MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: 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 in this Annual Report on Form 10-K.
+Added: 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.
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References to “we,” “our,” “us” and “the Company” refer to Compass Pathways plc.
+Added: Operating Results
We are a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.
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Our initial focus is on TRD, comprising patients who are inadequately served by current treatment options.
−Removed: In 2018, we received Breakthrough Therapy designation from the FDA for COMP360 for the treatment of TRD.
+Added: In 2018, we received Breakthrough Therapy designation from the U.S.
+Added: 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.
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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.
−Removed: At the beginning of 2023, we commenced our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD.
−Removed: The Phase 3 program is composed of two pivotal trials, each with a long-term follow-up component.
+Added: In 2025, we completed enrollment for each of the two pivotal trials in our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD,.
+Added: Each of the two pivotal trials has a long-term follow-up component.
The pivotal program design is as follows:
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This trial is designed to investigate whether a second dose can increase therapeutic response.
−Removed: • The primary endpoint in both pivotal trials is the change from baseline in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score at week 6.
+Added: • 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.
+Added: 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.
+Added: The COMP005 trial is on-going and is comprised of three parts:
+Added: Part A, which concluded during the second quarter of 2025, and was blinded through 6 weeks;
+Added: Part B, which remained blinded through week 26;
+Added: and Part C, which contains an open-label treatment part from week 26 to 52.
+Added: 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.
+Added: 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.
+Added: 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.
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The study met its primary safety endpoint and available secondary efficacy endpoints.
−Removed: 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.
+Added: 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.
−Removed: Based on the data from this trial, we are in the process of designing a late-stage PTSD program.
+Added: In September 2025, the results of this study were published in the Journal of Psychopharmacology .
+Added: 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.
+Added: 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.
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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.
−Removed: 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.
−Removed: Sales of our ADSs, if any, will be made at market prices.
−Removed: Since the establishment of the ATM offering program, t hrough December 31 , 2024 , we sold 5,491,836 ADSs under our ATM offering program , resulting in $54.8 million in net proceeds.
−Removed: On February 27, 2025, we entered into a new Sales Agreement to govern our ATM offering program with TD Cowen 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 and only after the registration statement covering such ATM offering program has been declared effective.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Sales of our ADSs, if any, will generally be made at market prices.
+Added: 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.
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The PIPE Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the PIPE Warrants.
−Removed: Through December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds.
+Added: During the year ended December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds.
+Added: 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.
−Removed: We have incurred recurring losses since our inception, including net losses of $155.1 million and $118.5 million for the years ended December 31, 2024 and 2023, respectively.
+Added: 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.
+Added: 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.
+Added: The Pre-funded Warrants have an exercise price of $0.0001 per ADS and are exercisable immediately.
+Added: The Pre-funded Warrants expire when exercised in full.
+Added: The 2025 ADS Warrants have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone.
+Added: The 2025 ADS Warrants will expire three years after such warrants become exercisable.
+Added: 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.
+Added: During the year ended December 31, 2025, 2,344,720 Pre-funded Warrants were exercised on a cashless basis.
+Added: 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.
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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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
−Removed: As a result, we will need substantial additional funding in the longer term to support our continuing operations and pursue our growth strategy.
+Added: 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 .
−Removed: We believe that our existing cash and cash equivalents, together with the net proceeds raised to date during the first quarter of 2025 of $140.4 million, will be sufficient for us to fund our operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from our COMP006 study, which is expected in the second half of 2026.
+Added: 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.
+Added: We received net proceeds of approximately $140.5 million, after deducting underwriting discounts and commissions and estimated offering costs.
+Added: 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.
+Added: 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.
−Removed: Recent Developments
−Removed: In January 2025, the Company issued and sold (i) 24,014,728 American Depositary Shares, each representing one ordinary share, nominal value £0.008 each, of the Company and accompanying warrants to purchase up to 24,014,728 ADSs,
−Removed: 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.
−Removed: The offering price is $4.2750 per ADS and accompanying 2025 ADS Warrant, and $4.2649 per Pre-Funded Warrant and accompanying 2025 ADS Warrant.
−Removed: The Pre-Funded Warrants have an exercise price of $0.0001 per ADS and are exercisable immediately.
−Removed: The Pre-Funded Warrants expire when exercised in full.
−Removed: The 2025 ADS Warrants have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone.
−Removed: The 2025 ADS Warrants will expire after three years.
−Removed: 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 $5.796 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered.
−Removed: Macroeconomic Conditions
−Removed: 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.
