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COMPASS Pathways plc

For the period ended Sep 30, 2026. Filed Nov 3, 2026.

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, 2026 · Filed Nov 3, 2026

CMPS$8.61+10.2%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 2026-06-30; filed 2026-08-05.

0001816590-26-000058

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

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-03.

0001816590-26-000076

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.

94 unchanged; 40 reworded; 9 added; 9 removed; 3 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (9)

Current report

In September 2026, we announced Part C results from our Phase 3 COMP005 trial. The open-label Part C data demonstrate the following: (i) notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at week 52 and extended out to 1 year for participants who were randomized to the 25 mg arm and received an additional dose in Part C; (ii) for participants in the Placebo arm who received their first dose of COMP360 25 mg in Part C, these findings further reinforce that a single dose of 25 mg has the potential to produce rapid onset, meaningful effect and durability; (iii) for all participants in Part C who received a 25 mg dose, strong response and remission rates were observed with 40%-45% responders and approximately 30% remitters across all timepoints in the 6 weeks post the Part C dose; and (iv) the COMP360 safety profile in Part C is consistent with Parts A and B and continues to show a generally well-tolerated and safe profile with no new safety findings.

Current report

Comparison for the Three and Nine months ended September 30, 2026 and 2025

Current report

For the three and nine months ended September 30, 2026, the increase in selling, general and administrative expenses, as compared to the same periods in 2025, was primarily attributable to commercial readiness activities in advance of potential FDA approval and commercialization of COMP360 for TRD, including investments in commercial infrastructure, market access and reimbursement capabilities, supply chain readiness and other launch preparation activities, as follows:
Removed paragraphs (9)

Previous report

Comparison for the Three and Six months ended June 30, 2026 and 2025

Previous report

For the three months ended June 30, 2026, the increase in general and administrative expenses, as compared to the same periods in 2025, was primarily attributable to the following:

Previous report

For the six months ended June 30, 2026, the increase in general and administrative expenses, as compared to the same period in 2025, was primarily attributable to the following:

Previous report

•continue to advance our Phase 3 program for investigational COMP360 psilocybin treatment in TRD and clinical and preclinical supporting studies and continue preparing our rolling NDA submission;
Reworded paragraphs (40)

Previous wording

Our lead development program is in TRD, comprising patients who are inadequately served by current treatment options. In 2018, we received Breakthrough Therapy designation from the U.S. Food and Drug Administration, or the FDA for COMP360 for the treatment of TRD. In November 2021, we announced positive top-line results from our Phase 2b clinical trial evaluating COMP360 for the treatment of TRD. On November 3, 2022, The New England Journal of Medicine published the positive results from our Phase 2b trial. This is the largest, randomized, controlled, double-blind psilocybin treatment clinical trial completed to date. The objective of the Phase 2b study was to evaluate the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. The trial achieved its primary endpoint for the 25mg dose, with a 25mg dose of COMP360 demonstrating a statistically significant and clinically relevant treatment difference against the 1mg dose of COMP360 in reducing depressive symptom severity after three weeks.

Current wording

Our lead development program is in TRD, comprising patients who are inadequately served by current treatment options. In 2018, we received Breakthrough Therapy designation from the U.S. Food and Drug Administration, or the FDA for COMP360 for the treatment of TRD. In November 2021, we announced positive top-line results from our Phase 2b clinical trial evaluating COMP360 for the treatment of TRD. On November 3, 2022, The New England Journal of Medicine published the positive results from our Phase 2b trial. At the time of its completion, this was the largest, randomized, controlled, double-blind psilocybin treatment clinical trial. The objective of the Phase 2b study was to evaluate the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD. The trial achieved its primary endpoint for the 25mg dose, with a 25mg dose of COMP360 demonstrating a statistically significant and clinically relevant treatment difference against the 1mg dose of COMP360 in reducing depressive symptom severity after three weeks.

