What changed in this filing

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Item 1. Business

2026-03-24 compared with 2025-02-27 · 290 added, 245 removed, 922 unchanged (37% of the section changed)

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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 FDA for COMP360 for the treatment of TRD.

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.

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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.

At the beginning of 2023, we commenced our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD.

The Phase 3 program is composed of two pivotal trials, each with a long-term follow-up component.

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:

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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 MADRS (Montgomery-Åsberg Depression Rating Scale) total score at week 6.

• 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.

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.

In line with the study design, the study enrolled 22

participants who were monitored for a 12-week period post dosing.

The study met its primary safety endpoint and available secondary efficacy endpoints.

Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life.

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.

Based on the data from this trial, we are in the process of designing a late-stage PTSD program.

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.

The phase 2b/3 multicenter, randomized, double-blind, controlled study, with an open label extension, aims to investigate the efficacy, safety, and tolerability of COMP360 in participants with PTSD.

The study is comprised of 2 parts:

Part A (blinded) is a 12-week fixed repeat-dose, double-blinded, controlled part to confirm the efficacy of two administrations of COMP360 25 mg versus two administrations of COMP360 1 mg.

The second COMP360 administration session will occur approximately 4 weeks later.

The primary efficacy endpoint is the change from baseline in CAPS-5 total severity score at Week 8.

Part B (open-label) is a 40-week open-label follow-up to evaluate the long-term safety and efficacy of treatment in Part A.

Eligible participants will receive a single open label retreatment with COMP360 25 mg.

In both Part A and Part B, COMP360 may be administered adjunctively to a single permitted oral antidepressant.

The need for innovation in mental health care is significant, given that current treatment options are ineffective for millions of people.

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Key elements of our strategy to achieve this include:

• Advance our Phase 3 registrational program for our investigational COMP360 psilocybin treatment for the treatment of TRD.

• Complete our Phase 3 registrational program and submit our NDA for our investigational COMP360 psilocybin treatment for the treatment of TRD.

In 2021, we completed a randomized, controlled Phase 2b clinical trial in 233 TRD patients, at 22 sites across North America and Europe.

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Based on the results from the Phase 2b trial, we advanced clinical development in TRD and our Phase 3 registrational program is ongoing.

We are nearing completion of enrollment in our first pivotal study in TRD, COMP005, and expect to report top-line 6-week data in the second quarter of 2025.

We expect to report 26-week data from our COMP006 study in the second half of 2026.

• Expand our investigational COMP360 psilocybin treatment into new indications, with our next focus on advancing a late-stage development program in PTSD.

We completed enrollment in both pivotal trials during 2025 and have reported that we successfully achieved the primary endpoint in both pivotal trials.

We expect to report 26-week data from our COMP006 study in early third quarter of 2026 and expect to complete our NDA submission in the fourth quarter.

• Expand our investigational COMP360 psilocybin treatment into additional indications, with our next focus on advancing a Phase 2b/3 clinical trial in PTSD.

We believe that our investigational COMP360 psilocybin treatment may offer beneficial effects in other areas of high unmet need in mental health.

Following positive Phase 2a results in May 2024 and securing additional funding in the first quarter of 2025, we are now in the process of designing a late-stage program in PTSD.

Based on the positive Phase 2a results in May 2024, we decided to advance COMP360 into late-stage development in PTSD.

Following the FDA’s acceptance of our IND, we are initiating our Phase 2b/3 clinical trial in PTSD.

• Maximize the potential to reach patients and realize the value of our investigational COMP360 psilocybin treatment by creating a new approach to treating mental health conditions.

We retain global development and commercialization rights for our investigational COMP360 psilocybin treatment and are developing a commercial rollout plan in the event we are granted approval from regulatory authorities, working with payors to enable reimbursement and with health systems to enable broad patient access.

Delivering COMP360 is expected to require the ability to implement COMP360 seamlessly within a provider’s operating practice.

In order to ensure we understand implementation challenges, we have entered into agreements with several representative healthcare delivery centers such as Hackensack Meridian Health, a leading not-for-profit health care organization in New Jersey, and Greenbrook TMS (acquired by Neuronetics, Inc.

in December 2024), which operates a network of treatment centers throughout the United States.

We retain global development and commercialization rights for our investigational COMP360 psilocybin treatment.

If we obtain FDA approval for COMP360, our first launch market will be the U.S.

and we are accelerating our commercial planning readiness activities in the U.S.

and plan to be launch ready by the end of 2026.

Delivering COMP360 is expected to require the ability to implement COMP360

seamlessly within a provider’s operating practice.

In order to ensure we understand implementation challenges, we have entered into collaboration agreements with numerous different types of health care delivery systems in the U.S.

The purpose of these agreements is to research and investigate models for the delivery of scalable, commercial COMP360 treatment within different types of healthcare delivery systems, assuming FDA approval.

We are currently focusing our efforts on progressing our Phase 3 clinical program in TRD and starting a late-stage development program in PTSD.

The following table summarizes the status of all our pipeline assets:

We are currently focusing our efforts on progressing our Phase 3 clinical program in TRD and our Phase 2b/3 clinical trial in PTSD.

Investigational COMP360 Psilocybin Treatment

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The World Health Organization estimates as of 2025 that approximately 332 million people worldwide are suffering with MDD.

The National Institute of Mental Health estimates as of 2021 that MDD affects approximately 21 million adults in the U.S.

Based on our review of claims data, we estimate that MDD affects approximately 23 million adults in the U.S.

It is estimated that approximately 12 million adults with MDD in the U.S.

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There are only two medicines approved by the FDA for TRD in the US:

esketamine and the fixed combination of olanzapine/fluoxetine (fluoxetine a selective serotonergic reuptake inhibitor).

esketamine and the fixed combination of olanzapine and fluoxetine (fluoxetine is a selective serotonergic reuptake inhibitor).

Esketamine was approved in 2019 by the FDA.

In addition to pharmacotherapies, various forms of somatic intervention are also used, although these treatments tend to be

invasive and/or onerous, and there is limited data supporting their long-term benefit.

In addition to pharmacotherapies, various forms of somatic intervention are also used, although these treatments tend to be invasive and/or onerous, and there is limited data supporting their long-term benefit.

Psychotherapy is another common treatment approach, but it requires a significant time commitment and is subject to large variability in availability and administration.

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Clinicians often rely on a trial-and-error approach, course correcting as patients experience these relapses or difficult side effects.

Experts are beginning to recommend a shift to more multi-modal treatments where different types of therapy are delivered concomitantly (i.e., a mix of pharmacotherapy, psychological/behavioral, and device interventions).

beginning to recommend a shift to more multi-modal treatments where different types of therapy are delivered concomitantly (i.e., a mix of pharmacotherapy, psychological/behavioral, and device interventions).

Patients suffering with TRD are currently treated through a variety of approaches, each of which is associated with significant shortcomings.

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Both are DEA Schedule III products indicating potential for abuse.

There are mixed efficacy results associated with the use of esketamine and esketamine treatments require frequent administration in a

controlled environment under medical supervision.

There are mixed efficacy results associated with the use of esketamine and esketamine treatments require frequent administration in a controlled environment under medical supervision.

This frequency makes administration costly for payors and burdensome for patients.

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Some people with PTSD experience symptoms immediately after the event, while for others symptoms may appear years later.

It is estimated that approximately 311 million people globally will experience PTSD at some point during their lives.

Only 20 -30% of patients treated with currently approved pharmacological interventions for PTSD will reach full remission.

The World Health Organization estimates as of 2025 that approximately 3.9% of the global population, or approximately 320 million people globally, will experience PTSD at some point during their lives.

In the U.S., approximately 13 million people suffer from PTSD every year.

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The total economic burden for PTSD in the US surpassed $232.2 billion in 2018, or $19,630 per individual with PTSD.

There are limited treatment options for patients with PTSD.

Currently only sertraline and paroxetine are approved by the FDA for PTSD.

The FDA has not approved any new treatments for PTSD in over 25 years.

There remains significant unmet need for PTSD treatments, as only 20-30% of patients treated with currently approved pharmacological interventions for PTSD will reach full remission.

Psilocybin Therapy

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Our trial protocols provide that such support is delivered over three different phases:

preparation, the COMP360 administration session, and post-administration follow-up (integration).

preparation, the COMP360 administration session, and post-administration follow-up.

• Preparation:

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After the acute effects of psilocybin subside, patients are evaluated for safety and discharged.

• Post-administration follow-up (integration):

• Post-administration follow-up:

The objectives of the follow-up sessions are to help patients process the range of emotional and physical experiences facilitated by the psychedelic experience and to integrate any new insights that can lead to cognitive and behavioral changes.

