BICYCLE THERAPEUTICS PLC

Previous wording

Our product candidates zelenectide pevedotin, formerly BT8009, and BT5528 are each a Bicycle Drug Conjugate, or BDC® molecule. These Bicycle molecules are chemically attached to a toxin that when administered is cleaved from the Bicycle molecule and kills the tumor cells. We are evaluating zelenectide pevedotin, a BDC molecule targeting Nectin-4, in an ongoing company-sponsored Phase I/II clinical trial to assess the safety, pharmacokinetics and clinical activity in patients with Nectin-4 expressing advanced malignancies and an ongoing Phase II/III registrational trial called Duravelo-2, designed to allow for potential accelerated approval in untreated and previously treated metastatic urothelial cancer. We are also evaluating zelenectide pevedotin in ongoing company-sponsored Phase I/II clinical trials to assess the efficacy and safety of zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer and NECTIN4 amplified advanced or metastatic non-small cell lung cancer, which commenced recruiting patients in the first and third quarters of 2025, respectively. Enrollment in these trials is ongoing. In addition, we are evaluating BT5528, a BDC molecule targeting Ephrin type A receptor 2, or EphA2, in a company-sponsored Phase I/II clinical trial, for which enrollment is ongoing. Additionally, our other product candidate, BT7480, is a Bicycle Tumor-Targeted Immune Cell Agonist®, or Bicycle TICA®molecule. A Bicycle TICA molecule links immune cell receptor binding Bicycle molecules to tumor antigen binding Bicycle molecules. We are evaluating BT7480, a Bicycle TICA molecule targeting Nectin-4 and agonizing CD137, in a company-sponsored Phase I/II clinical trial. Our discovery pipeline in oncology includes next-generation BDC molecules and Bicycle* *Radioconjugates, or BRC® molecules.

Current wording

Our product candidates zelenectide pevedotin, formerly BT8009, and BT5528 are each a Bicycle Drug Conjugate, or BDC® molecule. These Bicycle molecules are chemically attached to a toxin that when administered is cleaved from the Bicycle molecule and kills the tumor cells. We are evaluating zelenectide pevedotin, a BDC molecule targeting Nectin-4, in an ongoing company-sponsored Phase I/II clinical trial to assess the safety, pharmacokinetics and clinical activity in patients with Nectin-4 expressing advanced malignancies and an ongoing Phase II/III registrational trial called Duravelo-2, designed to allow for potential accelerated approval in untreated and previously treated metastatic urothelial cancer. We are also evaluating zelenectide pevedotin in ongoing company-sponsored Phase I/II clinical trials to assess the efficacy and safety of zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer and NECTIN4 amplified advanced or metastatic non-small cell lung cancer, which commenced recruiting patients in the first and third quarters of 2025, respectively. Enrollment in these trials is ongoing. In addition, we are evaluating BT5528, a BDC molecule targeting Ephrin type A receptor 2, or EphA2, in an ongoing company-sponsored Phase I/II clinical trial. Additionally, our other product candidate, BT7480, is a Bicycle Tumor-Targeted Immune Cell Agonist®, or Bicycle TICA®molecule. A Bicycle TICA molecule links immune cell receptor binding Bicycle molecules to tumor antigen binding Bicycle molecules. We are evaluating BT7480, a Bicycle TICA molecule targeting Nectin-4 and agonizing CD137, in a company-sponsored Phase I/II clinical trial. Our discovery pipeline in oncology includes next-generation BDC molecules and Bicycle* *Radioconjugates, or BRC® molecules.

Previous wording

In addition, at the ESMO Congress 2024, we announced updated Phase I/II clinical results for BT5528 in advanced solid tumors, including metastatic urothelial cancer and ovarian cancer, and updated Phase I/II clinical results for BT7480 in advanced solid tumors. In October 2024, first human imaging data for a BRC molecule targeting MT1-MMP was presented by the German Cancer Consortium, or DKTK, and we presented preclinical data about BRC molecules for radioisotope delivery to solid tumors at the European Association of Nuclear Medicine, or EANM, 2024 Congress. In April 2025, DKTK presented additional human imaging data for a BRC molecule targeting MT1-MMP at the American Association for Cancer Research, or AACR, Annual Meeting 2025.