Previous wording

In June 2025, we reported that the first pivotal trial, the COMP005 trial, achieved its primary endpoint, with a single 25mg dose of COMP360 versus placebo demonstrating a highly statistically significant reduction in symptom severity as measured by MADRS with a p-value of p<0.001 and a clinically meaningful difference of -3.6 in change at six weeks. The COMP005 trial is on-going and is comprised of three parts: Part A, which concluded during the second quarter of 2025, and was blinded through 6 weeks; Part B, which remained blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.

Current wording

In June 2025, we reported that the first pivotal trial, the COMP005 trial, achieved its primary endpoint, with a single 25mg dose of COMP360 versus placebo demonstrating a highly statistically significant reduction in symptom severity as measured by MADRS with a p-value of p<0.001 and a clinically meaningful difference of -3.6 in change at six weeks. The COMP005 trial was comprised of three parts: Part A, which concluded during the second quarter of 2025, and was blinded through 6 weeks; Part B, which remained blinded through week 26; and Part C, which contained an open-label treatment part from week 26 to 52.

Previous wording

In February 2026, we announced the successful achievement of the primary endpoint in our ongoing Phase 3 COMP006 trial and Part B results from our Phase 3 COMP005 trial. We reported that the COMP006 trial achieved its primary endpoint with two fixed doses, administered 3 weeks apart, of COMP360 25 mg versus 1 mg demonstrating a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in change at six weeks.

Current wording

In February 2026, we announced the successful achievement of the primary endpoint in our Phase 3 COMP006 trial and Part B results from our Phase 3 COMP005 trial. We reported that the COMP006 trial achieved its primary endpoint with two fixed doses, administered 3 weeks apart, of COMP360 25 mg versus 1 mg demonstrating a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in change at six weeks.

Previous wording

In July 2026, we announced Part B results from our ongoing Phase 3 COMP006 trial, which confirm COMP360’s rapid onset and durable profile. The 26-week findings from our Phase 3 COMP006 trial build on previously reported results from our Phase 3 COMP005 trial, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD.

Current wording

In July 2026, we announced Part B results from our Phase 3 COMP006 trial, which confirm COMP360’s rapid onset and durable profile. The 26-week findings from our Phase 3 COMP006 trial build on previously reported results from our Phase 3 COMP005 trial, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD.

Previous wording

Since our formation, we have devoted substantially all of our resources to conducting preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital and establishing our intellectual property portfolio. We do not have any therapeutic candidates approved for sale and have not generated any revenue. We have funded our operations primarily with proceeds from the sale of our ordinary shares and ADSs in public and private equity offerings, including in our offerings pursuant to our at-the-market, or ATM, offering program, and proceeds from a loan agreement with Hercules, or the Hercules Loan Agreement.

Current wording

Since our formation, we have devoted substantially all of our resources to conducting nonclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital and establishing our intellectual property portfolio. We do not have any therapeutic candidates approved for sale and have not generated any revenue. We have funded our operations primarily with proceeds from the sale of our ordinary shares and ADSs in public and private equity offerings, including in our offerings pursuant to our at-the-market, or ATM, offering program, and proceeds from a loan agreement with Hercules, or the Hercules Loan Agreement.

