COMPASS Pathways plc 10-K

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the consolidated financial statements and the related notes to those statements included earlier in this Annual Report on Form 10-K. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, beliefs and expectations that involve risks and uncertainties. Our actual results and the timing of events could differ materially from those discussed in these forward-looking statements. Important factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in Part I, Item 1A. “Risk Factors” and the section titled “Special Note Regarding Forward-Looking Statements.” References to “we,” “our,” “us” and “the Company” refer to Compass Pathways plc. Operating Results Overview We are a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. COMP360 is our proprietary psilocybin formulation that includes our pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. We believe that our COMP360 psilocybin treatment could offer a new approach to treatment of serious mental health conditions, including treatment-resistant depression, or TRD, which is a subset of major depressive disorder, or MDD, post-traumatic stress disorder, or PTSD, and potentially many other serious mental health conditions. Our initial focus is on 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. In 2025, we completed enrollment for each of the two pivotal trials in our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD,. Each of the two pivotal trials has a long-term follow-up component. The pivotal program design is as follows: • Pivotal trial 1 (COMP005) (n=258): a single dose (25mg) monotherapy compared with placebo. • Pivotal trial 2 (COMP006) (n= 581): 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. • The primary endpoint in both pivotal trials is the change from baseline in the Montgomery-Åsberg Depression Rating Scale, or MADRS, total score at week 6. 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. 173 Table of Contents 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 ongoing 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. Following these data read-outs, we submitted a request for a meeting with the FDA to discuss a rolling submission and review and the FDA has accepted our meeting request. 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, or 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. In September 2025, the results of this study were published in the Journal of Psychopharmacology . Based on the data from this trial, we determined to advance development of COMP360 for PTSD and finalized the design of a Phase 2b/3 clinical trial in PTSD. In January 2026, the FDA accepted our IND application for COMP360 in PTSD, enabling the initiation of a Phase 2b/3 (COMP202) clinical trial in patients living with PTSD. 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 were 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 were able to 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. Pursuant to the Sales Agreement dated October 8, 2021, t hrough February 27, 2025, we sold 5,491,836 ADSs under our 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. 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. During the year ended December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds. During the year ended December 31, 2025, no PIPE warrants were exercised. We will receive up to an additional approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised. 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 174 Table of Contents 2025 ADS Warrants become exercisable, we may force the exercise of the 2025 ADS Warrants (by way of cash or cashless exercise, at our option), in whole or in part, by delivering a notice of forced exercise to the holders, provided that the closing price for our 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 year ended December 31, 2025, 2,344,720 Pre-funded Warrants were exercised on a cashless basis. We have incurred recurring losses since our inception, including net losses of $287.86 million and $155.1 million for the year ended December 31, 2025 and 2024, respectively. In addition, as of December 31, 2025, we had an accumulated deficit of $822.6 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 Phase2b/3 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 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 to finance 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. As of December 31, 2025 , we had cash and cash equivalents of $149.6 million . In February 2026, we issued and sold in an underwritten offering, or the February 2026 Offering, 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. In February 2026, subsequent to the February 2026 Offering, we received net proceeds of $203.2 million following the exercise of 35,059,448 ADS warrants, which were issued on January 13, 2025. We believe that our existing cash and cash equivalents as of December 31, 2025, together with the net proceeds from the February 2026 Offering and the net proceeds from the exercise of all of our outstanding 2025 ADS Warrants, 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. Macroeconomic Conditions and Changes in Regulatory Landscape 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, 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. 