Skip to main content

Silence Therapeutics plc

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

SLN$19.73+0.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-07.

0000950170-25-104593

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001193125-25-268116

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 146 previous paragraphs and 143 current paragraphs.

105 unchanged; 33 reworded; 5 added; 6 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

In October 2025, we announced the completion of patient enrollment in the SANRECO Phase 2 clinical trial of divesiran for the treatment of PV. The Phase 2 portion of SANRECO is a global, randomized, double-blind, placebo-controlled trial that enrolled 48 phlebotomy-dependent PV patients.

Current report

Following accelerated completion of Phase 2 enrollment, initial topline results from SANRECO are anticipated in the third quarter of 2026.

Current report

Revenue for the nine months ended September 30, 2025 was $0.5 million, reflecting a decrease of $17.4 million from the same period in 2024. This decrease for the period primarily relates to the decrease of $15.7 million in revenue from the AstraZeneca Collaboration, as we did not record any milestones in the nine months ended September 30, 2025 as opposed to the achievement of a milestone in the amount of $10 million in the same period in 2024.

Current report

Research and development costs for the three months ended September 30, 2025 increased by $0.4 million to $20.5 million. This change was mainly due to an increase in other costs of $1.4 million associated with the reduction of a prepayment to a manufacturing provider that we will no longer use for preferred access to manufacturing services, which was offset by a reduction in contracted development costs of $0.5 million as well as a decrease in personnel costs of $0.5 million.
Removed paragraphs (6)

Previous report

In June 2025, we exceeded 50% enrollment in the SANRECO Phase 2 trial of divesiran in PV patients and remain on track to complete enrollment of the trial by year-end 2025.

Previous report

In June 2025, we presented updated Phase 1 data from the SANRECO PV study at the European Hematology Association (EHA) 2025 Annual Meeting in Milan, Italy. The results of the data shared included analysis of 21 phlebotomy-dependent PV patients with a combined history of 79 phlebotomies prior to dosing. Following divesiran treatment, therapeutic phlebotomies were essentially eliminated and mean HCT levels were lowered and maintained to less than or equal to 45% for all cohorts regardless of baseline levels.

Previous report

We have advanced extra-hepatic cell targeting of siRNA where we are seeing promising initial preclinical activity in mice models. As a result, we are prioritizing our extra-hepatic activities and have decided to pause initiating a Phase 1 study of SLN548, our wholly owned siRNA for complement-mediated diseases.

Previous report

A Phase 1 trial of our siRNA product candidate, SLN312, which is licensed to AstraZeneca, is ongoing.

Previous report

Revenue for the six months ended June 30, 2025 was $0.4 million, reflecting a decrease of $16.1 million from the same period in 2024. This change was mainly due to an impact of the revenue from the AstraZeneca Collaboration, which decreased by $14.7 million as we did not achieve any milestones during the period under the terms of the AstraZeneca Collaboration. This difference was mainly due to the fact that there were no similar milestones in 2025.
Reworded paragraphs (33)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements, the related notes thereto appearing elsewhere in this Quarterly Report. The following discussion is based on our financial information prepared in accordance with accounting principles generally accepted in the U.S., or U.S. GAAP, as found in the Accounting Standards Codification and Accounting Standards Update of the Financial Accounting Standards Board and the rules and regulations of the SEC. 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. Our actual results, performance or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Risk Factors” included elsewhere in this