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safe and supportive environment during the session.

Participants received two post-administration follow-up (integration) sessions with their healthcare professionals in which the psychedelic experience was discussed.

Participants received two post-administration follow-up sessions with their healthcare professionals in which the psychedelic experience was discussed.

Participants were followed for up to 12 weeks, with a visit the day after administration followed by weekly visits for the first three weeks, and visits every three weeks for the remaining nine weeks.

Primary, secondary and exploratory endpoints

The primary endpoint of this trial was the change in the MADRS total score from baseline to week 3.

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This Phase 2b clinical trial was powered to capture a statistically significant reduction in MADRS.

Secondary endpoints of the trial included:

• The proportion of participants with a response (defined as a ≥50% decrease in MADRS total score from baseline) at week 3;

• The proportion of participants with remission (defined as a MADRS total score ≤10) at week 3;

• The proportion of participants who had a sustained response at week 12.

Sustained response was defined as the proportion of participants fulfilling response criteria at any visit up to and including week 3, that also fulfills response criteria at all subsequent visits up to and including week 12;

• Time to event measures:

including restarting of antidepressant medication for any reason, suicidality, hospitalization for depression, and relapse from a previous response to COMP360 psilocybin treatment.

The safety and tolerability of COMP360 in study participants was assessed based on AEs, vital signs, clinical laboratory assessments, ECG findings and suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale, or C-SSRS score, at all visits).

The trial also assessed exploratory endpoints including, but not limited to, quality of life (EQ-5D-3L), functional impairment (Sheehan Disability Scale, SDS), psychosocial functioning (Work and Social Adjustment scale, WSAS), cognition (Digit Symbol Substitution Test, DSST), anxiety (Generalized anxiety disorder, GAD-7), and self-reported depression severity (QIDS-SR-16).

Enrollment Criteria

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Clinical findings

The Phase 2b study met its primary endpoint.

The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS depression scale at week 3 (p<0.001).

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The MADRS was assessed by independent raters who were remote from the trial site, and blind to intervention and study design, effectively creating a triple blind.

Change from baseline in MADRS total score

MADRS = Montgomery-Åsberg Depression Rating Scale

At week 3, 36.7% (29 patients) in the 25mg group were classified as responders (defined as a ≥50% decrease in MADRS total score from baseline), compared with 17.7% (14 patients) in the 1mg group.

Furthermore, 29.1% (23 patients) in the 25mg group were deemed to be in remission (defined as a MADRS total score ≤10) at week 3, compared with 7.6% (6 patients) in the 1mg group.

At week 12, 20.3% (16 patients) in the 25mg group were sustained responders (defined as meeting the MADRS response criteria at week 3 and week 12, and at least at one visit out of week 6 and week 9) compared with 10.1% (8 patients) in the 1mg group.

MADRS response and remission rates

MADRS = Montgomery-Åsberg Depression Rating Scale

MADRS sustained response rates

MADRS = Montgomery-Åsberg Depression Rating Scale.

Number of sustained responders stated in bar.

Patients meeting the MADRS response criteria at any visit up to and including week 3 and at all subsequent visits up to and including at week 12, and who did not start any new treatments for depression.

As well as looking at clinician-rated depression severity on the MADRS, the trial explored other aspects recognized as being important for patients with TRD - and essential to recovery - including positive and negative affect, anxiety, self-rated depression severity, quality of life, functioning and cognition.

These exploratory measures also showed that patients in the 25mg dose group of COMP360 psilocybin treatment reported benefits on those measures over those in the 1mg group.

On the Positive and Negative Affect Schedule measuring positive and negative affect, patients in the 25mg group had a higher increase in positive affect (e.g., including feeling interested, excited, strong) and a greater decrease in negative affect (including feeling distressed, upset, afraid) on the day after COMP360 administration and at the questionnaire’s final administration at week 3.

On scales measuring anxiety (the Generalized Anxiety Disorder – 7 item scale), self-rated depression (QIDS-SR-16) and functioning (Sheehan Disability Scale and Work and Social Adjustment Scale), a greater improvement was also shown at week 3 by patients in the 25mg group compared with the 1mg group.

A post-hoc analysis of the 16 sustained responders in the 25mg group found that changes in quality of life, self-reported depression severity, and functioning, were clinically meaningful, with mean scores for these patients returning to “normal” levels and maintained to 12 weeks, the end of the trial.

Additionally, sustained responders were found to have clinically meaningful increases in positive affect from baseline at day 2 and week 3.

COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity and greater than 77% of TEAEs occurring on the day of administration being resolved on the same day or the next day.

COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events, or TEAEs, being mild or moderate in severity and greater than 77% of TEAEs occurring on the day of administration being resolved on the same day or the next day.

179 patients reported at least one TEAE;

the most common TEAEs across treatment groups (>10% overall

incidence) were headache, nausea, fatigue, and insomnia.

There were 12 patients, 5 patients in the 25 mg group, 6 patients in the 10 mg group and 1 in the 1 mg group, who reported treatment-emergent serious adverse events (TESAEs).

the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea, fatigue, and insomnia.

There were 12 patients, 5 patients in the 25 mg group, 6 patients in the 10 mg group and 1 in the 1 mg group, who reported treatment-emergent serious adverse events, or TESAEs.

These TESAEs included, among others, suicidal behavior, intentional self-injury, and suicidal ideation, which are regularly observed in a TRD patient population.

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There was a rapid response from day 2 to week 3 after COMP360 therapy, which is consistent with the Phase 2b result.

Change from baseline in MADRS total score

COMP360 psilocybin treatment using a 25mg dose also showed overall signals of improvement in most other measures including improvement in anxiety, clinician and self-rated depressive symptoms, and positive and negative affect.

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Long-Term Phase 2 Study

During 2022, we completed a long-term follow-up study of 66 participants who took part in our Phase 2b trial.

In March 2025, the results from our observational, 52-week follow-up study (COMP004) of 66 participants who took part in our Phase 2b trial were published in the Journal of Clinical Psychiatry .

Of the 66 participants, 22 participants were in the 25mg group, 19 participants were in the 10mg group, 17 participants were in the 1mg group and 8 participants were in the 25mg plus SSRI group.

The primary endpoint of this Phase 2b follow-up study was the median time to a new depressive event.

The pre-specified primary analysis was of the median time for such an event for all participants in our Phase 2b trial, not only those who took part in the long-term follow-up study.

The primary endpoint of this COMP004 study was the median time to a new depressive event.

The pre-specified primary analysis was of the median time for such an event for all participants in our Phase 2b trial, not only those who enrolled in the COMP004 study.

The median time to a new depressive event was 92 days for the COMP360 25mg group compared to 86 days for the 10mg group and 62 days for the 1mg group.

In an additional post-hoc analysis to support the primary endpoint only including those participants from our Phase 2b study who took part in the long-term follow up study (COMP004) the median time to such an event was longer (189 days) for the COMP360 25mg group compared to the 10mg group (43 days) and the 1mg group (21 days) (patients entering from our Phase 2b study).

Twenty-seven or 40.9% of participants had an adverse event that was ongoing as of, or started, after week 12.

In addition, a lower proportion of participants started new treatments for depression in the 25mg and 10mg arm compared to the 1mg arm.

Suicidality was recorded as an adverse event twice in the 25mg group, twice in the 10mg group, and once in the 1mg group.

A post hoc analysis of the 58 participants who enrolled in the COMP004 from our Phase 2b trial revealed a substantial difference in median time to depressive event for those in the 25 mg group compared to the 10mg and 1mg groups, with median times of 189 days for the 25 mg group, 43 days for the 10 mg group, and 21 days for the 1 mg group.

COMP360 was generally well tolerated.

Three participants reported experiencing a treatment emergent serious adverse event post-enrollment to COMP004, occurring more than 6 months after a single dose administration and all deemed unrelated to study drug.

With respect to adverse events, twenty-seven or 40.9% of participants had an adverse event that was ongoing as of, or started, after week 12.

In addition, a lower proportion of participants started new treatments for depression in the 25mg

and 10mg arm compared to the 1mg arm.

Suicidality was recorded as an adverse event across all arms with two in each of the 25mg group and the 10mg group, and one in the 1mg group.

The outcomes of the long-term follow-up study informed the design of our Phase 3 registrational program, including investigating whether a second administration of COMP360 may achieve improved durability, response and remission outcomes.

Phase 3 Registrational Program and Supportive Studies

Our Phase 3 program evaluating our COMP360 psilocybin treatment in TRD is ongoing.

