Full Year 2021 Compass Pathways PLC Earnings Call

Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, thank you for calling please remain on your lines. Your conference call will begin momentarily. Thank you for your patience.

[music].

Stephen Schultz: Good day, ladies and gentlemen, and welcome to the COMPASS conference call. At this time, all participants are going to listen only mode. After the speaker's presentation, there will be a question and answer session. If you would like to ask a question during this session, please press star then one on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference call, Stephen Schultz.

Stephen Schultz: You may begin. Thank you for joining us today for our fourth quarter and full year 2021 results conference call. We hope you've had a chance to review the press release issued earlier today covering our 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, Chief

Stephen Schultz: If you would like to introduce your host for today's conference call, please press star then one on your telephone keypad. Please press star then one on your telephone keypad, for joining us today for our fourth quarter and full year 2021 results conference call. We hope you've had a chance to review the press release issued earlier today covering our 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, Chief Financial Officer.

Unknown Executive: This 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 Security 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 annual report on Form 10K, filed with the U.S. Securities and Exchange Commission, and in subsequent filings made by COMPASS 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 at any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement.

Stephen Schultz: 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 annual report on Form 10-K filed with the U.S. Securities and Exchange Commission, and in subsequent filings made by COMPASS 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 at any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement.

I'll now hand the call over to our Chairman and CEO, George Goldsmith. Thank you, Steve. And welcome, everyone.

George Goldsmith: I'll now hand the call over to our chairman and CEO George Goldsmith. Thank you, Steve. And welcome, everyone.

Okay.

Good day, ladies and gentlemen, and welcome to the Companys Conference call. At this time, all participants are in a listen only mode.

George Goldsmith: Let me begin by welcoming Mike Falvey to his first COMPASS quarterly results call. Mike joined our team in December and has a track record in building strong financial teams and valuable experience in launching and commercializing products. This experience will be important as we work to bring our COMP360 psilocybin therapy through clinical trials, regulatory approval, and ultimately to patient access as a reimbursed therapy. I will begin today's call with a business update on Eureka's in progress. Guy will talk about additional data from the Phase 2B study and our open-label study with SSRIs. And Mike will provide a financial review.

After the Speakers' presentation there'll be a question and answer session. If you would like to ask a question. During this session. Please press Star then one on your telephone keypad.

As a reminder, this conference call is being recorded I would now like to introduce your host for today's conference call. Stephen Schultz you may begin.

Yeah.

Yeah.

Yeah.

For joining us today for our fourth quarter and full year 2021 results conference call.

Hope you've had a chance to review the press release issued earlier today covering our 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 Guide, Good wind, Chief Medical Officer, and Mike Falvey Chief financial.

George Goldsmith: We will then open the call to questions. In the fourth quarter of 2021, COMPASS Pathways made significant progress, toward our goal of accelerating patient access to evidence-based innovation in mental health with the successful completion of our Phase 2B trial of COMP360 psilocybin therapy in treatment-resistant depression, or TRD. This trial is the largest randomized controlled psilocybin therapy study ever completed, and it showed rapid and sustained response after just a single 25 milligram dose of COMP360 psilocybin with psychological support.

George Goldsmith: The trial provided COMPASS with a target dose for our planned Phase 3 program and a wealth of information to guide us in finalizing our trial design, which will be reviewed with the FDA in our upcoming end of Phase 2 meeting, which has been scheduled for late April. In the trial, in addition to looking at the safety and efficacy of COMP360 psilocybin therapy, we examined a number of exploratory measures recognized as being important to recovery for patients with TRD, and we're pleased to see positive data.

George Goldsmith: In December, we also announce results from our Open Label Study of COMP360, Silasiven Therapy in TRD patients who remained on their SSRI antidepressants, unlike those in our phase 2B trial in which patients were withdrawn from their engines. [inaudible] The study results demonstrated that COMP360 has potential as an adjunctive therapy as well as a monotherapy, providing greater flexibility to patients. We believe this increase in patient choice could increase the number of prescribers and patients who would consider this therapy option.

Officer COO.

Is being recorded and will be available on the company's 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.

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 annual report on Form 10-K filed with the U S Securities and Exchange Commission.

And in subsequent filings made by Compass 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 at any subsequent date we.

We specifically disclaim any obligation to update or revise any forward looking statements.

Ill now hand, the call over to our chairman and CEO George Goldsmith.

Thank you, Steve and welcome everyone. Let me begin by welcoming Mike Salvi to his first conference quarterly results call. Mike joined our team in December and has a track record in building strong financial teams in valuable experience in launching and commercializing products. This experience will be important as we work to.