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements, the related notes thereto appearing elsewhere in this Quarterly Report. The following discussion is based on our financial information prepared in accordance with accounting principles generally accepted in the U.S., or U.S. GAAP, as found in the Accounting Standards Codification and Accounting Standards Update of the Financial Accounting Standards Board and the rules and regulations of the SEC. 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. Our actual results, performance or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Divesiran (SLN124) is our wholly owned siRNA product candidate that works by temporarily silencing TMPRSS6 expression in the liver. TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism, including its absorption, distribution and storage. Divesiran has shown promising pre-clinical potential in several hematological disorders and is a potentially first-in-class siRNA in Phase 2 development for polycythemia vera, or PV. PV is a rare, myeloproliferative neoplasm – a type of blood cancer – characterized by the excessive production of red blood cells, often resulting in elevated hematocrit, or HCT, levels. Elevated HCT, defined as 45% or higher, is associated with a four-times higher rate of death from cardiovascular or thrombotic events. PV is associated with a range of burdensome symptoms, including fatigue, cognitive disturbance and pruritus. Longer term, PV may also progress to myelofibrosis and acute myeloid leukemia. The aim of PV treatment is to maintain HCT less than 45%, a level that is associated with a reduced incidence of thrombosis and cardiovascular-associated death. The current standard of care includes repeated phlebotomies to reduce HCT and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and HCT. By silencing TMPRSS6 in people living with PV, divesiran aims to increase hepcidin levels and redirect iron delivery away from the bone marrow, lowering red blood cell production and potentially reducing the high red blood cell count. In the SANRECO Phase 1 clinical trial of divesiran in PV patients, divesiran lowered and maintained durable control of HCT and essentially eliminated the need for phlebotomies in phlebotomy-dependent PV patients. Importantly, divesiran was well tolerated with no dose-limiting toxicities. The SANRECO Phase 2 clinical trial is ongoing and remains on track to complete enrollment by year-end 2025. The U.S. Food and Drug Administration, or FDA, has granted divesiran Fast Track and orphan drug designations for PV. In December 2024, the European Commission, or EC, granted divesiran orphan drug designation for PV in Europe.

Current wording

Divesiran (SLN124) is our wholly owned siRNA product candidate that works by temporarily silencing TMPRSS6 expression in the liver. TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism, including its absorption, distribution and storage. Divesiran has shown promising pre-clinical potential in several hematological disorders and is a potentially first-in-class siRNA in Phase 2 development for polycythemia vera, or PV. PV is a rare, myeloproliferative neoplasm – a type of blood cancer – characterized by the excessive production of red blood cells, often resulting in elevated hematocrit, or HCT, levels. Elevated HCT, defined as 45% or higher, is associated with a four-times higher rate of death from cardiovascular or thrombotic events. PV is associated with a range of burdensome symptoms, including fatigue, cognitive disturbance and pruritus. Longer term, PV may also progress to myelofibrosis and acute myeloid leukemia. The aim of PV treatment is to maintain HCT less than 45%, a level that is associated with a reduced incidence of thrombosis and cardiovascular-associated death. The current standard of care includes repeated phlebotomies to reduce HCT and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and HCT. By silencing TMPRSS6 in people living with PV, divesiran aims to increase hepcidin levels and redirect iron delivery away from the bone marrow, lowering red blood cell production and potentially reducing the high red blood cell count. In the SANRECO Phase 1 clinical trial of divesiran in PV patients, divesiran lowered and maintained durable control of HCT and essentially eliminated the need for phlebotomies in phlebotomy-dependent PV patients. Importantly, divesiran was well tolerated with no dose-limiting toxicities. The ongoing SANRECO Phase 2 clinical trial is fully enrolled, and we anticipate the announcement of initial topline results from the trial in the third quarter of 2026. The U.S. Food and Drug Administration, or FDA, has granted divesiran Fast Track and orphan drug designations for PV. In December 2024, the European Commission, or EC, granted divesiran orphan drug designation for PV in Europe.

Previous wording

based registry study in over 16,000 individuals showed that there is substantial risk of major cardiovascular events in individuals with elevated levels below the current accepted risk threshold of 125 nmol/L. Guidelines from the European Atherosclerosis Society and Canadian Cardiovascular Society suggest at least one test in an adult lifetime. The American College of Cardiology, or ACC, and American Heart Association, or AHA, recommend testing for those with a family history of premature atherosclerotic cardiovascular disease, or ASCVD, or personal history of ASCVD. In Phase 1 and Phase 2 clinical trials, zerlasiran substantially lowered Lp(a) levels in ASCVD patients with persisting effects following infrequent dosing. Importantly, zerlasiran was well tolerated with no major safety concerns. During the fourth quarter of 2024, we received positive regulatory feedback from the FDA and European Medicines Agency, or EMA, on the Phase 3 cardiovascular, or CV, outcomes study design for zerlasiran in patients with high Lp(a). We are engaged in global partnership discussions to seek a third-party partner for potential Phase 3 development of zerlasiran as well as potential future commercialization activities.