The Phase 3 program is composed of two pivotal trials, each with a long-term follow-up component.

The pivotal program design is as follows:

• Pivotal trial 1 (COMP005) (n=255):

a single dose (25mg) monotherapy compared with placebo.

We are conducting the COMP005 study at sites in the U.S.

We are nearing completion of enrollment and expect to report top-line six-week data in the second quarter of 2025 and then the 26-week 005 data once all participants in the 006 trial have completed Part A of the ‘006 trial.

• Pivotal trial 2 (COMP006) (n= 568):

a fixed repeat dose monotherapy using three dose arms:

25mg, 10mg and 1mg.

This trial is designed to investigate whether a second dose can increase therapeutic response.

We are conducting this study at sites in the U.S., UK, Canada and Europe.

We expect to report 26-week data by the second half of 2026.

• The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6.

Phase 3 Registrational Program

We are conducting two Phase 3 pivotal trials.

The first pivotal trial, COMP005, is a randomized, double-blind, placebo-controlled study, with 258 dosed participants across 40 trial sites in the United States, and is assessing the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD (COMP360 25 mg:

The second pivotal trial, COMP006, is a randomized, double-blind study with 581 dosed participants across 116 trial sites in the United States, Canada and Europe and is comparing the efficacy and safety of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360 (25 mg:

The primary endpoint in both pivotal trials is the change from baseline in the MADRS total score at week 6.

Each of these trials has three parts:

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We believe that this design will enable us to appropriately characterize the efficacy, safety and durability of COMP360 administration.

During the first quarter of 2023, we also commenced a Phase 2 (n=102) study to investigate the safety and tolerability of COMP360 psilocybin treatment in patients with major depressive disorder, or MDD.

In addition, pharmacokinetics of COMP360 psilocybin treatment will be investigated.

We expect to submit the results of this study as part of our submission package for approval of COMP360 psilocybin treatment in TRD.

Clinical Findings

COMP005 Trial

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.

Primary endpoint - Change in MADRS at Week 6

Part B - Change in MADRS through Week 26

Through the randomized and blinded Part B up to week 26, the results show that there was a consistent separation between 25 mg of COMP360 and placebo.

During Part B, based on pre-specified criteria, participants were eligible either for a second administration of the treatment to which they were randomized or to resume antidepressants.

During Part B, 70% of participants in the 25mg arm and 53% of participants in the placebo arm received a second administration.

For participants who had a clinically meaningful reduction in MADRS (≥ 25%), a statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in the 25 mg arm.

Twenty-five percent of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6 with durability lasting out through 26 weeks after just one or two doses of 25 mg.

Over 40% of those who achieved a clinically meaningful reduction in MADRS but had not remitted by 6 weeks went into remission after the second dose in Part B.

COMP006 Trial

We reported that the second pivotal trial, 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.

Thirty-nine percent of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6.

For participants who achieved a clinically meaningful reduction in MADRS (≥ 25%), a statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in the 25 mg arm.

Primary endpoint - Change in MADRS at Week 6

Phase 3 Program - Safety Data

Across Parts A and B of the ongoing COMP005 trial and Part A of the ongoing COMP006 trial, COMP360 is demonstrating a generally well tolerated and safe profile, with most TEAEs being mild or moderate in severity and resolving within a day.

In Parts A and B of the ongoing COMP005 trial, 66% of TEAEs occurred on the day of administration and 88% of TEAEs resolved within a day.

In Part A of the ongoing COMP006 trial, 73% of TEAEs occurred on the day of administration and 83% of TEAEs resolved within a day.

For Parts A and B of the ongoing COMP005 trial, the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea and visual hallucination.

For Part A of the ongoing COMP006 trial, the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea, anxiety, visual hallucination, illusion, dizziness, fatigue, crying and increased blood pressure.

In the ongoing COMP005 trial, through 26 weeks, there were 11 TESAEs reported by 8 participants in the 25 mg arm.

In the ongoing COMP006 trial, through Part A, there were 6 TESAEs reported by 6 participants in the 25 mg arm.

Across both trials, for the data available as of our February 17, 2026 data announcement, the rate for SAE suicidal ideation was less than 1% and there was only one event of SAE suicidal behavior, which occurred in the 1 mg arm in COMP006.

Phase 2 Study in PTSD

We completed a Phase 2 clinical trial to assess the safety and tolerability of COMP360 psilocybin treatment, as a monotherapy in participants with PTSD, as a result of trauma experienced as adults.

It was a multicenter, fixed-dose open label study.

In August 2025, the results from our Phase 2 clinical trial to assess the safety and tolerability of COMP360 psilocybin treatment, as a monotherapy in participants with PTSD, as a result of trauma experienced as adults, were published in the Journal of Psychopharmacology .

Trial Design and Demographics

The Phase 2 trial was a multicenter, fixed-dose open label trial.

Participants were required to taper off their medicines.

Twenty-two participants received a single 25mg dose of investigational COMP360 psilocybin treatment.

Twenty-two participants received a single 25mg dose of investigational COMP360 psilocybin treatment, along with support and monitoring provided by a licensed medical professional, which consisted of preparing participants for the treatment session, observing and being present with participants during the session and supporting them after the session.

In line with the study design, participants were monitored for a 12-week period post dosing.

In May 2024, we reported top-line results from this study.

Primary endpoint was safety at week 12;

available secondary endpoints were change in CAPS-5 from baseline and change in SDS total score from baseline.

The mean baseline severity of symptoms was a baseline of 47.5 (minimum of 25;

maximum of 64) CAPS-5 total score, which is considered severe.

The CAPS-5 assessment involves a structured interview that provides a PTSD diagnosis and measures symptom severity.

The average age of participants at the time of screening was 39 and patients diagnosed with complex PTSD were excluded from study eligibility.

The study was conducted at The Institute of Psychiatry, Psychology and Neuroscience at King’s College London, Icahn School of Medicine at Mount Sinai in New York and Sunstone Therapies in Rockville, Maryland.

Clinical Findings

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.

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Improvement in mean CAPS-5 total score from a baseline of 47.5 was observed (29.9 point reduction at week 4 and 29.5 point reduction at week 12).

• Improvement over time in Sheehan Disability Scale (SDS) measure of functional impairment over 12 weeks.

• Improvement over time in SDS measure of functional impairment over 12 weeks.

From a mean SDS total score of 22.7 at baseline, there was a 11.7 point reduction at week 4 and a 14.4 point reduction at week 12.

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• No patients withdrew from the study and no patients returned to antidepressant medication treatment during the trial.

The open-label, multi-center, phase 2 safety study evaluated investigational COMP360 psilocybin treatment in 22 patients with PTSD resulting from trauma in adulthood.

Participants received a single 25mg dose along with psychological support.

Psychological support was provided by a licensed medical professional to ensure patient safety, which consisted of preparing participants for the treatment session, observing and being present with patients during the session and supporting them after the session.

Primary endpoint was safety at week 12;

available secondary endpoints were change in CAPS-5 from baseline and change in SDS total score from baseline.

The mean baseline severity of symptoms was a baseline of 47.5 (minimum of 25;

maximum of 64) CAPS-5 total score, which is considered severe.

The CAPS-5 assessment involves a structured interview that provides a PTSD diagnosis and measures symptom severity.

The average age of participants at the time of screening was 39 and patients diagnosed with complex PTSD were excluded from study eligibility.

Phase 2 Study in Anorexia

We closed enrollment in the second half of 2024 for a double-blind randomized controlled Phase 2 clinical trial investigating the safety and efficacy of COMP360 psilocybin in participants with anorexia nervosa.

It is a multicenter study and enrolled 32 patients.

We expect to report data from this study in 2025.

The outcomes of this Phase 2 trial informed the design of our Phase 2b/3 trial in PTSD.

Phase 2b/3 Trial in PTSD

The phase 2b/3 multicenter, randomized, double-blind, controlled trial, with an open label extension, aims to investigate the efficacy, safety, and tolerability of COMP360 in participants with PTSD.

The study is comprised of 2 parts:

Part A (blinded) is a 12-week fixed repeat-dose, double-blinded, controlled part to confirm the efficacy of two administrations of COMP360 25 mg versus two administrations of COMP360 1 mg.

The second COMP360 administration session will occur approximately 4 weeks later.

The primary efficacy endpoint is the change from baseline in CAPS-5 total severity score at Week 8.

Part B (open-label) is a 40-week open-label follow-up to evaluate the long-term safety and efficacy of treatment in Part A.

Eligible participants may receive a single open label retreatment with COMP360 25 mg.

In both Part A and Part B, COMP360 may be administered adjunctively to a single permitted oral antidepressant.