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 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, 175 Table of Contents 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 . Our ability to raise additional funds may be adversely impacted by macroeconomic conditions and geopolitical events, changing regulatory conditions, including potential impacts of regulatory agency staffing cuts and policy changes on regulatory feedback and timing thereof, and disruptions to and volatility in the credit and financial markets in the U.S. and worldwide. Failure to raise capital or secure other funding as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies. There can be no assurances, however, that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all. 176 Table of Contents Components of Our Results of Operations Revenue To date, we have not generated any revenue and do not expect to generate any revenue from the sale of therapeutic candidates in the near future. If our development efforts for our investigational COMP360 psilocybin treatment are successful and result in regulatory approval of COMP360, we may generate revenue in the future. Operating Expenses Research and Development 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 in TRD and initiate a new Phase 2b/3 clinical trial for our COMP360 psilocybin treatment in PTSD. The successful development and commercialization of our investigational COMP360 psilocybin treatment is highly uncertain. This is due to the numerous risks and uncertainties associated with development and commercialization, including the following: • 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; • 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; • receiving regulatory approvals or clearance for conducting our planned clinical trials or future clinical trials; • receiving positive data from our clinical trials that support an acceptable risk-benefit profile of COMP360 psilocybin treatment and any future therapeutic candidates in the intended patient populations; • receipt and maintenance of regulatory and marketing approvals from applicable regulatory authorities; • establishing and scaling up, through third-party manufacturers, manufacturing capabilities of clinical supply for our clinical trials and commercial manufacturing, if any therapeutic candidates are approved; • entry into collaborations to further the development of our investigational COMP360 psilocybin treatment and our future therapeutic candidates; • obtaining and maintaining patent and trade secret protection or regulatory exclusivity for COMP360 and any future therapeutic candidates; • successfully launching commercial sales of our investigational COMP360 psilocybin treatment and any future therapeutic candidates, if approved; • acceptance of our current and future therapeutic candidates’ benefits and uses, if approved, by patients, the medical community and third-party payors; and • maintaining a continued acceptable safety profile of our investigational COMP360 psilocybin treatment and our future therapeutic candidates following approval. 177 Table of Contents 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. General and Administrative 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 further Phase 3 data in 2026, 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. Other Income, Net Benefit from Research and Development Tax Credit 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 have historically benefited from the Small and Medium sized Enterprise, or SME, Program and from January 1, 2025, the new merged regime. Qualifying expenditures largely comprise employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs. 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 SME regime for the year ended December 31, 2024, and the new merged regime for the year ended December 31, 2025. For the year ended December 31, 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. The UK R&D tax credit is fully refundable to us and is not dependent on current or future taxable income. As a result, we have recorded the entire benefit from the UK R&D tax credit as a benefit which is included in our net loss before income tax and, accordingly, not reflected as part of the income tax provision. If, in the future, any UK R&D tax credits generated are needed to offset a corporation tax liability in the UK, that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded within other income, net. Interest Income Interest income relates to interest earned on cash deposits. Interest Expense Interest expense relates to interest paid on debt. 178 Table of Contents Fair value changes of warrant liabilities The fair value changes in warrant liabilities are attributable to the warrant liabilities which are 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 the consolidated statements of operations and comprehensive loss. Foreign exchange gains (losses) Foreign exchange gains (losses) consist of foreign exchange impacts arising from foreign currency transactions, primarily related to the translation of intercompany balances as a result of a change in our functional currency, as well as bank balances held in a foreign currency. Corporate Income Tax Expense We are subject to corporate taxation in the U.S. and the UK (known as corporation tax in the UK). Due to the nature of our business, we have generated losses since inception and have therefore not been required to pay UK corporation tax. Our corporate income tax expense represents only income taxes in the U.S. UK losses not surrendered may be carried forward indefinitely and may be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of UK taxable profits. After accounting for tax credits receivable, we had