from sale of therapies, net of $295.5 million, due to the sale of KIMMTRAK, of which $188.0 million was in the United States, $99.4 million in Europe (including the impact of a net decrease in estimated reserves related to prior periods of $6.0 million) and $8.2 million in International.

Revenue from sale of therapies, net increased in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, due primarily to increased volume in the United States and Europe as well as global country expansion.

The following table summarizes our R&D expenses (in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

2025 2024 Increase /

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Total R&D expenses $ 196,048 $ 161,301 $ 34,747 21.5 %

For the six months ended June 30, 2025, our R&D expenses were $125.5 million, compared to $108.5 million for the six months ended June 30, 2024.

For the six months ended June 30, 2025, our external R&D expenses increased by $11.9 million primarily due to an increase in all other external clinical and preclinical costs of $15.5 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiation.

For the nine months ended September 30, 2025, our R&D expenses were $196.0 million, compared to $161.3 million for the nine months ended September 30, 2024.

For the nine months ended September 30, 2025, our external R&D expenses increased by $28.0 million due to an increase in all other external clinical and preclinical costs of $24.7 million related to continued progress in the pipeline, primarily for our autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiation.

In addition, R&D expenses incurred for our tebentafusp programs increased by $11.4 million as a result of the TEBE-AM and ATOM Phase 3 trials and purchases of drug consumables.

There was a decrease of $10.6 million in expenses incurred for our PRAME programs resulting from higher costs in the six months ended June 30, 2024 due to timing of manufacturing batches and purchases of drug consumables for our clinical trials partially offset by higher costs in the six months ended June 30, 2025 due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial.

For the six months ended June 30, 2025, our internal R&D expenses increased by $5.1 million primarily due to an increase in all other internal R&D costs due to the growth of our clinical and preclinical programs.

There was a decrease of $7.2 million in expenses incurred for our PRAME programs primarily resulting from higher costs in the nine months ended September 30, 2024 due to timing of manufacturing batches and purchases of drug consumables for our clinical trials, partially offset by higher costs in the nine months ended September 30, 2025 due to enrollment in our PRISM-MEL-301 Phase 3 clinical trial.

For the nine months ended September 30, 2025, our internal R&D expenses increased by $6.7 million primarily due to an increase in salaries and other employee-related costs and all other internal R&D costs due to the growth of our clinical and preclinical programs.

SG&A Expenses

For the six months ended June 30, 2025, our SG&A expenses were $83.0 million, compared to $77.9 million for the six months ended June 30, 2024, an increase of $5.1 million.

For the nine months ended September 30, 2025, our SG&A expenses were $122.8 million, compared to $113.5 million for the nine months ended September 30, 2024, an increase of $9.3 million.

The increase was due to costs related to commercial and business support functions to support our growing pipeline and global commercial expansion.

Interest Income and Interest Expense

For the six months ended June 30, 2025, interest income was $8.4 million compared to $14.5 million for the six months ended June 30, 2024.

This decrease of $6.1 million was due to reduced cash and cash equivalents balances primarily related to purchases of marketable securities of $350.0 million in the second quarter of 2024.

For the six months ended June 30, 2025, interest expense was $6.1 million compared to $7.5 million for the six months ended June 30, 2024, and the decrease was primarily related to interest on the Pharmakon loan in 2024, which was repaid in November 2024.

Foreign Currency Gain (Loss)

For the six months ended June 30, 2025, foreign currency gain was $2.3 million compared to a loss of $2.9 million for the six months ended June 30, 2024.

For the nine months ended September 30, 2025, interest income was $12.6 million compared to $20.4 million for the nine months ended September 30, 2024.

This decrease of $7.8 million was due to reduced cash and cash equivalents balances primarily related to purchases of marketable securities of $350.0 million in the second quarter of 2024 and lower interest rates earned on our money market funds in the nine months ended September 30, 2025.

For the nine months ended September 30, 2025, interest expense was $9.1 million compared to $11.8 million for the nine months ended September 30, 2024, and the decrease was related to interest on the Pharmakon loan which was repaid in November 2024.

Foreign Currency Gain

For the nine months ended September 30, 2025, foreign currency gain was $3.7 million compared to $1.0 million for the nine months ended September 30, 2024.

