Q1 2022 Compass Pathways PLC Earnings Call

Ladies and gentlemen for standby your conference call will begin shortly we thank you for your patience Peter Mineralize Your conference call will begin Sir.

Operator: Ladies and gentlemen, please stand by. Your conference call will begin shortly. We thank you for your patience. Please remain in line.

[music].

Operator: Your conference call will begin shortly. [music] Good morning and welcome to COMPASS Pathways' first quarter 22 earnings call. During the presentation, all participants will be in a listen-only mode.

Good morning, and welcome to Compass pathways first quarter 'twenty two earnings call. During the presentation, all participants will be in a listen only mode.

Operator: Afterward, we will conduct a question and answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star zero.

Afterwards, we will conduct a question and answer session at that time. If you have a question. Please press the one followed by the four on your telephone.

If at any time during the conference you need to reach an operator, Please press star zero.

Operator: As a reminder, today's conference is being recorded. I would like to turn the conference over to Stephen Schultz, VP of Investor Relations. Please go ahead, sir.

As a reminder, today's conference is being recorded I would like to turn the conference over to Stephen Schultz VP Investor Relations. Please go ahead Sir.

Welcome all of you and thank you for joining us today for our first quarter 2022 results conference call. We hope you've had a chance to review the press release issued earlier today covering these results again my name is Steve Schultz Senior Vice President of Investor Relations at Compass pathways.

Stephen Schultz: Welcome all of you and thank you for joining us today for our first quarter 2022 results conference call. We hope you've had a chance to review the press release issued earlier today covering these results. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today, I'm joined by George Goldsmith, Chairman and Chief Executive Officer, Dr. Guy Goodwin, Chief Medical Officer, and Mike Falvey, our Chief Financial Officer.

Today Im joined by George Goldsmith, Chairman and Chief Executive Officer, Dr. Guy Goodwin, Chief Medical Officer, and Mike <unk>, Our Chief Financial Officer.

Stephen Schultz: The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading Risk Factors in our quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission and in subsequent filings made by COMPASS with the SEC.

The call is being recorded and will be available on the compass pathways Investor Relations website. Shortly after the conclusion of the call.

Stephen Schultz: Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward statement.

Before we begin let me remind everyone that during the call today the team will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 as amended.

Should not place undue reliance on these forward looking statements actual events or results could differ materially from those expressed or implied by any forward looking statements. As a result of various risks uncertainties and other factors, including those risks and uncertainties described under the heading risk factors.

Our quarterly report on Form 10-Q filed with the U S Securities and Exchange Commission.

And in subsequent filings made by Congress with the SEC. Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

We specifically disclaim any obligation to update or revise any forward looking statements with that I'll now hand, the call over to our chairman and CEO George Goldsmith.

George Goldsmith: With that, I'll now hand the call over to our chairman and CEO, George Goldsmith. Thank you, Steve, and welcome, everyone. I will begin today's call with an update on our business progress. I will then ask Guy to provide some high-level comments on the recently completed End of Phase 2 meeting with the FDA, and then Mike will provide a financial review. After our prepared remarks, we will open the call to questions.

Thank you, Steve and welcome everyone I will begin today's call with an update on our business progress I will then ask guy to provide some high level comments on the recently completed end of phase II meeting with the FDA and then Mike will provide a financial review.

After our prepared comments, we will open the call to questions.

George Goldsmith: I'm pleased to report to you that in this first quarter, COMPASS continued to make significant progress toward our goal of transforming mental health care. Too many individuals who suffer from mental health conditions are not properly served by the current standard of care.

I am pleased to report to you that in this first quarter club has continued to make significant progress toward our goal of transforming mental health care.

Too many individuals who suffer from mental health conditions are not properly served by the current standard of care Compas is addressing this through innovations and novel medicines, evidenced based therapeutic protocols and digital tools that support patients and therapists to dramatically improve the way we care for these patients.

George Goldsmith: COMPASS is addressing this through innovations in novel medicines, evidence-based therapeutic protocols, and digital tools that support patients and therapists to dramatically improve the way we care for these patients. The increasing number of people with significant mental health challenges is a global crisis, and one that carries with it a large and growing cost burden on patients and healthcare systems. In the face of this growing crisis, COMPASS continues to advance its development programs in both treatment-resistant depression, TRD, and in post-traumatic stress disorder, PTSD, two substantially underserved patient populations.

The increasing number of people with significant mental health challenges is a global crisis and one that carries with it a large and growing cost burden to patients and health care systems.

In the face of this growing crisis carpets continues to advance our development programs in both treatment resistant depression, CRD and in post traumatic stress disorder PTSD to substantially underserved patient populations, our strong cash position and experienced team of experts across the key disciplines.

George Goldsmith: Our strong cash position and experienced team of experts across key disciplines continues to differentiate COMPASS in this area of science and also keep us on track to bring our therapy safely to patients as quickly as possible. Our innovative clinical care pathways that integrate psychedelic medicine, digital platforms, data science, and psychological support to help people get well and stay well are novel and valuable propositions for patients, health care providers, and payers. This integrated approach is unique both in psychedelic research and in the treatment of mental health challenges overall.

<unk> continues to differentiate corpus in this area of science and also keeps us on track to bring our therapy safely to patients as quickly as possible.

Our innovative critical care pathways that integrates psychedelic medicine digital platform is data science and psychological support to help people get well and stay well are novel.

And valuable proposition for patients healthcare providers and payers. This integrated approach is unique both in psychedelic research and in the treatment of mental health challenges overall, our strategy of innovation is one that we believe will propel corpus to a much broader leadership role in developing personalized predictive and.

George Goldsmith: Our innovation strategy is one that we believe will propel COMPASS to a much broader leadership role in developing personalized, predictive, and preventative approaches in mental health care. We know that psychiatrists and therapists caring for patients with these severe mental health conditions are eager for new treatment options. This was reflected in a survey conducted late last year, in which doctors surveyed believed psilocybin therapy has potential benefits for patients with TRD. In this survey, half would prescribe psilocybin therapy if it were approved.

<unk> approaches in mental health care.

We know that psychiatrist and therapist caring for patients with these severe mental health conditions are eager for new treatment options. This was reflected in a survey conducted late last year, and which doctor surveyed believe suicide gene therapy has potential benefit for patients with D. R. D. In this survey halfway prescribed suicide in therapy.

If it were approved.

George Goldsmith: We are also aware of the desire of individuals with these conditions to have access to new, non-invasive ways of addressing their depression. They see this as a move from drugs that may only partially alleviate symptoms of depression to a treatment that provides the opportunity for a breakthrough in emotional understanding, a life-changing experience. Based on our clinical results to date, we believe this better outcome is within reach for a significant number of these individuals. With that, let me now turn to Guy, who will provide his thoughts on the next steps in our planned Phase 3 program. Guy?

We are also aware of the desire of individuals with these conditions to have access to new noninvasive ways of addressing their depression they.

They see this as a move from drugs that may only partially alleviate symptoms of depression to a treatment that provides the opportunity for a breakthrough and emotional understanding a life changing experience.

Based on our clinical results to date, we believe this better outcome is within reach for a significant number of these individuals with that let me now turn to Guy who will provide his thoughts on the next steps in our planned phase III program Guide.