Current wording

based registry study in over 16,000 individuals showed that there is substantial risk of major cardiovascular events in individuals with elevated levels below the current accepted risk threshold of 125 nmol/L. Guidelines from the European Atherosclerosis Society and Canadian Cardiovascular Society suggest at least one test in an adult lifetime. The American College of Cardiology, or ACC, and American Heart Association, or AHA, recommend testing for those with a family history of premature atherosclerotic cardiovascular disease, or ASCVD, or personal history of ASCVD. In Phase 1 and Phase 2 clinical trials, zerlasiran substantially lowered Lp(a) levels in ASCVD patients with persisting effects following infrequent dosing. Importantly, zerlasiran was well tolerated with no major safety concerns. We received positive regulatory feedback from the FDA and European Medicines Agency, or EMA, on the Phase 3 cardiovascular, or CV, outcomes study design for zerlasiran in patients with high Lp(a). We have completed core Phase 3 readiness activities, including manufacturing and supply scale up, and we are seeking a third-party partner for Phase 3 development of zerlasiran as well as potential future commercialization.

Previous wording

In October 2021, we announced a collaboration agreement with Hansoh, or the Hansoh Collaboration, one of the leading biopharmaceutical companies in China, to develop siRNAs for three undisclosed targets leveraging our proprietary mRNAi GOLD™ platform. Under the terms of the Hansoh Collaboration, Hansoh had the exclusive option to license rights to the first two targets in Greater China, Hong Kong, Macau and Taiwan following the completion of Phase 1 trials. We retained exclusive rights for those two targets in all other territories. We were responsible for all activities up to option exercise and will retain responsibility for development outside the China region post Phase 1 trials. Hansoh also had the exclusive option to license global rights to a third target at the point of Investigational New Drug filing. Hansoh was responsible for all development activities post option exercise for the third target. Hansoh made a $16 million upfront payment to us in December 2021. We achieved our first $2 million research milestone payment in the Hansoh collaboration in April 2022. In 2023, we achieved two additional preclinical milestones and received $4 million from the Hansoh Collaboration. In 2024, we achieved an additional preclinical milestone of $2.0 million from the Hansoh Collaboration. In December 2024, Hansoh notified us that it will not pursue further development under the Hansoh Collaboration. This represented the conclusion of all required development activities and commitments under the terms of the Hansoh Collaboration and we will retain exclusive rights globally for all three targets.

Current wording

In October 2021, we announced a collaboration agreement with Hansoh, or the Hansoh Collaboration, one of the leading biopharmaceutical companies in China, to develop siRNAs for three undisclosed targets leveraging our proprietary mRNAi GOLD™ platform. Under the terms of the Hansoh Collaboration, Hansoh had the exclusive option to license rights to the first two targets in Greater China, Hong Kong, Macau and Taiwan following the completion of Phase 1 trials. We retained exclusive rights for those two targets in all other territories. We were responsible for all activities up to option exercise and will retain responsibility for development outside the China region post Phase 1 trials. Hansoh also had the exclusive option to license global rights to a third target at the point of Investigational New Drug filing. Hansoh was responsible for all development activities post option exercise for the third target. Hansoh made a $16 million upfront payment to us in December 2021. We achieved our first $2 million research milestone payment in the Hansoh collaboration in April 2022. In 2023, we achieved two additional preclinical milestones and received $4 million from the Hansoh Collaboration. In 2024, we achieved an additional preclinical milestone of $2.0 million from the Hansoh Collaboration. In December 2024, Hansoh notified us that it will not pursue further development under the Hansoh Collaboration. This represented the conclusion of all required development activities and commitments under the terms of the Hansoh Collaboration. We retain exclusive rights globally for all three targets.