Current wording

In addition, at the ESMO Congress 2024, we announced updated Phase I/II clinical results for BT5528 in advanced solid tumors, including metastatic urothelial cancer and ovarian cancer, and updated Phase I/II clinical results for BT7480 in advanced solid tumors. In October 2024, first human imaging data for a BRC molecule targeting MT1-MMP was presented by the German Cancer Consortium, or DKTK, and we presented preclinical data about BRC molecules for radioisotope delivery to solid tumors at the European Association of Nuclear Medicine, or EANM, 2024 Congress. In April 2025, DKTK presented additional human imaging data for a BRC molecule targeting MT1-MMP at the American Association for Cancer Research, or AACR, Annual Meeting 2025. In October 2025, at the EANM 2025 Congress, we presented data outlining the first clinical experience with an early BRC molecule targeting MT1-MMP and DKTK presented preclinical data about BRC molecules demonstrating high specificity and tunability supporting their potential for radiotheranostic use.

Previous wording

In August 2025, we announced cost reduction initiatives that are expected to reduce planned operating costs by approximately 30% over the course of our expected financial runway period, primarily through a workforce reduction that is expected to result in a reduction of approximately 25% of our current and planned workforce. We estimate that we will incur aggregate charges, representing cash expenditure for severance and other employee termination benefits, of approximately $5.3 million, the majority of which is expected to be recognized in the third quarter of 2025.

Current wording

In August 2025, we announced cost reduction initiatives that are expected to reduce planned operating costs by approximately 30% over the course of our expected financial runway period, primarily through a workforce reduction that is expected to result in a reduction of approximately 25% of our current and planned workforce. We expectthe workforce reduction to be substantially completed by the fourth quarter of 2025. As a result, we anticipate that we will incur aggregate charges, representing cash expenditure for severance and other employee termination benefits, of approximately $5.3 million, $4.1 million of which was recognized during the three months ended September 30, 2025.

Previous wording

Since our inception, we have devoted substantially all of our resources to developing our Bicycle platform and our product candidates, conducting research and development of our product candidates and preclinical programs, raising capital and providing general and administrative support for our operations. To date, we have financed our operations primarily with proceeds from the sale of our equity securities; proceeds received from upfront payments, research and development payments, and development milestone payments from our collaboration agreements; and borrowings pursuant to a loan and security agreement, or the Loan Agreement, with Hercules Capital, Inc., or Hercules. From our inception in 2009 through June 30, 2025, we have received gross proceeds of $1.4 billion from the sale of our equity securities; and $236.9 million of cash payments under our collaboration arrangements, including $45.6 million from Bayer, $53.0 million from Novartis, $47.7 million from Ionis, and $56.0 million from Genentech. We do not have any products approved for sale and have not generated any revenue from product sales.

Current wording

Since our inception, we have devoted substantially all of our resources to developing our Bicycle platform and our product candidates, conducting research and development of our product candidates and preclinical programs, raising capital and providing general and administrative support for our operations. To date, we have financed our operations primarily with proceeds from the sale of our equity securities; proceeds received from upfront payments, research and development payments, and development milestone payments from our collaboration agreements; and borrowings pursuant to a loan and security agreement, or the Loan Agreement, with Hercules Capital, Inc., or Hercules. From our inception in 2009 through September 30, 2025, we have received gross proceeds of $1.4 billion from the sale of our equity securities; and $239.3 million of cash payments under our collaboration arrangements, including $45.9 million from Bayer, $53.0 million from Novartis, $49.7 million from Ionis, and $56.0 million from Genentech. We do not have any products approved for sale and have not generated any revenue from product sales.

Previous wording

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $79.0 million and $139.7 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2025, we had an accumulated deficit of $820.5 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

Current wording

ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $879.6 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

Previous wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, charitable and governmental grants, monetization transactions or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Current wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, charitable and governmental grants, monetization transactions or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $721.5 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of filing of this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our available capital resources sooner than we expect. See “—Liquidity and Capital Resources” and “—Capital Resources and Funding Requirements.”

Current wording

As of September 30, 2025, we had cash and cash equivalents of $648.3 million. In October 2025, we received $38.2 million of research and development incentives related to relevant expenditures incurred in the year ended December 31, 2024. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of filing of this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our available capital resources sooner than we expect. See “—Liquidity and Capital Resources” and “—Capital Resources and Funding Requirements.”