Guy Goodwin: Thank you, George, and good day to all. Indeed, we had our meeting with the FDA, and we were pleased with how the discussion developed. We had the opportunity to share our thoughts on the phase two results, which showed that COMP360 psilocybin therapy was acceptable to patients, rapid acting, and durable for an important fraction of the patient population that does not respond to the current antidepressant standard of care. Individuals in the 25 milligram COMP360 arm compared to a one milligram control arm showed an immediate benefit, and at week three, the primary endpoint had a reduction The clear separation between doses is compelling evidence of true drug efficacy.

Thank you George and good tail indeed.

Indeed, we had a meeting with the FDA and we were pleased with how the discussion develops we have the opportunity to share our thoughts on the phase II results, which showed that <unk> 360 suicide gene therapy was acceptable to patients rapid acting enjoyable for an important fraction of the patient population that does not respond to current antidepressant standards.

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Individuals in the 25 milligram come $3 61, compared to a one milligram control arm showed an immediate benefits.

And sweet three the primary endpoint had a reduction in the mattress depression score of six six points with a P value of less than 0.001, and a response rate of 37% compared to 18% in both the 10 milligram and one milligram arms.

Clear separation between doses is compelling evidence for true drug efficacy.

But the 12 week time point, the full length of the trial, 20% to 25% of those in the 25 milligram arm continued to show a sustained response from that treatment resistant depression.

Guy Goodwin: At the 12-week time point, the full length of the trial, 20-25% of those in the 25mg arm continued to show a sustained response from their treatment-resistant depression. Furthermore, these were patients who did not return to any antidepressant use over the duration of the trial. This is very striking because it contrasts with both lower rates of response and higher rates of relapse in comparable patients treated in the STAR-D trial. A number of patients who participated in either the Phase 2b monotherapy trial or the SSRI adjunct study chose to enter a 12-month long-term follow-up study.

Moreover, these were patients who did not return to any antidepressant use over the duration of the trial.

This is very striking because it contrasts with both lower rates of response and higher rates of relapse in comparable patients treated in the study trial.

A number of patients who participated in either the phase <unk> monotherapy trial, all the SSRI adjunct study chose to enter a 12 month long term follow up study, we look forward to reporting the results of this study later in the year and gaining additional insight into the durability of our single comp 360 silicide.

Guy Goodwin: We look forward to reporting the results of this study later in the year and gaining additional insight into the durability of a single COMP360 psilocybin dose with psychological support. Crucially for clinical use, in measurements of quality of life, self-reported mood, and positive thinking, the individuals who responded to psilocybin returned to the same levels as those in the healthy population.

In dose with psychological support.

Critically for clinical use in measurements of quality of life self reported mood and positive thinking the individuals who responded to psilocybin returned to the same levels as those in the healthy population.

Guy Goodwin: We believe this can prove to be an important differentiating feature of COMP360 therapy that will be valued by patients and clinicians alike. So these are the key points we shared with the agency, and we look forward to receiving official meeting follow-up and finalizing the pivotal program design and moving forward. The informal feedback from the network of investigators who participated in Phase 2B has been strongly positive.

We believe this can prove to be an important differentiating feature of <unk> 360 therapy that will be valued by patients and clinicians alike.

So these are the key points, we shared that the agency and we look forward to receiving official meeting follow up and finalizing the pivotal program design and moving forward. The informal feedback from the network of investigators who participated in phase II B has been strongly positive there is palpable enthusiasm from them to participate.

Guy Goodwin: There is palpable enthusiasm from them to participate in the next phase of the trial program. We're also looking forward to sharing more details of the Phase 2b study results this year through publication in peer-reviewed journals and various medical meetings. Beyond the TRD program, we are also moving forward with a Phase II program in PTSD. Like TRD, we believe the clinical potential of COMP360 therapy is high, and the patient need is great. The symptoms of PTSD are often severe and long-lasting, and current treatment approaches are ineffective for many patients. First-line treatment includes psychological interventions such as trauma-based cognitive behavior therapy, followed by pharmacological approaches such as SSRIs.

The page and the next phase of the trial program.

We're also looking forward to sharing more details of the phase <unk> study results in this year two publication in peer reviewed journals and various medical meetings.

Beyond the T. O D program. We are also moving forward with a phase II program in PTSD.

T O D. We believe the clinical potential of <unk> 360, <unk> therapy is high and the patient need is great. The symptoms of PTSD are often severe and long lasting and current treatment approaches are ineffective for many patients.

First line treatments include psychological interventions, such as trauma face cognitive behavior therapy, followed by pharmacological approaches such as Ssris.

Guy Goodwin: Unfortunately, about 40% of those with PTSD will not improve with this treatment. The PTSD Psychopharmacology Working Group recently described current treatment outcomes as a crisis and called for novel, effective, and efficient trauma-focused interventions to be developed. The PTSD study is an open-label study and will enroll 20 participants. It is designed to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer from PTSD resulting from trauma experienced as adults.

Unfortunately about 40% of those with PTSD will not improve with this treatment.

The PTSD Psychopharmacology working group recently described current treatment outcomes as a crisis.

Cold for novel effective and efficient trauma focused interventions to be developed.

The PTSD study is an open label study and will enroll 20 participants. It is designed to evaluate the safety and Tolerability of <unk> hundred 60, psilocybin therapy in people, who suffer with PTSD, resulting from trauma experienced has adult.

Guy Goodwin: The Institute of Psychiatry, Psychology, and Neuroscience at King's College London is the first of multiple expected sites. Participants will receive a single 25 milligram dose of COMP360 psilocybin given in conjunction with psychological support in line with the COMP360 psilocybin therapy protocol and will be followed up for 12 weeks. The primary objective of the study is to assess the safety of COMP360 psilocybin

The Institute of Psychiatry, psychology, and neuroscience at King's College, London is the first of multiple expected site.

Participants will receive a single 25 milligram dose of <unk> 360, psilocybin given in conjunction with psychological support in line with the <unk> 360, psilocybin therapy protocols and will be followed up for 12 weeks. The primary objective of the study is to assess the safety of cop 360 suicide in therapy. It will all.

Guy Goodwin: It will also measure whether the treatment appears to improve PTSD symptoms, functionality, and quality of life. Such a study is necessary for designing and powering definitive studies of Africa. We also continue to see encouraging findings from COMP360 independent investigator-led studies. Just last week, two posters were presented at the Society of Biological Psychiatry annual meeting in the USA showing positive early signals in exploratory open-label studies for anorexia nervosa and more severe treatment-resistant depression.

So measure whether the treatment appears to improve PTSD symptoms functionality and quality of life.

Such a study is necessary for designing empowering definitive studies of efficacy.

We also continued to see encouraging findings from the <unk> 360 independent investigator led studies just last week two posters were presented at the society of biological Psychiatry annual meeting in the USA showing positive early signals an exploratory open label studies for anorexia nervosa and more severe.

Treatment resistant depression, we will be evaluating the implications of these studies for our R&D plans.

Mike Falvey: We will be evaluating the implications of these studies for our R&D plans. Also, you may have seen an announcement earlier this week on an additional IIS that has been started in autism. Autism fits well with COMPASS's focus on areas of unmet medical needs and support for those who are suffering and have run out of options. The study is co-sponsored by King's College London and South London and Morsley NHS Foundation Trust. Let me now turn the call over to Mike for financial...

Also you will have seen an announcement earlier this week on an additional I I ask that just started in autism.

