COMPASS Pathways plc

Previous wording

• Pivotal trial 1 (COMP005) (n=255): a single dose (25mg) monotherapy compared with placebo. This trial is designed to replicate the treatment response seen in our Phase 2b trial (n=233). We expect to report top-line data in the fourth quarter of 2024.

Current wording

• Pivotal trial 1 (COMP005) (n=255): a single dose (25mg) monotherapy compared with placebo. This trial is designed to replicate the treatment response seen in our Phase 2b trial (n=233). We expect to report top-line data in the second quarter of 2025.

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 treatment responders and whether a second dose can improve responses observed in our Phase 2b trial and to explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg. We expect to report top-line data by mid-2025.

Current 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 treatment responders and whether a second dose can improve responses observed in our Phase 2b trial and to explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg. We expect to report top-line data by the second half of 2026.

Previous wording

Beyond TRD, we recently completed and announced top-line data from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment, administered with psychological support, in people with PTSD, as a result of trauma experienced as adults. In line with the study design, the study enrolled twenty-two participants and participants were monitored for a 12-week period post dosing. In addition, we have an ongoing Phase 2 trial in anorexia nervosa.

Current wording

Beyond TRD, in May 2024, we completed and announced top-line data from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment, administered with psychological support, in people with PTSD, as a result of trauma experienced as adults. In line with the study design, the study enrolled twenty-two participants and participants were monitored for a 12-week period post dosing. In addition, we recently closed enrollment in our Phase 2 trial in anorexia nervosa and have enrolled 32 patients in the study. We expect to report data from this study in 2025.

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, ADSs, including in our offerings pursuant to our at-the-market, or ATM, offering program, proceeds from a loan agreement with Hercules, or the Hercules Loan Agreement, and proceeds from a private placement transaction, or the PIPE. On October 8, 2021, we entered into a Sales Agreement for our ATM offering program with Cowen and Company, LLC, or Cowen, under which we may issue and sell from time to time up to $150.0 million of our ADSs, each representing one ordinary share, through Cowen, as the sales agent. Sales of our ADSs, if any, will be made at market prices. Since the establishment of the ATM offering program, through June 30, 2024, we sold 5,491,836 ADSs underour ATM offering program, resulting in $54.8 million in net proceeds. During the three months ended June 30, 2024, we did not sell any ADSs under the ATM offering program. On June 30, 2023, or the Effective Date, we entered into the Hercules Loan Agreement, which provided for aggregate maximum borrowings of up to $50.0 million, including a term loan of $30.0 million, which was funded on the Effective Date. On August 16, 2023, we entered into a Securities Purchase Agreement, pursuant to which we agreed to sell and issue in a private placement transaction (i) 16,076,750 ADSs and (ii) PIPE Warrants to purchase up to 16,076,750 ADSs, at a purchase price of approximately $7.78 per ADS and accompanying PIPE Warrant to purchase one ADS. Each PIPE Warrant has an exercise price of $9.93 per ADS and is exercisable for a three year period beginning in February 2024. The PIPE Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the PIPE Warrants. Through June 30, 2024, 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.

Current 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, ADSs, including in our offerings pursuant to our at-the-market, or ATM, offering program, proceeds from a loan agreement with Hercules, or the Hercules Loan Agreement, and proceeds from a private placement transaction, or the PIPE. We are party to a Sales Agreement for our ATM offering program, dated October 8, 2021, with TD Securities (USA) LLC, or TD Cowen, under which we may issue and sell from time to time up to $150.0 million of our ADSs, each representing one ordinary share, through TD Cowen, as the sales agent. Sales of our ADSs, if any, will be made at market prices. Since the establishment of the ATM offering program, through September 30, 2024, we sold 5,491,836 ADSs underour ATM offering program, resulting in $54.8 million in net proceeds. During the three months ended September 30, 2024, we did not sell any ADSs under the ATM offering program. On June 30, 2023, we entered into the Hercules Loan Agreement, which provided for aggregate maximum borrowings of up to $50.0 million, including a term loan of $30.0 million, which was funded on June 30, 2023. On August 16, 2023, we entered into a Securities Purchase Agreement, pursuant to which we agreed to sell and issue in a private placement transaction (i) 16,076,750 ADSs and (ii) PIPE Warrants to purchase up to 16,076,750 ADSs, at a purchase price of approximately $7.78 per ADS and accompanying PIPE Warrant to purchase one ADS. Each PIPE Warrant has an exercise price of $9.93 per ADS and is exercisable for a three year period beginning in February 2024. The PIPE Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the PIPE Warrants. Through September 30, 2024, 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.