Previous wording

Our direct external research and development expenses are tracked on a program-by-program basis and consist of costs, such as fees paid to consultants, contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, in connection with our preclinical and clinical development activities. Costs incurred after a product candidate has been designated and that are directly related to the product candidate are included in direct research and development expenses for that program. Costs incurred prior to designating a product candidate are

Current wording

Our direct external research and development expenses are tracked on a program-by-program basis and consist of costs, such as fees paid to consultants, CROs and contract manufacturing organizations, or CMOs, in connection with our preclinical and clinical development activities. Costs incurred after a product candidate has been designated and that are directly related to the product candidate are included in direct research and development expenses for that program. Costs incurred prior to designating a product candidate are included in discovery, platform and other expenses. We do not allocate employee costs, costs associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.

Previous wording

The U.K. research and development tax credit is fully refundable to us after surrendering tax losses and is not dependent on current or future taxable income. As a result, we have recorded the entire benefit from the U.K. research and development tax credit as a reduction to research and development expenses and is not reflected as part of the income tax provision. If, in the future, any U.K. research and development tax credits generated are needed to offset a corporate income tax liability in the U.K., that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded as a reduction to research and development expenses.

Current wording

The U.K. research and development tax credit is fully refundable to us after surrendering tax losses and is not dependent on current or future taxable income. As a result, we have recorded the entire benefit from the U.K. research and development tax credit as a reduction to research and development expenses and is not reflected as part of the income tax provision.

Previous wording

We are subject to corporate taxation in the United States and the U.K. We have generated losses since inception and have therefore not paid U.K. corporation tax. The (benefit from) provision for income taxes included in the condensed consolidated statements of operations and comprehensive loss represents the tax impact from operating activities in the United States, which has generated taxable income based on intercompany service arrangements.

Current wording

We are subject to corporate taxation in the United States and the U.K. We have generated losses since inception and have therefore not paid U.K. corporation tax. The provision for (benefit from) income taxes included in the condensed consolidated statements of operations and comprehensive loss represents the tax impact from operating activities in the United States, which has generated taxable income based on intercompany service arrangements.

Previous wording

Research and development expenses increased by $31.0 million in the three months ended June 30, 2025 compared to the three months ended June 30, 2024, due to increases of $28.8 million in clinical program expenses for zelenectide pevedotin primarily due to the ongoing Phase II/III Duravelo-2 registrational trial as well as the ongoing Phase I/II clinical trial assessing zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer,

Current wording

Research and development expenses increased by $10.2 million in the three months ended September 30, 2025 compared to the three months ended September 30, 2024, due to increases of $5.5 million in clinical program expenses for zelenectide pevedotin primarily due to the ongoing Phase II/III Duravelo-2 registrational trial as well as the ongoing

Previous wording

which commenced recruiting patients in the first quarter of 2025; $5.4 million in discovery, platform and other expense due to continued development of our pipeline programs, including advancing our BRC molecule pipeline; and $4.1 million in employee and contractor related expenses primarily attributable to increased headcount. These increases were primarily offset by $4.2 million of incremental research and development incentives due to the corresponding increase in qualifying research and development spending and decreases of $2.1 million in Bicycle TICA program development expenses due to the timing of clinical program activities, including the reimbursement of $0.9 million of certain program-related costs, and $0.6 million in BT5528 clinical program expenses.

Current wording

Phase I/II clinical trials assessing zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer and NECTIN4 amplified advanced or metastatic non-small cell lung cancer, which commenced recruiting patients in the first and third quarters of 2025, respectively; $3.9 million in discovery, platform and other expense due to continued development of our pipeline programs, including advancing our BRC molecule pipeline; $3.0 million in employee and contractor related expenses primarily attributable to increased headcount as well as incremental severance-related costs of $1.4 million period over period; and $0.9 million resulting from lower research and development incentives primarily due to restrictions, effective in 2025, on the tax relief that can be claimed on expenditures for certain activities that are not carried out in the U.K. These increases were primarily offset by decreases of $1.0 million in Bicycle TICA program development expenses due to the timing of clinical program activities and $0.8 million in share-based compensation expense due to the Company’s workforce reduction in August 2025.