This increase of $2.7 million reflects favorable exchange rate movements mainly due to the weakening of the U.S.

dollar against the pound sterling and the euro in the three months ended June 30, 2025.

dollar against the pound sterling and the euro in the nine months ended September 30, 2025.

Other Income, Net

For the six months ended June 30, 2025, other income, net was $10.2 million compared to other income, net of $4.2 million for the six months ended June 30, 2024.

The change was primarily related to income on our marketable securities purchased in the second quarter of 2024, including the unrealized gains resulting from the change in fair value.

Income Tax Expense

For the six months ended June 30, 2025, the income tax expense was $1.7 million compared to $1.8 million for the six months ended June 30, 2024.

For the nine months ended September 30, 2025, other income, net was $15.2 million compared to $13.2 million for the nine months ended September 30, 2024.

The increase was primarily related to income on our marketable securities purchased in the second quarter of 2024, including the unrealized gains resulting from the change in fair value, partially offset by lower unrealized gains due to less favorable interest rate movement in the nine months ended September 30, 2025.

Income Tax (Expense) Benefit

For the nine months ended September 30, 2025, the income tax expense was $2.1 million compared to an income tax benefit of $0.8 million for the nine months ended September 30, 2024.

This change was due to a favorable discrete item in the nine months ended September 30, 2024 related to U.S.

research tax credits claimed on our 2023 U.S.

income tax return.

Liquidity and Capital Resources

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Although we have recorded revenue from the sale of therapies, we have continued to incur operating losses and cumulative negative cash flows from our operations since our inception.

We have an accumulated deficit of $801.0 million as of June 30, 2025.

Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, product sales, debt financings and historical payments from collaboration partners.

As of June 30, 2025 and December 31, 2024, we had cash and cash equivalents of $487.9 million and $455.7 million, respectively, and marketable securities of $394.9 million and $364.6 million, respectively.

We have an accumulated deficit of $801.2 million as of September 30, 2025.

Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, revenue from sale of therapies, debt financings and historical payments from collaboration partners.

As of September 30, 2025 and December 31, 2024, we had cash and cash equivalents of $498.4 million and $455.7 million, respectively, and marketable securities of $393.9 million and $364.6 million, respectively.

In September 2022, we entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may issue and sell ADSs, each representing one ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal.

The at-the-market facility has been registered under the Securities Act pursuant to our Registration Statement on Form S-3ASR (File No.

As of June 30, 2025, no issuances or sales had been made pursuant to the Sales Agreement.

The at-the-market facility has been registered under the Securities Act of 1933, as amended, pursuant to our Registration Statement on Form S-3ASR (File No.

As of September 30, 2025, no issuances or sales had been made pursuant to the Sales Agreement.

In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes.

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Part of the proceeds were used to repay in full loans outstanding under our previous loan agreement with Pharmakon.

In the second half of 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.

In the three months ending December 31, 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.

Other than the above mentioned indebtedness and payments, we currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our lease obligations and supplier purchase commitments in the normal course of business.

As of June 30, 2025, we had cash and cash equivalents of $487.9 million, as compared to $455.7 million as of December 31, 2024 and we also have marketable securities of $394.9 million as of June 30, 2025 as compared to $364.6 million as of December 31, 2024.

Our working capital was $832.2 million as of June 30, 2025, compared to $717.7 million as of December 31, 2024.

As of September 30, 2025, we had cash and cash equivalents of $498.4 million, as compared to $455.7 million as of December 31, 2024 and we also have marketable securities of $393.9 million as of September 30, 2025 as compared to $364.6 million as of December 31, 2024.

Our working capital was $852.5 million as of September 30, 2025, compared to $717.7 million as of December 31, 2024.

The following table summarizes the primary sources and uses of cash and cash equivalents for each period presented (in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

Cash and cash equivalents at beginning of period

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Net foreign exchange difference on cash held

28,112 11,326

Cash and cash equivalents at end of period

$ 498,413 $ 537,767

Net cash provided by our operating activities was $26.4 million for the six months ended June 30, 2025, compared to $18.9 million for the six months ended June 30, 2024.

This increase of $7.5 million was primarily due to an increase in net revenue from sale of therapies and cash collections, partially offset by a smaller outflow in accrued expenses, reflecting the timing of payments.

