COMPASS Pathways plc

Previous wording

• Pivotal trial 2 (COMP006) (n= 568): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg. This trial is designed to investigate whether a second dose can increase therapeutic response.

Current wording

• Pivotal trial 2 (COMP006) (n= 585): a fixed repeat dose monotherapy using three dose arms: 25mg, 10mg and 1mg. This trial is designed to investigate whether a second dose can increase therapeutic response.

Previous wording

In June 2025, we reported that the COMP005 trial achieved its primary endpoint, with a single 25 mg 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 remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52. We plan to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA) which has not yet reviewed the data.

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 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 remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.

Previous wording

We expect to report the 6-week safety and secondary endpoint data and 26-week data from the COMP005 trial once all participants in the COMP006 trial have completed Part A of the COMP006 trial. The COMP006 trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from weeks 26 to 52. We expect to report 26-week data from the COMP006 trial in the second half of 2026.

Current wording

We have completed enrollment for the second pivotal trial, the COMP006 trial, and enrolled 585 participants. The COMP006 trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from weeks 26 to 52. To facilitate our plans to submit a proposal for a rolling submission and formal request for rolling review to the FDA, the Company has decided to unblind and disclose primary endpoint and safety data from Part A (9 weeks) of COMP006.

Previous wording

Beyond TRD, we have been exploring other indications, including PTSD. In May 2024, we completed and announced top-line results from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment in participants with PTSD, as a result of trauma experienced as adults. In line with the study design, the study enrolled 22 participants who were monitored for a 12-week period post dosing. The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies of COMP360. Based on the data from this trial, we are in the process of designing a late-stage PTSD program.

Current wording

Beyond TRD, we have been exploring other indications, including PTSD. In May 2024, we completed and announced top-line results from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment in participants with PTSD, as a result of trauma experienced as adults. In line with the study design, the study enrolled 22 participants who were monitored for a 12-week period post dosing. The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies of COMP360. Based on the data from this trial, we are in the process of finalizing the design of a late-stage PTSD program.

Previous wording

In January 2025, we issued and sold (i) 24,014,728 ADSs and accompanying warrants to purchase up to 24,014,728 ADSs, and (ii) in lieu of ADSs, to certain investors, Pre-funded Warrants to purchase up to 11,044,720 ADSs and accompanying 2025 ADS Warrants to purchase up to 11,044,720 ADSs. The offering price was $4.2750 per ADS and accompanying 2025 ADS Warrant, and $4.2649 per Pre-funded Warrant and accompanying 2025 ADS Warrant. The Pre-funded Warrants have an exercise price of $0.0001 per ADS and are exercisable immediately. The Pre-funded Warrants expire when exercised in full. The 2025 ADS Warrants have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone. The 2025 ADS Warrants will expire three years after such warrants become exercisable. Once the ADS Warrants become exercisable, the Company may force the exercise of the 2025 ADS Warrants (by way of cash or cashless exercise, at the Company’s option), in whole or in part, by delivering a notice of forced exercise to the holders, provided that the closing price for the Company’s ADSs on Nasdaq exceeded the warrant exercise price of $5.7960 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered.

Current wording

In January 2025, we issued and sold (i) 24,014,728 ADSs and accompanying warrants to purchase up to 24,014,728 ADSs, and (ii) in lieu of ADSs, to certain investors, Pre-funded Warrants to purchase up to 11,044,720 ADSs and accompanying 2025 ADS Warrants to purchase up to 11,044,720 ADSs. The offering price was $4.2750 per ADS and accompanying 2025 ADS Warrant, and $4.2649 per Pre-funded Warrant and accompanying 2025 ADS Warrant. The Pre- funded Warrants have an exercise price of $0.0001 per ADS and are exercisable immediately. The Pre-funded Warrants expire when exercised in full. The 2025 ADS Warrants have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone. The 2025 ADS Warrants will expire three years after such warrants become exercisable. Once the ADS Warrants become exercisable, the Company may force the exercise of the 2025 ADS Warrants (by way of cash or cashless exercise, at the Company’s option), in whole or in part, by delivering a notice of forced exercise to the holders, provided that the closing price for the Company’s ADSs on Nasdaq exceeded the warrant exercise price of $5.7960 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered. During the three months ended September 30, 2025, 2,344,720 Pre-funded Warrants were exercised on a cashless basis.