<unk> fits well with companies focus on areas of unmet medical need and support for those who are suffering and have run out of options.

The study has co sponsored by King's College, London, and South London, and mostly NHS Foundation Trust.

Let me now turn the call over to Mike for Financial review.

Mike Falvey: Thanks, Guy. I will now recap our financial results for the three months ended March 31, 2022. Net loss for the three months ended March 31, 2022, of $21.2 million, or 50 cents per share, compared with a net loss of $12.7 million, or 35 cents per share, during the same period in 2021.

Thanks, Scott I'll now recap our financial results for the three months ended March 31 2022.

Net loss for the three months ended March 31, 2022 was $21 $2 million or <unk> 50 per share compared with a net loss of $12 $7 million or <unk> 35 per share during the same period in 2021.

Mike Falvey: These results include non-cash share-based compensation of $3.1 million in 2022 and $1.7 million in 2021. R&D expenses were $15.4 million for the three months ended March 31, 2022, compared with $6.9 million during the same period in 2021. The increase was attributable to an increase of $5.1 million in external development expenses, $2.6 million in personnel expenses, and $1 million in non-cash share-based compensation. This was partially offset by a reduction of $0.2 million in other expenses.

These results include noncash share based compensation of $3 $1 million in 2022, and $1 $7 million in 2021.

R&D expenses were $15 $4 million for the three months ended March 31, 2022, compared with $6 $9 million during the same period in 2021 the.

The increase was attributable to an increase of $5 $1 million in external development expenses $2 $6 million in personnel expenses and $1 million in noncash share based compensation.

This was partially offset by a reduction of <unk> $2 million and other expenses.

The increases in the quarter were primarily due to preparation for the expected launch of our phase III trial in T. R. D scheduled for the second half of this year.

G&A expenses were $10 1 million for the three months ended March 31, 2022, compared with $6 $7 million during the same period in 2021.

Mike Falvey: The increases in the quarter were primarily due to preparation for the expected launch of our Phase 3 trial and TRD scheduled for the second half of this year. G&A expenses were $10.1 million for the three months ended March 31, 2022, compared with $6.7 million during the same period in 2021.

Mike Falvey: This increase was attributable to an increase of $1 million in personnel expenses, $0.5 million in non-cash share-based compensation, $1.4 million in legal and professional fees, and $0.4 million in facilities and other expenses. The increases this quarter were primarily in support of our growing R&D organization and operations and activities to support our operation as a public company. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $243.7 million at March 31st, 2022, compared with $273.2 million at December 31st, 2021.

This increase was attributable to an increase of $1 million in personnel expenses <unk> 5 million in noncash share based compensation $1 $4 million in legal and professional fees and <unk> $4 million in facilities and other expenses.

The increases this quarter were primarily in support of our growing R&D organization and operations and activities to support operation as a public company.

George Goldsmith: With these resources, we expect to be able to fund our operations into 2024. We view our strong balance sheet as an important strategic asset, which we will continue to manage carefully as we invest to advance these promising potential therapies while creating value for our shareholders. Thank you, and I'll turn the call back to George. Thank you, Mike.

<unk> continues to maintain a strong financial position with cash and cash equivalents of $243 7 million at March 31, 2022, compared with $273 $2 million at December 31, 2021, with these resources, we expect to be able to fund our operations into 2024, we view our store.

<unk> balance sheet is an important strategic asset, which we will continue to manage carefully as we invest to advance these promising potential therapies, while creating value for our shareholders. Thank you and I'll turn the call back to George.

George Goldsmith: As you heard from Guy, our FDA meeting went well. I know that you are all highly interested to know more about this program design. We respect the FDA's process and will share the Phase 3 program with our investors when it is finalized. Our goal is to host a robust R&D data after that, where we will explain our TRD program in detail and review the progress we are making in our programs addressing additional indications, including PTSD, and share more information on our work on digitally-enabled clinical care innovation. In the meantime, we are actively preparing to be Phase 3 ready ahead of the final design confirmation.

Thank you Mike as you heard from Guy our FDA meeting went well.

Know that you were all highly interested to know more about this program design. We respect the fda's process. They will share the phase III program with our investors. When it is finalized our goal is to host a robust R&D day to after that.

Where we will explain our T. R. D program in detail and review the progress, we're making in our programs addressing additional indications, including PTSD and share more information on our work or digitally enabled critical care innovation.

In the meantime, we are actively preparing to be phase III ready ahead of the final design confirmation. This includes recruiting and Onboarding critical sites further scaling and enhancement of our therapists trading platform to support the significant global expansion of treatment sites that will participate in the phase III trial program fine tuning training materials.

George Goldsmith: This includes recruiting and onboarding clinical sites, further scaling and enhancement of our therapist training platform to support the significant global expansion of treatment sites that will participate in the Phase 3 trial program, fine-tuning training materials, supporting therapist training and certification, and expanding our suite of digital tools. Let me also highlight an important long-term public-private partnership that we launched this past quarter with King's College London and the South London and Maudsley NHS Foundation Trust to establish the Centre for Mental Health Research and Innovation.

Supporting therapist training and certification and expanding our suite of digital tools let.

Let me also highlight an important long term public private partnership that we launched this past quarter with Kings College, London, and the South London, and Bosley NHS Foundation Trust to establish the center for mental Health research and innovation.

George Goldsmith: This partnership, designed to accelerate psychedelic research and develop new models of care for mental health in the UK, demonstrates direct support for the significant unmet need in mental health and a confirmation that the health system is committed to supporting new therapeutic models. We believe this partnership is a forerunner to health system and payer support on a broader scale as we progress with COMP360 therapy development. We are also pleased to announce that COMPASS has been awarded an Innovation Passport, which is an innovative medicines designation and marks entry into the UK's innovative licensing and access pathway, which is designed to accelerate the time to market and facilitate patient access to innovative therapies.

This partnership designed to accelerate psychedelic research and develop new models of care for mental health in the UK demonstrates the direct support for the significant unmet needs in mental health and a confirmation that the health system is committed to supporting new therapeutic models. We believe this partnership as a forerunner two health system and payer.

Back to you on a broader scale as we progress with called 360 therapy development. We are also pleased to announce that corpus has been awarded and innovation passport, which is an innovative medicines designation at marks <unk> entry into the Uk's innovative licensing and access pathway, which is designed to accelerate the time.

The market and facilitating patient access to innovative therapies.

2022 will be another active year of milestones and which we expect the launch of additional called 360 <unk> clinical development program beyond the ongoing Georgi in PTSD programs publication of our phase two called 360 critical data in a major peer reviewed medical journal and at a number.

George Goldsmith: 2022 will be another active year of milestones in which we expect the launch of an additional COMP360 clinical development program beyond the ongoing TRD and PTSD programs, publication of our Phase 2 COMP360 clinical data in a major peer-reviewed medical journal, and at a number of medical meetings. The results of our 12-month follow-up outcome study in TRD.

<unk> of medical meetings.

The results of our 12 month follow up outcomes study in T. R D.

George Goldsmith: Critical results from one or more independent investigator-led studies. Further expansion of our IP portfolio, further strengthening our focus on innovation, and continuing progress in advancing COMP360 payer partnership. Our operational leadership and strong cash position are key differentiators and enable us to continue at pace toward our goal of building a personalized, predictive, and preventative model for transforming the treatment of mental health, which has the potential to change people's lives for the better for generations to come. Thank you for your time today. We will now open the line for questions. Operator?