Net cash used in investing activities was $20.7 million for the six months ended June 30, 2025, compared to $350.8 million for the six months ended June 30, 2024.

The decrease of $330.1 million is predominantly due to higher purchases of marketable securities in the six months ended June 30, 2024 compared to the same period in 2025.

Net cash provided by our financing activities during the six months ended June 30, 2025 was $6.2 million compared to $395.2 million for the six months ended June 30, 2024.

The decrease of $389.0 million was primarily the result of the net cash proceeds from the Notes of $389.1 million received in the six months ended June 30, 2024 with no similar proceeds received in the six months ended June 30, 2025.

Net cash provided by our operating activities was $21.9 million for the nine months ended September 30, 2025, compared to $40.0 million for the nine months ended September 30, 2024.

This decrease of $18.1 million was primarily driven by a reduction in accrued expenses and other liabilities, reflecting the timing of payments, partially offset by an increase in net revenue from sale of therapies and cash collections.

Net cash used in investing activities was $15.5 million for the nine months ended September 30, 2025, compared to $351.6 million for the nine months ended September 30, 2024.

The decrease of $336.1 million is predominantly due to higher purchases of marketable securities in the nine months ended September 30, 2024 compared to the same period in 2025.

Net cash provided by our financing activities during the nine months ended September 30, 2025 was $8.1 million compared to $395.4 million for the nine months ended September 30, 2024.

The decrease of $387.3 million was primarily the result of the net cash proceeds from the Notes of $389.1 million received in the nine months ended September 30, 2024 with no similar proceeds received in the nine months ended September 30, 2025.

Future Capital Requirements

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Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

We held cash and cash equivalents of $487.9 million and marketable securities of $394.9 million as of June 30, 2025.

We held cash and cash equivalents of $498.4 million and marketable securities of $393.9 million as of September 30, 2025.

Based on our current operating plans, we expect that our existing cash and cash equivalents and marketable securities balances, along with anticipated revenue from KIMMTRAK, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report.

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Critical Accounting Estimates

Our condensed consolidated financial statements as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 , respectively, have been prepared in accordance with U.S.

Our condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024 , respectively, have been prepared in accordance with U.S.

The preparation of the condensed consolidated financial statements requires us to make judgments, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues and expenses arising during the fiscal period.

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Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to patients in France was also required in the assessment of rebates payable.

We applied judgement to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue.

For other European markets where the price is open to negotiation, judgements are made in line with expected pricing outcomes.

Our total accrued revenue deductions as of June 30, 2025 were $149.5 million, including amounts of $10.0 million for the critical estimates subject to greater estimation uncertainty and judgments described above.

These amounts are included within Accrued expenses and other current liabilities and Accrued expenses, non-current in the Condensed Consolidated Balance Sheet as of June 30, 2025.

In the second half of 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.

A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have resulted in a $2.0 million reduction or increase in Revenue from sale of therapies, net reported in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the six months ended June 30, 2025.

We applied judgment to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue.

For other European markets where the price is open to negotiation, judgments are made in line with expected pricing outcomes.

Our total accrued revenue deductions as of September 30, 2025 were $170.2 million, including amounts of $10.2 million for the critical estimates subject to greater estimation uncertainty and judgments described above.

These amounts are included within Accrued expenses and other current liabilities and Accrued expenses, non-current in the Condensed Consolidated Balance Sheet as of September 30, 2025.

In the three months ending December 31, 2025, we expect to pay approximately $65.0 million related to accrued revenue deductions.

We believe our expected values of accruals reported in the Condensed Consolidated Balance Sheet are materially appropriate;

however, due to the uncertainties and judgements outlined above, it is possible eventual amounts could significantly differ to these estimates.

For critical estimates reported as of December 31, 2024, additional information including completing price negotiations in France and Germany in the six months ended June 30, 2025 resulted in a change in estimate of $6.0 million of net decrease to our total accrued revenue deductions as of June 30, 2025.

however, due to the uncertainties and judgments outlined above, it is possible eventual amounts could significantly differ to these estimates.

For critical estimates reported as of December 31, 2024, additional information including completing price negotiations in France and Germany in the nine months ended September 30, 2025 resulted in a change in estimate of $6.0 million of net decrease to our total accrued revenue deductions as of September 30, 2025.

Recently Issued and Adopted Accounting Pronouncements

2 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