−Removed: and global economies, fluctuations in foreign exchange rates, the potential for a government shutdown in the United States, the potential for significant changes in U.S.
−Removed: policies or regulatory environment or disruption for U.S.
−Removed: government agencies, the risk of economic slowdown or recession in the United States, the potential for significant changes in U.S.
−Removed: policies or regulatory environment and geopolitical tensions from 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.
−Removed: Our ability to raise additional funds may be adversely impacted by macroeconomic conditions and disruptions to and volatility in the credit and financial markets in the U.S.
+Added: Macroeconomic Conditions and Changes in Regulatory Landscape
+Added: 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.
+Added: policies or regulatory environment or disruption to U.S.
+Added: 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.
+Added: Changes in policy or resources of governmental agencies, including, but not limited to, changes at the FDA, DEA, SEC, IRS and U.S.
+Added: Patent and Trademark Office, could impact our business and results of operations.
+Added: 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.
+Added: 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.
+Added: 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,
+Added: the ability of the government to hire and retain key personnel, and shifting policy priorities.
+Added: 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 .
+Added: 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.
−Removed: Our inability 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.
+Added: 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.
Components of Our Results of Operations
−Removed: To date, we have not generated any revenue and do not expect to generate any revenue from the sale of therapeutic candidates in the foreseeable future.
+Added: 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.
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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.
−Removed: 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 potential or future therapeutic candidates.
+Added: 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:
−Removed: • successful enrollment in and completion of clinical trials and preclinical studies, including our Phase 3 clinical trials in TRD;
+Added: • 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;
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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.
−Removed: 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.
+Added: 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.
−Removed: In the short-term, we expect reduced personnel expenses as a result of the reorganization that took place in the fourth quarter of 2024.
−Removed: 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.
+Added: 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
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Benefit from R&D tax credit consists of the R&D tax credit received in the UK, which is recorded within other income, net.
−Removed: 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.
−Removed: 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.
−Removed: 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 year ended December 31, 2024 and 2023.
+Added: 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.
+Added: Qualifying expenditures largely comprise employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: As a result, we have recorded the entire benefit from the UK research and development 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.
+Added: 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.
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Interest expense relates to interest paid on debt.
+Added: Fair value changes of warrant liabilities
+Added: 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.
+Added: Foreign exchange gains (losses)
+Added: 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
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Our corporate income tax expense represents only income taxes in the U.S.
−Removed: Unsurrendered UK losses may be carried forward indefinitely and may be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
+Added: 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.
−Removed: During the year ended December 31, 2024 and 2023, we recorded a tax provision of $1.6 million and $0.8 million, respectively, related to the corporate income tax obligations of our operating company in the U.S., which generates a profit for tax purposes.
+Added: 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.
Results of Operations
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LOSS FROM OPERATIONS (179,037) (178,205)
−Removed: OTHER INCOME, NET:
+Added: OTHER (EXPENSE) INCOME, NET:
+Added: Fair value change of warrant liabilities (122,561) —
Benefit from R&D tax credit 3,747 21,097
Interest income 7,182 8,268
+Added: Foreign exchange gains (losses) 3,471 (1,032)
Interest expense (4,517) (4,479)
−Removed: (4,479) (2,204)
−Removed: Foreign exchange (losses) gains
−Removed: (1,032) 3,686
−Removed: Total other income, net 24,677 19,235
+Added: Other income 1,380 823
+Added: Total other (expense) income, net (111,298) 24,677
Loss before income taxes (290,335) (153,528)
−Removed: Income tax expense (1,594) (780)
+Added: Income tax benefit (expense) 2,473 (1,594)
Net loss $ (287,862) $ (155,122)
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Personnel expenses 24,420 26,707 (2,287)
−Removed: Non-cash share-based compensation expense 10,309 8,910 1,399
Facilities and other expenses
6,556 5,030 1,526
+Added: Non-cash share-based compensation expense 5,088 10,309 (5,221)
Total research and development expenses $ 118,436 $ 119,039 $ (603)
−Removed: For the year ended December 31, 2024, the increases in research and development expenses, as compared to the same period in 2023, were primarily attributable to the following:
+Added: 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:
+Added: • 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.
• an increase in development expenses associated with advancing our late-stage COMP360 clinical trials;
−Removed: • an increase in personnel expenses as a result of increased staffing levels supporting our research and development teams as well as one-time costs associated with the reorganization that took place in the fourth quarter of 2024;
−Removed: • an increase in non-cash share-based compensation expense primarily due to the accounting for certain equity-based awards.