George Goldsmith: A number of patients who participated in either the Phase IIb or the Open Label Study entered a 12-month long-term follow-up study. We will be reporting the results of this study later in the year and expect additional insight on the durability of a single COMP360 psilocybin dose with psychological support. Guy will walk through these data in more detail in a moment.

Bringing our called 360 suicide different therapy through clinical trials regulatory approval and ultimately to patient access is a reimbursed therapy.

I will begin today's call with a business update on our Rechristen progress Guy will talk about additional data from the phase <unk> study and our open label study with Ssris and Mike will provide a financial review.

George Goldsmith: Beyond TRD, we commenced a COMPASS-sponsored Phase 2 study of COMP360 psilocybin therapy for the treatment of post-traumatic stress disorder, or PTSD, another indication of significant unmet need and representing an urgent problem with few current therapeutic options, we expect to expand into a further indication over the course of this year. These COMPASS-sponsored programs are in addition to the ongoing investigator-initiated studies. In a variety of therapeutic areas is including anorexia nervosa, bipolar depression, and severely resistant TRD.

We'll then open the call to questions.

In the fourth quarter of 2021, compas pathways made significant progress toward our goal of accelerating patient access to evidence based innovation in mental health with the successful completion of our phase two b trial with comp 360, psilocybin therapy in treatment resistant depression or T. R D. Let's try.

It was the largest randomized controlled suicide gene therapy study ever completed and it showed rapid and sustained response. After just a single 25 milligram dose of <unk> 360 suicide than with psychological support.

George Goldsmith: We continue to expand our leadership in preclinical research, exploring new psychedelic compounds through our Discovery Center and through our recently acquired Intellectual Property Portfolio, covering a variety of psychedelic and pathogenic substances. This IP was developed together with inventor Dr. Matthias Grill, who will be working with COMPASS on an exclusive research project to advance new product candidates. With that, let me now hand over to Guy.

The trial provided confidence with a target dose for our planned phase III program and a wealth of information to guide us in finalizing our trial design, which will be reviewed with the F. D. A in our upcoming end of phase two meeting which has been scheduled for late April .

In the trial in addition to looking at the safety and efficacy of Cop 360 suicide in therapy, we examined a number of exploratory measures recognized as being important to recovery for patients with T. R. D and we're pleased to see positive data.

Guy Goodwin: Thank you, George, and good day all. Late last year we presented the top line results from the COMP360 TRD study. Since then, we have generated additional analyses of primary and secondary endpoints that validated the top-line findings. I will talk briefly through these today.

In December we also announced results from our open label study of <unk> 360, psilocybin therapy in T. R. D patients who remained on their SSO or I antidepressants.

Guy Goodwin: We will be submitting our trial data for publication in a peer-reviewed journal this year. In our analysis of exploratory measures, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, Daily Functioning, Cognition, and Self-Reported Depression. We believe such improvements underline the comprehensive nature of the response to COMP360, Remember, a quarter of the patients in the 25 milligram group maintained their symptomatic response at 12 weeks after a single administration with no other antidepressant medication. This finding is unprecedented for this patient population.

Those in our phase two b trial in which patients were withdrawn from their antidepressants.

The study results demonstrated that <unk> 360 has potential as an adjunctive therapy as well as a monotherapy, providing greater flexibility to patients.

We believe this increase in patient choice could increase the number of prescribers and patients who would consider this therapy option.

The number of patients who participated in either the phase two b or the open label study entered a 12 month long term follow up study, we will be reporting the results of this study later in the year and expect additional insight on the durability of a single comp 360 suicide bid dose with psychological support.

Guy Goodwin: Furthermore, a post hoc analysis of sustained responders showed clinically meaningful improvements in measures such as the QIDS self-report scale and quality of life, which underline that patients returned to levels typical of the healthy population and remained there for the length of the trial. Additionally, on the Positive and Negative Affect Schedule, or PANAS, scale, on the day after COMP360 administration and at the questionnaire's final administration at Week 3, patients in the 25 mg group had a higher increase in positive affect, including feeling interested, excited and strong.

Guy will walk through these data in more detail in a moment.

Beyond T. R. D. We commenced the compass sponsored phase two study of comp 360, psilocybin therapy for the treatment of post traumatic stress disorder or PTSD, another indications with significant unmet need in representing an urgent problem with few current therapeutic options, we expect to expand into a further indication.

Over the course of this year.

These conquer sponsored programs are in addition to the ongoing investigator initiated studies in a variety of therapeutic areas, including anorexia nervosa, bipolar depression and severely resistant T. R D.