Previous wording

We begin to separately track program expenses at candidate nomination, at which point we accumulate all direct external program costs to support that program to date. Through June 30, 2025, we have incurred approximately $233.4 million and $53.1 million of direct external expenses for the development of zelenectide pevedotin and BT5528, respectively, since their candidate nominations, and an aggregate of $50.4 million of direct external expenses for the development of two named Bicycle TICA candidates since their nominations.

Current wording

We begin to separately track program expenses at candidate nomination, at which point we accumulate all direct external program costs to support that program to date. Through September 30, 2025, we have incurred approximately $260.8 million and $55.4 million of direct external expenses for the development of zelenectide pevedotin and BT5528, respectively, since their candidate nominations, and an aggregate of $50.9 million of direct external expenses for the development of two named Bicycle TICA candidates since their nominations.

Previous wording

General and administrative expenses increased by $2.5 million in the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This increase is primarily due to increases of $1.5 million in personnel-related costs as a result of increased headcount and $0.6 million in professional and consulting fees primarily associated with increased legal and consulting fees to support our growth.

Current wording

General and administrative expenses increased by $0.6 million in the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is primarily due to an increase of $1.5 million in personnel-related costs as a result of increased headcount as well as incremental severance-related costs of $0.8 million period over period, offset by a decrease of $0.7 million in professional and consulting fees due to ongoing cost reduction initiatives.

Previous wording

(Benefit from) Provision for Income Taxes

Current wording

The provision for income taxes of $0.2 million for the three months ended September 30, 2025 was primarily due to the impact of the August 2025 workforce reduction on our estimated effective tax rate. The benefit of income taxes of $3.4 million for the three months ended September 30, 2024 was mainly the result ofincremental income tax benefits of approximately $3.5 million recognized during the third quarter of 2024 related to the completion of a U.S. research and development tax credit study.

Previous wording

Collaboration revenue decreased by $6.4 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024, due to decreases of $3.0 million from our collaboration with Ionis due to the completion of the combined licenses and research and discovery performance obligation in the second quarter of 2024, $2.3 million from our collaboration with Novartis due to the recognition of revenue related to the expiration of Novartis’ material rights for limited substitution rights for the first and second targets in the second quarter of 2024, and $1.3 million from our collaboration with Genentech.

Current wording

Collaboration revenue decreased by $6.9 million in the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, due to decreases of $6.9 million from our collaboration with Ionis primarily due to the completion of the combined licenses and research and discovery performance obligation in the second quarter of 2024, and $1.2 million from our collaboration with Novartis due to the recognition of revenue related to the expiration of Novartis’ material rights for limited substitution rights for the first and second targets in the second quarter of 2024. These decreases were offset by an increase of $0.8 million from our collaboration with Genentech.

Previous wording

Research and development expenses increased by $55.2 million in the six months ended June 30, 2025 compared to the six months ended June 30, 2024, due to increases of $43.4 million in clinical program expenses for zelenectide pevedotin primarily related to the ongoing Phase II/III Duravelo-2 registrational trial as well as the ongoing Phase I/II clinical trial assessing zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer,

Current wording

Research and development expenses increased by $65.3 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, due to increases of $48.9 million in clinical program expenses for zelenectide pevedotin primarily related to the ongoing Phase II/III Duravelo-2 registrational trial as well as the ongoing Phase I/II clinical trials assessing zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer and NECTIN4 amplified advanced or metastatic non-small cell lung cancer, which commenced recruiting

Previous wording

which commenced recruiting patients in the first quarter of 2025; $7.9 million in employee and contractor related expenses primarily attributable to increased headcount; $6.2 million in discovery, platform and other expense due to continued development of our pipeline programs, including advancing our BRC molecule pipeline; and $1.8 million resulting from a decrease in research and development incentives due to the retroactive impact of U.K. R&D tax credit reimbursement rate changes that were enacted and effective in the first quarter of 2024, retroactively applied to April 1, 2023. These increases were primarily offset by a decrease of $3.6 million in Bicycle TICA program development expenses due to the timing of clinical program activities, including the reimbursement of $0.9 million of certain program-related costs.