Phase 2 Trial in Anorexia

In August 2025, we reported data from a double-blind randomized controlled Phase 2 clinical trial investigating the safety and efficacy of COMP360 psilocybin in participants with anorexia nervosa.

It was a multicenter study and enrolled 32 patients.

This Phase 2 clinical trial evaluated COMP360 dosed at 25mg against a control arm of participants receiving COMP360 1mg.

There was an encouraging positive signal of improvement in eating disorder symptom score sustained through 12 weeks in the 25mg arm, but the low overall numbers of participants and high number of dropouts in the control arm (only 6 of the 11 participants in the control arm completed the study) limited the statistical power of the study.

The safety profile was aligned with the high-risk patient population of anorexia nervosa and no unexpected safety signals were reported.

There was no clinically meaningful imbalance in suicidal ideation across arms.

Other Indications:

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This exploratory study is being conducted by a research scientist who is employed by us and is a PhD student at King’s College London.

The study is being conducted at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and is co-sponsored by King’s IoPPN and South London and Maudsley NHS Foundation Trust.

The study is being conducted at the Institute of Psychiatry, Psychology & Neuroscience, or IoPPN, at King’s College London and is co-sponsored by King’s IoPPN and South London and Maudsley NHS Foundation Trust.

It will enroll 70 adult participants, including 40 autistic people and 30 non-autistic people.

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Adjusted-response rates for QIDS-SR-16 (defined as ≥50% reduction from baseline in the QIDS-SR-16 total score) at week 6 were 70.2% for the COMP360 arm vs.

48.0% for the

escitalopram arm and adjusted-remission rates (defined as a QIDS-SR-16 total score ≤5) at week 6 were 57.1% and 29.1%, respectively.

48.0% for the escitalopram arm and adjusted-remission rates (defined as a QIDS-SR-16 total score ≤5) at week 6 were 57.1% and 29.1%, respectively.

For the MADRS – a more widely used and accepted clinician-rated scale which Compass is using as the primary endpoint in their clinical trials – a least square means treatment difference of -7.2 was found.

Similar patterns were found on other secondary endpoints measuring work and social functioning, anxiety, avoidance, anhedonia, and wellbeing.

Similar patterns were found on

other secondary endpoints measuring work and social functioning, anxiety, avoidance, anhedonia, and wellbeing.

This work has been published in the New England Journal of Medicine (Carhart-Harris et al.

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The primary aim of this study was to assess the safety and tolerability of a single 25mg dose of psilocybin in participants with anorexia nervosa based on adverse events, changes in vital signs, electrocardiograms and clinical laboratory tests.

Forty percent (n=4) experienced clinically meaningful reductions at the 3-month follow-up, based on global score on the Eating Disorder Examination (EDE).

Forty percent (n=4) experienced clinically meaningful reductions at the 3-month follow-up, based on global score on the Eating Disorder Examination, or EDE.

Participants demonstrated nominally statistically significant reductions in shape concerns on the EDE at the 1-month follow-up (mean change from pre-treatment=1.3;

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In July 2023, the results of this study showing the potential of investigational COMP360 psilocybin treatment in anorexia nervosa were published in Nature Medicine .

In 2022, Sheppard Pratt Health System completed an IIS of COMP360 titled “The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.” (ClinicalTrials.gov Identifier:

In 2022, Sheppard Pratt Health System completed an IIS of COMP360 titled “The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder Depression.” (ClinicalTrials.gov Identifier:

NCT0443384512).

The investigator presented data from this study at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2022.

The investigator presented data from this study at the Annual Meeting of the American College of Neuropsychopharmacology in December 2022.

In this open-label study involving 14 patients with type 2 bipolar depression, patients received a 25mg dose of COMP360 with psychological support.

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The investigator published data from this study in The Lancet (Von Rotz et al, Lancet 2023;

this double-blind, randomized clinical trial, 52 patients with major depressive disorder were randomized 1:1 to receive either a single, moderate dose (0.215 mg/kg body weight) of COMP360 psilocybin or placebo in conjunction with psychological support.

MADRS and Beck's Depression Inventory (BDI) scores were assessed to estimate depression severity and the primary endpoints were defined as changes from baseline to two weeks after the administration of COMP360.

In this double-blind, randomized clinical trial, 52 patients with major depressive disorder were randomized 1:1 to receive either a single, moderate dose (0.215 mg/kg body weight) of COMP360 psilocybin or placebo in conjunction with psychological

MADRS and Beck's Depression Inventory, or BDI, scores were assessed to estimate depression severity and the primary endpoints were defined as changes from baseline to two weeks after the administration of COMP360.

At the two-week endpoint, response rates resulted in 58% for MADRS (COMP360 psilocybin:

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Drug Discovery Center

On August 5, 2020, we established a Drug Discovery Center under a sponsored research agreement with the University of the Sciences in Philadelphia, Pennsylvania (which merged into Saint Joseph’s University in 2022), or USciences, to focus on developing optimized psychedelic and related compounds targeting the 5-HT 2A receptor, which is believed to mediate the potential therapeutic effects of psychedelics.

potential therapeutic effects of psychedelics.

Further to the strategic reorganization we announced in the fourth quarter of 2024 and our decision to stop non-COMP360 preclinical and discovery work and focus all our resources on advancing development of our investigational COMP360 treatment, this agreement with USciences was not renewed and will terminate in the second quarter of 2025.

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Delix Therapeutics

On March 6, 2020 we made a strategic investment to acquire 1,250,000 shares of series seed preferred stock in Delix Therapeutics, Inc., a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders..

Using Digital Technology

We believe digital technology can help increase patient access to mental health treatment and services and manage their mental health conditions.

Furthermore, digital tools have the potential to enable greater self-care, as they may support patients managing depressive episodes on their own and may complement and augment psychotherapy and pharmacological treatments.

Working with third parties, we currently use digital technology in our clinical trials in a number of ways:

• An online and mobile app preparation platform for participants in our TRD trial to educate them and help prepare them for their psilocybin experience;

• A web-based “shared knowledge” interactive healthcare professional training platform, complementing our comprehensive face-to-face training program;

• Collection of measurements in our clinical trials, including remote data collection using mobile devices so patients do not need to travel into study sites for all in-clinic visits;

• Collection of some digital phenotyping information through the measurement of human-smartphone interactions;

• Harnessing AI and natural language processing capabilities to potentially characterize the mechanism of change and assess fidelity to our treatment protocol for psychological support.

We have built an in-house digital team with experience in digital technology, engineering and AI, which we refer to as augmented intelligence as well as artificial intelligence.

This team has focused on researching and developing proprietary digital tools and technology to test evidence-based methods for assessing mental health treatments.

We are exploring externalizing this team and these technologies and the associated intellectual property to a new company established by our co-founders, George Goldsmith and Ekaterina Malievskaia that could potentially support an evidence-based approach for any company developing or delivering mental health treatments.

We expect to have a final decision on this externalization in the second quarter of 2025.

We have a strategic investment in Delix Therapeutics, Inc., a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders.

In March 2020, we purchased 1,250,000 shares of series seed preferred stock.

In November 2025, we participated in a simple agreement for future equity financing to the extent of our pro-rata ownership of Delix and invested an additional approximately $20,500.

Manufacturing and Supply

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We rely on contract drug manufacturing organizations, or CDMOs, to synthesize the active pharmaceutical ingredient, or API, that comprises COMP360, and to blend the API excipients and encapsulate.

All manufacturing processes are contracted to be compliant with current Good Manufacturing Practice (cGMP).

All manufacturing processes are contracted to be compliant with current Good Manufacturing Practice, or cGMP.

We expect to continue to rely on third parties for the production of all clinical supply drug substance and drug product that we may use.

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We recognize that COMP360 psilocybin treatment, if approved, represents a new approach for many clinical practices and that delivering COMP360 is expected to require the ability to implement COMP360 seamlessly within a provider’s operating practice.

In order to ensure we understand implementation challenges, we entered into agreements with different types of healthcare delivery centers, including Hackensack Meridian Health, a leading not-for-profit health care organization in New Jersey, and Greenbrook TMS (acquired by Neuronetics, Inc.

in December 2024), which operates a network of treatment centers throughout the United States, to research and investigate models for the delivery of scalable, commercial COMP360 psilocybin treatment within various types of healthcare delivery systems, assuming FDA approval.

In order to ensure we understand implementation challenges, we have entered into a number of collaboration agreements with numerous different types of health care delivery systems in the U.S.