Previous wording

We have incurred recurring operating losses since our inception. While we reported net income in certain periods, those results were attributable to non-recurring, non-cash items rather than ongoing operations. For the six months ended June 30, 2026 and 2025, we recognized net losses of $162.6 million and $56.3 million, respectively. In addition, as of June 30, 2026, we had an accumulated deficit of $985.2 million. Our historical losses have resulted principally from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. In the future, we intend to continue to conduct research and development, preclinical testing, clinical trials, regulatory compliance, market access and commercialization activities that, together with anticipated general and administrative expenses, will result in incurring further significant losses until such time as we can generate revenue from sales of COMP360 or other therapeutic candidates sufficient to sustain profitability, if ever. Our operating losses stem primarily from the development of our investigational COMP360 psilocybin treatment for TRD, and we expect they will continue to increase as we complete our Phase 3 program in TRD for our investigational COMP360 psilocybin treatment candidate, continue preparing our rolling NDA submission and prepare for a potential commercial launch, among other activities. In addition, our spending in the future may also increase as we advance our Phase 2b/3 clinical trial in PTSD, or if we choose to expand into additional indications, or initiate the development for different therapeutic candidates. Furthermore, since the completion of our IPO, we have incurred, and expect to continue to incur, significant costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. As a result, we will need additional funding in the longer term to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of COMP360 or other therapeutic candidates, if ever, we expect tofinance our operations through a combination of equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

Current wording

We have incurred recurring operating losses since our inception. While we reported net income in certain periods, those results were attributable to non-recurring, non-cash items rather than ongoing operations. For the nine months ended September 30, 2026 and 2025, we recognized net losses of $172.4 million and $194.0 million, respectively. In addition, as of September 30, 2026, we had an accumulated deficit of $995.0 million. Our historical losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. In the future, we intend to continue to conduct research and development, nonclinical testing, clinical trials, regulatory compliance, market access and commercialization activities that, together with anticipated selling, general and administrative expenses, will result in incurring further significant losses until such time as we can generate revenue from sales of COMP360 or other therapeutic candidates sufficient to sustain profitability, if ever. Our operating losses stem primarily from the development of our investigational COMP360 psilocybin treatment for TRD, and we expect they will continue to increase as we complete our rolling NDA submission and prepare for a potential commercial launch, among other activities. In addition, our spending in the future may also increase as we advance our Phase 2b/3 clinical trial in PTSD, or if we choose to expand into additional indications, or initiate the development for different therapeutic candidates. Furthermore, since the completion of our IPO, we have incurred, and expect to continue to incur, significant costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. As a result, we will need additional funding in the longer term to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of COMP360 or other therapeutic candidates, if ever, we expect tofinance our operations through a combination of equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

Previous wording

As of June 30, 2026, we had cash and cash equivalents of$433.3 million. We believe that our existing cash and cash equivalents will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources—Funding Requirements” below.

Current wording

As of September 30, 2026, we had cash and cash equivalents of$444.0 million. We believe that our existing cash and cash equivalents will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources—Funding Requirements” below.

Previous wording

We continue to monitor current macroeconomic and geopolitical events, including, among others, financial and economic conditions (such as fluctuating inflation and interest rates, and fluctuations in foreign exchange rates) and the risk of an economic slowdown or recession in the U.S., significant changes in U.S. policies or regulatory environment or disruption to U.S. government agencies, and significant changes in geopolitics and international tensions (such as from the effects from announced or future tariff increases, the war between Ukraine and Russia and conflict in the Middle East), for any potential impact that these or other events or conditions may have on our business.

Current wording

We continue to monitor current macroeconomic and geopolitical events, including, among others, financial and economic conditions (such as fluctuating inflation and interest rates, and fluctuations in foreign exchange rates) and the risk of an economic slowdown or recession in the U.S., significant changes in U.S. policies or regulatory environment or disruption to U.S. government agencies, and significant changes in geopolitics and international tensions (such as from the effects from changes in trade policy, announced or future tariff increases, the war between Ukraine and Russia and conflict in the Middle East), for any potential impact that these or other events or conditions may have on our business.

Previous wording

14401, “Accelerating Medical Treatments for Serious Mental Illness,” issued on April 18, 2026, which seeks to expedite research, regulatory review, and patient access to psychedelic therapies for serious mental health conditions, the Trump administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of our current product or future products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. In addition, the ability of the DEA to inspect clinical trial sites and issue controlled substance licenses to our clinical trial sites in a timely manner and the ability of the FDA to review and clear or approve new products has in the past and may in the future be affected by changes in government budget and funding levels, the ability of the government to hire and retain key personnel, and shifting policy priorities. If we become negatively impacted by future governmental orders, regulations, policies or guidance or a prolonged government shutdown, there could be a material adverse effect on us and our business.

