What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-07 compared with 2025-05-07 · 136 added, 82 removed, 255 unchanged (46% 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 26 countries globally including the United States, Germany and France through March 31, 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 June 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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While we have successfully generated revenue from KIMMTRAK, which is our first marketed product, our ability to generate higher levels of revenue from other marketed products, which may never be fully developed or commercialized, depends on the successful development and regulatory approval of one or more of our product candidates and our ability to finance operations.

Since inception, we have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners.

We have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners.

These funds have been and are being used to fund operations and invest in activities for technology creation, drug discovery and clinical development programs, infrastructure, creation of portfolio of intellectual property and commercial and administrative support.

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

We had net income of $5.0 million and a net loss of $24.4 million, for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, our accumulated deficit was $790.7 million.

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 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 March 2025 at the Conference on Retroviruses and Opportunistic Infections ("CROI 2025"), we presented initial data from the multiple ascending dose (MAD) portion of our Phase 1/2 STRIVE trial of IMC-M113V, our functional cure candidate for HIV.

The data included 16 people living with HIV (PLWH) who were stable on antiretrovial therapy (ART).

While continuing ART, three sequential cohorts evaluated weekly IV infusions of IMC-M113V up to doses of 60 mcg (n=5), 120 mcg (n=5), and 300 mcg (n=6) administered over 12 weeks, followed by analytical treatment interruption for up to 12 weeks, after which participants resumed their prior ART regimen.

• All doses were well tolerated and no serious adverse events (“AEs”) or dose limiting toxicities were observed.

Grade 1 cytokine release syndrome, consisting of fever alone that resolved within 4 hours, was observed in five of the six PLWH in the 300 mcg cohort when receiving their first 300 mcg dose.

There were no discontinuations due to AEs.

One person withdrew prior to completing the dose schedule in the 300 mcg cohort for reasons unrelated to IMC-M113V.

• In the 15 evaluable PLWH, delayed viral rebound and/or viremia control at any point during analytical treatment interruption was observed in 0 of 5 PLWH at 60 mcg, 1 of 5 PLWH at 120 mcg, and 2 of 5 PLWH at 300 mcg.

The 3 PLWH with evidence of viral control had a viral load of approximately 200 c/mL at week 8.

The historical rate for this observation is 5%.

Furthermore, 2 of these 3 PLWH remained off ART for the entire 12 week analytical treatment interruption period that was pre-specified in the protocol.

• In the 3 PLWH with evidence of viral control, the pattern consisted of initial viral rebound followed by viral reduction to approximately 200 c/mL, including 1 PLWH at 300 mcg who had initial viremia to >104 c/mL before subsequent decrease to <50 c/mL at week 12.

Such ‘regained’ post-treatment control may be associated with an immune response to the virus.

• There was also a reduction in CD4+ T cell-associated HIV Gag RNA in some PLWH during treatment, indicating a reduction in the active virus reservoir, which was quantified at weeks 1, 7 and 13.

A trend of reduction in intact HIV DNA was also observed post-treatment in a preliminary analysis of 6 people treated at the two highest doses.

The Company has completed price negotiations in France and Germany.

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.

Components of Results of Operations

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The amount of revenue recognized reflects the consideration to which we expect to be entitled, net of estimated deductions for rebates, chargebacks and product returns.

These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and, in certain countries including France, pricing negotiations.

Further information on estimates is provided under the section below headed, “Critical Accounting Estimates”.

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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.

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.

Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.

Due to the low costs involved in manufacturing KIMMTRAK, cost of revenue from sale of therapies is currently not material, and while these costs are expected to increase in future periods as inflationary pressures increase, we do not expect such costs to be material for the foreseeable future.

Research and development expenses

Research and development ("R&D") expenses consist primarily of costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical knowledge and understanding and consist primarily of personnel-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations, and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits.

R&D expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations, and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits.

R&D expenses are expensed as incurred, although the timing of expense recognition can vary with contractual and payment terms in order to determine when services are received.

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However, for certain preclinical programs and other research spend incurred externally, such spend is not assigned to individual programs.

Internal R&D expenses primarily relate to personnel-related costs, facilities, information technology used in R&D activities and laboratory consumables.

Internal R&D expenses primarily relate to employee-related costs, facilities, information technology used in R&D activities and laboratory consumables.

Due to the cross functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.

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Research and development tax credits

As a company that carries out extensive R&D activities, we benefit from the U.

As a company that carries out extensive R&D activities, we benefit from the U.K.

R&D tax regime.

For the periods ending March 31, 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 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.