Current wording

patients in the first and third quarters of 2025; $10.9 million in employee and contractor related expenses primarily attributable to increased headcount; $10.1 million in discovery, platform and other expense due to continued development of our pipeline programs, including advancing our BRC molecule pipeline; and $2.7 million resulting from a decrease in research and development incentives due to the retroactive impact of U.K. R&D tax credit reimbursement rate changes that were enacted and effective in the first quarter of 2024, retroactively applied to April 1, 2023. These increases were primarily offset by decreases of $4.6 million in Bicycle TICA program development expenses due to the timing of clinical program activities, and $1.4 million in share-based compensation expense due to our workforce reduction in August 2025.

Previous wording

General and administrative expenses increased by $7.3 million in the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This increase is primarily due to increases of $3.1 million in professional and consulting fees primarily associated with increased legal and consulting fees to support our growth, $2.9 million in personnel-related costs as a result of increased headcount, and $1.1 million of incremental share-based compensation expense primarily associated with equity grants issued since the same period in the prior year.

Current wording

General and administrative expenses increased by $7.9 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is primarily due to increases of $4.3 million in personnel-related costs as a result of increased headcount, $2.4 million in professional and consulting fees primarily associated with increased legal and consulting fees to support our growth, and $1.5 million of incremental share-based compensation expense primarily associated with equity grants issued since the same period in the prior year.

Previous wording

Other income, net increased by $4.0 million in the six months ended June 30, 2025 compared to the six months ended June 30, 2024, which was primarily due to an increase in interest income of $2.5 million primarily related to higher average interest-bearing cash and cash equivalents balances period over period, as well as a decrease in interest expense of $1.5 million due to the repayment and termination of the Loan Agreement in July 2024.

Current wording

Other income, net increased by $1.1 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, which was primarily due to a decrease in interest expense of $1.5 million due to the repayment and termination of the Loan Agreement in July 2024 as well as the loss on extinguishment of debt of $1.0 million recognized in the third quarter of 2024, offset by a decrease in interest income of $1.4 million primarily related to lower average interest rates period over period as well as higher cash and cash equivalents balances during the second half of 2024.

Previous wording

The benefit from income taxes of $1.3 million and $0.2 million for the six months ended June 30, 2025 and 2024, respectively, is mainly the result of deferred tax assets in the United States that do not have a valuation allowance against them because of profits that will be generated by an intercompany service agreement.

Current wording

The benefit from income taxes of $1.1 million and $3.7 million for the nine months ended September 30, 2025 and 2024, respectively, is mainly the result of deferred tax assets in the United States that do not have a valuation allowance against them because of profits that will be generated by an intercompany service agreement. The benefit from income taxes for the nine months ended September 30, 2024 includes incremental income tax benefits of approximately $3.5 million recognized during the third quarter of 2024 related to the completion of a U.S. research and development tax credit study.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $159.2 million as compared to $115.5 million for the six months ended June 30, 2024. The increase in cash used in operations of $43.7 million is primarily due to an increase in cash payments for clinical program activities, primarily related to the multiple ongoing clinical trials for zelenectide pevedotin, including for the ongoing Phase II/III registrational trial for zelenectide pevedotin in patients with untreated and previously treated metastatic urothelial cancer and the initiation of the Phase I/II clinical trial for zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $230.3 million as compared to $155.3 million for the nine months ended September 30, 2024. The increase in cash used in operations of $75.0 million is primarily due to an increase in cash payments for clinical program activities, primarily related to the multiple ongoing clinical trials for zelenectide pevedotin, including for the ongoing Phase II/III registrational trial for zelenectide pevedotin in patients with untreated and previously treated metastatic urothelial cancer and the initiation of the Phase I/II clinical trials for zelenectide pevedotin in patients with NECTIN4 amplified advanced breast cancer and NECTIN4 amplified advanced or metastatic non-small cell lung cancer.

Previous wording

During the six months ended June 30, 2025 and 2024, we used $1.1 million and $0.4 million, respectively, of cash in investing activities for purchases of property and equipment, consisting primarily of laboratory equipment.

Current wording

During the nine months ended September 30, 2025 and 2024, we used $1.8 million and $0.9 million, respectively, of cash in investing activities for purchases of property and equipment, consisting primarily of laboratory equipment.

Previous wording

During the six months ended June 30, 2025, net cash used in financing activities was $0.1 million, primarily consisting of payments of finance lease obligations.

Current wording

During the nine months ended September 30, 2025, net cash used in financing activities was $0.1 million, primarily consisting of payments of finance lease obligations.