Current wording

Changes in policy or resources of governmental agencies, including, but not limited to, changes at the FDA, DEA, SEC, IRS and U.S. Patent and Trademark Office, could impact our business and results of operations. Despite Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” issued on April 18, 2026, which seeks to expedite research, regulatory review, and patient access to psychedelic therapies for serious mental health conditions, the Trump administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of our current product or future products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. In addition, the ability of the DEA to inspect clinical trial sites and issue controlled substance licenses to our clinical trial sites in a timely manner and the ability of the FDA to review and clear or approve new products has in the past and may in the future be affected by changes in government budget and funding levels, the ability of the government to hire and retain key personnel, and shifting policy priorities. If we become negatively impacted by future governmental orders, regulations, policies or guidance or a prolonged government shutdown, there could be a material adverse effect on us and our business.

Previous wording

Research and development activities are central to our business model. Product or therapeutic candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials and related product manufacturing expenses. As a result, we expect that our research and development expenses will increase as we seek to complete the clinical development for our investigational COMP360 psilocybin treatment for TRD, we continue our rolling NDA submission and prepare for regulatory filings related to our COMP360 psilocybin treatment in TRD and initiate a new Phase 2b/3 clinical trial for our COMP360 psilocybin treatment in PTSD.

Current wording

Research and development activities are central to our business model. Product or therapeutic candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials and related product manufacturing expenses. Having completed clinical development of our investigational COMP360 psilocybin treatment for TRD, we expect expenses associated with our TRD program to decrease, whilst regulatory expenses associated with our rolling NDA submission are expected to increase. We expect expenses associated with our PTSD program to increase as we advance our Phase 2b/3 clinical trial of COMP360 in PTSD. As a result, the level and mix of our research and development expenses may vary as our programs progress through clinical development and regulatory review.

Previous wording

•successful completion of our Phase 3 trials in TRD and successful enrollment in and completion of our Phase 2b/3 trial in PTSD and future clinical trials;

Current wording

•successful completion of our rolling NDA submission in TRD and successful enrollment in and completion of our Phase 2b/3 trial in PTSD and future clinical trials;

Previous wording

•sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, including our Phase 3 clinical trials in TRD, and our ability to raise capital on favorable terms or at all;

Current wording

•sufficiency of our financial and other resources to complete the necessary nonclinical studies and clinical trials, including our Phase 3 clinical trials in TRD, and our ability to raise capital on favorable terms or at all;

Previous wording

A change in the outcome of any of these variables, amongst others, with respect to the development of our investigational COMP360 psilocybin treatment in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of our investigational COMP360 psilocybin treatment. For example, if the FDA, the European Medicines Agency, or EMA, the European Commission, or the EC, the Medicines and Healthcare products Regulatory Agency, or MHRA, or another regulatory authority were to require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience additional significant delays in enrollment in any of our planned clinical trials, we could be required to commit significant additional financial resources and time on the completion of clinical development of that therapeutic candidate.

Current wording

A change in the outcome of any of these variables, amongst others, with respect to the development of our investigational COMP360 psilocybin treatment in nonclinical and clinical development could mean a significant change in the costs and timing associated with the development of our investigational COMP360 psilocybin treatment. For example, if the FDA, the European Medicines Agency, or EMA, the European Commission, or the EC, the Medicines and Healthcare products Regulatory Agency, or MHRA, or another regulatory authority were to require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience additional significant delays in enrollment in any of our planned clinical trials, we could be required to commit significant additional financial resources and time on the completion of clinical development of that therapeutic candidate.

