Item 2. Management’s Discussion and Analysis
Item 2. 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 condensed consolidated financial statements and the related notes thereto appearing elsewhere in this Quarterly Report. The accompanying MD&A, including all periods presented, has been prepared under U.S. GAAP. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and notes thereto, and the section titled “Risk Factors” each of which appear in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on February 26, 2025 (the "Annual Report") as well as the section titled “Special Note Regarding Forward-Looking Statements".
Overview
We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging our proprietary, flexible, off-the-shelf ImmTAX ( I mmune m obilizing m onoclonal T CRs A gainst X disease) platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced preclinical programs in autoimmune disease and earlier preclinical programs across three therapeutic areas.
In 2022, we received approval for our lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma ("mUM") from the FDA, the European Commission, and other health authorities. 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.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM. To date, we have treated over 2,000 cancer patients with KIMMTRAK, tebentafusp, and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any TCR therapeutic. Our clinical programs are being conducted with patients with a broad range of cancers including melanoma, ovarian, lung, and colorectal, among others. We believe that these tumor types have large addressable patient populations and significant unmet need. We are progressing three late-stage clinical programs within our ImmTAC ( I mmune m obilizing m onoclonal T CRs A gainst C ancer) portfolio, including KIMMTRAK and PRAME-targeted brenetafusp.
Since our inception, we have focused on organizing and staffing our company, raising capital, performing research and development activities to advance our research, development and technology, and commercialization of KIMMTRAK. 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. 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 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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We do not expect to generate revenue from the sale of our other product candidates unless and until we successfully complete clinical development of and obtain regulatory approval for such product candidates. As a result, we may need additional funding to support our continued operations and pursue our clinical development and growth strategy. Until we can generate sufficient revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt financings, government funding arrangements, collaborations and marketing and distribution and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements on favorable terms, or at all, particularly in light of recently worsening macroeconomic conditions, such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets. If we fail to raise capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
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.
Components of Results of Operations
Revenue
Revenue from sale of therapies, net
Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval. We recognize net revenue from sale of therapies at the point in time that control transfers to a customer, which is typically on delivery to our distributors and healthcare providers. We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory. 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, pricing negotiations. Further information on estimates is provided under the section below headed, “Critical Accounting Estimates”.
Collaboration revenue
Historically, collaboration revenue arose under our collaboration agreements and consisted of non-refundable upfront payments, development milestone payments, as well as reimbursement of certain research and development expenses. We have no continuing performance obligations under our historical collaboration agreements.
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Operating Expenses
Cost of revenue from sale of therapies
Cost of revenue from sale of therapies represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to sale. 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.
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. 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.
R&D expenses incurred with external organizations to undertake R&D activities on our behalf typically relate to clinical programs and are assigned to the individual programs in tables further below. 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 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.
We expect our R&D expenses to increase in the future as we advance existing and future product candidates into and through clinical studies and pursue further regulatory approval. The process of conducting the necessary clinical studies to obtain regulatory approval is costly and time-consuming. We maintain our headcount at a level required to support our continued research activities and development of our product candidates. Clinical trials generally become larger and more costly to conduct as they advance into later stages. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. As a result, our R&D expenses may vary substantially from period to period based on the timing of our R&D activities.
Research and development tax credits
As a company that carries out extensive R&D activities, we benefit from the U.K. 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.
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. The headline rate under the RDEC program increased from 13% to 20% on April 1, 2023 and can generate cash rebates of up to 15% (increased from 10.5%) on qualifying R&D expenses incurred from this date.
Recent amendments to the U.K. R&D tax credit regime introduced restrictions on the tax relief that can be claimed for expenses incurred on subcontracted R&D activities or externally provided workers, where such subcontracted activities are not carried out in the United Kingdom or such workers are not subject to U.K. payroll taxes, subject to limited exceptions.
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Selling, general and administrative expenses
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 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
Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash equivalents.
Interest expense
Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.
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
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. Due to the nature of our business and on a consolidated basis, we have generated cumulative losses since inception. Our income tax expense represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by deferred tax credits arising on deferred tax assets generated.