accumulated trading losses for carry forward in the UK of $577.9 million and $280.8 million as of December 31, 2025 and 2024, respectively, which is offset by a full valuation allowance. During the years ended December 31, 2025 and 2024, we recorded a tax benefit of $2.5 million and income tax provision of $1.6 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes. 179 Table of Contents Results of Operations The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 OPERATING EXPENSES: Research and development $ 118,436 $ 119,039 General and administrative 60,601 59,166 Total operating expenses 179,037 178,205 LOSS FROM OPERATIONS (179,037) (178,205) OTHER (EXPENSE) INCOME, NET: Fair value change of warrant liabilities (122,561) — Benefit from R&D tax credit 3,747 21,097 Interest income 7,182 8,268 Foreign exchange gains (losses) 3,471 (1,032) Interest expense (4,517) (4,479) Other income 1,380 823 Total other (expense) income, net (111,298) 24,677 Loss before income taxes (290,335) (153,528) Income tax benefit (expense) 2,473 (1,594) Net loss $ (287,862) $ (155,122) Comparison For The Years Ended December 31, 2025 and 2024 Research and Development Research and development expenses consist of the following (in thousands): Year ended December 31, 2025 2024 Change Development expenses $ 82,372 $ 76,993 $ 5,379 Personnel expenses 24,420 26,707 (2,287) Facilities and other expenses 6,556 5,030 1,526 Non-cash share-based compensation expense 5,088 10,309 (5,221) Total research and development expenses $ 118,436 $ 119,039 $ (603) For the year ended December 31, 2025, the decrease in research and development expenses, as compared to the same period in 2024, was primarily attributable to the following: • a decrease in non-cash share-based compensation expense and personnel expenses as a result of decreased staffing levels associated with the reorganization that took place in the fourth quarter of 2024. Offset by: • an increase in development expenses associated with advancing our late-stage COMP360 clinical trials; and • an increase in facilities and other expenses primarily due to an increase in external consulting fees. 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. 180 Table of Contents General and Administrative General and administrative expenses consist of the following (in thousands): Year ended December 31, 2025 2024 Change Legal and professional fees $ 23,521 $ 14,535 $ 8,986 Personnel expenses 19,716 23,422 (3,706) Facilities and other expenses 8,862 12,001 (3,139) Non-cash share-based compensation expense 8,502 9,208 (706) Total general and administrative expenses $ 60,601 $ 59,166 $ 1,435 For the year ended December 31, 2025, the increase in general and administrative expenses, as compared to the same period in 2024, was primarily attributable to the following: • an increase in legal and professional fees, primarily related to issuance costs related to the January 2025 Financing as well as expenses associated with consulting, accounting and legal advice. Offset by: • a decrease in personnel expenses and non-cash share-based compensation expense as a result of decreased staffing levels associated with the reorganization that took place in the fourth quarter of 2024. • 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. 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. Other Income, Net Other income, net consists of the following (in thousands): Year ended December 31, 2025 2024 Change Fair value change of warrant liabilities $ (122,561) $ — $ (122,561) Benefit from R&D tax credit 3,747 21,097 (17,350) Interest income 7,182 8,268 (1,086) Interest expense (4,517) (4,479) (38) Foreign exchange gains (losses) 3,471 (1,032) 4,503 Other income 1,380 823 557 Total other (expense) income, net $ (111,298) $ 24,677 $ (135,975) 181 Table of Contents For the year ended December 31, 2025 , the decrease in other (expense) income, net, as compared to the same period in 2024, was primarily attributable to the following: • a decrease due to the change in fair value of the warrant liabilities during the period, related to the warrants issued in the January 2025 Financing; and • a decrease in the benefit from R&D tax credit due to the uncertainty of meeting the R&D intensity condition and therefore eligibility for the enhanced effective rates, which is currently under discussion with the HMRC; and • a decrease in interest income primarily due to interest earned on lower cash deposit levels. Partially offset by: • an increase due to foreign exchange gains following remeasurement of foreign currency denominated assets and liabilities; and Comparison For The Years Ended December 31, 2024 and 2023 Please refer to the Annual Report on Form 10-K filed for December 31, 2024 for details on the comparisons for the years ended December 31, 2024 and 2023. Liquidity and Capital Resources 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. We currently expect that, if we receive marketing approval from the FDA for our first product candidate and are able to successfully launch and commercialize such product, we could begin generating revenue from product sales as early as next year. However, there can be no assurance as to the timing of any such approval, the success of any commercial launch, the level of market acceptance, or whether we will generate revenue on that timeline, 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, t hrough February 27, 2025, we sold 5,491,836 ADSs under our 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. During the year ended December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds. During the year ended December 31, 2025, no PIPE warrants were exercised. 