Previous wording

We anticipate we will continue to incur significant accounting, audit, legal, regulatory and compliance costs, as well as investor and public relations expenses associated with being a public company. Subject to FDA approval, we anticipate increases in both personnel and other expenses as we prepare for potential commercial operations, particularly as it relates to the planned sales and marketing activities of our therapeutic candidate.

Current wording

We anticipate we will continue to incur significant accounting, audit, legal, regulatory and compliance costs, as well as investor and public relations expenses associated with being a public company. We have also incurred, and expect to continue to incur, significant pre-commercialization expenses as we prepare for the potential commercialization of COMP360, including investments in personnel and planned sales and marketing activities. Subject to FDA approval, we expect these expenses to increase further as we build the capabilities and infrastructure necessary to support potential commercial operations.

Previous wording

Based on criteria established by His Majesty’s Revenue and Customs, or HMRC, a portion of expenditures being recognized in relation to our pipeline research and development, clinical trial management and third-party manufacturing development activities were eligible under the new merged regime for the three and six months ended June 30, 2026 and 2025. Restrictions have also been introduced on relief that may be claimed for expenditure on contracted out R&D activity where the work is undertaken outside the UK, save for certain exceptions. These restrictions and the application of the exceptions have been taken into account in the assessment of qualifying expenditure. We expect such elements to be eligible for R&D incentives in the future although there may be some limitations on expenditure on activities undertaken outside the UK.

Current wording

Based on criteria established by His Majesty’s Revenue and Customs, or HMRC, a portion of expenditures being recognized in relation to our pipeline research and development, clinical trial management and third-party manufacturing development activities was eligible under the new merged regime for the three and nine months ended September 30, 2026 and 2025. Restrictions have also been introduced on relief that may be claimed for expenditure on contracted out R&D activity where the work is undertaken outside the UK, save for certain exceptions. These restrictions and the application of the exceptions have been taken into account in the assessment of qualifying expenditure. We expect such elements to be eligible for R&D incentives in the future although there may be some limitations on expenditure on activities undertaken outside the UK.

Previous wording

Foreign exchange (losses) gains consist of foreign exchange impacts arising from foreign currency transactions, primarily related to the translation of intercompany balances, as well as bank balances held in a foreign currency.

Current wording

Foreign exchange gains (losses) consist of foreign exchange impacts arising from foreign currency transactions, primarily related to the translation of intercompany balances, as well as bank balances held in a foreign currency.

Previous wording

During the six months ended June 30, 2026 and 2025, we recorded a tax provision of $0.3 million and $0.5 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes.

Current wording

During the nine months ended September 30, 2026 and 2025, we recorded a tax benefit of $0.8 million and a tax provision of $0.3 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes.

Previous wording

For thethree and six months ended June 30, 2026, the decrease in research and development expenses, as compared to the same period in 2025, was primarily attributable to the following:

Current wording

For thethree and nine months ended September 30, 2026, the decrease in research and development expenses, as compared to the same periods in 2025, was primarily attributable to the following:

Previous wording

•a decrease in development expenses primarily due to lower clinical trial expenses as our Phase 3 program for COMP360 psilocybin therapy in TRD progresses toward completion, as well as reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the termination of related contracts in 2025.

Current wording

•a decrease in development expenses primarily due to lower clinical trial expenses following completion of our Phase 3 program for COMP360 psilocybin treatment in TRD, as well as reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the termination of related contracts in 2025.

Previous wording

Notwithstanding recent declines in R&D expenses, we expect to incur significant research and development costs at least through completion of our Phase 3 program for COMP360 psilocybin therapy in TRD and our Phase 2b/3 clinical trial in PTSD.

Current wording

Notwithstanding recent declines in R&D expenses, we expect to incur significant research and development costs as we advance our Phase 2b/3 clinical trial of COMP360 psilocybin treatment in PTSD, as well as costs related to regulatory activities for COMP360 in TRD following completion of our Phase 3 program.