Previous wording

We have incurred recurring losses since our inception, including net losses of $56.3 million and $73.3 million for the six months ended June 30, 2025 and 2024, respectively. In addition, as of June 30, 2025, we had an accumulated deficit of $591.0 million. Our historical losses 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 for at least the next several years. Our operating losses stem primarily from development of our investigational COMP360 psilocybin treatment for TRD, and we expect they will continue to increase as we conduct our Phase 3 program in TRD for our investigational COMP360 psilocybin treatment candidate. In addition, our spending in the future may increase as we initiate our planned late-stage clinical trial in PTSD, or if we choose to expand into additional indications, or to 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 substantial 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 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 losses since our inception, including net losses of $194.0 million and $111.8 million for the nine months ended September 30, 2025 and 2024, respectively. In addition, as of September 30, 2025, we had an accumulated deficit of $728.7 million. Our historical losses 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 for at least the next several years. 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 and accelerate plans for our NDA submission and commercial launch, although a majority of the planned commercialization activities will be subject to further Phase 3 data. In addition, our spending in the future may increase as we initiate our planned late-stage clinical trial in PTSD, or if we choose to expand into additional indications, or to 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 substantial 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 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, 2025, we had cash and cash equivalents of$221.9 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 2027. 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, 2025, we had cash and cash equivalents of$185.9 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 2027. 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, fluctuating inflation and interest rates, instability in the banking system and the related impact on U.S. and global economies, fluctuations in foreign exchange rates, significant changes in U.S. policies or regulatory environment or disruption for U.S government agencies, the risk of economic slowdown or recession in the U.S., significant changes in geopolitics and international tensions, including from the effects from announced or future tariff increases, the ongoing 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. In addition, the budget reconciliation legislation of 2025, nicknamed the One Big Beautiful Bill Act, or the OBBBA, was signed into law on July 4, 2025. Although we are still evaluating the impact of the OBBBA on our business, the OBBBA contains a variety of provisions that could impact our business, including certain changes to Medicaid and the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended, among other provisions. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions.

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, instability in the banking system, 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 (whether from the continued government shutdown or reduced resources), 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.

Previous 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. 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 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 as a result of the Trump administration, 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. 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 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. Currently, federal agencies in the United States are operating under a federal government shutdown due to expiration of the continuing resolution that expired on September 30, 2025 and certain federal agencies, such as the FDA, have had to furlough critical employees and stop critical activities, which may which may impact the timeliness of our interactions with the FDA. 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 continue to increase as we seek to complete the clinical development for our investigational COMP360 psilocybin treatment for TRD and prepare for regulatory filings related to our existing therapeutic candidates or potential future therapeutic candidates.

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. As a result, we expect that our research and development expenses will continue to increase as we seek to complete the clinical development for our investigational COMP360 psilocybin treatment for TRD and prepare for regulatory filings related to our COMP360 psilocybin treatment or potential future therapeutic candidates.

Previous wording

•successful enrollment in and completion of clinical trials and preclinical studies, including successful enrollment in our Phase 3 COMP006 trial and completion of our Phase 3 COMP005 and COMP006 clinical trials in TRD;

Current wording

•successful completion of our Phase 3 trials in TRD and successful enrollment in and completion of future clinical trials;

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. In the short-term, we expect reduced personnel expenses as a result of the reorganization that we undertook in the fourth quarter of 2024. However, in the long-term, we anticipate future increases in both personnel and other expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing 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. For 2025, we expect reduced personnel expenses compared to 2024 as a result of the reorganization that we undertook in the fourth quarter of 2024. However, subject to further Phase 3 data next year, we anticipate future increases in both personnel and other expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our therapeutic candidate.