Guy Goodwin: These improvements in positive mood could provide important differentiation for Comp360 when eventually compared directly with other available treats. These findings are very encouraging and will be included in the end of Phase 2 meeting with the FDA in April. Additional safety data were also generated. As noted in the top line data, COMP360 psilocybin was generally well tolerated. Further analysis showed that there were no concerns with vital signs, ECG, or clinical laboratory data in any of the treatment groups.

We continue to expand our leadership in preclinical research exploring new psychedelic compounds, where discovery center and through a recently acquired intellectual property portfolio covering a variety of psychedelic and pathogenic substances beside P was developed together with inventor, Dr. Mathias Grill, who will.

Working with Congress wanted exclusive research project to advance new product candidates.

With that let me now hand over to Guy.

Thank you George and good day all.

Late last year, we presented the topline results from the 360 T O D study.

Guy Goodwin: The majority of treatment emergent adverse events occurring on the day of COMP360 administration resolved on the same day or the day after. Suicidal ideation, suicidal behavior, and intentional self-injury are always a concern in patients with clinical depression. There are currents in our phase two trials determined at each time the patient was seen with the Columbia Suicide Severity Rating Scale. Suicidal ideation was observed in all treatment groups within a range of 5-7% which is comparable with other studies of treatment-resistant patients.

Since then we have generated additional analyses of primary and secondary end points that validated the topline findings I will talk briefly through these today.

We will be submitting our trial data for publication in a peer reviewed journal this year.

In our analysis of exploratory measures, we observed consistent improvement and matches the anxiety positive or negative affect quality of life daily functioning cognition and self reported depression.

We believe such improvements underline the comprehensive nature of the response to <unk> 360 psilocybin therapy.

Guy Goodwin: Independently, repeated remote rating by a blinded rater showed that levels of suicidality on item 10 of the Madras scale were lower during the study than at baseline, with no differences between treatment groups. We do not believe that there is a causal relationship between the serious adverse events of suicidal ideation, suicidal behavior, and self-injury, and administration of COMP360 psilocybin therapy. Unfortunately, these events occur unpredictably and are to be expected in this patient population.

Remember a quarter of the patients in the 25 milligram group maintained that symptomatic response at 12 weeks after a single administration with no other antidepressant medication.

This finding is unprecedented for this patient population.

Furthermore, a post hoc analysis of sustained responders showed clinically meaningful improvements in measures such as the Quids self report scale and quality of life.

Which underline that patients returned to levels typical of the healthy population and remain there for the length of the trial.

Guy Goodwin: The timing and circumstance of other adverse events in the trial demonstrated that COMP360 psilocybin therapy was generally well tolerated. As George noted, we also announced in December the results from our exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. This was a single arm open label study of 19 patients who received a single dose of 25 milligram COMP360 psilocybin with psychological support. They showed comparable average treatment outcomes to patients in our Phase 2b trial where patients were withdrawn from their SSRI prior to COMP360 psilocybin therapy.

Additionally, on the positive and negative ethic schedule Panis scale on the day. After 360 administration and the question that final administration at week three patients.

Patients in the 25 milligram group had a higher increase in positive effect, including feeling interested excited on strong. These.

These improvements in positive mood could provide important differentiation for <unk> 360, when eventually compared directly with other available treatments.

These findings are very encouraging and will be included in the end of phase two meeting with the FDA in April .

Additional safety data, we're also generates it.

As noted in the top line data Com 360, psilocybin was generally well tolerated.

Guy Goodwin: These results challenged the widely held belief that the use of FSRI medication could interfere with psilocybin therapeutic effects. For some patients with treatment-resistant depression, withdrawal from SSRIs is a difficult step, even though, by definition, treatment-resistant means that those antidepressants are not working.

Further analysis showed that there were no concerns with vital signs E. C G well clinical laboratory data in any of the treatment groups.

The majority of treatment emergent adverse events occurring on the day of country 60 Administration result on the same day or the day after.

Guy Goodwin: These findings and placebo-controlled results from a healthy volunteer study published by others last year provide the basis for our belief that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressants as well as a monotherapy. This will have the effect of increasing the number of patients potentially eligible for treatment with COMP360, and will offer patients greater choice in how they access treatment with COMP360. We are now looking forward to meeting with the FDA to review these data and to finalize our plans for the Phase 3 program which we expect to commence in the second half of this year.

Suicidal ideation suicidal behavior and intentional self injury are always a concern in patients with clinical depression.

Their recurrence in a phase two trial was determined that each time, the patient with seeds with the Columbia suicides severity rating scale.

Suicidal ideation was observed in all treatment groups within a range of 5% to 7%.

Which is comparable with other studies that treatment resistant patients.

Independently repeated remote writing by blinded writer showed that levels of suicide Alexey on item 10 of the mattress scale will lower joined the study then at baseline with no differences between treatment groups.