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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Selling, general and administrative expenses

Selling, general and administrative ("SG&A") expenses consist primarily of personnel-related costs, including salaries and share-based compensation expense, for selling, corporate and other administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.

Selling, general and administrative ("SG&A") expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, for selling, corporate and other administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.

In order to support our continued commercialization and global expansion of KIMMTRAK, R&D activities, and our operations as a public company, we expect that we will continue to incur selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses.

Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in personnel-related costs and expenses in connection with our commercial operations.

We have experienced, and may continue to experience, increased personnel-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.

Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in employee-related costs and expenses in connection with our commercial operations.

We have experienced, and may continue to experience, increased employee-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.

Interest income

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Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.

Foreign currency gain (loss)

Foreign currency gain (loss) arises on a variety of items, including on U.S.

dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents.

Other income (expense), net

Other income (expense), 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.

Foreign currency (loss) gain

Foreign currency (loss) gain arises on a variety of items, including on U.S.

dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including cash and cash equivalents.

Other income, net

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

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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 $277.0 million as of March 31, 2025.

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.

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 March 31, 2025 and 2024

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

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

Three Months Ended March 31,

Three Months Ended June 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):

Three Months Ended March 31,

Three Months Ended June 30,

2025 2024 Increase /

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$ 97,964 $ 75,347 $ 22,617 30.0 %

For the three months ended March 31, 2025, we generated net revenue from sale of therapies of $93.9 million, due to the sale of KIMMTRAK, of which $56.6 million was in the United States, $32.8 million in Europe (including the impact of a net decrease in estimated reserves related to prior periods of $6.0 million) and $4.5 million in International.

Revenue from sale of therapies, net increased in the three months ended March 31, 2025 compared to the three months ended March 31, 2024, due primarily to global country expansion and increased sales volume in the United States, as we continued our commercialization efforts.

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.

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

Three Months Ended March 31,

Three Months Ended June 30,

2025 2024 Increase /

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All other external clinical and preclinical costs

15,253 4,449 10,804 242.8 %

Total external R&D expenses 47,673 32,377 15,296 47.2 %

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R&D tax credits

(2,216) (1,831) (385) 21.0 %

Total internal R&D expenses 21,335 18,695 2,640 14.1 %

Total R&D expenses $ 69,008 $ 51,072 $ 17,936 35.1 %

For the three months ended March 31, 2025, our R&D expenses were $56.5 million, compared to $57.5 million for the three months ended March 31, 2024.

For the three months ended March 31, 2025, our external R&D expenses decreased by $3.4 million primarily due to a decrease of $9.4 million in expenses incurred for our PRAME programs as a result of higher costs related to timing of manufacturing batches and purchases of drug consumables for our clinical trials in the three months ended March 31, 2024.

This was partially offset by expenses incurred for our tebentafusp programs which increased by $2.1 million primarily due to the advanced cutaneous melanoma ("TEBE-AM") and ATOM Phase 3 trials.

All other external clinical and preclinical costs increased by $4.7 million due to continued progress in the pipeline, primarily related to our autoimmune programs.

For the three months ended March 31, 2025, our internal R&D expenses increased by $2.4 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.

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.

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 March 31, 2025, our SG&A expenses were $40.2 million, compared to $39.3 million for the three months ended March 31, 2024, an increase of $0.9 million.

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

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.

Interest Income and Interest Expense

For the three months ended March 31, 2025, interest income was $4.2 million compared to $8.2 million for the three months ended March 31, 2024.

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 March 31, 2025, interest expense was $3.0 million compared to $3.2 million for the three months ended March 31, 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 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.

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

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

Six Months Ended June 30,

2025 2024 Increase /

(decrease) % Increase /

Revenue from sale of therapies, net

$ 191,845 $ 145,689 $ 46,156 31.7 %

Collaboration revenue

— 213 (213) (100.0) %

Total revenue

$ 191,845 $ 145,902 $ 45,943 31.5 %

Revenue from sale of therapies, net

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,

2025 2024 Increase /

(decrease) % Increase /

United States

$ 120,694 $ 105,632 $ 15,062 14.3 %

65,846 34,356 31,490 91.7 %

International

5,305 5,701 (396) (6.9) %

Revenue from sale of therapies, net

$ 191,845 $ 145,689 $ 46,156 31.7 %

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.