Previous wording

We have incurred recurring losses since its inception, including net losses of $73.3 million and $52.5 million for the six months ended June 30, 2024 and 2023, respectively. In addition, as of June 30, 2024, we had an accumulated deficit of $452.9 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 and potentially including expanding into additional indications, and initiating preclinical and clinical development of additional programs for different therapeutic candidates, as well as using digital technologies and solutions to enhance our therapeutic offering. 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 $111.8 million and $85.9 million for the nine months ended September 30, 2024 and 2023, respectively. In addition, as of September 30, 2024, we had an accumulated deficit of $491.4 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, although our non-COMP360 preclinical efforts will be stopped in connection with the strategic reorganization, our spending in the future may increase if we choose to expand into additional indications or initiate the development for different therapeutic candidates.

Previous wording

As of June 30, 2024, we had cash and cash equivalents of$228.6 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 2026. 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, 2024, we had cash and cash equivalents of$207.0 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 2026. 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

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 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 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 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 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. Additionally, we anticipate an increase in payroll 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. In the short-term, we expect reduced personnel expenses as a result of the planned reorganization that we expect to undertake 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.

Previous wording

Benefit from R&D tax credit consists of the R&D tax credit received in the UK, which is recorded within other income, net. As a company that carries out extensive research and development activities, we seek to benefit from the Small and

Current wording

Benefit from R&D tax credit consists of the R&D tax credit received in the UK, which is recorded within other income, net. As a company that carries out extensive research and development activities, we seek to benefit from the Small and Medium sized Enterprise, or SME, Program. Qualifying expenditures largely comprise employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs incurred as part of research projects for which we do not receive income.

Previous wording

Based on criteria established by His Majesty’s Revenue and Customs, (“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, 2024 and 2023. 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 were eligible for the SME regime for the nine-months ended September 30, 2024 and 2023. 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

During the six-months ended June 30, 2024 and 2023, we recorded a tax provision of $0.4 million and $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.

Current wording

During the nine-months ended September 30, 2024 and 2023, we recorded a tax provision of $0.6 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.

Previous wording

The following table summarizes our results of operations (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

For the three and six months ended June 30, 2024, the increases in research and development expenses, as compared to the same periods in 2023, were primarily attributable to the following:

Current wording

For the three and nine months ended September 30, 2024, the increases in research and development expenses, as compared to the same periods in 2023, were primarily attributable to the following:

Previous wording

•an increase in personnel as a result of increased staffing levels supporting the expansion of our preclinical and clinical teams; and

Current wording

•an increase in personnel expenses as a result of increased staffing levels supporting the expansion of our research and development teams; and

Previous wording

For the three months ended June 30, 2024 the increase in general and administrative expenses, as compared to the same periods in 2023, was primarily attributable to the following:

Current wording

For the three and nine months ended September 30, 2024 the increase in general and administrative expenses, as compared to the same periods in 2023, was primarily attributable to the following:

Previous wording

•an increase in non-cash share based compensation expense primarily due to the accounting for certain equity-based awards; and

Current wording

•an increase in non-cash share-based compensation expense, primarily due to the accounting for certain equity-based awards.

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 growth initiatives.

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.

Previous wording

For the three months ended June 30, 2024 the increase in other income, net, as compared to the same period in 2023, was primarily attributable to the following:

Current wording

For the three and nine months ended September 30, 2024, the increase in other income, net, as compared to the same periods in 2023, was primarily attributable to the following:

Previous wording

•an increase in interest income primarily due to higher interest rates earned on our cash deposits;

Current wording

•an increase in interest income primarily due to higher interest rates earned on our cash deposits; and

Previous wording

•an increase in net foreign exchange losses following remeasurement of foreign currency denominated assets and liabilities;

Current wording

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

Previous wording

We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our operating, lease, and debt obligations under our Loan Agreement with Hercules described below in the footnotes to our condensed consolidated financial statements.

Current wording

We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than our operating lease, and debt obligations under our Loan Agreement with Hercules described in the footnotes to our condensed consolidated financial statements.

Previous wording

Net cash used in operating activities increased during the six months ended June 30, 2024, compared to the same period ended 2023, primarily due to a $20.8 million increase in our net loss which was fully offset by favorable working capital related activities of $13.4 million, primarily attributable to the timing of $14.6 million cash received in 2024 relating to the 2022 R&D tax credit, as well as an increase of $4.7 million of non-cash adjustments.