Previous wording

In March 2024, Mallinckrodt notified us that they will not pursue further development of the SLN501 program following the completion of the Phase 1 clinical trial. The completion of the Phase 1 clinical trial also represented the conclusion of all required development activities and commitments under the terms of the Mallinckrodt Collaboration. During the six months ended June 30, 2025, we did not recognize revenue under the Mallinckrodt Collaboration (six months ended June 30, 2024: $0.7 million).

Current wording

In March 2024, Mallinckrodt notified us that they will not pursue further development of the SLN501 program following the completion of the Phase 1 clinical trial. The completion of the Phase 1 clinical trial also represented the conclusion of all required development activities and commitments under the terms of the Mallinckrodt Collaboration. During the nine months ended September 30, 2025, we did not recognize revenue under the Mallinckrodt Collaboration (nine months ended September 30, 2024: $0.6 million).

Previous wording

Under the AstraZeneca Collaboration , we received an upfront cash payment of $20.0 million and an additional payment of $40.0 million in May 2021. We are also eligible to receive specified development and commercial milestone payments as well as tiered royalties on net sales, if any. We recognize the upfront payment and milestone payments over time. During the six months ended June 30, 2025, we recognized a total of $0.4 million in revenue under the AstraZeneca Collaboration (six months ended June 30, 2024: $15.0 million).

Current wording

Under the AstraZeneca Collaboration, we received an upfront cash payment of $20.0 million and an additional payment of $40.0 million in May 2021. We are also eligible to receive specified development and commercial milestone payments as well as tiered royalties on net sales, if any. We recognize the upfront payment and milestone payments over time. During the nine months ended September 30, 2025, we recognized a total of $0.5 million in revenue under the AstraZeneca Collaboration (nine months ended September 30, 2024: $16.3 million).

Previous wording

Under the Hansoh Collaboration, we received an upfront cash payment of approximately $16.0 million (net of taxes based on the exchange rate at the payment date) in December 2021. In December 2024, Hansoh notified us that it will not pursue further development under the Hansoh Collaboration. This represented the conclusion of all required development activities and commitments under the terms of the Hansoh Collaboration. During the six months ended June 30, 2025, we did not recognize revenue under the Hansoh Collaboration (six months ended June 30, 2024: $0.6 million).

Current wording

Under the Hansoh Collaboration, we received an upfront cash payment of approximately $16.0 million (net of taxes based on the exchange rate at the payment date) in December 2021. In December 2024, Hansoh notified us that it will not pursue further development under the Hansoh Collaboration. This represented the conclusion of all required development activities and commitments under the terms of the Hansoh Collaboration. During the nine months ended September 30, 2025, we did not recognize revenue under the Hansoh Collaboration (nine months ended September 30, 2024: $1.0 million).

Previous wording

In December 2018, we entered into a settlement and license agreement with Alnylam Pharmaceuticals Inc., or Alnylam, pursuant to which we settled outstanding patent litigation with Alnylam related to its RNAi product ONPATTRO. As part of the settlement, we license specified patents to Alnylam, and Alnylam pays us a tiered royalty of up to one percent of net sales of ONPATTRO in the European Union. We were eligible to receive these royalties until December 2023. We invoice Alnylam quarterly in arrears based on sales data for that quarter as reported to us by Alnylam. Royalty revenue is recognized based on the level of sales when the related sales occur. During the six months ended June 30, 2025, we did not recognized any royalty income from Alnylam (six months ended June 30, 2024: $0.1 million).

Current wording

In December 2018, we entered into a settlement and license agreement with Alnylam Pharmaceuticals Inc., or Alnylam, pursuant to which we settled outstanding patent litigation with Alnylam related to its RNAi product ONPATTRO. As part of the settlement, we license specified patents to Alnylam, and Alnylam pays us a tiered royalty of up to one percent of net sales of ONPATTRO in the European Union. We were eligible to receive these royalties until December 2023. We invoice Alnylam quarterly in arrears based on sales data for that quarter as reported to us by Alnylam. Royalty revenue is recognized based on the level of sales when the related sales occur. During the nine months ended September 30, 2025, we did not recognize any royalty income from Alnylam (nine months ended September 30, 2024: $0.1 million).