Guy Goodwin: We will be discussing this with the FDA in our upcoming meeting. Let me now hand over to Mike for the financial review. Mike. Thanks, Guy. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $273.2 million at December 31, 2021, compared with $190.3 million at December 31, 2020.

We do not believe that there is a causal relationship between the serious adverse events suicidal ideation suicidal behavior and self injury and administration of <unk> 360 psilocybin therapy.

Mike Falvey: With these resources, we expect to be able to fund our operations into 2024. I will now recap our financial results for the year ended and the three months ended December 31st, 2021. Net loss for the full year 2021 was $71.7 million, or $1.79 per share, compared with the net loss of $60.4 million, or $3.55 per share, during the same period in 2020. These results include non-cash share-based compensation of $8.6 million in 2021 and $18 million in 2020.

Unfortunately, these events occur unpredictably and ought to be expected in this patient population.

The timing and circumstances other adverse events in the trial demonstrated that <unk> 360 set aside in therapy was generally well tolerated.

Mike Falvey: Net loss for the three months ended December 31, 2021 with $25.7 million or $0.61 per share compared with $18.8 million or $0.52 per share during the same period in 2020. These results include non-cash share based compensation of $2.8 million in 2021 and $1.4 million in 2020. Research and development expenses were $44 million for the full year of 2021, compared with $23.4 million during the same period in 2020. The increase was due to an increase of $16.1 million, $6 million, and $0.4 million in development costs, personnel expenses, and other expenses, respectively, partially offset by a reduction of $1.8 million in non-cash, share-based compensation.

As George noted, we also announced in December the results from our exploratory study of <unk> 360, psilocybin therapy in conjunction with Paas, that's all I use.

This was a single arm open label study of 19 patients who received a single dose of 25 milligram comp 360, psilocybin with psychological support.

Asia comparable average treatment outcomes to patients in our phase two b trial, where patients were withdrawn from their SSRI prior to come 360 silicide in therapy.

These results challenge the widely held belief that the use of SSRI medication could interfere with psilocybin therapeutic effect.

For some patients with treatment resistant depression withdrawal from Ssris is a difficult step even though by definition treatment resistant means that those antidepressants are not working.

These findings and placebo controlled results from a healthy volunteer study published by others last year provide the basis for our belief that 360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressant as well as a monotherapy.

Mike Falvey: As COMPASS progresses its COMP360 psilocybin therapy in CRD and continues to explore additional integrations in therapeutic approaches. For the three months ended December 31st, 2021, R&D expenses were $13.6 million compared with $4.5 million during the same period in 2020. The increase was due to an increase of $7.3 million, $2.1 million, and $1 million in development costs, personnel expenses, and non-cash share-based compensation, respectively, partially offset by a reduction of $1.3 million in other R&D expenses.

This will have the effect of increasing the number of patients potentially eligible for treatment with <unk> 360.

And we will offer patients greater choice in how they access treatment with <unk> 360.

We are now looking forward to meeting with the FDA to review these data and to finalize our plans for the phase three program, which we expect to commence in the second half of this year.

We will be discussing this with the F D a in our upcoming meeting.

Let me now hand over to Mike for the financial review Mike.

Thanks, Guy carpets continues to maintain a strong financial position with cash and cash equivalents of $273 $2 million at December 31, 2021.

Mike Falvey: G&A expenses were $39.1 billion in the full year 2021 compared with $28 million during the same period in 2020. The increase was due to an increase of $7.9, $1.8 million in personnel expenses, legal and professional fees and facilities and other expenses respectively. Partially offset by a reduction of $7.6 million in non-cash share-based compensation. For the three months ended December 31st, 2021, G&A expenses were $14.7 million, compared with $7 million during the same period in 2020.

Compared with $193 million at December 31, 2020 with.

With these resources, we expect to be able to fund our operations into 2024.

I will now recap our financial results for the year ended in the three months ended December 31 2021.

Net loss for the full year 2021 was $71 7 million or $1 79 per share compared with a net loss of $64 million or $3.55 per share during the same period in 2020. These.

Mike Falvey: This increase was due to an increase of 2.2, 0.5, 1, and $4 million in personnel expenses, non-cash share-based compensation, legal and professional fees, and facilities and other expenses, respectively. The sequential increases in our operating expenses over the last few quarters reflect continued support of our development programs and staffing increases to build an organization to support our growth and our operations as a public company. We expect these types of increases to continue over the next couple of quarters as we prepare for our Phase 3 trial in TRD. When our trial design is finalized and communicated, we intend to provide more detailed financial guidance for the remainder of the year. Thank you, and I'll now turn the call back. Thank you, Mike.