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 January 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. Through December 31, 2025, 2,344,720 Pre-funded Warrants were exercised. In February 2026, we issued and sold in an underwritten offering, or the February 2026 Offering, 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 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 leases, and debt obligations under our Loan Agreement with Hercules described in the notes to our consolidated financial statements. 182 Table of Contents Cash Flows The following table summarizes our cash flows for each of the periods (in thousands): to f Year Ended December 31, 2025 2024 Change Net cash used in operating activities $ (157,240) $ (119,186) $ (38,054) Net cash provided by financing activities $ 140,712 $ 63,824 $ 76,888 Effect of exchange rate changes on cash, cash equivalents and restricted cash $ 1,045 $ 194 $ 851 Net (decrease)/increase in cash, cash equivalents and restricted cash $ (15,483) $ (55,168) $ 39,685 Net Cash Used in Operating Activities Net cash used in operating activities increased during the year ended December 31, 2025, compared to the same period in 2024, primarily due to unfavorable working capital related activities of $26.0 million, as well as an increase of $120.7 million of non-cash adjustments, including the change in fair value of warrant liabilities of $122.6 million, which was offset by a $132.8 million increase in our net loss. Net Cash Provided by Financing Activities Net cash provided by financing activities increased during the year ended December 31, 2025, compared to the same period in 2024, primarily as a result of proceeds from the January 2025 Financing for the issuance of ADSs and the Pre-funded Warrants of $140.4 million, compared to the proceeds from the issuance of ordinary shares through our ATM facility of $26.2 million and the proceeds from the exercise of warrants of $37.3 million in 2024. Funding Requirements 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 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 will increase as we: • continue to advance our Phase 3 program for investigational COMP360 psilocybin treatment in TRD and clinical and preclinical supporting studies and accelerate our plans for NDA submission ; • we prepare for commercial launch of COMP360 psilocybin treatment in TRD, if approved, including establishing a sales, marketing and distribution infrastructure and scaling-up manufacturing capabilities; • advance our commercialization strategy; • initiate and advance our Phase 2b/3 clinical trial in PTSD; • continue the training of qualified healthcare professionals to monitor and safeguard participants in our Phase 3 program and other clinical trials; • service our outstanding indebtedness; 183 Table of Contents • 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 trial s ; • establish and expand the network of public healthcare institutions and private clinics that could administer our investigational COMP360 psilocybin treatment if approved; • experience heightened regulatory scrutiny; • 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; • obtain, maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending against alleged patent or other intellectual property infringement claims; • add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our therapeutic development and potential future commercialization efforts; • experience any delays or encounter any issues with respect to any of the above, including failed studies, ambiguous trial results, safety issues or other regulatory challenges, including, for example, delays and other impacts as a result of pandemics or other public health crises; • expand our operations in the U.S. and Europe in the future; and • incur additional legal, accounting and other expenses associated with operating as an English-domiciled public company listed in the U.S. As of December 31, 2025 , we had cash and cash equivalents of $149.6 million . In February 2026, we issued and sold in an underwritten offering, or the February 2026 Offering, 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. In February 2026, subsequent to the February 2026 Offering, we received proceeds of approximately $203.2 million following the exercise of 35,059,448 2025 ADS Warrants. 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. We believe that our existing cash and cash equivalents, together with the net proceeds from the February 2026 Offering and the net proceeds from the exercise of all of our outstanding 2025 ADS Warrants, 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. Because of the numerous risks and uncertainties associated with research, development and commercialization of therapeutic candidates and programs, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including: • 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 planned NDA submission and potential commercialization activities; • the progress, timing and completion of our Phase 2b/3 clinical trial in PTSD; • 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 184 Table of Contents preclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to; • the outcome and timing of any scheduling-related decisions by the DEA, individual states, and comparable foreign authorities; • the number of potential future 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; • the