Previous wording

General and administrative expenses consist of personnel costs, allocated expenses and other expenses for outside professional services, including legal, audit, tax and accounting services, public relations and investor relations services. Personnel costs consist of salaries, bonuses, benefits, recruitment costs and share-based payment expenses for personnel in executive, finance, business development and other support functions. Other administrative expenses include office space-related costs not otherwise allocated to research and development costs, insurance expenses, and costs of our information systems and costs for compliance with the day-to-day requirements of being a public company listed in the United States. We will continue to be prudent with administrative expenses required to support our continued research and development and potential commercialization of our product candidates. We also will continue to incur expenses related to being a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance expenses, expenses related to investor relations activities and other administrative and professional services.

Current wording

General and administrative expenses consist of personnel costs, allocated expenses and other expenses for outside professional services, including legal, audit, tax and accounting services, public relations and investor relations services. Personnel costs consist of salaries, bonuses, benefits, recruitment costs and share-based payment expenses for personnel in executive, finance, business development and other support functions. Other administrative expenses include office space-related costs not otherwise allocated to research and development costs, insurance expenses, and costs of our information systems and costs for compliance with the day-to-day requirements of being a public company listed in the United States. We will continue to be prudent with administrative expenses required to support our continued research and development and potential commercialization of our product candidates. We also will continue to incur expenses related to being a public company, including expenses related to compliance with the rules and regulations of the SEC and the Nasdaq Stock Market, or Nasdaq, additional insurance expenses, expenses related to investor relations activities and other administrative and professional services.

Previous wording

We have incurred non-recurring restructuring charges associated with a reduction in force during the three month period ended June 30, 2025.

Current wording

We have incurred non-recurring restructuring charges associated with a limited reduction in workforce during the nine month period ended September 30, 2025.

Previous wording

Unsurrendered U.K. tax losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to $6.5 million (£5.0 million) plus an incremental 50% of U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $214.7 million as of June 30, 2025 ($203.6 million as of June 30, 2024). However, in the event of a change in ownership of a U.K. company, certain provisions may apply to restrict the utilization of carried forward tax losses in future periods. These provisions apply where there is a major change in the nature or conduct of a trade in connection with the change in ownership. For the avoidance of doubt, we do not recognize a deferred tax asset in respect of the accumulated tax losses. In addition to our accumulated tax losses in the United Kingdom, we also had $52.6 million of accumulated tax losses as of June 30, 2025 ($51.2 million as of June 30, 2024), related to our operations in Germany for corporate income taxes. We also had $50.9 million of accumulated losses related to trade taxes in our German entity ($49.7 million as of June 30, 2024). We had a foreign tax expense in Germany of nil for the six months ended June 30, 2025 (six months ended June 30, 2024: $0.3 million). Tax losses in the United States were negligible.

Current wording

Unsurrendered U.K. tax losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to $6.5 million (£5.0 million) plus an incremental 50% of U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $221.0 million as of September 30, 2025 ($236.8 million as of September 30, 2024). However, in the event of a change in ownership of a U.K. company, certain provisions may apply to restrict the utilization of carried forward tax losses in future periods. These provisions apply where there is a major change in the nature or conduct of a trade in connection with the change in ownership. For the avoidance of doubt, we do not recognize a deferred tax asset in respect of the accumulated tax losses. In addition to our accumulated tax losses in the United Kingdom, we also had $52.3 million of accumulated tax losses as of September 30, 2025 ($52.7 million as of September 30, 2024), related to our operations in Germany for corporate income taxes. We also had $50.6 million of accumulated losses related to trade taxes in our German entity ($51.1 million as of September 30, 2024). We had a foreign tax expense in Germany of nil for the nine months ended September 30, 2025 (nine months ended September 30, 2024: $0.03 million). Tax losses in the United States were negligible.