−Removed: • a decrease in facilities and other expenses primarily due to a decrease in external consulting fees.
−Removed: We expect research and development costs to continue to increase substantially through completion of our Phase 3 program for COMP360 psilocybin therapy in TRD.
+Added: • an increase in facilities and other expenses primarily due to an increase in external consulting fees.
+Added: 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.
General and Administrative
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2025 2024 Change
−Removed: Personnel expenses $ 23,422 $ 18,192 $ 5,230
Legal and professional fees $ 23,521 $ 14,535 $ 8,986
+Added: Personnel expenses 19,716 23,422 (3,706)
Facilities and other expenses 8,862 12,001 (3,139)
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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:
−Removed: • an increase in personnel expenses as a result of increased staffing levels supporting our corporate functions as well as one-time costs associated with the reorganization that took place in the fourth quarter of 2024;
−Removed: • an increase in legal and professional fees, primarily related to expenses associated with consulting, legal advice and patent applications;
−Removed: • an increase in non-cash share-based compensation expense, primarily due to the accounting for certain equity-based awards.
−Removed: • a decrease in facilities and other expenses, primarily due to a decrease in banking fees and reduced insurance premiums.
−Removed: 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.
+Added: • 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.
+Added: • 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.
+Added: • 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.
+Added: 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
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2025 2024 Change
+Added: Fair value change of warrant liabilities $ (122,561) $ — $ (122,561)
Benefit from R&D tax credit 3,747 21,097 (17,350)
−Removed: $ 21,097 $ 12,875 $ 8,222
Interest income 7,182 8,268 (1,086)
−Removed: 8,268 4,623 3,645
−Removed: Foreign exchange (losses) gains
−Removed: (1,032) 3,686 (4,718)
Interest expense (4,517) (4,479) (38)
−Removed: (4,479) (2,204) (2,275)
+Added: Foreign exchange gains (losses) 3,471 (1,032) 4,503
Other income 1,380 823 557
−Removed: Total other income, net
−Removed: $ 24,677 $ 19,235 $ 5,442
−Removed: For the year ended December 31, 2024 , the increase in other income, net, as compared to the same period in 2023, was primarily attributable to the following:
−Removed: • an increase in the benefit from R&D tax credit primarily due to higher R&D expenditures claimed at the enhanced research intensive rate in the current year;
−Removed: • an increase in interest income primarily due to higher interest rates earned on higher cash deposit levels.
−Removed: • a decrease due to foreign exchange losses following remeasurement of foreign currency denominated assets and liabilities;
−Removed: • an increase in interest expense related to the Loan Agreement with Hercules entered into on June 30, 2023, as well as the payment-in-kind (PIK) interest on the loan.
+Added: Total other (expense) income, net $ (111,298) $ 24,677 $ (135,975)
+Added: 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:
+Added: • 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;
+Added: • 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;
+Added: • a decrease in interest income primarily due to interest earned on lower cash deposit levels.
+Added: Partially offset by:
+Added: • an increase due to foreign exchange gains following remeasurement of foreign currency denominated assets and liabilities;
Comparison For The Years Ended December 31, 2024 and 2023
3 unchanged sentences
We have incurred significant operating losses since our formation.
−Removed: We have not yet commercialized any therapeutic candidates and we do not expect to generate revenue from sales of any therapeutic candidates for the foreseeable future, if at all.
+Added: We have not yet commercialized any therapeutic candidates.
+Added: 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.
+Added: 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.
−Removed: Since the establishment of the ATM offering program, t hrough December 31 , 2024 , we sold 5,491,836 ADSs under our ATM offering program, resulting in $54.8 million in net proceeds.
−Removed: On February 27, 2025, we entered into a new Sales Agreement to govern our ATM offering program with TD Cowen 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 and only after the registration statement covering such ATM offering program has been declared effective.
+Added: 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.
+Added: 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.
+Added: Sales of our ADSs, if any, will generally be made at market prices.
+Added: 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.
1 unchanged sentence
Each PIPE Warrant has an exercise price of $9.93 per ADS and is exercisable for a three-year period beginning in February 2024.
−Removed: Through December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds.
−Removed: We will receive up to an additional approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised.
−Removed: In January 2025, the Company 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.
−Removed: The 2025 ADS Warrants have an exercise price of $5.7960 per ADS and are exercisable following a specified data milestone.
−Removed: The 2025 ADS Warrants will expire after three years.
−Removed: 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 $5.796 for the three consecutive trading days prior to the date on which the notice of forced exercise is delivered.
−Removed: 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 footnotes to our consolidated financial statements.