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

Six Months Ended June 30,

2025 2024 Increase /

(decrease) % Increase /

External R&D expenses:

PRAME programs $ 37,983 $ 48,632 $ (10,649) (21.9) %

Tebentafusp programs 18,407 10,451 7,956 76.1 %

Infectious disease programs 2,730 3,685 (955) (25.9) %

All other external clinical and preclinical costs 26,484 10,948 15,536 141.9 %

Total external R&D expenses 85,604 73,716 11,888 16.1 %

Internal R&D expenses:

Salaries and other employee-related costs 23,950 21,975 1,975 9.0 %

Share-based compensation expense 4,499 4,152 347 8.4 %

All other internal R&D costs 15,725 12,342 3,383 27.4 %

R&D tax credits

(4,302) (3,654) (648) 17.7 %

Total internal R&D expenses 39,872 34,815 5,057 14.5 %

Total R&D expenses $ 125,476 $ 108,531 $ 16,945 15.6 %

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.

In addition, R&D expenses incurred for our tebentafusp programs increased by $8.0 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.

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.

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 three months ended March 31, 2025, foreign currency gain was $3.1 million compared to a loss of $2.4 million for the three months ended March 31, 2024.

This change of $5.5 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 March 31, 2025.

Other Income (Expense), Net

For the three months ended March 31, 2025, other income, net was $5.5 million compared to other expense, net of $0.2 million for the three months ended March 31, 2024.

The change is 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.

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.

This increase of $5.2 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.

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 three months ended March 31, 2025, the income tax expense was $1.1 million compared to $0.4 million for the three months ended March 31, 2024.

This was driven by a lower deduction in the United States related to share option exercises in the three months ended March 31, 2025.

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.

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 $790.7 million as of March 31, 2025.

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 March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $476.8 million and $455.7 million, respectively, and marketable securities of $360.2 million and $364.6 million, respectively.

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.

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 March 31, 2025, no issuances or sales had been made pursuant to the Sales Agreement.

As of June 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.

Other than the above mentioned indebtedness, 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 March 31, 2025, we had cash and cash equivalents of $476.8 million, as compared to $455.7 million as of December 31, 2024 and we also have marketable securities of $360.2 million as of March 31, 2025 as compared to $364.6 million as of December 31, 2024.

Our working capital was $799.5 million as of March 31, 2025, compared to $717.7 million as of December 31, 2024.

In the second half of 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.

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

Three Months Ended March 31,

Six Months Ended June 30,

Cash and cash equivalents at beginning of period

$ 455,731 $ 442,626

Net cash provided by (used in) operating activities 435 (4,587)

Net cash provided by (used in) investing activities 9,702 (430)

Net cash provided by operating activities 26,399 18,885

Net cash used in investing activities (20,712) (350,761)

Net cash provided by financing activities 6,221 395,194

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$ 487,933 $ 504,985

Net cash provided by our operating activities was $0.4 million for the three months ended March 31, 2025, compared to cash used in operating activities of $4.6 million for the three months ended March 31, 2024.

The increase of $5.0 million in the three months ended March 31, 2025 was primarily due to an increase in net revenue from sale of therapies and cash collections, partially offset by a decrease in accrued expenses related to timing of payments.

Net cash provided by investing activities was $9.7 million compared to cash used in investing activities of $0.4 million for the three months ended March 31, 2025 and 2024, respectively.

The net cash provided by investing activities increased for the three months ended March 31, 2025 due to proceeds from the sale of marketable securities.

Net cash provided by our financing activities during the three months ended March 31, 2025 was $2.6 million compared to $396.0 million for the three months ended March 31, 2024.

The decrease of $393.4 million was the result of the net cash proceeds from the Notes of $389.1 million in the three months ended March 31, 2024 with no similar proceeds received in March 31, 2025, in addition to a decrease in exercise of share options.

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.

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 $476.8 million and marketable securities of $360.2 million as of March 31, 2025.

We held cash and cash equivalents of $487.9 million and marketable securities of $394.9 million as of June 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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• the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

• the costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and

• the costs, associated with, and terms and timing of, any future potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and

• the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.

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We expect to continue to incur expenses for such leases for the foreseeable future.

As we continue to grow, launch further products or expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would further increase our cash outflows.

Further obligations or commitments in the near term relate to our capital expenditure requirements for the purpose of improving our leased facilities.

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Our Key Collaboration Agreements

BMS Collaboration

Bristol-Myers Squibb ("BMS") Collaboration

In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01, brenetafusp, in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.

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Critical Accounting Estimates

Our condensed consolidated financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 , respectively, have been prepared in accordance with U.S.

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.

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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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 March 31, 2025 were $121.3 million, including amounts of $8.6 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 March 31, 2025.

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 $1.7 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 three months ended March 31, 2025.

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 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 three months ended March 31, 2025 resulted in a change in estimate of $6.0 million of net decrease to our total accrued revenue deductions as of March 31, 2025.

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.

Recently Issued and Adopted Accounting Pronouncements

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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