Critical results for Mortarboard independent investigator led studies.

Further expansion of our IP portfolio further strengthening our focus on innovation and continuing progress in advancing <unk> 360 payer partnerships.

Our operational leadership and strong cash position, our key differentiators and enable us to continue at pace toward our goal of building a personalized predictive and preventative model for transforming the treatment of mental health, which has the potential to change People's lives for the better for generations to come.

Thank you for your time today, we will now open the line for questions operator.

Yeah.

Operator: Thank you very much. And once again, on the phones, if you'd like to register a question... Please press the 1, 4 by the 4 on your telephone, and your three-tone prompt will acknowledge your request. If your question has been answered, let your driver give you a refund.

Thank you very much and once again on the phone to if you like to register a question. Please.

Please press the one followed by the four on your telephone.

Three Tom prompt technocracy request.

<unk> has been answered, but her driving your frustration and its the one four by history. Once again on the floor for any questions or comments you may have after you one four on your telephone keypad one moment. Please for our first question.

Operator: It is the one. Once again, on the phone, for any questions or comments you may have, it is the 1-4 on your telephone keypad. One moment, please, for our first question. We'll get to our first question on the line from Josh Schimmer with Evercore. Please go right ahead.

Well get to our first question on the line from Josh <unk> with Evercore. Please go right ahead.

Great. Thanks for taking the questions first can you. Please explain the rationale for exploring the use of psilocybin for treatment of autism and then can you also please discuss the outcome measures that are typically used in PTSD and what type of signal are you looking for in the phase III study to advance to a registrational trial.

George Goldsmith: Great, thanks for taking the questions. First, can you please explain the rationale for exploring the use of psilocybin for the treatment of autism, and then can you also please discuss the outcome measures that are typically used in PTSD, and what type of signal are you looking for in a Phase II study to advance to a registrational enabling trial? Thank you. Hi Josh.

<unk>.

Yeah.

Guy Goodwin: Thank you so much. Guy will respond to this question, but I really appreciate those questions. Yeah, so starting with autism, Josh, this is an experimental medicine study that is really designed to look at measures which are tapping into the assumed function of serotonin. The details are fairly technical, so I'm not sure we want to go into this point, but they're really designed to establish whether we can see a convincing effect of different doses of psilocybin on those pathways within the brain.

Hi, Josh. Thank you so much guy will respond to this question, but really appreciate those questions.

Yes, so just starting with the autism. Josh. This is an experimental medicine study, which is really designed to look at are measures, which are tapping into the assumed function.

Serotonin.

The details are fairly technical so I'm not sure we want to go into at this point, but theyre really designed to establish whether we can see a convincing effects of different doses of.

Guy Goodwin: And of course, because people are very interested in the underlying mechanisms in autism rather than the symptoms, per se, or the problems that people have, we will get insight at a fundamental level. So it's essentially looking at a series of preclinical questions. Your second question was about PTSD. I mean, it's conventional to look at change in, or at least change in, a single or the main traumatic symptom.

Psilocybin on those pathways within the brain and of course, because people are very interested in the underlying mechanisms in autism rather than the symptoms per se of the problems that people have.

We will get inside it out of the fundamental level. So it's essentially looking at a series of preclinical question.

Your second question was about PTSD.

It's conventional to look at change in or at least in change in a single or the main traumatic symptom. We will also be looking at quality of life and General response General wellbeing, but of course. The purpose of this study is essentially to establish safety and to look at the methodology.

Guy Goodwin: We will also be looking at quality of life and general response, general well-being. But, of course, the purpose of this study is essentially to establish safety and to look at the methodology around preparing patients for the experience of a different clinical group. And that, I think, is where we would mainly expect to see learning. So, essentially, this is a feasibility study. And obviously, we will get a sense of what outcome measures are relevant and sensitive to the treatment.

Around preparing patients for the experience from a different clinical group and that I think is where we mainly expect to see learning. So essentially this is a feasibility study.

We will get a sense of what outcome measures.

Relevance insensitive to the treatment and the point of course is then to get a really good power calculation to take this into a randomized controlled study at some point.

Guy Goodwin: And the point, of course, is then to get a really good power calculation to take this into a randomized controlled study at some point. But I would just add, Josh, for your information and those on the call, that everything that we pursue is based on very, very strong preclinical signals that we've achieved through the most robust program that we're aware of, looking at preclinical activity across a variety of different disorders. So this is evidence-based, as we are, and we're moving forward exploring these. Thank you. Thank you very much. We have our next question on the line. It is from Charles Duncan with our Cantor Fitzgerald. Go ahead, please. Hey, good morning.

I would just add Josh Greear information and those on the call that.

Everything that we pursue is based on a very very strong preclinical signals that we have achieved through the most robust program that we're aware of looking at preclinical activity in across a variety of different.

Disorders. So this is evidenced based as we are and we're moving forward exploring this.

Got it thank you.

Thank you very much.

Our next question on the line.

From Charles Duncan with Cantor Fitzgerald.

Hey, good morning, Thanks for taking my question and congrats on the progress in in this last call. It six months charge and the recent meeting with the agency I respect that you are not going to be able to talk a lot about.

George Goldsmith: Thanks for taking my question and congratulations on the progress in the last six months, George, and the recent meeting. With agency, I respect that you're not going to be able to talk a lot about that at this point. But I did have a question on next steps regarding COMP360 and TRD. Could you characterize, maybe not the agency's response, but your perspective on whether or not it makes sense to pursue development in patients who are taking SSRIs or not? And then what is an appropriate control arm?

At this point.

But I did have a question on next steps regarding comp 360, and TRT I guess could you characterize.

Maybe not the agency's response, but your perspective on whether or not it makes sense to pursue.

Pursue development in patients who are taking ssris or not and then what is an appropriate control arm is it consistent with your phase two b or what what could we anticipate going gone forward and acknowledging that you really need those meeting minutes to be able to speak definitively.

George Goldsmith: Is it consistent with your Phase 2B? Or what can we anticipate going forward and acknowledging that you really need those meeting minutes to be able to speak definitively? Hi, Chas.

Hi, Chaz. Thank you so much for recognizing what I will not be able to share with you.

George Goldsmith: Thank you so much for recognizing what I will not be able to share with you. And I love the creativity of your question. So I think where we are right now is very much focusing on waiting for the response from the FDA. This will be a theme, I'm sure, of our discussion today. We don't want to, in any way, second-guess or anticipate what they'll say to us. This is really important.

And I love the creativity of your question.

So I think where we are right now is very much focusing on waiting for the response from the FDA. This will be a theme I'm sure of our discussion today, we don't want to in any way second gas or anticipate what they will say to us. This is really important and so at this point.

George Goldsmith: So at this point, we will be disclosing more as we go through the summer and receive the minutes as you recommend, suggested. And I think that the general perspective that we have is we're going to follow our data and really go in the kind of direction that we have the most robust data, and obviously, that is focused on monotherapy, and we have additional data and adjuncts which we're obviously going to be considering.

We will be disclosing more as we go through the summer and receive the minutes as you record.

Suggested.

And I think that the general perspective that we have is we're going to follow our data and really go in the direction that we have the most robust data and obviously that is focused on monotherapy and we have additional data in adjunct which we're obviously going to be considering.