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 for the SME regime for the six months ended June 30, 2025 and 2024. We expect such elements to be eligible for R&D incentives under the new merged regime in the year ended December 31, 2025 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 were eligible for the SME regime for the nine months ended September 30, 2025 and 2024. We expect such elements to be eligible for R&D incentives under the new merged regime in the year ended December 31, 2025 although there may be some limitations on expenditure on activities undertaken outside the UK.

Previous wording

During the six months ended June 30, 2025 and 2024, we recorded a tax provision of $0.5 million and $0.4 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, 2025 and 2024, we recorded a tax provision of $0.3 million and $0.6 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes. During the three months ended September 30, 2025 and 2024, the Company recorded a tax benefit of $0.2 million and income tax provision of $0.2 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes. The tax benefit of $0.2 million for the three months ended September 30, 2025, includes the Foreign Derived Intangible Income, or FDII, deduction arising during the period.

Previous wording

Comparison for the Three and Six months ended June 30, 2025 and 2024

Current wording

Comparison for the Three and Nine months ended September 30, 2025 and 2024

Previous wording

For thethree and six months ended June 30, 2025, the increase in research and development expenses, as compared to the same periods in 2024, was primarily attributable to the following:

Current wording

For thethree months ended September 30, 2025, the decrease in research and development expenses, as compared to the same period in 2024, was primarily attributable to the following:

Previous wording

We expect research and development costs to continue to increase at least through completion of our Phase 3 program for COMP360 psilocybin therapy in TRD.

Current wording

We expect to continue to incur significant research and development costs at least through completion of our Phase 3 program for COMP360 psilocybin therapy in TRD and our late-stage development program in PTSD.

Previous wording

For the six months ended June 30, 2025, the increase in general and administrative expenses, as compared to the same period in 2024, was primarily attributable to the following:

Current wording

For the nine months ended September 30, 2025, the increase in general and administrative expenses, as compared to the same period in 2024, was primarily attributable to the following:

Previous wording

•a decrease in facilities and other expenses as a result of lower insurance premiums and banking fees.

Current wording

•a decrease in facilities and other expenses as a result of lower insurance premiums, lower banking fees, and the reduction of spend from vendors that were associated with the reorganization that took place in the fourth quarter of 2024 .

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.

Current 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.

Previous wording

•an increase due to the change in fair value of the warrant liabilities during the period, related to the warrants issued in the 2025 Financing;

Current wording

•a decrease due to the change in fair value of the warrant liabilities during the period, related to the warrants issued in the 2025 Financing, including the exercise of 2,344,720 Pre-funded Warrants; and

Previous wording

•an increase due to foreign exchange gains following remeasurement of foreign currency denominated assets and liabilities.

Current wording

•a decrease due to foreign exchange losses following remeasurement of foreign currency denominated assets and liabilities.

Previous wording

For the six months ended June 30, 2025, the increase in other income, net, as compared to the same periods in 2024, was primarily attributable to the following:

Current wording

For the nine months ended September 30, 2025, the decrease in other income, net, as compared to the same periods in 2024, was primarily attributable to the following:

Previous wording

•an increase in the benefit from R&D tax credit due to higher R&D expenditures claimed at the enhanced research intensive rate in the current year as well as a resubmission of the Company’s 2023 claim at the enhanced rate given clarity provided by HMRC in April 2025; and

Current wording

•an increase in the benefit from R&D tax credit due to higher R&D expenditures claimed at the enhanced research intensive rate in the current year as well as a resubmission of the Company’s 2023 claim at the enhanced rate given clarity provided by HMRC in April 2025.