costs involved in growing our organization in the near term to the size needed to prepare for the potential commercialization of our investigational COMP360 psilocybin treatment in TRD and any future therapeutic candidates, including increases to personnel costs; • the costs of developing sales and marketing capabilities to prepare for potential commercial launch of COMP360 psilocybin treatment in TRD to target public and private healthcare providers and clinic networks in the U.S. and other major markets; • the costs of training qualified healthcare professionals to monitor and safeguard participants in our clinical trials; • the costs of maintaining research collaborations, such as the Center for Mental Health Research, which includes conducting clinical trials, including proof of concept studies, to refine our treatment delivery model; • the time and costs involved in generating and collecting data and advancing and defending our intellectual property portfolio, including the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringements or invalidity raised by third parties; • 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; • the time and costs involved in obtaining regulatory approval for COMP360 or any future therapeutic candidates, and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to COMP360 or any future therapeutic candidates; • selling and marketing activities undertaken in connection with the potential commercialization of our investigational COMP360 psilocybin treatment or any future therapeutic candidates, if approved, and costs involved in the creation of an effective sales and marketing organization; • the amount of revenue, if any, we may derive either directly or in the form of royalty, milestone or other payments from future sales of our investigational COMP360 psilocybin treatment and any future therapeutic candidates, if approved; • the impact of macroeconomic and geopolitical events, including, among others, fluctuating inflation and interest rates, fluctuations in foreign exchange rates, 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 • the costs of operating as a public company. Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity offerings, debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additional financing may not be available at all or on acceptable terms. To the extent that we raise additional capital through the sale of equity or exercise of outstanding warrants, current ownership interests will be diluted. If we raise additional funds through government or third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish future revenue streams, research programs or therapeutic candidates or grant licenses 185 Table of Contents on terms that may not be favorable to us. Debt financing, if available, may involve high interest rates or agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or therapeutic candidates that we would otherwise prefer to develop and market ourselves. Critical Accounting Policies and Significant Judgments and Estimates Our consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, income and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. We do not have any significant judgments or estimates. Critical Accounting Policies While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements, we believe that the following accounting policies are those most critical to the preparation of our consolidated financial statements. Research and Development Incentives and Receivables We are subject to corporate taxation in the UK. Due to the nature of our business, we have generated losses since our inception. The benefit from research and development, or R&D, tax credit is recognized in our consolidated statements of operations and comprehensive loss as a component of other income (expense), net, and represents the sum of our R&D tax credits recoverable in the UK. Each reporting period, we evaluate which UK R&D tax credit programs we expect to be eligible for, that we plan to submit a claim for, and we have reasonable assurance that the amount will ultimately be realized. The UK R&D tax credit is fully refundable to us and is not dependent on current or future taxable income. As a result, we have recorded the entire benefit from the UK R&D tax credit as a benefit which is included in our net loss before income tax and accordingly, not reflected as part of our income tax provision. If, in the future, any UK R&D tax credits generated are needed to offset a corporation tax liability in the UK, that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded within other income (expense), net. As a Company, we currently meet the conditions of the SME regime. A large portion of costs relating to R&D, clinical trials and clinical manufacturing activities are eligible for inclusion within these tax credit cash rebate claims. We carry out extensive R&D activities and, therefore, have historically benefited from the UK R&D tax credit regime under the scheme for small or medium-sized enterprises, (“SME’s”). For accounting periods starting on or after April 1, 2024, the UK R&D regimes have changed, such that the effective cash credit will be 16.2% for in-house expenditure and 10.5% for any work that is contracted out. However, new rules were introduced by the Finance Act 2024 for an enhanced rate of relief for research intensive companies (“ERIS”), which are approximately 27.0% for qualifying expenditure and approximately 17.5% for qualifying subcontracted expenditure (paid to an unconnected