Okay, and maybe if I could follow up.

George Goldsmith: Okay, and maybe I could ask a follow-up question that you won't likely be able to answer, but in a different way, which is, When you've gotten feedback from thought leaders, how do they see the responses? You pointed, or Guy pointed to, durability of effect over 12 months or 12 weeks.

Follow up question that you won't likely be able to answer but in a different way which is.

When you've you've gotten feedback from salt leaders, how do they see the responses <unk> you Paul.

Our guy pointed to durability of effect over a 12 month or 12 weeks. It seems like that's that's really a pretty interesting clinical response, but is that going to be sufficient to.

Guy Goodwin: It seems like that's really a pretty interesting clinical response, but is that going to be sufficient to really demonstrate an effect which is clinically meaningful after 12 weeks? Maybe I should take this because I've talked to the PIs from the 2B study at some length, almost all of them now. And I think what is striking is that virtually all of them who recruited a significant number of patients, because obviously it was a blinded study, but I think virtually all of them described patients they knew really well who had a fairly dramatic improvement that was durable. And I think it's that group that we're all kind of pretty convinced by.

Really demonstrate an effect, which is clinically meaningful 12 week.

Well, maybe I should take this because I've talked to the.

From the <unk> study at some length almost all of them now and I think what is striking is that virtually all of them have recruited a significant number of patients because obviously with the blinded study, but I think virtually all of them described patient then you really well who had a fairly dramatic improvement that was durable.

And I think it's that group that we're all kind of pretty convinced by obviously, that's not the same as doing clinical trial, but it is extremely important in the impression that clinicians have of the promise of the treatment and the way in which they can develop it in the future once of course, they get a chance to use it in real life. So to speak so thats what essentially encourage you. This.

Guy Goodwin: Obviously, that's not the same as doing a clinical trial, but it is extremely important in the impression that clinicians have of the promise of the treatment and the way in which they can develop it in the future once, of course, they get a chance to use it in real life, so to speak. So that's what essentially encourages us from a purely clinical point of view. And I also think that it's absolutely extraordinary that patients on no other medications, after a single experience, 12 weeks later, have this response. So I think this is really the birth, perhaps, of a new paradigm, and we're really examining that deeply. I agree with you 100%.

From a purely clinical point of view.

And I also think that it's absolutely extraordinary that patients are on no. Other medications. After a single experience 12 weeks later.

Have this response so I think this is really the birth, perhaps of a new paradigm and we are really examining that deeply.

Guy Goodwin: Last quick question hopping over to PTSD and a follow-on to Josh's question. Will CAPS-5 be considered an endpoint or at least exploratory in that study? We haven't released that information, we haven't published the protocol yet, but we will do so in due course.

I agree with you, 100% last quick question hopping over to PTSD and a follow on to <unk>.

<unk> question will caps five be considered as an endpoint or at least exploratory.

In that study.

We haven't released that information, we haven't published the protocol, yet, but we will do in Q4.

Operator: Okay, very good. Thanks for taking my questions. Look forward to the update. Thank you very much. Our next question on the line is from Nina Betrito-Gart with Citi. Go right ahead.

Very good thanks for taking my questions look forward to the updates.

Yes.

Thank you very much.

Question on the line.

Nina retreat Hilgart with Citi go right ahead.

Hey, guys. Thanks for taking my question just following on the PTSD line of questioning.

Operator: Hey guys, thanks for taking my question. Just following on the PTSD line of questioning, I found one of the posters that was presented last week, I think, for the severe TRD patients, that there were a few that did have PTSD who didn't necessarily respond as well as those who didn't. I guess any thoughts on maybe why that was and how that may read through at all to the phase two study in PTSD? Well, I mean, it's a great question.

I found one of the poster that was presented last week I think for that severe tier D. Patients that there were a few that did have PTSD.

Didn't necessarily respond as well as those who didn't I guess any thoughts on maybe why that was and how that may read through at all.

As Keith said in PTSD.

Well I mean, it's a great question of course is why we do research I mean.

Guy Goodwin: Of course, that's why we do research. I mean, I think essentially we will find out whether there is something about how we prepare patients, their experience. We need the experience ourselves of running this study and of working out what the limitations are in this patient group. But you're absolutely right to highlight that there were three cases in the study from Shepard Pratt. And obviously, we've looked at that and spoken to the PI about it. At the moment, you know, it's just a straw in the wind.

I think essentially we will find out whether there was something about how we prepare patients their experience we need the experienced ourselves that running the study.

Working out what the limitations are in this patient group.

But you're absolutely right to highlight that there were three cases.

The study from Shepherd and obviously, we we've looked at that and spoken to the pie about this at the moment, it's just destroying the win but we are very aware of it.

Guy Goodwin: But we're very aware of what he says about those patients, and we'll take that information into the design of the study that is being started at King's College London of it. Thank you. Vis Meetup, Thank you very much.

What he says about those patients and we take that <unk>.

<unk> into the design of the study that he started at.

Kings College in London.

Got it thank you.

Thanks Nina.

Yes.

Thank you very much. Okay. So next question on the line from Ritu <unk> with Cowen go right ahead.

Operator: We'll get your next question on the line from Ritu Baral with Cowan. Go right ahead. Good morning, guys.

Hey, good morning, guys.

Hi, guys I'm going to ask John asked the question about the FTE.

GA Guy.

Operator: I guess I'm going to try and ask the question about the FDA in a different way. George and Guy, could I ask what the main topics of discussion were at least? And more specifically, you don't have FDA's final feedback, but what did you guys propose for the psychological support around phase three? I know clinicians and you guys had talked about sort of more streamlining of monitoring potential sort of group sessions, group monitoring through AV, and also qualifications of those patients, I'm sorry, those caregivers providing the psychological support. Can you at least walk us through what was proposed and how does that align with, say, your commercial plans? And then I have a follow-up. Great. Thank you, Ritu.

I ask what the discussion topics at least work.

And more specifically.

You don't have that final tobacco, what's keeping you guys proposed for the psychological support around.

Our phase III I know, our clinicians and you guys had talked about sort of more streamlining of <unk>.

Monitoring potential sort of group sessions quick monitoring.

True.

And also qualifications at those patients I'm, sorry, those caregivers providing.

Mycological support.

Can you at least walk us through what was what was proposed and does that align with faith.

Our commercial plan.

And then I have a follow up thanks.

Thank you Ritu and you are right in anticipating that we won't go into what we proposed in that meeting.

George Goldsmith: And you're right in anticipating that we won't go into what we proposed in that meeting. I'm sorry to frustrate you, but I think this is a really important thing. The regulators exist for a purpose, and we really want them to be able to come back to us with their perspective. So we aren't going to be second-guessing them, as I said at the beginning. I do think that your point around psychological support is really important.

I am sorry to frustrate you, but I think this is a really important thing the regulators exists for a purpose and we really want them to be able to come.

Come back to us with their perspective, so we aren't going to be second guessing them as I said at the beginning.

I do think that your point around the psychological support is really important.

This is a critical aspect of this therapy.

George Goldsmith: This is a critical aspect of this therapy, and we really are looking at how we can enhance that based on the data that we have. So we're doing a lot of work on our Phase IIb data. And we also have something that is unique in this area, which is recordings, video, and audio, of each session.

And we really are looking at how do we enhance that based on the data that we have so we're doing a lot of work on our phase two b.