Previous wording

We are a clinical-stage biotechnology company and we have not yet generated any revenue to date. We have incurred significant operating losses since our formation. We have not yet commercialized any therapeutic candidates and we do not expect to generate revenue from sales of any therapeutic candidates in the near future, if at all. We have primarily funded our operations with proceeds from the sale of our ordinary shares, ADSs, including our ATM offering program, proceeds from the Hercules Loan Agreement, and proceeds from the PIPE. The ATM offering program allows us to issue and sell from time to time up to $150.0 million of our ADSs. Pursuant to the Sales Agreement dated October 8, 2021, through February 27, 2025, we sold 5,491,836 ADSs underour ATM offering program, resulting in $54.8 million in net proceeds. 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. To date, we have not sold any ADSs under this Sales Agreement. The Hercules Loan Agreement provided for aggregate maximum borrowings of up to $50.0 million, of which we have funded $30.0 million. 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. Through June 30, 2025, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds. We will receive up to an additional approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised for cash. 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 have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone. The 2025 ADS Warrants will expire three years after such warrants become exercisable. Once the ADS Warrants become exercisable, the Company may force the exercise of the 2025 ADS Warrants (by way of cash or cashless exercise, at the Company’s option), in whole or in part, by delivering a notice of forced exercise to the holders, provided that the closing price for the Company’s ADSs on Nasdaq exceeded the warrant exercise price of $5.7960 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered.

Current wording

We are a clinical-stage biotechnology company and we have not yet generated any revenue to date. We have incurred significant operating losses since our formation. We have not yet commercialized any therapeutic candidates and we do not expect to generate revenue from sales of any therapeutic candidates in the near future, if at all. We have primarily funded our operations with proceeds from the sale of our ordinary shares, ADSs, including our ATM offering program, proceeds from the Hercules Loan Agreement, and proceeds from the PIPE. The ATM offering program allows us to issue and sell from time to time up to $150.0 million of our ADSs. Pursuant to the Sales Agreement dated October 8, 2021, through February 27, 2025, we sold 5,491,836 ADSs underour ATM offering program, resulting in $54.8 million in net proceeds. 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. To date, we have not sold any ADSs under this Sales Agreement. The Hercules Loan Agreement provided for aggregate maximum borrowings of up to $50.0 million, of which we have funded $30.0 million. 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. Through September 30, 2025, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds. We will receive up to an additional approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised for cash. 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 have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone. The 2025 ADS Warrants will expire three years after such warrants become exercisable. Once the ADS Warrants become exercisable, the Company may force the exercise of the 2025 ADS Warrants (by way of cash or cashless exercise, at the Company’s option), in whole or in part, by delivering a notice of forced exercise to the holders, provided that the closing price for the Company’s ADSs on Nasdaq exceeded the warrant exercise price of $5.7960 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered. Through September 30, 2025, 2,344,720 Pre-funded Warrants were exercised.

Previous wording

Net cash used in operating activities increased during thesix months ended June 30, 2025, compared to the same period in 2024, primarily due to unfavorable working capital related activities of $30.5 million, as well as an increase of $15.7 million of non-cash adjustments, including the change in fair value of warrant liabilities of $16.9 million, which was offset by a $17.0 million decrease in our net loss.

Current wording

Net cash used in operating activities increased during thenine months ended September 30, 2025, compared to the same period in 2024, primarily due to unfavorable working capital related activities of $45.36 million, as well as an increase of $85.5 million of non-cash adjustments, including the change in fair value of warrant liabilities of $84.4 million, which was offset by a $82.2 million increase in our net loss.

Previous wording

Net cash provided by financing activities increased during the six months ended June 30, 2025, compared to the same period in 2024, primarily as a result of proceeds from the 2025 Financing for the issuance of ADSs and proceeds from the Pre-funded Warrants of $140.4 million, partially offset by the proceeds from the issuance of ordinary shares to settle warrants exercised of $26.2 million and the proceeds from the exercise of warrants of $37.3 million in 2024.

Current wording

Net cash provided by financing activities increased during the nine months ended September 30, 2025, compared to the same period in 2024, primarily as a result of proceeds from the 2025 Financing for the issuance of ADSs and the Pre-funded Warrants of $140.4 million, partially offset by the proceeds from the issuance of ordinary shares to settle warrants exercised of $26.2 million and the proceeds from the exercise of warrants of $37.3 million in 2024.