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. 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. A deferred tax asset is, however, recognized in respect of the subsidiary in the United States, relating to unused tax credits on share-based compensation expense and other temporary differences on the basis that we expect to continue generating U.S. taxable income against which deductible temporary differences can unwind.
As we begin to generate significant net revenue from sale of therapies, we may benefit from the U.K.’s “patent box” regime, which allows profits attributable to revenues from patents or patented products to be taxed at a lower rate than other revenue. The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%.
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Comparison of the Three Months Ended June 30, 2025 and 2024
Revenue
The following table summarizes our total revenue (in thousands):
Three Months Ended June 30,
2025 2024 Increase /
(decrease) % Increase /
(decrease)
Revenue from sale of therapies, net
$ 97,964 $ 75,347 $ 22,617 30.0 %
Collaboration revenue
— 53 (53) (100.0) %
Total revenue
$ 97,964 $ 75,400 $ 22,564 29.9 %
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):
Three Months Ended June 30,
2025 2024 Increase /
(decrease) % Increase /
(decrease)
United States
$ 64,087 $ 55,606 $ 8,481 15.3 %
Europe
33,042 15,404 17,638 114.5 %
International
835 4,337 (3,502) (80.7) %
Revenue from sale of therapies, net
$ 97,964 $ 75,347 $ 22,617 30.0 %
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.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Three Months Ended June 30,
2025 2024 Increase /
(decrease) % Increase /
(decrease)
External R&D expenses:
PRAME programs $ 20,678 $ 21,932 $ (1,254) (5.7) %
Tebentafusp programs 10,417 4,557 5,860 128.6 %
Infectious disease programs 1,325 1,439 (114) (7.9) %
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 %
Internal R&D expenses:
Salaries and other employee-related costs 12,907 12,221 686 5.6 %
Share-based compensation expense 2,318 2,172 146 6.7 %
All other internal R&D costs 8,326 6,133 2,193 35.8 %
U.K. 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 %
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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 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 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.
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
Revenue
The following table summarizes our total revenue (in thousands):
Six Months Ended June 30,
2025 2024 Increase /
(decrease) % Increase /
(decrease)
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 %
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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 /
(decrease)
United States
$ 120,694 $ 105,632 $ 15,062 14.3 %
Europe
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.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Six Months Ended June 30,
2025 2024 Increase /
(decrease) % Increase /
(decrease)
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 %
U.K. 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.
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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 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 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
Sources of Liquidity
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.
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. 333-278120). 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. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. 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.
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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.
Cash Flows
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):
Six Months Ended June 30,
2025 2024
Cash and cash equivalents at beginning of period
$ 455,731 $ 442,626
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
Net foreign exchange difference on cash held
20,294 (959)
Cash and cash equivalents at end of period
$ 487,933 $ 504,985
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
We expect to continue to incur significant operating losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize KIMMTRAK in additional territories, continue our research and development programs and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates.
The amounts and timing of our actual expenditure may vary significantly depending on numerous factors. Our expenses will continue to increase if, and as, we:
• pursue further approval and commercialization of KIMMTRAK in additional indications and territories;
• continue to advance the development of our clinical trials and preclinical programs;
• continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;
• change or add additional suppliers;
• add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;
• seek to attract and retain skilled personnel;
• create additional infrastructure to further support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;
• seek marketing approvals and reimbursement for our other product candidates;
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• further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval;
• seek to identify and validate additional product candidates;
• acquire or in-license other product candidates and technologies;
• maintain, protect, defend, enforce and expand our intellectual property portfolio; and
• experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the conflict in the Middle East, global geopolitical tension, worsening macroeconomic conditions, including supply chain disruptions, fluctuations in interest rates, rising inflation, tariffs and other trade barriers, or health epidemics or pandemics.