Data and we also have something that is unique in this area, which are raw.

Recordings video and audio of each session and we can really start linking that through our machine learning activities. Our natural language processing activities to develop a better picture of what leads to improved outcomes in terms of the preparation the support during the session in the integration afterwards, that's really unique in this whole area and.

George Goldsmith: And we can really start linking that through our machine learning activities, our natural language processing activities, to develop a better picture of what leads to improved outcomes in terms of the preparation, the support during the session, and the integration afterwards. That's really unique in this whole area, and we're diving deep into that. And we'll take those learnings into Phase IIIb, as you can imagine.

Diving deep on that and we'll take those learnings into phase III as you can imagine.

Got it.

Operator: My follow-up is sort of the same question but focused on PTSD, which is in phase two. So hopefully, you can you can talk about it. Guy, you mentioned that the psychological support around PTSD is similar to the MDD program. I'm just wondering if there are any material differences in the approach, knowing that the sort of psychological support offered as part of the MAPS program, for instance, is very focused on the actual triggering trauma of PTSD. So I'm wondering, is there an element of that wrapped around your PTSD protocol? Thanks for tuning in.

The follow up is sort of the same question, but focused on PTSD, which is in phase III. So hopefully you can you can talk about it Guy you mentioned that the I guess the psychological support.

Around the PTSD is similar to the MTT program.

I'm just wondering if there are any material.

You'll differences to the approach.

Knowing that sort of psychological support offered as part of our next program for instance is there.

<unk> focused on the actual triggering trauma of PTSD. So I'm wondering is there an element of that.

Wrapping around your PTSD protocol, thanks for taking my question.

The protocol is not radically different from the.

Guy Goodwin: The protocol is not radically different from the Phase II DRD program. What we are very interested in, and this comes from the general literature and, particularly, recent publications from the Imperial Group, is the importance of emotional breakthrough in predicting outcomes. And we're certainly looking at that in detail, as George explained, from the transcripts of the preparatory studies for patients with TRD. But how we extrapolate that to PTSD is obviously a challenge. We think that the essence of the therapy lies in the drug effect, as you know, and the way in which the drug effect facilitates emotional learning in patients who receive the drug.

<unk> two <unk> program.

What we are very interested in and if this comes from the general literature, and particularly the publications recently from the Imperial group is the importance of emotional breakthrough in predicting outcomes and we're certainly looking at that in detail as George explained from the transcripts of the preparatory studies for pay.

<unk> with Tid.

How do we extrapolate that too.

To PTSD is obviously a challenge.

We think that the essence of the therapy lies in the drug effect as you know and the way in which the drug effects facilitates emotional learning in patients who received the drug and essentially we will be endeavoring again to ensure that our preparation is essentially for safeguarding patients so being with the patients on the <unk>.

Guy Goodwin: And essentially, we will be endeavoring again to ensure that our preparation is essentially for safeguarding patients, so being with the patient on the day and also allowing the patient to have a safe experience. And I think we have a lot to learn about how that works in PTSD, and the safest way to start is with essentially a very similar protocol to what worked in TRD. We plan to, obviously, adopt the same learning approach in terms of recording the sessions and looking at kind of what is clearly the best way to do this.

Day, and also allowing the patient to have a safe experience and I think we have a lot to learn about how that works and PTSD.

And the safest way to start is with essentially a very similar protocol worked in T O D.

But we plan to obviously to adopt the same learning approach in terms of recording sessions and looking at kind of what is clearly the best way to do this for patients.

Okay.

George Goldsmith: Thanks for taking the call. I might just add one quick thing here based on what Guy pointed out, but just to bring it out. I think one of the really important things that we're doing is an empirical basis for how to help therapists be better in their work and with their supportive patients, and to do that by applying machine learning and looking at how that links to outcomes. So this is something that's really important as we advance this whole field. Thank you very much. We'll get to our next question on the line, from the line of Bert Haslett with BTIG. Go right ahead.

Got it thanks for taking the question.

I might just add one quick thing here based on what the Guy pointed to but just to bring it out I think one of the really important things that we're doing as an empirical base of how to help therapist be better.

In their work and their support of patients and to do that where by applying machine learning and looking at how that links to outcomes. So this is something that's really important as we advance this whole field.

Sure.

Yes.

Operator: Yes, thank you. Thank you for your comments. And I won't ask about the phase 3 study design, I promised. Thank you, Bert.

Thank you very much we'll get to our next question on the line.

From the line of Bert Hazlett with be Tid go right ahead.

Thank you and thank you for your comments.

I won't ask you about the phase III study design I promise.

[laughter]. Thank you Bert.

Well with regard to some of the other indications that you've discussed in press releases recently in particular anorexia nervosa.

Operator: Well, with regard to some of the other indications that you've discussed in press releases recently, in particular, anorexia nervosa, you and the study out of UCSD, I believe, discussed or commented on a 30% reduction in eating disorder psychopathology at one month, a 40% reduction at three months. And I'd love for you to comment as to whether that rises to the level of additional investment for your COMP360 p And if you could, if there are additional endpoints of interest in this setting, and if you could comment on safety tolerability in this setting, that would be interesting as well.

This study out of UCSD I believe discussed or commented on a 30% reduction in the eating order psychopathology at one month, a 40% reduction at three months.

I'd Love for you to.

Harman as to whether that rises to the level of additional investment.

For your called 360 saw a solid seven program and if you could.

If there are additional endpoints of interest in that setting and if you could comment on safety and Tolerability in this setting.

That would be.

Interesting as well thank you.

So this was obviously an independent study, which we were very interested to receive the results from as I'm sure you will.

Guy Goodwin: Thank you. So this was obviously an independent study, which we were very interested to receive the results from, as I'm sure you were. The impression of Walt Kay, who's an extremely experienced and internationally renowned researcher, was that he thought the results for several of the patients were really extremely impressive.

The impression of World K who's extremely experienced an internationally renowned researcher was that he thought the results for several of the patients was really extremely impressive.

Guy Goodwin: Now, this is the kind of story we've had in other indications, so we're encouraged by that. But we obviously have a lot to do before we think about the commitment to further investment in this area. And since that's not really my role, I shall defer to George or Mike in that regard. Yes, and I think that we're obviously looking at anything that could benefit patients with high unmet needs. This is certainly one of those populations.

This is the kind of story we've had in other indications. So we're encouraged by that.

But we obviously have a lot to do before we think about the the commitment to further investments in this area and since that's not really my role I sure will defer to George or Mike in that regard.

Yes, and I think that we're obviously looking at anything that could benefit patients with high unmet need. This is certainly one of those populations.

And we're looking at that as we dig into the data and look at what might be possible.

George Goldsmith: And we're looking at that as we dig into the data and look at what might be possible. Any brief comments on safety or tolerability of COMP360 psilocybin in this study result? There were really no red flags detected in that study.

And any any brief comments on safety or Tolerability of Cop 360, <unk> aside but in the in this study results.

There were really no red flags detected in that study and of course.

Guy Goodwin: And of course, the investigators were extremely cautious initially because of the potential metabolic state of the patients. And therefore, there was quite a lot of interest in finding that this was really, as far as we can tell, well-tolerated, and acceptable. And that's as encouraging at this point as you can be on a handful of patients. But nevertheless, that's the way it starts.