We have entered into collaboration agreements with Greenbrook Mental Wellness Centers (acquired by Neuronetics, Inc.

in December 2024), a leading provider of interventional psychiatric treatments in the U.S.;

Hackensack Meridian Health, a leading not-for-profit health care organization in New Jersey, addressing the full continuum of care for people living with mental health conditions;

Reliant Medical Group, an Optum company and integrated primary and specialty care organization;

Journey Clinical, a leading psychedelic-assisted psychotherapy platform in the US;

Mindful Health Solutions, one of the U.S.’s leading providers of innovative behavioral health care;

HealthPort, a multi-site comprehensive community health organization helping people impacted by social determinants of health;

and Radial Health, a growing national network of interventional psychiatry

practices leveraging technology and operations expertise to optimize models of care delivery.

The goal of these collaborations is to research and investigate models for the delivery of scalable, commercial COMP360 psilocybin treatment within various types of healthcare delivery systems, assuming FDA approval.

We have established Centers of Excellence to serve as research facilities and innovation labs.

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Several biopharmaceutical companies have therapies in clinical development for TRD.

We are aware that Supernus

Pharmaceuticals, Neurocrine Biosciences, GH Research and Beckley Psytech, among others, are developing treatments for TRD or inadequate response to treatment in major depressive disorder.

We are aware that Supernus Pharmaceuticals, Neurocrine Biosciences, GH Research and Beckley Psytech, among others, are developing treatments for TRD or inadequate response to treatment in major depressive disorder.

Multiple somatic therapies are also used in TRD, such as ECT and rTMS.

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We also face competition from 501(c)(3) non-profit medical research organizations, including the Usona Institute.

In March 2024, Usona Institute announced the launch of its Phase 3 trial evaluating the efficacy and safety of psilocybin 25 mg in as a treatment for major depressive disorder, which is expected to enroll approximately 240 adult patients.

Usona has 26 clinical trial sites, continues to progress its Phase 3 trial and expects to complete the primary endpoint in its Phase 3 trial in April 2025 and the long-term follow-up portion of its Phase 3 trial in April 2026.

In March 2024, Usona Institute announced the launch of its Phase 3 trial evaluating the efficacy and safety of psilocybin 25 mg as a treatment for major depressive disorder, which is expected to enroll approximately 240 adult patients.

Usona has 29 clinical trial sites, completed enrollment for its Phase 3 trial and expects to complete the primary endpoint in its Phase 3 trial in April 2026 and the long-term follow-up portion of its Phase 3 trial in December 2026.

Such non-profits may be willing to provide psilocybin-based products at cost or for free, undermining our potential market for COMP360.

In addition, a number of for-profit biotechnology companies or institutions are specifically pursuing the development of psilocybin to treat mental health illnesses, including Cybin Inc.

In March 2024, Cybin announced the design of its Phase 3 program for its deuterated psilocybin analog for the adjunctive treatment of major depressive disorder, which includes two Phase 3 trials and is expected to enroll approximately 550 adult patients.

In November 2024, Cybin announced the initiation of its Phase 3 program.

In addition, a number of for-profit biotechnology companies or institutions are specifically pursuing the development of psilocybin to treat mental health illnesses, including Helus Pharma, Inc.

(formerly Cybin Inc.), or Helus.

In March 2024, Helus announced the design of its Phase 3 program for its deuterated psilocybin analog for the adjunctive treatment of major depressive disorder, which includes two Phase 3 trials and is expected to enroll approximately 550 adult patients.

In November 2024, Helus announced the initiation of its Phase 3 program.

We are aware of other organizations or institutions evaluating the use of psilocybin in mental health and neurocognitive conditions.

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Patents and Other Intellectual and Proprietary Rights

Obtaining, maintaining and defending global patents and other intellectual property (“IP”) rights, whether independently or in collaboration with our partners, are of key importance in the protection and commercialization of the Company’s innovative therapies and technology solutions.

Obtaining, maintaining and defending global patents and other intellectual property, or IP, rights, whether independently or in collaboration with our partners, are of key importance in the protection and commercialization of our innovative therapies and technology solutions.

We shall continue to seek global patent, trademark, and trade secret protection of our innovations in the U.S., EU, UK, and other key jurisdictions.

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Upon regulatory approval in a particular jurisdiction, we will also seek to meaningfully protect our innovations by asserting available regulatory exclusivity including regulatory data protection and market exclusivity.

For example, upon approval from the U.S.

FDA, we may be entitled to five years of regulatory exclusivity for New Chemical Entity, or NCE, status and upon approval from the European Medicines Agency, or EMA, we may be entitled to ten years of regulatory exclusivity.

For example, upon approval from the FDA, we may be entitled to five years of regulatory exclusivity for New Chemical Entity, or NCE, status and upon approval from the European Medicines Agency, or EMA, we may be entitled to ten years of regulatory exclusivity.

We will defend our patents and other IP and proprietary rights as appropriate if and when we are subjected to third-party challenges (e.g., litigation, post-grant review, inter-partes review, oppositions).

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Pharmaceutical formulations ca.

US 19/296,560 Crystalline psilocybin;

Pharmaceutical formulations ca.

US 12,459,965 Crystalline psilocybin;

Pharmaceutical formulations ca.

US 12,312,375 Crystalline psilocybin;

Pharmaceutical formulations ca.

GB 2571696 Method of manufacturing ca.

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US 12,447,164 Method of treating eating disorders ca.

US 12,433,904 Method of treating migraines ca.

US 19/296,581 Method of treating bipolar disorder ca.

US 19/569,250 Method of treating substance use disorder ca.

PCT WO2020/212948

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2040* Applications filed in Australia, Canada, China, European Patent Office, Hong Kong, Japan and Republic of Korea.

US 17/604,606

Method of treating attention-deficit hyperactivity disorder, autism spectrum disorder, or chronic pain ca.

US 12,377,112 Method of treating attention-deficit hyperactivity disorder, or autism spectrum disorder ca.

US 19/234,582 Method of treating neurocognitive disorders ca.

PCT WO2020/212952

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US 18/718,103 Method of treating treatment resistant depression with psilocybin and serotonin reuptake inhibitor ca.

PCT WO2025/215243 Scalable Methods of Manufacturing Psilocybin ca.

2042* Applicants filed in US and TW.

*In general, a U.S.

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Further, in the U.S., it may also be possible to extend beyond the 20-year patent term as a result of prosecution delays caused by the U.S.

Patent and Trademark Office.

Trademark Office.

Patent No 10,519,175, was granted on December 31, 2019, with claims directed to methods of treating treatment-resistant depression with oral dosage formulations of Compass’s high-purity crystalline psilocybin (including COMP360).

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filed a request for rehearing on July 22, 2022, and a request for Precedential opinion panel on August 16, 2022.

The USPTO Board denied the request for Precedential Opinion Panel (POP) review on February 10, 2023.

The USPTO Board denied the request for Precedential Opinion Panel review on February 10, 2023.

On May 23, 2023, the USPTO Board denied the request for rehearing.

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Freedom to Operate, Inc.

filed a request for rehearing on July 22, 2022, and a request for Precedential opinion panel

on August 16, 2022.

The USPTO Board denied the request for Precedential Opinion Panel (POP) review on February 10, 2023.

filed a request for rehearing on July 22, 2022, and a request for Precedential opinion panel on August 16, 2022.

The USPTO Board denied the request for Precedential Opinion Panel review on February 10, 2023.

On May 23, 2023, the USPTO Board denied the request for rehearing.

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national phase entry of WO2022/207746.

The Company has pursued protection for its trademarks across Classes 5, 9, 10, 35, 41, 42, 44 or various combinations thereof.

Our trademark portfolio includes active filings for the COMPASS, COMPASS PATHWAYS, C Design, MYPATHFINDER, CHANTERELLE, COMPASS PATHWAVES, NUFONDIS, and EMPAQUIST marks in the United States, European Union, and United Kingdom, as detailed in the chart below.

The Company owns registrations for the COMPASS, COMPASS PATHWAYS, C Design, and MYPATHFINDER marks in the United States, European Union, and United Kingdom;

We have pursued protection for our trademarks across Classes 5, 9, 10, 35, 41, 42, 44 or various combinations thereof.

We own registrations for the COMPASS, COMPASS PATHWAYS, C Design, and MYPATHFINDER marks in the United States, European Union, and United Kingdom;

and for the CHANTERELLE, COMPASS PATHWAVES, NUFONDIS and EMPAQUIST marks in the European Union and United Kingdom.

Applications are pending for the CHANTERELLE, COMPASS PATHWAVES, NUFONDIS, and EMPAQUIST marks in the United States.

The Company also owns trademark registrations and pending applications in other countries.