These results include noncash share based compensation of $8 $6 million in 2021 and $18 million in 2020.

Net loss for the three months ended December 31, 2021 was $25 $7 million or <unk> 61 per share compared with $18 $8 million or <unk> 52 per share during the same period in 2020.

These results include noncash share based compensation of $2 $8 million in 2021, and $1 $4 million in 2020.

Research and development expenses were $44 million for the full year 2021, compared with $23 $4 million during the same period in 2020 the.

The increase was due to an increase of $16 1 million $6 million and $24 million.

George Goldsmith: Again, we're very pleased with our progress in the last year and even more confident in our ability to provide new options for patients to help them lead happier and healthier lives. Looking forward, this year we are excited to add a new chapter to our record of achievement. We have an active year of milestones ahead across numerous programs, beginning with the advancement into Phase III for COMP360 psilocybin therapy for TRD. In addition, we expect to complete the Phase 2B long-term follow-up study around the middle of the year.

Development costs personnel expenses and other expenses respectively.

Partially offset by a reduction of $1 $8 million in noncash share based compensation.

As <unk> progresses, its cop 360, psilocybin therapy in CRD and continues to explore additional indications and therapeutic approaches.

For the three months ended December 31, 2021, R&D expenses were $13 $6 million compared with $4 $5 million during the same period in 2020.

George Goldsmith: We expect to launch an additional COMP 360 clinical development program beyond the ongoing TRD and PTSD program. We aim to publish a detailed Phase II COMP360 clinical data in a major peer-reviewed medical journal and at a number of medical meetings.

The increase was due to an increase of 7.3 million $2 1 million and $1 million in development costs personnel expenses and noncash share based compensation, respectively, partially offset by a reduction of $1 $3 million in other R&D expenses.

G&A expenses were $39 $1 million and the full year 2021, compared with $28 million during the same period in 2020.

Operator: We expect to generate innovation around our COMP360 therapy and build our, IP Portfolio with additional patent grants. We will continue to advance COMP360-payer partnerships in anticipation of commercial launch and we expect to forge strategic relationships and collaborations, pursue our data and technology strategy, and further enhance our scalable therapist training platform that can support the significant global expansion of treatment sites that will participate in the Phase III trial program. Overall, the Phase IIb data package, our impending start of the Phase III program, and the advancement of our earlier stage pipeline will strengthen the significant leadership position we have established in this area of time.

The increase was due to an increase of 791.8 and $9 million in personnel expenses legal and professional fees and facilities and other expenses, respectively, partially offset by a reduction of $7 6 million in noncash share based compensation expenses.

For the three months ended December 31, 2021, G&A expenses were $14 $7 million compared with $7 million. During the same period. In 2020. This increase was due to an increase of 2.2 0.51 and $4 million in personnel expenses noncash share based compensation.

Legal and professional fees and facilities and other expenses respectively.

Operator: With broad, reimbursed patient access as our North Star, and supported by a strong operational foundation and the financial resources to fuel our continued progress, we are making encouraging progress toward our goal of building a personalized, predictive, and preventative model for transforming mental health care. We believe this 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 a line for questions.

The sequential increases in our operating expenses over the last few quarters reflect continued support of our development programs and staffing increases to build an organization to support our growth and our operations as a public company. We expect these types of increases to continue over the next couple of quarters as we prepare for our phase III trial in <unk>.

D Wayne.

And our trial design is finalized and communicated we intend to provide more detailed financial guidance for the remainder of the year.

Operator: Operator. Ladies and gentlemen, if you have a question or comment at this time, please press star then one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key.

Thank you and I'll now turn the call back to George.

Thank you Mike again, we're very pleased with our progress in the last year and even more confident in our ability to provide new options for patients to help them lead happier and healthier lives.

Operator: Again, if you have a question or a comment at this time, please press star then 1 on your telephone keypad. Our first question or comment comes from the line of Ritu Baral from Cowan, your line is open. Good morning guys, thanks for taking the question. I wanted to ask about basically the proposed phase 3 design that George you mentioned you're going to sit with FDA in late April, sounds like you probably have the briefing book together and at least a proposed design.

Looking forward. This year, we are excited to add a new chapter to a record of achievement. We have an active year of milestones ahead across numerous programs beginning with the advancement into phase III for <unk> 360, psilocybin therapy for <unk>.

Operator: Can you maybe just bracket for us what we should be thinking in terms of patient numbers, thoughts about what control will be, will it still be sort of one milligram or any requirements for placebo and also the number of sites, especially given the trial prep and site training that's important for this trial that you know your average one of the mil MDD studies, wouldn't need to consider. Hi Ritu, thank you so much for your question.