The investigators were extremely cautious initially because of the metabolic state of the patients potentially.

And therefore, there's quite a lot of interest in finding that this was really.

As far as we can tell was well tolerated with acceptable.

And that is encouraging at this point as you can be on a handful of patients, but nevertheless, the wait staff.

Great. Thank you we look forward to further updates thank you very much.

Operator: Great, thank you. We look forward to further updates. Thank you very much. Piro is the best part of the world.

Okay.

Yes.

Operator: Thank you. We'll get to our next question on the line from Franois Brisebois with Oppenheimer. Go right ahead.

Thank you we'll get to our next question on the line from profiles for his work with Oppenheimer go right ahead.

Okay.

Alright, thanks for taking my questions. So.

Operator: Hi, thanks for taking the question. So I was just wondering, you mentioned the survey late last year and 50 based on the data to be about 50% of physicians would prescribe or want to use COMP360. I was just wondering, just to play devil's advocate here, was there any stratification or any information on why a physician might not want it? Frank, hi. Hello, Guy Goodwin here.

I was just wondering you mentioned the survey late last year.

And based on the data to.

To be about 50% of <unk>.

Our physicians prescribed.

Prescribed or want to use the cocktail 60 I was just wondering just to play Devil's advocate here.

Was there a stratification or any information on why a physician might not want to use it.

No Frank Hi, Hello.

Guy Goodwin: I don't believe so. I mean, we were essentially interested in the people who did want to use it, I guess. But you're right that we should certainly attend to that, the group who don't. But we kind of attributed that to a lack of knowledge.

I don't believe so I mean, we were essentially interested in the people who did want to use it I guess, but you're right that we should suddenly tend to that to.

The group had done, but we kind of attributed that to a lack of knowledge.

George Goldsmith: And in other surveys, that's often seemed to be the case that patients, rather than clinicians, and indeed the general public, when they say they're not interested, usually because they don't really know very much about it. And I think this is simply our first foray into this area to understand the baseline, and our focus is really to do much more comprehensive medical education and so forth. And you'll be hearing more about that as we move forward. But it's a key part to help educate prescribers and other key stakeholders, and you'll see more from us in this coming year. Okay, no, that's helpful.

And another survey, that's often seem to be the case that patients rather the clinicians and indeed the general public.

When they when they say, they're not interested it usually because they don't really know very much about it.

And I think this is our simply our first foray into this area to understand the baseline and our focus is really to do much more comprehensive medical education, and so forth and you'll be hearing more about that as we move forward, but it's a key part to help educate prescribers and other key stakeholders and you'll see more from us and this was.

Coming here.

Okay. No. That's helpful. And then I was just wondering in terms of the therapy. The psychotherapy, there's just been a lot of discussion around it.

Operator: And then I was just wondering, in terms of therapy, psychotherapy, there's just been a lot of discussion around it. And I was wondering your thoughts more at a high level about the psychotherapy process just being standardized, and obviously, maybe some variation between disease states or patients, but any thoughts on the standardization of the process? I'll turn it over to Guy in a moment, but just the high-level view is that one of the key issues confronting payers and providers is really about how to deliver and ensure a linkage between psychotherapy and outcomes.

And I was wondering your thoughts more at a high level about the psychotherapy process, just being standardized and obviously, maybe some variation between disease states.

Patients, but any thoughts on the standardization of the process.

Okay.

I'll turn it over to Guy in a moment, but just the high level view is that one of the key issues confronting.

Payers and providers is really about how to deliver and ensure a linkage between psychotherapy and outcomes and I think our focus is really to start providing a greater connection based on evidence in training and we're aiming to do that in all of our work. So that we can deliver a more standardized approach.

Operator: And I think our focus is really to start providing a greater connection based on evidence and training, and we're aiming to do that in all of our work so that we can deliver a more standardized approach that actually links to the data to improve outcomes. So that's our goal and ambition. Guy, I don't know if you want to build on that at all. Yeah, I think we can certainly standardize the psychoeducational component of the preparation. One can do that with a really effective teaching platform.

That actually links to the data to improve outcomes. So that's our goal and ambition guide I know if you want to build on that at all I think I think we can suddenly.

Standardize the Psycho educational component of the preparation.

One can do that with a really effective teaching platform on can use the methods used widely in education to check with people People's training has been successful I don't see any reason why we shouldnt apply that in the preparation of patients through this experience and indeed, that's what our digital team is working on at the moment.

George Goldsmith: One can use the methods, you know, used widely in education to check that people's training has been successful. I don't see any reason why we shouldn't apply that in the preparation of patients for this experience. And indeed, that's what our digital team is working on at the moment. Okay, great. Just lastly here, you mentioned more medical meetings throughout the year and recent medical meetings. It's nice to see that a lot of these are in person again.

Okay, Great and just lastly here you mentioned that you know more medical meetings throughout the year.

Guy Goodwin: I'm just wondering if there are any specific meetings that you want to highlight that could be, Yeah, I mean, the American Psychiatric Association meeting is obviously the biggest meeting in the US, and we will be there for that and presenting a poster. ASCP, which is a clinical pharmacology meeting, probably the most influential in the US, and we will be presenting new data there. And then, finally, in Europe, the

In a recent medical meetings, it's nice to see that a lot of these are in person again I'm. Just wondering if there's any specific meetings that you want to highlight that could be interesting.

Yes, I mean, the American Psychiatric Association meeting is obviously the biggest meeting in the U S and we shall be there for that and presenting a poster ISP pay which is the clinical pharmacology meeting probably the most influential in the U S. We should be presenting new data there and then finally in Europe the CMP <unk>.

In October and very very very much finally in December nearly the end of the.

Guy Goodwin: And very, very, very much finally, in December, nearly the end of the year, the ACNP meeting, where we expect again to present new data on mechanisms. Great, thank you very much. Thank you. I'll get our next question on the line. It is from Esther Hong with Birnberg.

The Icmp meeting, where we expect again to present new data on mechanism.

Great. Thank you very much.

Thank you Richard.

Next question on the line is from Esther Hong with Barnbrook go right ahead.

Operator: Go right ahead. Hi, thanks for taking our questions. This is Elaine Kim on behalf of Esther.

Hi, Thanks for taking our questions. This is Elaine Kim Entre Esther.

Operator: Our first question is, how similar is anorexia to TRD in terms of patients responding to treatment? For example, eating concerns versus depressive symptoms. Then we have a follow-up question. I think we don't really see them as tapping the same functional domains. TRD and anorexia nervosa really do look very different.

First question is how similar is anorexia oxy Cherokee in terms of patients responding to treatment for example, Ian concerns persist depressive symptoms and we have a follow up question.

I think we don't really see them as really tapping the same functional domains tid and anorexia nervosa really do look very different.

Guy Goodwin: I mean, the key issue being the preoccupation in anorexia with weight and shape. There are some potential similarities in the sense that these both patient groups have very persistent troubling preoccupations, and we think we understand part of the neurobiology of that as lying in the so-called default mode network, which is kind of the introspective side of human experience. And that seems to be particularly rigid in both conditions. So there is that sense that there may be a mechanistic similarity, which is not necessarily at the symptom level but at the functional level. And, of course, we believe that one of the ways in which psilocybin works is actually to break up the rigidity of those connections and to offer greater connectedness to different parts of the brain.

I mean, the key issue being the preoccupation and anorexia with weight and shape.