Previous wording

Value Added Tax, or VAT, is charged on all qualifying goods and services by VAT-registered businesses. Where applicable, an amount of 20% of goods and services is added to all sales invoices and is payable to the U.K. tax authorities. Similarly, VAT paid on purchase invoices is reclaimable from the U.K. tax authorities.

Current wording

Value Added Tax, or VAT, is charged on all qualifying goods and services by VAT-registered businesses. Where U.K. VAT applies at a standard rate, an amount of 20% of goods and services is added to all sales invoices and is payable to the U.K. tax authorities. Similarly, U.K. VAT paid on purchase invoices may be reclaimable from the U.K. tax authorities.

Previous wording

Comparison of the three months and six months ended June 30, 2025, and 2024

Current wording

Comparison of the three months and nine months ended September 30, 2025, and 2024

Previous wording

The following table summarizes the results of our operations for the three months and six months ended June 30, 2025, and 2024 (in thousands).

Current wording

The following table summarizes the results of our operations for the three months and nine months ended September 30, 2025, and 2024 (in thousands).

Previous wording

Revenue for the three months ended June 30, 2025 was $0.2 million, reflecting a decrease of $0.5 million as compared to the same period in 2024. This change was mainly due to the lessened work under the Hansoh Collaboration as we have concluded all required development activities and commitments under the terms of the Hansoh Collaboration in 2024.

Current wording

Revenue for the three months ended September 30, 2025 was $0.2 million, reflecting a decrease of $1.3 million as compared to the same period in 2024. This change was mainly due to a decrease in activity associated with the AstraZeneca Collaboration. Revenue associated with the Hansoh Collaboration also decreased as we have concluded all required development activities and commitments under the terms of the Hansoh Collaboration in 2024.

Previous wording

Cost of sales decreased $3.2 million for the three months ended June 30, 2025, as compared to the same period in 2024. The change was due to activity associated with our collaboration agreements, which fluctuates based on the timing of activities and project progression.

Current wording

Cost of sales decreased $3.6 million for the three months ended September 30, 2025, as compared to the same period in 2024. The change was due to activity associated with our collaboration agreements, which fluctuates based on the timing of activities and project progression.

Previous wording

Cost of sales decreased $6.0 million for the six months ended June 30, 2025, as compared to the same period in 2024. The change was due to activity associated with our collaboration agreements, which fluctuates based on the timing of activities and project progression.

Current wording

Cost of sales decreased $9.6 million for the nine months ended September 30, 2025, as compared to the same period in 2024. The change was due to activity associated with our collaboration agreements, which fluctuates based on the timing of activities and project progression.

Previous wording

The following table summarizes our research and development costs for the three and six months ended June 30, 2025 and 2024, based on their classification (in thousands).

Current wording

The following table summarizes our research and development costs for the three and nine months ended September 30, 2025 and 2024, based on their classification (in thousands).

Previous wording

Research and development costs increased by $3.8 million for the three months ended June 30, 2025, and $12.8 million for the six months ended June 30, 2025, as compared to the same periods in 2024. This was largely due to advancement of our proprietary programs; primarily the Phase 2 clinical trial for diversiran and an increase in contract manufacturing activities related to our zerlasiran Phase 3 readiness.

Current wording

Research and development costs for the nine months ended September 30, 2025 increased by $13.2 million to $59.0 million, as compared to the same period in 2024 due to an increase in contracted development costs of $12.3 million. This was largely due to advancement of our proprietary programs, including specifically our Phase 2 clinical trial for divesiran and an increase in costs related to contract manufacturing activities related to our zerlasiran Phase 3 readiness.

Previous wording

General and administrative expenses decreased by $1.9 million for the three months ended June 30, 2025, and $0.8 million for the six months ended June 30, 2025, as compared to the same periods in 2024. This was mainly due to a reduction in reporting and compliance requirements as we no longer expected to be a large accelerated filer in 2026. This was also due to an effort to reduce administrative costs in connection with our restructuring.