Previous wording

General and administrative expenses consist of the following (in thousands):

Current wording

Selling, general and administrative expenses consist of the following (in thousands):

Previous wording

•an increase in personnel expenses as a result of increasing staffing levels to support our commercial preparedness activities; and

Current wording

•an increase in personnel and non-cash share-based compensation expenses as a result of increasing staffing levels to support our commercial preparedness activities;

Previous wording

We expect to continue to incur significant general and administrative expenses as a result of ongoing requirements as a public company, in addition to ongoing general and administrative support for research and development activities, as well as commercial preparedness activities.

Current wording

We expect to continue to incur significant selling, general and administrative expenses as a result of ongoing requirements as a public company, in addition to ongoing selling, general and administrative support for research and development activities, as well as commercial preparedness activities.We have also incurred significant pre-commercialization expenses as we prepare for the potential commercialization of COMP360 and expect these expenses to increase as we expand our commercial capabilities and advance our launch preparation activities.

Previous wording

Other (expense) income, net consists of the following (in thousands):

Current wording

Other income (expense), net consists of the following (in thousands):

Previous wording

For the three and six months ended June 30, 2026, the increase in other (expense) income, net as compared to the same periods in 2025, was primarily attributable to the following:

Current wording

For the three and nine months ended September 30, 2026, the increase in other income (expense), net as compared to the same periods in 2025, was primarily attributable to the following:

Previous wording

•the change in fair value of the warrant liabilities, primarily driven by the issuance of pre-funded warrants in connection with the February 2026 Offering, the impact of the exercise of all the outstanding warrants issued in the January 2025 Financing, with a portion of such warrants exercised for Pre-funded warrants, and stock price appreciation during the period;

Current wording

•the change in fair value of the warrant liabilities, primarily driven by the issuance of pre-funded warrants in connection with the February 2026 Offering, the impact of the exercise of all the outstanding warrants issued in the January 2025 Financing, with a portion of such warrants exercised for Pre-funded warrants, and stock price appreciation during the period; and

Previous wording

•a decrease in the benefit from R&D tax credit due to the prior year being recorded at the enhanced effective rates. The current year benefit is recorded at the non-enhanced rate due to uncertainty regarding satisfaction of the R&D intensity condition and eligibility for the enhanced effective rates, which is currently under discussion with HMRC;

Current wording

•a decrease in the benefit from R&D tax credit due to the prior year being recorded at the enhanced effective rates. The current year benefit is recorded at the non-enhanced rate due to uncertainty regarding satisfaction of the R&D intensity condition and eligibility for the enhanced effective rates, which is currently under discussion with HMRC; and

Previous wording

On February 27, 2025, we entered into a new Sales Agreement under which we may issue and sell from time to time up to $150.0 million of our ADSs, subject to the terms of the Sales Agreement. Sales of our ADSs, if any, will generally be made at market prices. Pursuant to the Sales Agreement dated February 27, 2025, through July 30, 2026, we sold 2,798,696 ADSs under the ATM offering program, resulting in $33.1 million in net proceeds.

Current wording

On February 27, 2025, we entered into a new Sales Agreement under which we may issue and sell from time to time up to $150.0 million of our ADSs, subject to the terms of the Sales Agreement. Sales of our ADSs, if any, will generally be made at market prices. Pursuant to the Sales Agreement dated February 27, 2025, through September 30, 2026, we sold 1,903,373 ADSs under the ATM offering program, resulting in $25.6 million in net proceeds.

Previous wording

Within the PIPE agreement, we agreed to sell and issue PIPE Warrants to purchase up to 16,076,750 ADSs. Each PIPE Warrant has an exercise price of $9.93 per ADS and is exercisable for a three-year period beginning in February 2024. As of June 30, 2026, PIPE Warrants had been exercised for an aggregate of 4,267,050 ADSs, resulting in proceeds of $42.4 million. During the six-months ended June 30, 2026, PIPE Warrants were exercised for an aggregate of 515,000 ADSs, resulting in proceeds of $5.1 million. We may receive up to an additional approximately $117.3 million in gross proceeds if the PIPE Warrants are fully exercised for cash.