Trademark Application/Registration

Filing/Registration Date

5, 9, 10, 35, 41, 44

February 22, 2022

5, 9, 10, 35, 41, 44

August 10, 2020

COMPASS PATHWAYS

5, 9, 10, 35, 41, 44

February 22, 2022

5, 9, 10, 35, 41, 44

August 14, 2020

5, 35, 41, 42, 44

September 6, 2022

June 29, 2021

June 30, 2022

December 15, 2021

December 15, 2022

October 11, 2022

Applications are pending for the CHANTERELLE,

COMPASS PATHWAVES, NUFONDIS, and EMPAQUIST marks in the United States.

We also own trademark registrations and pending applications in other countries.

Government Regulation

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The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and imposes a full or partial clinical hold.

FDA must notify the sponsor of the grounds for the hold and any identified deficiencies must be resolved before the clinical trial can begin.

The FDA must notify the sponsor of the grounds for the hold and any identified deficiencies must be resolved before the clinical trial can begin.

Submission of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND.

A clinical hold can also be imposed once a trial has already begun, thereby halting the trial until the deficiencies articulated by FDA are corrected.

A clinical hold can also be imposed once a trial has already begun, thereby halting the trial until the deficiencies articulated by the FDA are corrected.

The clinical stage of development involves the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, who generally are physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirements that all research subjects provide their informed consent for their participation in any clinical trial.

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A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND.

If a foreign clinical trial is not conducted under an IND, FDA will nevertheless accept the results of the study in support of an NDA if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.

If a foreign clinical trial is not conducted under an IND, the FDA will nevertheless accept the results of the study in support of an NDA if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials to evaluate therapeutic indications to support NDAs for marketing approval are typically conducted in three sequential phases, which may overlap.

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• Phase 2— Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the drug’s potential efficacy, to determine the optimal dosages and administration schedule and to identify possible adverse side effects and safety risks.

• Phase 3— Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and physician labeling.

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Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for additional FDA programs intended to expedite the review and approval process, including Priority Review designation and Accelerated Approval.

A product is eligible for Priority Review designation, once an NDA or BLA is submitted, if the drug that is the subject of the marketing application has the potential to provide a significant

improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition.

A product is eligible for Priority Review designation, once an NDA or BLA is submitted, if the drug that is the subject of the marketing application has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition.

Under priority review, the FDA’s goal date to take action on the marketing application is six months compared to ten months for a standard review.

Products are eligible for Accelerated Approval if they can be shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, which is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

Accelerated Approval is usually contingent on a sponsor’s agreement to conduct additional post-approval studies to verify and describe the product’s clinical benefit.

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Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such uses.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be

subject to significant liability, including investigation by federal and state authorities.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including investigation by federal and state authorities.

Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use or first publication.

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I n addition, the Drug Supply Chain Security Act, or DSCSA, was enacted in 2013 with the aim of building an electronic system to identify and trace certain prescription drugs and biologics distributed in the United States.

The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers over a 10-year period that culminated in November 2023.

The FDA established a one-year stabilization period until November 2024 for trading partners to continue to build and validate interoperable systems and processes to meet certain requirements of the DSCSA.

In late 2024, the FDA announced it is allowing a further exemption period for eligible trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.

The exemption period for eligible manufacturers and repackagers now extends until May 27, 2025.

The stabilization period for building and validating interoperable electronic tracing systems has ended and trading partners who have not achieved compliance with these requirements must secure an exemption from the FDA.

The DSCSA requirements include the quarantine and prompt investigation of a suspect product, to determine if it is illegitimate, notifying trading partners and the FDA of any illegitimate product, and compliance with product tracking and tracing requirements.

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The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing, distribution, importation and other requirements under the oversight of the DEA.

The DEA is the federal

agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled substances to illicit channels of commerce.

The DEA is the federal agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled substances to illicit channels of commerce.

The DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with varying qualifications for listing in each schedule.

Schedule I substances by definition have a high potential for abuse, have no currently accepted medical use in treatment in the United States and lack accepted safety for use under medical supervision.

Pharmaceutical products having a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances, with Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances presenting the lowest relative potential for abuse and dependence.

psychological dependence, and Schedule V substances presenting the lowest relative potential for abuse and dependence.

COMP360, if approved in the United States, will require rescheduling by the DEA before it can be marketed.

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Whether or not it obtains FDA approval for a product, an applicant will need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can initiate clinical trials or marketing of the product in those countries or jurisdictions.

Specifically, the

process governing approval of medicinal products in the EU generally follows the same lines as in the United States, although the approval of a medicinal product in the United States is no guarantee of approval of the same product in the EU, either at all or within the same timescale as approval may be granted in the United States.

Specifically, the process governing approval of medicinal products in the EU generally follows the same lines as in the United States, although the approval of a medicinal product in the United States is no guarantee of approval of the same product in the EU, either at all or within the same timescale as approval may be granted in the United States.

It entails satisfactory completion of pharmaceutical development, non-clinical studies and adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal product for each proposed indication.

It also requires the submission to relevant competent authorities for clinical trials authorization and subsequently of a marketing authorization application, or MAA, before the product can be marketed and sold in the EU or any of its Member States.

If we fail to comply with applicable requirements, we may be subject to withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

If we fail to comply with applicable requirements, we

may be subject to withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Clinical Trial Approval

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The Clinical Trials Regulation also makes it more efficient for EU Member States to evaluate and authorize applications together, via the Clinical Trials Information System.

The transitory provisions of the Clinical Trials Regulation provide that, by January 31, 2025, all ongoing clinical trials must have transitioned to the Clinical Trials Regulation.

Since January 31, 2025, all new and ongoing clinical trials are regulated by the Clinical Trials Regulation.

Marketing Authorization

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Clock stops may extend the timeframe of evaluation of an MAA considerably beyond 210 days.

Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the European Commission, who make the final decision to grant a marketing authorization.

Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the European Commission, which makes the final decision to grant a marketing authorization.

Within 67 days from the date of the CHMP opinion, the European Commission will adopt its final decision on the MAA.

Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation.

Accelerated assessment may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation.

If the CHMP accepts such a request, the timeframe of 210 days for assessment will be reduced to 150 days (excluding clock stops), but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate to conduct an accelerated assessment.

Now that the UK (which comprises Great Britain and Northern Ireland) has left the EU, Great Britain is no longer covered by EU centralized marketing authorizations.

On January 1, 2024, a new international recognition framework was put

in place by the MHRA, under which the MHRA may have regard to decisions on the approval of marketing authorizations made by the EMA and certain other regulators.

Now that the UK (which comprises Great Britain and Northern Ireland) has left the EU, the UK is no longer covered by EU centralized marketing authorizations.

On January 1, 2024, the MHRA introduced the International Recognition Procedure, under which the MHRA may have regard to decisions on the approval of marketing authorizations made by the EMA and certain other regulators when considering an application for a UK marketing authorization.

The MHRA also has the power to have regard to marketing authorizations approved in EU Member States through decentralized or mutual recognition procedures with a view to more quickly granting a marketing authorization in the United Kingdom.

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If a medicine is selected for the PRIME scheme, the EMA:

• appoints a rapporteur from the CHMP or from the Committee for Advanced Therapies (CAT) to provide continuous support and to build up knowledge of the medicine in advance of the filing of an MAA;

• appoints a rapporteur from the CHMP or from the Committee for Advanced Therapies to provide continuous support and to build up knowledge of the medicine in advance of the filing of an MAA;

• issues guidance on the applicant’s overall development plan and regulatory strategy;

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Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The grant of a marketing authorization for an orphan medicinal product leads to a ten-year period of market exclusivity.

The grant of a marketing authorization for an orphan medicinal product leads to a ten-

year period of market exclusivity.

During this market exclusivity period, neither the EMA nor the European Commission or competent authorities of the Member States can accept an application or grant a marketing authorization for the same therapeutic indication in respect of a “similar medicinal product”.

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Data and Market Exclusivity

In the EU, innovative medicinal products approved on the basis of a complete and independent data package qualify for eight years of data exclusivity upon grant of a marketing authorization and an additional two years of market exclusivity pursuant to Regulation (EC) No.

In the EU, innovative medicinal products containing a new active substance and approved on the basis of a complete and independent data package qualify for eight years of data exclusivity upon grant of a marketing authorization and an additional two years of market exclusivity pursuant to Regulation (EC) No.

726/2004, as amended, and Directive 2001/83/EC, as amended.

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During the additional two-year period of market exclusivity, a generic or biosimilar marketing authorization application can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar medicinal product can be marketed until the expiration of the market exclusivity period.