Current wording

General and administrative expenses decreased by $1.9 million for the three months ended September 30, 2025, and $2.7 million for the nine months ended September 30, 2025, as compared to the same periods in 2024. These decreases were mainly due to a reduction in SEC reporting and compliance requirements as we determined as of June 30, 2025 that we will not meet the eligibility criteria to be a large accelerated filer in fiscal year 2026. This was also due to an effort to reduce administrative costs in connection with our restructuring.

Previous wording

We have incurred non-recurring restructuring charges associated with a limited reduction in force, which took place during the three months ended June 30, 2025.

Current wording

We have incurred non-recurring restructuring charges associated with a limited reduction in workforce, which was implemented in June 2025.

Previous wording

Net foreign exchange gains and losses result primarily from foreign currency (USD and EUR) denominated bank accounts. The foreign exchange losses in the current year were primarily due to remeasurement of U.S. treasury bills held in USD to the related functional currency.

Current wording

Net foreign exchange gains and losses result primarily from foreign currency (USD and EUR) denominated bank accounts. The foreign exchange losses and gains in the current year were primarily due to remeasurement of U.S. treasury bills held in USD to the related functional currency.

Previous wording

Benefit from R&D tax credit relates to U.K. research and development tax credits.

Current wording

Benefit from R&D tax credit relates to U.K. research and development tax credits. The decrease in benefit in the current year was mainly related to changes in the U.K R&D tax credit regime which apply in respect of accounting periods commencing on or after April 1, 2024. These changes led to a reduction in costs that are eligible for the claim.

Previous wording

Since our inception, we have incurred significant operating losses and negative cash flows. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our research and development and administrative expenses will increase in connection with conducting clinical trials and seeking marketing approval for our product candidates, as well as costs associated with operating as a public company. As a result, we will need additional capital to fund our operations in the future, which we may obtain from additional equity financings, debt financings, research funding, collaborations, contract and grant revenue or other sources.

Current wording

Since our inception, we have incurred significant operating losses and negative cash flows. We anticipate that we will continue to incur losses for the foreseeable future. We expect to continue to incur expenses in connection with our ongoing research and development activities related to our product candidates, including outsourced manufacturing activities and other associated costs. We also expect to continue to incur costs associated with operating as a domestic issuer listed on Nasdaq. As a result, we will need additional capital to fund our operations in the future, which we may obtain from additional equity financings, debt financings, research funding, collaborations, contract and grant revenue or other sources.

Previous wording

As of June 30, 2025, we had cash, cash equivalents, and short-term investments of $114.2 million. We believe that our cash, cash equivalents, and treasury instruments will be sufficient to fund our anticipated operating and capital expenditure requirements into 2028, which includes receipt of anticipated milestones from collaboration agreements in the aggregate amount of $20 million in the next three years.

Current wording

As of September 30, 2025, we had cash, cash equivalents, and short-term investments of $102.2 million. We believe that our cash, cash equivalents, and treasury instruments will be sufficient to fund our anticipated operating and capital expenditure requirements into 2028, which includes receipt of anticipated milestones from collaboration agreements in the aggregate amount of $20.0 million in the next three years.

Previous wording

The following table summarizes the results of our cash flows for the six months ended June 30, 2025 and 2024.

Current wording

The following table summarizes the results of our cash flows for the nine months ended September 30, 2025 and 2024.

Previous wording

Net cash outflow from operating activities increased by $19.5 million for the six months ended June 30, 2025, compared with the prior period, mainly due to a reduction in milestones from our collaboration agreements. In the six months ended June 30, 2024, we received a $10 million milestone payment pursuant to the terms of the AstraZeneca Collaboration. This remainder was due to an increase in expenditures related to contracted development costs associated with our clinical studies.

Current wording

Net cash outflow from operating activities increased by $4.8 million for the nine months ended September 30, 2025, as compared with the prior period, mainly due to a reduction in milestone payments received pursuant to the terms of our collaboration agreements. In the nine months ended September 30, 2024, we received a $10.0 million milestone payment pursuant to the terms of the AstraZeneca Collaboration and there was no related cash inflow in the nine months ended September 30, 2025.