subcontractor). Beginning January 1, 2025, to be eligible as a research intensive company, the qualifying R&D expenditure for tax purposes must be at least 30% of the aggregate expenditure across the consolidated group. During the year ended December 31, 2024 the threshold was 40%. For the years ended December 31, 2023 to 2025, we are currently having discussions with HMRC regarding whether we have met the R&D intensity condition and therefore are eligible for the enhanced effective rate due to uncertainties over whether impairments on intercompany loans and investments in subsidiary companies should be taken into account in determining the R&D intensity threshold. The outcome of this matter under discussion with HMRC is currently unknown. As a result of these discussions the Company recorded a change in estimate for the 2023 claim, which was initially recorded during the first quarter of 2025, of $4.1 million to reduce its receivable for amounts claimed at the enhanced rate. The 186 Table of Contents Company recorded a change in estimate for the 2024 claim, which was initially recorded during the year ended December 31, 2025, of $7.0 million to reduce its receivable for amounts previously claimed at the enhanced rate. The Company believes that the impairments of intercompany loans and investments in subsidiary companies should be disregarded and that it meets the R&D intensity condition in the year ended December 31, 2023 and December 31, 2024. As the Company believes that it meets the R&D intensity condition for the year ended December 31, 2024, it should automatically fulfil the expenditure conditions to be eligible for the enhanced rate in the year ended December 31, 2025 as a company remains research intensive unless it fails to meet the eligibility requirement for two consecutive years. However, given the uncertainty over the outcome of the discussions with HMRC the enhanced R&D credits have not been reflected in the financial statements. If the Company reached a successful conclusion with HMRC additional credits of $4.1 million in the year ended December 31, 2023, $7.0 million in the year ended December 31, 2024 and $7.3 million in the year to December 31, 2025 could be claimed. Qualifying expenditures largely comprise employment costs for research staff for which an estimate of time spent directly or indirectly supporting the pursuit of R&D activities is made, consumables, outsourced contract research organization costs, which are considered to be subcontracted costs, and utilities costs incurred as part of our research projects. A large portion of costs relating to R&D, clinical trials and manufacturing activities are eligible for inclusion within our tax credit cash rebate claims. For the year ended December 31, 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. Included in the total employment costs are estimates relating to the allocation of time spent on R&D activities by individuals. These estimates are based on real time data such as time spent by various team members, considerations given for non-R&D related events and general day to day activities. The estimates are based on the most accurate representation of the total time spent on qualifying R&D activities. The classification of consumables, outsourced contract research organization costs and utilities costs are based on analysis undertaken by management relating to the direct nature of such costs. The costs incurred relate directly to our pursuit of R&D activities. We have recorded a benefit from the R&D tax credit in other income of $3.7 million and $21.1 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, our tax incentive receivable from the UK government was $26.3 million and $20.7 million, respectively. During the year ended December 31, 2025, we did not receive any cash proceeds from the UK government in respect of prior year R&D tax credit claims. Warrant Liabilities We account for our warrants in accordance with the guidance contained in ASC Topic 815-40-15-7D, or 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 consolidated statements of operations and comprehensive loss. The fair values of these warrants are determined using the Black-Scholes pricing model. The warrant liabilities are classified as current on the consolidated balance sheets due to the likelihood of exercise and it is reasonably expected that we 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. Smaller Reporting Company Status We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. As a result, we may take advantage of certain of the scaled disclosures available to smaller reporting companies. These include, but are not limited to, reduced disclosure obligations regarding executive compensation and an exemption from the requirement to provide a compensation discussion and analysis describing compensation practices and procedures. As a 187 Table of Contents smaller reporting company with annual revenues of less than $100.0 million and a non-accelerated filer, we are also not required to provide an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. We will be able to take advantage of these scaled disclosures and exemptions for so long as (i) our voting and non-voting shares held by non-affiliates is less than $250.0 million measured on the last business day of our most recent second fiscal quarter or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting shares held by non-affiliates is less than $700.0 million measured on the last business day of our most recent second fiscal quarter.