Previous wording

During the six months ended June 30, 2024, net cash provided by financing activities was $551.5 million, primarily consisting of net proceeds of $545.1 million from the Private Placement and $6.4 million from the exercise of share options.

Current wording

During the nine months ended September 30, 2024, net cash provided by financing activities was $519.5 million, primarily consisting of net proceeds of $544.1 million from the Private Placement and $7.3 million from the exercise of share options, offset by payments on debt of $31.9 million associated with the repayment and voluntary termination of the Loan Agreement.

Previous wording

are not included in the table above since the contracts are generally cancelable with advanced written notice, generally with a notice period of 90 days or less. From the time of notice until termination, we are contractually obligated to make certain minimum payments to the vendors, based on the timing of the notification and the exact terms of the agreement.

Current wording

In the ordinary course of business, we enter into various agreements with contract research organizations to provide clinical trial services, with contract manufacturing organizations to provide clinical trial materials, and with vendors for preclinical research studies, synthetic chemistry and other services for operating purposes. These payments are not included in the table above since the contracts are generally cancelable with advanced written notice, generally with a notice period of 90 days or less. From the time of notice until termination, we are contractually obligated to make certain minimum payments to the vendors, based on the timing of the notification and the exact terms of the agreement.

Previous wording

We have also entered into separate agreements with third parties which provide for various future milestone payments upon the achievement of specified development, regulatory, commercial and sales-based milestones with an aggregate total value of $105.9 million, as well as potential future royalty and other payments at percentages ranging from very low to low single digits. These additional milestone payments are contingent upon future events that are not considered probable of achievement as of June 30, 2025. As of June 30, 2025, we were unable to estimate the timing or likelihood of achieving these milestones.

Current wording

We have also entered into separate agreements with third parties which provide for various future milestone payments upon the achievement of specified development, regulatory, commercial and sales-based milestones with an aggregate total value of $105.8 million, as well as potential future royalty and other payments at percentages ranging from very low to low single digits. These additional milestone payments are contingent upon future events that are not considered probable of achievement as of September 30, 2025. As of September 30, 2025, we were unable to estimate the timing or likelihood of achieving these milestones.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $721.5 million. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of filing of this Quarterly Report.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $648.3 million. In October 2025, we received $38.2 million of research and development incentives related to relevant expenditures incurred in the year ended December 31, 2024. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of filing of this Quarterly Report.

Previous wording

Recent global trade disruption, volatility in the capital markets and continued uncertainty may contribute to a general global economic slowdown or recession. The resulting high inflation rates may materially affect our business and corresponding financial position and cash flows. Inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates and overhead costs may adversely affect our operating results. High interest rates also present a recent challenge impacting the U.S. economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future. Additionally, the general consensus among economists suggests that we should expect a higher recession risk to continue over the next year, which, together with the foregoing, could result in further economic uncertainty and volatility in the capital markets in the near term, and could negatively affect our operations. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increases in the near future (especially if inflation rates remain high or begin to rise again) on our operating costs, including our labor costs and research and development costs, due to supply chain constraints, consequences associated with geopolitical conflicts such as the ongoing wars involving Ukraine and Israel, worsening global macroeconomic conditions, including those resulting from changes in global trade policies, which may result in additional stress on our working capital resources. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts.

Current wording

Recent global trade disruption, volatility in the capital markets and continued uncertainty may contribute to a general global economic slowdown or recession. The resulting high inflation rates may materially affect our business and corresponding financial position and cash flows. Inflationary factors, such as increases in the cost of our clinical trial materials and supplies, interest rates and overhead costs may adversely affect our operating results. High interest rates also present a recent challenge impacting the U.S. economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future. Additionally, the general consensus among economists suggests that we should expect a higher recession risk to continue over the next year, which, together with the foregoing, could result in further economic uncertainty and volatility in the capital markets in the near term, and could negatively affect our operations. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increases in the near future (especially if inflation rates remain high or begin to rise again) on our operating costs, including our labor costs and research and development costs, due to supply chain constraints, consequences associated with geopolitical conflicts such as those involving Ukraine and Israel, worsening global macroeconomic conditions, including those resulting from changes in global trade policies, which may result in additional stress on our working capital resources. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts.

Previous wording

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

of our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.