The overall 10-year period will be extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit in comparison with existing therapies.

There is no guarantee that a product will be considered by the EMA to be an innovative medicinal product, and products may not qualify for data exclusivity.

Even if a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company obtained marketing authorization based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials.

The overall 10-year period may be extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to authorization, is determined to bring a significant clinical benefit in comparison with existing therapies.

There is no guarantee that a product will be considered to contain a new active substance for the purposes of EU data and market exclusivity, and products may not qualify for data exclusivity.

Even if a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company obtained a marketing authorization based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials.

Periods of Authorization and Renewals

A marketing authorization is valid for five years, in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by the EMA or by the competent authority of the authorizing EU Member State.

Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period.

Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or

the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period.

Any authorization that is not followed by the placement of the product on the EEA market (in the case of the centralized procedure) or on the market of the authorizing EU Member State (for a national procedure) within three years after authorization ceases to be valid (the so-called sunset clause).

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Furthermore, the manufacturing of authorized products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive (EU) 2017/1572, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice.

These requirements include compliance with the EU cGMP standards which mandate the methods, facilities and controls used in manufacturing, processing and packing of products to assure their safety and identity.

These requirements include compliance with EU good manufacturing practice, or GMP, standards which govern the methods, facilities and controls used in manufacturing, processing and packaging of products to assure their quality, safety and identity.

Finally, the marketing and promotion of authorized products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of products, are strictly regulated in the EU under Directive 2001/83/EC, as amended.

The advertising of prescription-only medicines to the general public is not permitted in the EU, or in the UK under the Human Medicines Regulations 2012.

Although general requirements for advertising and promotion of medicinal products

are established under EU Directive 2001/83/EC as amended, the details are governed by regulations in each EU Member State and can differ from one country to another.

Although general requirements for advertising and promotion of medicinal products are established under EU Directive 2001/83/EC as amended, the details are governed by regulations in each EU Member State and can differ from one country to another.

The aforementioned EU rules are generally applicable in the EEA (which consists of the EU Member States plus Norway, Iceland and Liechtenstein).

Reform of the Regulatory Framework in the European Union

The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children).

The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval, and, in April 2024 the European Parliament proposed amendments to the legislative proposals.

Once the European Commission’s legislative proposals are approved (with or without amendment), they will be adopted into EU law.

The European Commission introduced legislative proposals in April 2023 to replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children).

In April 2024, the European Parliament adopted its position on the legislative proposals, and in June 2025, the Council of the European Union adopted its position.

A common position on the text was agreed upon on December 11, 2025, in the context of subsequent inter-institutional trilogue negotiations.

The proposed revisions remain to be adopted, and are not expected to become applicable before 2028.

Brexit and the Regulatory Framework in the United Kingdom

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At present, the UK has implemented EU legislation on the marketing, promotion and sale of medicinal products through the Human Medicines Regulations 2012 (as amended) (under the Northern Ireland Protocol, the EU regulatory framework with respect to medicines continued to apply in Northern Ireland for a period following Brexit).

Except in respect of the EU Clinical Trials Regulation, the regulatory regime in the UK therefore largely aligns with EU regulations, however it is possible that these regimes will diverge more significantly in future now that the UK’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition of UK and EU pharmaceutical legislation.

However, notwithstanding that there is no wholesale recognition of EU pharmaceutical legislation under the TCA, under a new international recognition procedure mentioned above which was put in place by the MHRA on January 1, 2024, the MHRA may take into account decisions on the approval of a marketing authorization from the EMA (and certain other regulators) when considering an application for a the UK marketing authorization.

Except in respect of the EU Clinical Trials Regulation, the regulatory regime in the UK therefore largely aligns with EU regulations, however it is possible that these regimes will diverge more significantly in the future now that the UK’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition of UK and EU pharmaceutical legislation.

On February 27, 2023, the UK government and the European Commission announced a political agreement in principle to replace the Northern Ireland Protocol with a new set of arrangements, known as the “Windsor Framework”.

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This new framework fundamentally changes the previous system under the Northern Ireland Protocol, including with respect to the regulation of medicinal products in the UK.

In particular, the MHRA is now responsible for approving all medicinal products destined for the UK market (i.e., Great Britain and Northern Ireland), and the EMA no longer has any role in approving medicinal products destined for Northern Ireland under the EU centralized procedure.

A single UK-wide marketing authorization will be granted by the MHRA for all novel medicinal products to be sold in the UK, enabling products to be sold in a single pack and under a single authorization throughout the UK.

In addition, the new arrangements require all medicines placed on the UK market to be labelled “UK only”, indicating they are not for sale in the EU.

The Windsor Framework removes EU licensing processes and certain EU labeling and serialization requirements in relation to Northern Ireland and introduces a UK-wide licensing process for medicines.

In particular, the MHRA is now responsible for approving medicinal products placed on the UK market (i.e., Great Britain and Northern Ireland), and the EMA no longer has any role in UK marketing authorizations.

A single UK-wide marketing authorization will be granted by the MHRA for all medicinal products to be sold in the UK, enabling products to be sold in a single pack and under a single authorization throughout the UK.

In addition, the new arrangements generally require, for packs placed on the UK market on or after January 1, 2025, a "UK Only" label, indicating they are not for sale in the EU.

The MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, a 150-day assessment (subject to clock-stops) and a rolling review procedure.

The rolling-review procedure permits the separate or joint submission of quality, non-clinical, and clinical data to the MHRA which can be reviewed on a rolling basis.

After an application under the rolling-review procedure has been validated, the final decision should be received within 100 days (subject to clock-stops).

In the UK, the initial duration of a marketing authorization is five years and following renewal will be valid for an unlimited period unless the MHRA decides on justified grounds relating to pharmacovigilance, to proceed with only one additional five-year renewal.

Any authorization which is not followed by the actual placing of the medicine on the market in the UK within three years shall cease to be in force.

The UK regulatory framework in relation to clinical trials is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the Clinical Trials Directive 2001/20/EC, as implemented into UK national law through secondary legislation.

In April 2025, the UK introduced the Medicines for Human Use (Clinical Trials) (Amendment) Regulations.

These changes, which will take full effect from April 2026, aim to create a streamlined, risk-proportionate system that accelerates approvals while maintaining robust safety standards.

In addition, in October 2023, the

MHRA announced a new Notification Scheme for clinical trials which enables a more streamlined and risk-proportionate approach to initial clinical trial applications for Phase 4 and low-risk Phase 3 clinical trial applications.

We received an Innovation Passport designation from the MHRA for COMP360 for the treatment of treatment-resistant depression.

The Innovation Passport is the entry point to the UK's Innovative Licensing and Access Pathway, or ILAP, a scheme intended to accelerate the time to market and facilitate patient access in the UK to certain types of medicinal products in development that target a life-threatening or seriously debilitating condition, or where there is a significant patient or public health need in the UK.

Once an Innovation Passport designation is granted, the MHRA and its partner agencies (including the All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence, NHS England and the Scottish Medicines Consortium), will work with the Innovation Passport holder to define a Target Development Profile, or TDP.

The TDP sets out a unique product-specific roadmap towards patient access in the UK and provides access to tools intended to support stages of the design, development and approvals process, which may include enhanced regulatory and health technology assessment engagement and patient involvement.

However, although the goal of the ILAP is to reduce time to market and enable earlier patient access, participation does not accelerate the conduct of clinical trials or mean that the regulatory requirements are less stringent, nor does it ensure that a marketing authorization application will be approved or that any approval will be granted within a particular timeframe or at all.

Coverage, Pricing and Reimbursement

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A decision by a third-party payor not to cover or not to separately reimburse for our medical products or therapies using our products could reduce physician utilization of our products once approved and have a material adverse effect on our sales, results of operations and financial condition.

If there is coverage for our product candidates, or therapies using our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

If there is coverage for our product candidates, or therapies using our product

candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

We cannot be sure that coverage and reimbursement in the United States will be available for our current or future product candidates, or for any procedures using such product candidates, and any reimbursement that may become available may not be adequate or may be decreased or eliminated in the future.

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The requirements governing drug pricing vary widely from country to country.

For example, in the EU, pricing and reimbursement schemes vary widely from country to country.

For example, in the EU, pricing and reimbursement schemes are determined at the level of individual Member States and vary widely from country to country.

Some EU Member States provide that products may be marketed only after a reimbursement price has been agreed.

Some EU Member States may require the completion of additional studies that compare the cost effectiveness of a particular product candidate to currently available therapies (so called health technology assessments) in order to obtain reimbursement or pricing approval.