Current wording

Within the PIPE agreement, we agreed to sell and issue PIPE Warrants to purchase up to 16,076,750 ADSs. Each PIPE Warrant has an exercise price of $9.93 per ADS and is exercisable for a three-year period beginning in February 2024. As of September 30, 2026, PIPE Warrants had been exercised for an aggregate of 8,051,411 ADSs, resulting in proceeds of $80.0 million. We may receive up to an additional approximately $79.7 million in gross proceeds if the PIPE Warrants are fully exercised for cash.

Previous wording

In January 2025, we completed the 2025 Financing in which it issued and sold ADSs and, in lieu of ADSs, Pre-funded Warrants to certain investors along with accompanying 2025 ADS Warrants to purchase ADSs. The 2025 ADS Warrants had an exercise price of $5.7960 per ADS. In February 2026, all 35,059,448 2025 ADS warrants were exercised and we received net proceeds of $203.2 million. Upon exercise of these outstanding warrants, we issued 15,160,619 ADSs and in lieu of ADSs, to certain institutional investors, Pre-funded Warrants to purchase up to 19,898,829 ADSs.

Current wording

In January 2025, we completed the 2025 Financing in which we issued and sold ADSs and, in lieu of ADSs, Pre-funded Warrants to certain investors along with accompanying 2025 ADS Warrants to purchase ADSs. The 2025 ADS Warrants had an exercise price of $5.7960 per ADS. In February 2026, all 35,059,448 2025 ADS warrants were exercised and we received net proceeds of $203.2 million. Upon exercise of these outstanding warrants, we issued 15,160,619 ADSs and in lieu of ADSs, to certain institutional investors, Pre-funded Warrants to purchase up to 19,898,829 ADSs.

Previous wording

In February 2026, we completed the February 2026 Offering, in which it issued and sold 17,500,000 ADSs at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, Pre-funded Warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per Pre-funded Warrant. We received net proceeds of approximately $140.5 million, after deducting underwriting discounts and commissions and estimated offering costs.

Current wording

In February 2026, we completed the February 2026 Offering, in which we issued and sold 17,500,000 ADSs at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, Pre-funded Warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per Pre-funded Warrant. We received net proceeds of approximately $140.5 million, after deducting underwriting discounts and commissions and estimated offering costs.

Previous wording

Net cash used in operating activities increased during the six months ended June 30, 2026, compared to the same period in 2025, primarily due to favorable working capital related activities of $16.7 million, as well as an increase of $85.7 million of non-cash adjustments, including the change in fair value of warrant liabilities of $91.6 million, which was offset by a $106.3 million increase in our net loss.

Current wording

Net cash used in operating activities increased during the nine months ended September 30, 2026, compared to the same period in 2025, primarily due to a $54.4 million decrease in non-cash adjustments, including the gain on change in fair value of warrant liabilities of $50.5 million, partially offset by favorable working capital related activities of $13.3 million and a $21.6 million decrease in our net loss.

Previous wording

Net cash provided by financing activities increased during the six months ended June 30, 2026, compared to the same period in 2025, primarily as a result of aggregate net proceeds of $370.0 million from the February 2026 Offering for the issuance of ADSs and Pre-funded warrants, the exercise of the ADS Warrants from the 2025 Financing, from the issuance of debt, from the exercise of the PIPE Warrants and from the issuance of ADSs under the ATM facility; partially offset by the proceeds from the January 2025 Financing for the issuance of ADSs and the Pre-funded Warrants of $140.4 million in 2025.