Since our inception, we have raised funds from sales of equity securities, debt financing, revenue from sale of therapies and collaboration agreements. In order to maintain such levels of expenditure and our anticipated expenditure, we may raise further funds by exploring debt or equity financing, or potentially further collaborations, in the future. The amount we are able to raise from these options can vary with market conditions, including the impacts of macroeconomic conditions such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets, and our longer term strategy as a company is dependent on our ability to successfully raise such funding. 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. 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. Given our need for additional financing to support the long-term clinical development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
• the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential future clinical trials;
• the time and costs required to perform R&D to identify and characterize new product candidates from our research programs;
• the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;
• the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved;
• our ability to successfully commercialize our other product candidates;
• our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations;
• the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;
• the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;
• the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
• the continued costs of operating as a public company;
• the time and cost necessary to respond to technological, regulatory, political and market developments;
• 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 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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A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development and commercialization of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. Further, to the extent that we raise additional capital through the sale of ordinary shares or securities convertible or exchangeable into ordinary shares, our shareholders’ ownership interest will be diluted. If we raise additional capital through debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding on favorable terms when needed, we may have to delay, reduce the scope of or terminate one or more of our R&D programs or clinical trials.
Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, financial markets in the United States and worldwide. We are also mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. We sell our products in countries that face economic volatility and weakness. Although we have historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.
Contractual Obligations
Leases and manufacturing
As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $73.7 million. The majority of such payments represent longer-term commitments as outlined in the notes to our condensed consolidated financial statements. The lease agreements are cancellable assuming certain conditions are met prior to expiry. 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 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. If we continue to grow, such commitments may become significant in value.
We have a number of existing manufacturing obligations, some of which relate to the manufacture of KIMMTRAK. We have similar obligations related to our earlier stage programs. These obligations and potential obligations could result in payments of up to $23.0 million, and are expected to increase as we continue to advance our pipeline in 2025 and beyond. While we have already incurred costs for commercial launches of KIMMTRAK in the United States, Europe and other territories, additional manufacturing obligations may arise in future in relation to product sales in these territories. We have also entered into third-party agreements relating to marketing and distribution of KIMMTRAK. The majority of such obligations have standard payment terms, and our level of non-cancellable commitments with such parties is not considered material. To meet demand, we may amend or enter into further agreements with CMOs or other parties which could cause our cash requirements to increase. While receipts from the sale of KIMMTRAK or other future products may fund our ongoing manufacturing and sales efforts, there can be no assurance that we will earn such revenues. In the longer term, if we received regulatory approval for our other product candidates, we would expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
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In addition to the above obligations, commitments and potential future cash outflows, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally provide us the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
Financing obligations
Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by us under the agreement, the Gates Foundation has the right to sell, or require us to buy-back, any of the shareholdings of us held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, we experience a change in control at a valuation of more than 150% of the valuation used for the redemption or the sale of the shares, we have agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. See Note 5. “Interest-bearing loans and borrowings” of the notes to our condensed consolidated financial statements in Part I of this Quarterly Report for further information.
Our Key Collaboration Agreements
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. Under the terms of the BMS Agreement, we are sponsoring and funding the registrational Phase 3 clinical trial of brenetafusp in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS is providing nivolumab. No monetary consideration is transferred as a result of the BMS Agreement.
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. GAAP. 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.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.
Those judgments and estimates made, together with our significant accounting policies, are set out in our Annual Report.
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Expected rebate and chargeback percentage for revenue deductions
Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. We use the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance.
We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after we have sold vials to specialty distributors. We are also subject to chargebacks from its specialty distributors under the 340B program in the United States, whereby qualifying hospitals are entitled to purchase KIMMTRAK at a lower price. For such sales, our specialty distributors charge back the difference between the wholesale acquisition cost and this lower price. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to specialty distributors and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We form estimates of 340B chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by specialty distributors. For Medicaid and other rebates, we form estimates based on information obtained from claims received and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
Judgment has historically been required in determining expected rebate percentages for the amount of net revenue from sale of therapies in France. Rebates payable were subject to a high degree of estimation uncertainty. Our estimate of these rebates represented the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which has historically been subject to negotiation, and the initial price of tebentafusp and KIMMTRAK until the Company completed price negotiations in France during the three months ended March 31, 2025. 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 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.
Recently Issued and Adopted Accounting Pronouncements
We discuss the effect of recently issued and adopted pronouncements in Note 2. ''Summary of Significant Accounting Policies'' to the condensed consolidated financial statements.
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