Guy Goodwin: So we think there's a kind of link at the mechanistic level, but symptom-wise, in terms of presentation, and clinical difficulties, they're expressed, of course, in very different ways. Thank you. That makes a lot of sense. Our follow-up question is, in the same ADNOR-XDR study, there were statistically significant reductions in eating concerns at month three. So although the study is small, does this add support to psilocybin's durability of effect?

There are some potential similarities in the sense that these both patient groups have very persistent troubling preoccupations and we think we understand part of the neurobiology of that is lying in the so-called depot mode network, which is kind of the introspect it means respective side of human.

<unk> and that seems to be particularly rigid in both conditions. So there is that sense that there may be a mechanistic similarity.

Which is not necessarily the symptom level, but at the functional level and of course, we believe that the way in which we're one of the ways in which psilocybin works is actually to break up the rigidity of those connections and to offer a greater connectedness to different parts of the brain. So we think theres a kind of link the mechanistic level, but symptom.

Wise in terms of presentation clinical difficulties. They are expressed of course in very different ways.

Thank you.

A follow up question is in the same anorexia study there were statistically significant reductions in any concerns.

Gary.

So although the study is small doses at two point to show OS I think durability of effect.

It may do I think we are we obviously are cautious that this is an uncontrolled study is open label and Theres No control comparison group.

Guy Goodwin: It may do. I think we are obviously cautious that this is an uncontrolled study. It's open label, and there's no control comparison group. So the skeptic can be skeptical, but we're interested because of the intractability of what is traditionally regarded as an intractable condition. We're obviously very interested in those numbers but also in the impressions of experienced clinicians like Walt Kay, who actually described the patients in... He was very struck by the changes.

So the skeptic can be skeptical, but where we are.

We're interested because of the intractability of the traditionally regarded as an intractable condition. We're obviously very interested in those numbers, but also in the impression of the clinic experienced clinicians like Walt K, who actually describe the patient's in.

Guy Goodwin: So that kind of thing is important to our planning as well. Okay, thank you very much. Thank you. We've got our next question on the line. It's from Patrick Trucchio with HC Wainwright.

He was very struck by the changes so that kind of thing is important to our planning as well.

Okay. Thank you very much.

Thank you. Okay. So next question on the line for Patrick Truecar with H C. Wainwright go right ahead.

Operator: Go right ahead. Thanks. Good morning. Good afternoon.

Thanks, Good morning, and good afternoon. This.

This is the first question is just around as we're looking at the expansion of the Cop 360 program. You know we have T. R. D. Then now expanding.

Expanding into areas of PTSD.

Chisholm potentially anorexia, how should we think about how broad this program can become how many indications can you you know.

Realistically explored and then and how do we view it just in the context of the discovery efforts at <unk>.

Compass and.

Just in terms of kind of next generation compounds and how those would then factor into kind of your development plans.

Operator: This is the first question is just around as we're looking at the expansion of the COMP360 program, you know, we have TRD, then now, you know, expanding into areas of PTSD, you know, autism, potentially anorexia. How should we think about how broad this program can become? How many indications can you, you know, realistically explore it in? And how do we view it just in the context of the discovery efforts at COMPASS and, you know, just in terms of kind of next-generation compounds and how those would then factor into kind of your development plan? Hi Patrick, thanks so much for the question. I'll start off, and Guy will probably add some color commentary additionally.

Hi, Patrick Thanks, so much for the question I'll start off and I'll, probably add some color commentary. Additionally.

George Goldsmith: So, I think what's really important is that our North Star, our true north at COMPASS is simply how do we find ways to help people in areas of large unmet need who are failed by current treatment. And so that's what we focus on. And we started with TRD based on our conversations with payers, regulators, and providers that that was the place to start. Obviously, we'll be using a similar methodology to go next, and that's how we came up with PTSD as our second area of focus, and we'll be continuing to apply that.

So I think what's really important is that our northstar our true north at Compas is simply how do we find ways.

Ways to help people in areas of large unmet need who are failed by current treatments.

And so that's what we focus on and we started with TRT based on our conversations with payers and regulators and providers that that was the place to start obviously, we will be using a similar methodology to go next and Thats. How we came up with PTSD as our second area of focus and we'll be continuing to apply.

George Goldsmith: And we're going to focus on as many of these programs as we find that there's actually a rationale for approach and that there's a strong investor proposition as well. These are huge areas of unmet need, and I think we are really looking at how we address those. So that's the kind of overarching perspective.

That we're going to focus on as many of these programs as we find that theres actually a rationale to approach and that Theres, a strong investor proposition as well these are huge areas of unmet need.

We are really looking at how we address those so.

That's the kind of overarching.

Perspective, no and the other side, we want to make sure that we get this to patients as quickly as possible that means we're really focusing on our <unk> program first and foremost that's where we're furthest ahead not only in our development process, but for the entire field and the entire transformation of mental health. So that's where our priorities are.

Guy Goodwin: Now, on the other hand, we want to make sure that we get this to patients as quickly as possible. That means we're really focusing on our TRD program first and foremost. That's where we're furthest ahead, not only in our development process but for the entire field and the entire transformation of mental health. So that's where our priorities are. And as we look at these other areas, we'll be following the data, which is what we do.

And as we look at these other areas will be following the data which is what we do.

Yeah, that's really helpful and just one clarification on the on the PTSD program. So following this phase two trial would the intention be to move directly into a pivotal phase III program or would you need would you need to run another phase two.

Guy Goodwin: Yeah, that's really helpful. And just one clarification on the PTSD program. So following this phase two trial, would the intention be to move directly into a pivotal phase three program, or would you need to run another phase two? I think it's a little early to say, Frankly, Patrick, I think we'll wait and see what we find. I mean, this is still early days for PTSD.

I think it's a little early to say frankly Patrick.

I think I think we wait and see what we find I mean this is still early days with PTSD.

We're obviously interested and we're committed to finding out more but I mean, the first study will be informative in ways that we don't yet understand and we wait that understanding before we signal.

Guy Goodwin: We're obviously interested and committed to finding out more, but I mean, the first study will be informative in ways that we don't yet understand, and we wait for that understanding before we say more. Got it. Yep. Okay. That's helpful.

Got it yep. Okay. That's helpful. Thank you so much.

Operator: Thank you so much. Thank you, I look forward to seeing you soon at the conference. Thank you very much. And there are no further questions at this time.

Thank you and look forward to seeing you soon at the conference.

Thank you very much and there are no further questions at this time I'll now turn the call back to management for any closing remarks.

George Goldsmith: I now turn the call back to management for any closing remarks. We really appreciate your support and interest today. We continue down our path of executing as we do at pace. We are excited about the next steps that will be evolving this year. We are making a lot of progress on many different dimensions, and we'll look forward to sharing that as we move forward through the year.

We really appreciate your support and interest today, we continue down our path of executing as we do at pace.

We're excited about the next steps will be evolving this year, we're making a lot of progress on many different dimensions, and we'll look forward to sharing that as we move forward through the year again. Thank you.

Operator: Again, thank you. Thank you very much, and thank you everyone. That will conclude the conference call for today. We thank you for your participation as we disconnect the lines. Have a good day, everyone.

Thank you very much and thank you everyone that does conclude the conference call for today. We thank you for your participation you may disconnect your lines.

Have a good day everyone.

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