Previous wording

Net cash outflow from investing activities relates to purchases of U.S. treasury bills offset by redemptions for the six months ended June 30, 2025.

Current wording

Net cash outflow from investing activities relates to redemptions of U.S. treasury bills offset by purchases for the nine months ended September 30, 2025.

Previous wording

We have not achieved profitability on an annual basis since our inception, and we expect to incur net losses in the future. We expect that our operating expenses will increase as we continue to invest to grow our product candidate pipeline, hire additional employees and increase research and development expenses.

Current wording

We have not achieved profitability on an annual basis since our inception, and we expect to incur net losses in the future. We expect to continue to incur expenses in connection with our ongoing research and development activities related to our product candidates, including outsourced manufacturing activities and other associated costs. We also expect to continue to incur costs associated with operating as a domestic filer listed on Nasdaq.

Previous wording

The lease liability recognized on the balance sheet comprises our London office. Our balance sheet also reflects two short-term leases in Berlin, Germany and a lease in New Jersey, United States, neither of which is included in the "lease liability" line of the table above. Both leases in Berlin are on a rolling contract basis with either party being able to end the lease with a cancellation notice period of 11.5 months, while the leases in the United States are on a rolling contract basis with a notice period of three months, thus allowing exemption using the practical expedient.

Current wording

The lease liability recognized on the balance sheet comprises our London office. Our balance sheet also reflects two short-term leases in Berlin, Germany and a lease in New Jersey, United States, neither of which is included in the "lease liability" line of the table above. Both leases in Berlin are on a rolling contract basis with either party being able to end the lease with a cancellation notice period of 11.5 months, while the leases in the United States are on a rolling contract basis with a notice period of three months, thus allowing the exemption for short-term leases.

Previous wording

During the six months ended June 30, 2025, a significant portion of our revenue from collaboration agreements was derived from the AstraZeneca Collaboration (six months ended June 30, 2024, revenue was from our collaborations with Mallinckrodt, AstraZeneca, and Hansoh).

Current wording

During the nine months ended September 30, 2025, our revenue from collaboration agreements was derived from the AstraZeneca Collaboration (nine months ended September 30, 2024, revenue was from our collaborations with Mallinckrodt, AstraZeneca, and Hansoh).

Previous wording

For the six months ended June 30, 2025 and 2024, we determined actual costs and forecast costs for the remainder of the contract. We calculated total contract costs across the contract term, including costs that will be reimbursed to us, and costs incurred to date as a percentage of total contract costs. We multiplied this percentage by the consideration deemed highly probable of not having a significant reversal, calculating the cumulative revenue to be recognized. When variable consideration increases due to a further milestone becoming highly probable that a significant reversal of revenue will not occur, a catch-up in revenue is recorded to reflect efforts already expended by us up to that point.

Current wording

For the nine months ended September 30, 2025 and 2024, we determined actual costs and forecast costs for the remainder of the contract. We calculated total contract costs across the contract term, including costs that will be reimbursed to us, and costs incurred to date as a percentage of total contract costs. We multiplied this percentage by the consideration deemed highly probable of not having a significant reversal, calculating the cumulative revenue to be recognized. When variable consideration increases due to a further milestone becoming highly probable that a significant reversal of revenue will not occur, a catch-up in revenue is recorded to reflect efforts already expended by us up to that point.

Previous wording

We discuss the effect of recently issued and adopted pronouncements in Note 2.20 “Summary of Significant Accounting Policies” to the condensed consolidated financial statements.

Current wording

We discuss the effect of recently issued and adopted pronouncements in Note 2.20, “Summary of Significant Accounting Policies” to the condensed consolidated financial statements in our Annual Report.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Quarterly Report on Form 10-Q.

Previous report — wording carried elsewhere

We have completed core Phase 3 readiness activities for our zerlasiran program, including manufacturing and supply scale-up. We continue to be in dialogues with potential third-party partners for Phase 3 development of zerlasiran as well as potential future commercialization activities.