In addition, we expect to complete the phase to be long term follow up study around the middle of the year.

We expect to launch an additional comp 360 clinical development program beyond the ongoing T. R D in PTSD programs.

We aim to publish a detailed phase III comp 360 clinical data in a major peer reviewed medical journals and had a number of medical meetings.

We expect to generate innovation around our comp 360, <unk> therapy and builder.

IP portfolio with additional patent grants, we will continue to advance comp 360 payer partnerships in anticipation of commercial launch and we expect a forged strategic relation ships and collaborations pursue our data and technology strategy and further enhance our scalable tariffs.

George Goldsmith: I'm going to start by saying that probably across a number of these questions, I'll be responding by saying until we review the Phase 3 program with the FDA and get their guidance and support, we won't be making comments on specific aspects of it. Know that because we are who we are, we are addressing all of the outstanding questions that have emerged in our designs that we'll be taking to the FDA and work on resolving those and getting to a point where we have a well-articulated plan that we'll be sharing as soon as we complete our interactions with the FDA during the first half of this year.

Training platform that can support the significant global expansion of treatment sites that will participate in the phase III trial program.

Overall, the phase II B data package, our impending start of the phase III program and the advancement of our earlier stage pipeline will strengthen a significant leadership position. We have established in this area of science.

With broad reimburse patient access is our north star and supported by a strong operational foundation and the financial resources to fuel. Our continued progress we are making encouraging progress towards our goal of building a personalized predictive and preventative model for transforming mental health care.

George Goldsmith: With regard to the number of sites, we will have a significant uptick in these and have been preparing all of our therapist training approaches and so forth for that. Again, we view Phase 3, given our very promising results in Phase 2, as a path to bringing this to patients as quickly as possible and therefore we'll be working with more centers, more therapists, etc. We also are strongly developing our technology support to accelerate this process of rollout of therapy and therapist training. I'm sorry I couldn't tell you more, but I will be telling you more later. Got it.

We believe this 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.

Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue simply press the pound key.

Again, if you have a question or a comment at this time. Please press Star then one on your telephone keypad.

George Goldsmith: Looking forward to the May update once you guys have the few minutes you can. A quick follow-up just on the PTSD trial. Can you maybe, Guy, take us through the just high level of that trial design, even though it is investigative run? And then, you know, George, how do you see the evolution of the space? Maybe compare and contrast the right patient, the clinical benefit versus MDMA PTSD? for a guy who will turn that over to you as a medical crush. Hi, are you on mute?

Our first question or comment comes from the line of Ritu <unk> from Cowen Your line is open.

Yeah.

Good morning, guys. Thanks for taking the question.

I wanted to ask about.

Proposed.

<unk> designed that.

George you mentioned.

In late April it sounds like you probably have depreciated pumps, together and I'm pleased to propose design.

Can you maybe just bracket for us what was it.

In terms of.

This number.

Thoughts about what control will be what they'll be sort of one milligram or one.

Armando for placebo.

And also the number of sites, especially given trial prep on site training that's important clinical trial.

George Goldsmith: Okay, I will die. We've been having some technical difficulty with Guy's connection. So what we're really looking at here with the PTSD is this is a, first step to look at what psilocybin can do. We have interesting preclinical data on this and we believe that that gives us some reason to believe that this will be effective at work. So I think this is what we're going to be pursuing in this trial in our work and that's going to be announced further as we complete the announcement of our sites for that trial.

One of them.

Sorry.

Wouldnt equal.

Hi, <unk>. Thank you so much for your question.

I'm going to start by saying that probably across a number of these questions.

I'll be responding by saying until we've reviewed the phase III program with the FDA and get their guidance and support we won't be making comments on specific aspects of it know that because we are who we are we are addressing all of the outstanding questions sort of emerged in our designs that will be taken to the FDA and <unk>.

Work on.

Resolving those and getting to a point, where we have a well articulated plan that we'll be sharing as soon as we complete our interactions with the FDA during the first half of this year.

George Goldsmith: In terms of, could you remind me, sorry Ritu, it's been... Oh sure, just the compare and contrast the opportunity for psilocybin and PTSD versus MDMA. So I think what we see with the MDMA approach is that it's very significant amounts of psychotherapy.

With regard to the number of sites, we will have a significant uptick in these and have been preparing all of our therapists trading approaches and so forth for that.

Again, we view phase III, given our very promising results in phase two.

George Goldsmith: And we're informing our program with that. But some of the things we're looking at is whether there can be a shift in the therapy provision aspects of this using a different medicine. Psilocybin as opposed to that.

As a path to bring this to patients as quickly as possible and therefore, we'll be working with more centers more therapists, etc.

We also are strongly developing our technology support to.