Current wording

Net cash used in operating activities increased during the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to a 26.5 million increase in our net loss which was offset by favorable working capital related activities of $14.3 million, primarily attributable to the timing of $28.2 million cash received in 2024 relating to the 2022 and 2023 R&D tax credit, as well as an increase of $4.5 million of non-cash adjustments.

Previous wording

Net cash used in investing activities decreased during the six months ended June 30, 2024, compared to the same period ended 2023, primarily attributable to our purchases of property and equipment, which largely consisted of office equipment in 2023.

Current wording

Net cash used in investing activities remained consistent during the nine months ended September 30, 2024, compared to the same period in 2023.

Previous wording

Net cash provided by financing activities increased during the six months ended June 30, 2024, compared to the same period ended 2023, primarily related to proceeds from the issuance of ordinary shares through our ATM facility of $26.2 million and proceeds from the issuance of ordinary shares to settle warrants exercised of $37.3 million. Net cash provided by financing activities during the six months ended June 30, 2023, primarily consisted of proceeds from the issuance of ordinary shares through our ATM facility of $28.1 million and proceeds from the issuance of long term debt of $29.6 million.

Current wording

Net cash provided by financing activities decreased during the nine months ended September 30, 2024, compared to the same period in 2023, primarily related to net proceeds from the issuance of ordinary shares through our ATM facility of $26.2 million and proceeds from the issuance of ordinary shares to settle warrants exercised of $37.3 million. Net cash provided by financing activities during the nine months ended September 30, 2023, primarily consisted of net proceeds from the issuance of ordinary shares through our ATM facility of $28.1 million, net proceeds from the issuance of long-term debt of $29.6 million, and net proceeds from the issuance of shares under our PIPE offering of $116.9 million.

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 clinical program of COMP360 in TRD and preclinical activities, manufacturing and Phase 2 clinical trials of COMP360. 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 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:

Previous wording

•continue to advance our Phase 3 clinical program for investigational COMP360 psilocybin treatment in TRD;

Current 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;

Previous wording

•continue the research and development program for our other preclinical stage therapeutic candidates and discovery-stage programs;

Current wording

•may in the future resume and pursue research and development programs for our other preclinical stage therapeutic candidates and discovery-stage programs;

Previous wording

•continue to invest in our Discovery Center and/or develop additional therapeutic candidates;

Current wording

•may in the future invest in future discovery efforts and/or develop additional therapeutic candidates;

Previous wording

•pursue necessary scheduling-related decisions by the U.S. Drug Enforcement Administration, or the DEA, and various state governments to enable us to commercialize any future therapeutic candidates containing controlled substances for which we may obtain regulatory approval, including COMP360;

Current wording

•pursue necessary scheduling-related decisions by the U.S. Drug Enforcement Administration, or the DEA, and various state governments to enable us to commercialize any therapeutic candidates containing controlled substances for which we may obtain regulatory approval, including COMP360;

Previous wording

As of June 30, 2024, we had cash and cash equivalents of$228.6 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 2026. 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, 2024, we had cash and cash equivalents of$207.0 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 2026. 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 clinical program for our current investigational COMP360 psilocybin treatment program for TRD, our clinical trials in other indications, and our preclinical activities and clinical trials for future indications or any future therapeutic candidates;

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 the NDA filing;

Previous wording

•the number of potential new therapeutic candidates we identify and decide to develop, either internally through our research and development efforts or externally through acquisitions, licensing or other collaboration agreements;

Current wording

•the number of potential new therapeutic candidates we may choose to pursue and identify in the future and decide to develop, either internally through our research and development efforts or externally through acquisitions, licensing or other collaboration agreements;

Previous wording

•the costs involved in growing our organization to the size needed to prepare for the potential commercialization of our investigational COMP360 psilocybin treatment and future therapeutic candidates, including increasing personnel costs;

Current wording

•the costs involved in growing our organization in the long-term to the size needed to prepare for the potential commercialization of our investigational COMP360 psilocybin treatment and future therapeutic candidates, including increases to personnel costs;

Previous wording

•the costs of developing, testing and deploying digital technology solutions to improve the patient experience and therapeutic process;

Current wording

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

Previous wording

There have been no material changes in our significant accounting policies or critical accounting estimates during the first six months of 2024. For a complete discussion, 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, 2023, which we filed with the SEC on February 29, 2024.

Current wording

There have been no material changes in our significant accounting policies or critical accounting estimates during the first nine months of 2024. For a complete discussion, see the “Critical Accounting Policies and Significant Judgments and