+Added: During the year ended December 31, 2024, PIPE Warrants were exercised for 3,752,050 ADS, resulting in $37.3 million in exercise proceeds.
+Added: During the year ended December 31, 2025, no PIPE warrants were exercised.
+Added: We will receive up to an additional approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised for cash.
+Added: 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.
+Added: Through December 31, 2025, 2,344,720 Pre-funded Warrants were exercised.
+Added: 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.
+Added: 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.
The following table summarizes our cash flows for each of the periods (in thousands):
−Removed: Year Ended December 31,
+Added: to f Year Ended December 31,
2025 2024 Change
Net cash used in operating activities
−Removed: Net cash used in investing activities — (64) 64
+Added: $ (157,240) $ (119,186) $ (38,054)
Net cash provided by financing activities
+Added: $ 140,712 $ 63,824 $ 76,888
Effect of exchange rate changes on cash, cash equivalents and restricted cash
+Added: $ 1,045 $ 194 $ 851
Net (decrease)/increase in cash, cash equivalents and restricted cash
1 unchanged sentence
Net Cash Used in Operating Activities
−Removed: Net cash used in operating activities increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to a $36.7 million increase in our net loss which was offset by favorable working capital related activities of $8.2 million, primarily attributable to the timing of $28.5 million cash received in 2024 relating to the 2022 and 2023 R&D tax credit, as well as an increase of $6.6 million of non-cash adjustments.
−Removed: Net Cash Used in Investing Activities
−Removed: Net cash used in investing activities remained consistent during the year ended December 31, 2024, compared to the same period in 2023.
+Added: 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
−Removed: Net cash provided by financing activities decreased during the year ended December 31, 2024, compared to the same period in 2023.
−Removed: During the year ended December 31, 2023, net cash provided by financing activities 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 $116.8 million.
−Removed: Net cash provided by financing activities during the year ended December 31, 2024 primarily consisted of net proceeds from the issuance of ordinary shares through our ATM facility of $26.2 million and proceeds from the issuance of o rdinary shares to settle warrants exercised of $37.3 million.
+Added: 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
−Removed: 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.
−Removed: 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.
−Removed: Our expenses will also increase as we:
−Removed: • 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 ;
−Removed: • initiate a late-stage development program in PTSD;
−Removed: • continue the training of qualified healthcare professionals to monitor and safeguard participants receiving investigational COMP360 psilocybin treatment in our Phase 3 program and other clinical trials;
−Removed: • service our outstanding indebtedness;
−Removed: • may in the future resume and pursue research and development programs for our other preclinical stage therapeutic candidates and discovery-stage programs;
−Removed: • may in the future invest in further discovery efforts and/or develop additional therapeutic candidates;
−Removed: • establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any therapeutic candidates for which we may obtain regulatory approval, including COMP360;
+Added: 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.
+Added: 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.
+Added: Our expenses will increase as we:
+Added: • 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 ;
+Added: • 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;
−Removed: • establish and expand the network of public healthcare institutions and private clinics that administer our investigational COMP360 psilocybin treatment in conjunction with psychological support if approved;
−Removed: • seek regulatory approvals for any future therapeutic candidates that successfully complete clinical trials;
+Added: • initiate and advance our Phase 2b/3 clinical trial in PTSD;
+Added: • continue the training of qualified healthcare professionals to monitor and safeguard participants in our Phase 3 program and other clinical trials;
+Added: • service our outstanding indebtedness;
+Added: • 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 ;
+Added: • 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;
8 unchanged sentences
As of December 31, 2025 , we had cash and cash equivalents of $149.6 million .
−Removed: We believe that our existing cash and cash equivalents , together with the net proceeds raised to date during the first quarter of 2025 of $140.4 million, will be sufficient for us to fund our operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from our COMP006 study, which is expected in the second half of 2026.
+Added: 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.
+Added: We received net proceeds of approximately $140.5 million, after deducting underwriting discounts and commissions and estimated offering costs.
+Added: 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.
+Added: 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.
+Added: 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.
2 unchanged sentences
Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
−Removed: • 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;
−Removed: • the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA, the EMA, the MHRA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to;
+Added: • 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;
+Added: • the progress, timing and completion of our Phase 2b/3 clinical trial in PTSD;
+Added: • 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
+Added: 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;
−Removed: • 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;
−Removed: • 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;
−Removed: • the costs of developing sales and marketing capabilities to target public and private healthcare providers and clinic networks in major markets;
−Removed: • the costs of training and qualifying healthcare professionals to monitor and safeguard participants receiving our investigational COMP360 psilocybin treatment in our Phase 3 program and other clinical trials;
−Removed: • the costs of establishing research collaborations, such as our Centers of Excellence and the Center for Mental Health Research, which includes conducting clinical trials, including proof of concept studies, to refine our treatment delivery model;
+Added: • 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;
+Added: • 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;
+Added: • 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.