George Goldsmith: So we're going to be looking at understanding the therapy provision. We're working with leaders in PTSD therapy, and we'll be really looking at how we might optimize this, utilizing specific qualities of psilocybin in terms of its impact. So that's work underway, and we'll be sharing much more about this program later on in the year. Great. Thanks for the time and the insight. And my apologies, I've just heard that Guy is having very.., to give you a difficulty suit, you will not be able to join the call.

Accelerate this process of rollout of therapy, if the tariff is trading.

Operator: No problem. I'll follow up. Thank you very much.

Got it sorry, I couldn't tell you more but I will be telling you more later.

Got it looking forward to that.

Let me update.

Okay.

A quick follow up just on the <unk>.

Trial can you maybe.

Take us through the.

Just high level of that trial design, even though it is index data and then George how do you mean.

The evolution of the space, maybe compare and contrast.

<unk>.

Clinical benefit versus <unk>.

N BMO people can program.

Operator: Thank you. Our next question or comment comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open. Hi, George and team.

Sure Guy I'll turn it over two years.

Medical question.

George Goldsmith: Thanks for taking the question. Congrats on, I thought, a very good year of progress last year. I had a couple follow-ups. To Ritu's question, I'm respectful that you won't be able to provide a lot of details until you meet with the agency, makes a lot of sense. But one question that I had was, when you meet with the agency, will you be discussing the concomitant antidepressant medicines, or are you going to stick with the monotherapy versus the adjunctive therapy for the Phase III program? I'm sorry, will we be sticking with the, So we will be, could you repeat the question? Monotherapy's paradise.

Guy are you on mute.

Yeah.

Okay I will.

Guy.

We've been having some technical difficulty with guys Sue.

Just connection so what we're really looking at here with the PTSD as this is a.

First step to look at what psilocybin can do we have interesting preclinical data on this and we believe that that gives us. Some reason to believe that this will be effective at work.

So I think this is what we're going to be pursuing in this trial.

And our work and that's going to be announced further as we complete the <unk>.

George Goldsmith: Yes, so we'll just stick with the monotherapy paradigm. So we will certainly bring them on a therapy paradigm to them as well as the information coming from the adjunctive approach, which we think is a very, very promising set of early signals. And so we'll be discussing both with them obviously.

<unk> of our sites for that trial.

In terms of could you remind me sorry, ritu its oh sure.

Yeah.

Compare and contrast, the opportunity of course outside the non pizza.

Okay.

So I think what we see with the MDMA approach is that it's very significant amounts of psychotherapy or being informing our program without but.

George Goldsmith: Well, perhaps not obviously, but we will, in service of patients. Okay, so the Phase 3 program is intended to be a monotherapy program or possibly a broader program to include adjunctive therapy with SSRI? Possibly a broader, possibly a broader program again to be discussed. Okay, very good.

Some of the things we're looking at is whether there can be a shift in the therapy provision aspects of this using a different medicine.

So aside of them as opposed to that so we're going to be looking at understanding the therapy provision were working with leaders in PTSD therapy, and we'll be really looking at how we might optimize this utilizing specific qualities of suicide.

George Goldsmith: And then with regard to the 12 month longer term follow up study that you mentioned, I'm not sure if I heard this correctly. So if you could just clarify, was an additional dose available to patients if needed? and will you be evaluating durability based on that one as well?

In terms of its impact.

Thats work underway and we'll be sharing much more about this program.

Later on in the year.

Great. Thanks, Alright, thanks for the kind of momentum.

George Goldsmith: Yes, this is predominantly looking at durability, Chas, because one of the things that has just been unanswered since the beginning, which is why we designed the phase two trial that we did, was how long does this last for whom? And we don't want to be providing more psilocybin therapy than is required. So we really first and foremost want to understand durability. We saw that in 25% of our 25 milligram dose at three months, and obviously want to see how long did that continue for which patient, so that we can start understanding carefully how do we figure out who the responders will be, what dosing would look like, et cetera.

And I apologize I've just heard that guy is having very.

So you if you have difficulty certainly will not be able to join the call.

No problem I'll follow up.

Thank you very much.

Thank you. Our next question or comment comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.

Charles Yes, good morning, Hi, George and team. Thanks for taking the question. Congrats congrats on I thought a very good year of progress last year.

I had a couple of follow ups to Richard's question am respectful that you won't be able to provide line of details until you meet with the agency makes lot of sense.

George Goldsmith: So this is purely the long term is to follow those patients without any additional dosing and to look at how long did this single dose work for whom, and what are the characteristics of those patients that can help inform subsequent trials and commercial use. Okay, very good, George. And last question is perhaps for Mike. But you'll probably detect it's kind of a backdoor way of getting more information on the trial designs.