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 clinical and preclinical activities supporting studies and related preparatory work for an NDA filing, as well as manufacturing activities and commercial preparedness activities. 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 will also increase as we:

Current 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 related preparatory work for an NDA submission, including a potential rolling NDA submission, as well as manufacturing activities and commercial preparedness activities, the majority of which will be subject to further Phase 3 data, and as we initiate our planned late-stage development program 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 will increase as we:

Previous wording

•continue to advance our Phase 3 program for investigational COMP360 psilocybin treatment in TRD and clinical and preclinical supporting studies and related preparatory work for the NDA filing;

Current wording

•continue to advance our Phase 3 program for investigational COMP360 psilocybin treatment in TRD and clinical and preclinical supporting studies and accelerate plans for NDA submission and commercial launch;

Previous wording

As of June 30, 2025, we had cash and cash equivalents of$221.9 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 2027. 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, 2025, we had cash and cash equivalents of$185.9 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 2027. 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 and related preparatory work for the NDA filing;

Current 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 and related preparatory work for our NDA submission, including potential accelerated NDA submission, and related preparations for commercial launch;

Previous wording

•the impact of macroeconomic and geopolitical events, including, among others, fluctuating inflation and interest rates, fluctuations in foreign exchange rates, and the risk of economic slowdown or recession in the U.S., international tensions and changes in legislation and governmental policies, including the effects of announced or future tariff increases; and

Current wording

•the impact of macroeconomic and geopolitical events, including, among others, fluctuating inflation and interest rates, fluctuations in foreign exchange rates, and the risk of economic slowdown or recession in the U.S., international tensions and changes in legislation and governmental policies and resources, including the effects of announced or future tariff increases; and

Previous wording

During the first six months of 2025, our significant accounting policies or critical accounting estimates have been updated to include warrant liabilities, as described below. For a complete discussion of our other significant accounting policies and critical accounting estimates, see the “Critical Accounting Policies and Significant Judgments and Estimates” section of the

Current wording

During the first nine months of 2025, our significant accounting policies or critical accounting estimates have been updated to include warrant liabilities, as described below. For a complete discussion of our other significant accounting policies and critical accounting estimates, see the “Critical Accounting Policies and Significant Judgments and Estimates” section of the Management’s Discussion and Analysis of Financial Condition and Results of Operation in our Form 10-K for the year ended December 31, 2024, which we filed with the SEC on February 27, 2025.

Previous wording

We account for the warrants in accordance with the guidance contained in ASC Topic 815-40-15-7D, (“Derivatives and Hedging”), under which the warrants that do not meet the criteria for equity treatment must be recorded as liabilities. Accordingly, we classify the warrants as liabilities at their fair value and adjust the warrants to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value will be recognized in our condensed consolidated statements of operations and comprehensive loss. The fair values of these warrants are determined using the Black-Scholes pricing model. These values are subject to a significant degree of management’s judgment.

Current wording

We account for the warrants in accordance with the guidance contained in ASC Topic 815-40-15-7D, (“Derivatives and Hedging”), under which the warrants that do not meet the criteria for equity treatment must be recorded as liabilities. Accordingly, we classify the warrants as liabilities at their fair value and adjust the warrants to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value will be recognized in our condensed consolidated statements of operations and comprehensive loss. The fair values of these warrants are determined using the Black-Scholes pricing model.

Previous wording

The warrant liabilities are classified as non-current on the condensed consolidated balance sheets due to the underlying warrants having expiration dates beyond 12 months from the reporting date and it is not reasonably expected that the Company would be required to use existing resources classified as current assets, or create other current liabilities, to settle the warrant liabilities at this time. Management reviews the classification of warrant liabilities at each reporting period to determine whether any change in classification is warranted based on changes in facts or circumstances, including the proximity to expiration or likelihood of exercise.

Current wording

The warrant liabilities are classified as current on the condensed consolidated balance sheets due to the likelihood of exercise and it is reasonably expected that the Company would be required to use existing resources classified as current assets, or create other current liabilities, to settle the warrant liabilities at this time. Management reviews the classification of warrant liabilities at each reporting period to determine whether any change in classification is warranted based on changes in facts or circumstances, including the proximity to expiration or likelihood of exercise.