For example, EU Member States have the option to restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

Some EU Member States may require the completion of additional studies that compare the cost effectiveness or relative clinical value of a particular product candidate compared to currently available therapies (so called health technology assessments) in order to obtain reimbursement or pricing approval.

For example, EU Member States may restrict the range of products for which their national health insurance systems provide reimbursement and may control the prices of medicinal products for human use.

EU Member States may approve a specific price for a product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on the market.

Approaches between EU Member States are diverging.

For example, in France, effective market access will be supported by agreements with hospitals and products may be reimbursed by the Social Security Fund.

The price of medicines is negotiated

with the Economic Committee for Health Products, or CEPS.

Approaches between EU Member States differ and continue to evolve.

For example, in France, effective market access will be supported by agreements with hospitals and products may be reimbursed by the Social Security system.

The price of medicines is negotiated with the Economic Committee for Health Products, or CEPS.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.

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In addition, results-based rules of reimbursement may apply.

Historically, products launched in the EU do not follow price structures of the United States and generally prices tend to be significantly lower.

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Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval.

Our business operations and any current or future arrangements with third-party payors, healthcare providers and physicians may expose us to broadly applicable federal and state fraud and abuse laws, as well as other healthcare laws and regulations.

Our business operations and any current or future arrangements with

third-party payors, healthcare providers and physicians may expose us to broadly applicable federal and state fraud and abuse laws, as well as other healthcare laws and regulations.

These laws may impact, among other things, our business or financial arrangements and relationships through which we research, as well as market, sell and distribute the psilocybin therapies for which we obtain approval.

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or from knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of

false or fraudulent claims.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery.

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Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its respective implementing regulations, which imposes, among other things, certain requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates and their covered subcontractors relating to the privacy, security and transmission of individually identifiable health information.

certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates and their covered subcontractors relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, those independent contractors or agents of covered entities that create, receive, maintain, transmit or obtain protected health information in connection with providing a service on behalf of a covered entity.

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state laws that require pharmaceutical companies to comply with the pharmaceutical industry voluntary compliance guidelines and other relevant compliance guidance promulgated by the federal government, such as the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals;

state laws that require the reporting of information related to

drug pricing;

state laws that require the reporting of information related to drug pricing;

state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information;

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It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations, including our arrangements with physicians and other healthcare providers and entities, such as our Centers of Excellence or healthcare professionals providing psychological support in our clinical trials, are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to significant penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), imprisonment, and additional oversight and reporting obligations if we become subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our Centers of Excellence and healthcare professionals providing psychological support in our clinical trials, are found to be not in compliance with applicable laws, they may be subject to similar actions, penalties and sanctions.

If our operations, including our arrangements with physicians and other healthcare providers and entities, such as our Centers of Excellence or healthcare professionals supporting and monitoring participants in our clinical trials, are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to significant penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), imprisonment, and additional oversight and reporting obligations if we become subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring

of our operations, any of which could adversely affect our ability to operate our business and our financial results.

If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our Centers of Excellence and healthcare professionals supporting and monitoring participants in our clinical trials, are found to be not in compliance with applicable laws, they may be subject to similar actions, penalties and sanctions.

Ensuring that our current and future business arrangements with third parties, and our business generally, comply with applicable healthcare laws and regulations, as well as responding to possible investigations by government authorities, can be time- and resource- consuming and can divert a company’s attention from its business.

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imposes new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S.

government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge.

government to negotiate Medicare

Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge.

Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.

If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption.

Under the One Big Beautiful Bill Act of 2025, this restriction was eliminated;

and effective for the 2028 initial price applicability year, all orphan drugs, regardless of the number of orphan drug designations or indications, are exempt from the Medicare drug price negotiation program.

The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program.

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Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.

In addition, President Biden issued multiple executive orders that have sought to reduce prescription drug costs.

At a federal level, President Trump reversed some of President Biden’s executive orders including rescinding Executive Order 14087 entitled “Lowering Prescription Drug Costs for Americans." President Trump may issue new executive orders designed to impact drug pricing.

On December 19, 2025, CMS released two proposed rules that would incorporate most favored nation, or MFN, pricing principles into federal reimbursement for prescription drugs.

The first proposal, the Global Benchmark for Efficient Drug Pricing Model, or GLOBE, for Medicare Part B, would require manufacturers of specified single source drugs and sole source biologics to pay incremental rebates based on international benchmark prices, with participation triggered for products meeting CMS’s spending and eligibility criteria.

The second proposal, the Guarding U.S.

Medicare Against Rising Drug Costs, or GUARD, model for Medicare Part D, would similarly mandate manufacturer rebates for qualifying sole source drugs where the Medicare net price exceeds an MFN benchmark derived from international reference pricing methodologies.

As proposed, GLOBE would begin a five year performance period on October 1, 2026 and GUARD would begin its performance period in 2027.

These proposals will likely be subject to legal challenges that could delay their implementation or modify their impact on manufacturer pricing and revenue.

Additionally, in November 2025, CMS introduced the GENErating cost Reductions fOr U.S.

Medicaid, or GENEROUS, Model, a voluntary MFN framework for manufacturers participating in the Medicaid Drug Rebate Program.

Although it is voluntary, the GENEROUS Model could also impact the drug pricing landscape for manufacturers.

President Trump may issue new executive orders designed to impact drug pricing.

Although any proposed measures may require authorization through additional legislation to become effective, and the Trump administration may reverse or otherwise change these measures, both the Trump administration and Congress have indicated that they will continue to seek measures to control drug costs.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Certain states are also pursuing cost containment efforts through Prescription Drug Affordability Boards, or PDABs, and similar entities.

While many PDABs have been granted authority to promote drug price transparency and reporting, some states have granted PDABs more expansive authority, including to set Upper Payment Limits, or UPLs, on select, high price drugs.

The adoption and implementation of UPLs may put downward pressure on drug prices and impact our company’s future revenues.

We expect that additional foreign, federal and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

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As of December 31, 2025, we had 156 employees, which represented a decrease of 6.0% compared to the prior year, of whom 101 employees are engaged in research and development activities and 55 employees are engaged in general administrative functions.

As of December 31, 2023, we had 186 employees, of whom 141 employees are engaged in research and development activities and 45 employees are engaged in general administrative functions.

As of December 31, 2024, we had 166 employees, which represented a decrease of 11% compared to the prior year, of whom 125 employees were engaged in research and development activities and 41 employees were engaged in general administrative functions.

As of December 31, 2025, 49% of our employees are located in the US, while the remaining 51% are located in the UK.

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• company-paid employee health care coverage, including access and financial support for a private mental health care in the UK;

• a global employee assistance program run by certified counselors, offering up to 10 therapy sessions per issue for team members and full access to online resources for their families;

• a global employee assistance program run by certified counselors, offering up to a specified number of therapy sessions per issue for team members and full access to online resources for their families;

• one-to-one confidential well-being check-ins, onboarding and off boarding with our well-being community lead;

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• periodic training for managers on how to address well-being issues in their teams and provide support;

• access to a meditation app with weekly group meditation sessions;

• company-wide shutdown over the year-end holiday, to make it easier for team members to disconnect during their time off;

In 2023 we signed the StigmaFree pledge organized by the National Alliance on Mental Illness (NAMI), as part of our commitment to a company culture of openness, acceptance, and understanding about employees’ overall mental health and well-being.

• company-wide support for dependent childcare, helping both parents remain in the workforce, including pre-tax dependent care benefits in the US and a family allowance in the UK.

In 2023 we signed the StigmaFree pledge organized by the National Alliance on Mental Illness, or NAMI, as part of our commitment to a company culture of openness, acceptance, and understanding about employees’ overall mental health and well-being.

In 2024, after a thorough and rigorous selection process, we were approved as a Corporate Sponsor of NAMI, enabling an even stronger partnership with them.

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We are committed to the continued development of our employees, and to support their growth.

performance and rewards at the end of the year, and job architecture, providing employees with guidance and clear pathways for developing and progressing their career and twice-yearly promotions cycle.

To help us identify, foster, and retain high performing employees, we have a range of resources and initiatives, including talent reviews to assess and calibrate talent for the purposes of rewards and development, a process for performance and development goals that is tied to employees receiving feedback throughout the year and assessing individual performance and rewards at the end of the year, and job architecture, providing employees with guidance and clear pathways for developing and progressing their career and twice-yearly promotions cycle.

In 2025, we introduced a new leadership development program for senior leaders, to focus on strengthening the leadership pipeline and positively impacting our leadership culture.

Compensation and Benefits

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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.

What changed 10-K

Item 1. Business