+Added: and other major markets;
+Added: • the costs of training qualified healthcare professionals to monitor and safeguard participants in our clinical trials;
+Added: • 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;
−Removed: • 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;
+Added: • 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;
1 unchanged sentence
• 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;
−Removed: • the impact of macroeconomic 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.;
+Added: • 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;
• the costs of operating as a public company.
1 unchanged sentence
Additional financing may not be available at all or on acceptable terms.
−Removed: To the extent that we raise additional capital through the sale of equity, current ownership interests will be diluted.
−Removed: 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 on terms that may not be favorable to us.
+Added: To the extent that we raise additional capital through the sale of equity or exercise of outstanding warrants, current ownership interests will be diluted.
+Added: 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
+Added: 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.
17 unchanged sentences
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.
−Removed: As a company we carry out extensive R&D activities and, therefore, benefit from the UK R&D tax credit regime under the scheme for SMEs.
−Removed: We have assessed our research and development activities and expenditures to determine whether the nature of the activities and expenditures will qualify for credit under the SME regime and whether the claim will ultimately be realized based on the allowable reimbursable expense criteria established by the UK government.
−Removed: Under the SME regime, in effect through December 31, 2024, the Company is able to surrender some of its trading losses that arise from qualifying research and development activities for a cash rebate of a portion of such qualifying research and development expenditure.
−Removed: Up until April 1, 2023, the effective rate was 33.3% on in-house expenditures and 21.7% on work
−Removed: that was contracted out (to unconnected subcontractors).
−Removed: On and after April 1, 2023, the effective rates reduced to 18.6% and 12.1%, respectively.
−Removed: New rules were introduced by the Finance Act 2024 for an enhanced effective rate of relief for loss making research intensive SMEs, which are approximately 27.0% for qualifying in-house expenditures and approximately 17.5% for qualifying subcontracted expenditures (to unconnected subcontractors).
−Removed: To be eligible as a research intensive company (the R&D intensity condition), the qualifying R&D expenditure for tax purposes must be at least 40% of the aggregate expenditure across the consolidated group.
−Removed: The threshold has decreased from 40% to 30% from January 1, 2025.
−Removed: For the year ended December 31, 2023, the Company has accounted for its R&D tax credit on the basis that it was not research intensive.
−Removed: For the year ended December 31, 2024 the Company believes that it meets the R&D intensity condition and has therefore calculated its R&D tax credit at the enhanced rate on the basis that it is research intensive.
−Removed: The enhanced rate for a payable credit is 14.5% compared to the standard rate of 10%, which when applied to qualifying expenditure enhanced by 86% to 186%, gives an effective rate of 27% on qualifying in house expenditure and 17.5% for qualifying subcontracted expenditure (to unconnected subcontractors).
−Removed: We currently meet the conditions of the SME regime.
+Added: As a Company, we currently meet the conditions of the SME regime.
+Added: 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.
+Added: 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”).
+Added: 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.
+Added: 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).
+Added: 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.
+Added: During the year ended December 31, 2024 the threshold was 40%.
+Added: 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.
+Added: The outcome of this matter under discussion with HMRC is currently unknown.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
2 unchanged sentences
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.
−Removed: The costs incurred relate directly to the pursuit of R&D activities by the company.
−Removed: We have recorded a benefit from the R&D tax credit in other income, net of $21.1 million and $12.9 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: The refund is denominated in pounds sterling and, therefore, the receivable is remeasured into U.S.
−Removed: dollars as of each reporting date.
+Added: The costs incurred relate directly to our pursuit of R&D activities.
+Added: 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.
−Removed: During the year ended December 31, 2024, the Company received $14.9 million and $13.6 million from the UK government for the 2022 and 2023 R&D tax credit, respectively.
+Added: 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.
+Added: Warrant Liabilities
+Added: 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.
+Added: Accordingly, we classify the warrants as liabilities at their fair value and adjust the warrants to fair value at each reporting period.
+Added: 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.
+Added: The fair values of these warrants are determined using the Black-Scholes pricing model.
+Added: 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.
+Added: 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
2 unchanged sentences
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.
−Removed: As a 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.
+Added: 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.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.