Current wording

Net cash provided by financing activities increased during the nine months ended September 30, 2026, compared to the same period in 2025, primarily as a result of aggregate net proceeds of $433.1 million from the February 2026 Offering for the issuance of ADSs and Pre-funded warrants, the exercise of the ADS Warrants from the 2025 Financing, from the issuance of debt, from the exercise of the PIPE Warrants and from the issuance of ADSs under the ATM facility; partially offset by the proceeds from the January 2025 Financing for the issuance of ADSs and the Pre-funded Warrants of $140.4 million in 2025.

Previous wording

We expect our expenses to continue to increase substantially in connection with our ongoing activities, particularly as we continue to advance our Phase 3 program of COMP360 in TRD and supporting clinical and preclinical studies and prepare our rolling NDA submission, as well as increase our manufacturing activities and commercial preparedness activities, some of which will be subject to further Phase 3 data, and as we advance our Phase 2b/3 clinical trial in PTSD. In addition, we expect to continue to incur significant costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. Our expenses are expected to increase as we:

Current wording

We expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we complete our rolling NDA submission for COMP360 in TRD and undertake related regulatory activities, advance our Phase 2b/3 clinical trial in PTSD and supporting clinical and nonclinical studies, and continue our manufacturing activities. We are also incurring, and expect to continue to incur, significant pre-commercialization expenses as we prepare for the potential commercialization of COMP360, including investments in personnel and commercial capabilities. In addition, we expect to continue to incur significant costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. Our expenses are expected to increase as we:

Previous wording

•may in the future resume and pursue research and development programs for our other preclinical stage therapeutic candidates and discovery-stage programs and/or develop and seek regulatory approval for any future therapeutic candidates that successfully complete clinical trials;

Current wording

•may in the future resume and pursue research and development programs for our other nonclinical stage therapeutic candidates and discovery-stage programs and/or develop and seek regulatory approval for any future therapeutic candidates that successfully complete clinical trials;

Previous wording

•establish and expand the network of public healthcare institutions and private clinics that could administer our investigational COMP360 psilocybin treatment if approved;

Current wording

•establish and expand the number of public healthcare institutions and private clinics that could administer our investigational COMP360 psilocybin treatment if approved;

Previous wording

As of June 30, 2026, we had cash and cash equivalents of$433.3 million. We believe that our existing cash and cash equivalents will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. As we progress with our development programs and the regulatory review process, we expect to incur significant commercialization expenses related to product manufacturing, pre-commercial activities and commercialization.

Current wording

As of September 30, 2026, we had cash and cash equivalents of$444.0 million. We believe that our existing cash and cash equivalents will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. As we progress with our development programs and the regulatory review process, we expect to incur significant commercialization expenses related to product manufacturing, pre-commercial activities and commercialization.

Previous wording

•the progress, timing and completion of our Phase 3 program for our current investigational COMP360 psilocybin treatment program for TRD, and clinical and preclinical supporting studies, our rolling NDA submission and potential commercialization activities;

Current wording

•the progress, timing and completion of our rolling NDA submission and potential commercialization activities;

Previous wording

•the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA, the EC, the MHRA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more preclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to;

Current wording

•the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA, the EC, the MHRA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to;

Previous wording

•the costs of developing, testing and deploying technology solutions or paying a third-party to provide such digital technology solutions to improve the patient experience and therapeutic process via third-party service providers or internally;

Current wording

•the costs of developing, testing and deploying technology solutions or paying a third-party to provide such digital technology solutions for use in the conduct of our clinical trials;
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

Changes in policy or resources of governmental agencies, including, but not limited to, changes at the FDA, DEA, SEC, IRS and U.S. Patent and Trademark Office, could impact our business and results of operations. Despite Executive Order

Previous report — wording carried elsewhere

•an increase in personnel expenses as a result of increasing staffing levels to support our commercial preparedness activities;

Previous report — wording carried elsewhere

•an increase in facilities and other expense primarily due to an increase in external consulting fees, contractors, and technology infrastructure and software costs supporting commercial preparedness activities.