But one question that I had was when you when you meet with each N. C will you be discussing the concomitant anti depressant medicines are you going to stick with the mono therapy versus the adjunct therapy for the phase III program.

Yeah.

I'm, sorry would be sticking with the.

So we will be buying.

George Goldsmith: And that is regarding the cash, and I think he mentioned funding through or into 2024. And I guess I'm wondering, what are the assumptions behind that? Are you planning on one or two trials in the program for the, you know, the phase three program for COMP360 and TRT? Mike, do you want to take that?

Repeat mono therapy paradigm.

Yeah, So William mono therapy paradigm.

So we will certainly bring the mono therapy paradigm to them as well as the information coming from the adjunctive.

Approach, which we think is a very very promising set of early signals and so it will be discussing both with them obviously.

Well, perhaps not obviously, but we will in service of patients.

Mike Falvey: Sure. So first, thank you for walking your backdoor question through the front door. Um, and, uh, so the cash position that we have, uh, at the end of... 2021 was $273 million, and we believe that does carry us through 2022, 2023, and into 2024.

Okay.

So the phase three program is intended to be a mono therapy program or possibly a broader program to include adjunctive therapy. Several years says Saturn, possibly broader possibly a broader program again to be discussed.

Okay very good and then with regard to the 12 month longer term follow up study that you mentioned I'm not sure. If I heard this correctly. So if he could just clarify was an additional dose available to patients if needed.

Mike Falvey: Although we don't know the exact definition of that program, we're pretty confident that whatever the final design is, we can conduct that trial together with the Phase II trial and all the other activities associated with being a public company. So we're pretty confident in that runway, and in this kind of financial market, that kind of financial stability is, we believe, a real strategic asset, so we're going to continue to protect that because we think that's, in the end, really helpful.

And will you be evaluating durability based on that one as well.

Yes. This is predominantly looking at durability Chas because one of the things, which has just been unanswered since the beginning which is why we designed the phase II trial that we did was how long does this last for whom and we don't want to be providing more suicide in therapy than is required. So we really first and foremost.

Want to understand durability, we saw that in 25% of our 25 milligram dose at three months and obviously you want to see how long does that continue for which patients. So that we can start understanding carefully how do we figure out who the responders would be dosing would look like et cetera. So this is purely the long term.

Operator: Thanks for taking the question. You can see we're being resolute in our Phase 3 questions. Yeah, that's all right.

Operator: We want you to get the feedback from the agency, and we'll talk soon about that. Thank you. Our next question or comment comes from the line of Nina Barito-Garg from Citi. Your line is open.

Term has to follow those patients without any additional dosing and to look at how long did the single dose work for whom and what are the characteristics of those patients. We can help inform subsequent trials and commercial use.

George Goldsmith: Hey guys, thanks for taking the question. Another question on a phase three here. So I know you mentioned earlier that you are planning to, you know, extend to significantly more sites than in the face to be. And I guess maybe if you can tell us a little bit about how you're planning to ensure that you do have the right patients and roles given the expansion, the number of sites. And, you know, anything you can comment on at this point on how [inaudible] Nellings, Drosil Doppel, and maybe different than what you did in the past.

Okay very good George and last question is perhaps for Mike.

So youll, probably detect it's kind of a back back to our way of getting more information on the trial that trial designed.

And that is regarding the cash and and I think you mentioned two year or peak he mentioned.

Funding through or into 'twenty, 'twenty, four and I guess I'm wondering what are the assumptions behind that are you are you planning on one or two trials in the program for the you know.

The phase III program for <unk> for a cop 360 and TRT.

George Goldsmith: So I'll take your second question first, you know, we were very, very happy with how the phase to be played out and obviously we'll be taking those results to the FDA and discussing options for the phase three. And so until we do that, we really will be, You know, just kind of keeping the face redesigns to ourselves until we understand what their feedback is.

So actually I wanted to take that.

Sure. So first thank you for walking your backdoor question through the front door.

And.

So the cash position that we have at the end of.

2021 went to $273 million.

And we believe that does carry us through two.

2022, 23 and into two.

George Goldsmith: The second piece that I think is important here is that everything we're doing is looking at how do we rapidly and most rapidly get this into hands of patients as a reimbursed model of care. And so, when we are developing our work, we're doing a great deal of effort to make sure that our screening is appropriate, that we have the right patients, that we have as homogeneous a group of patients as possible.

2024.

And putting that together.

We contemplated fully funding.

The phase III study over that period.

Not knowing the exact definition of that program, we're pretty confident that.

Whatever the final design ins, we can prosecute that trial together with the phase II trial and all the.

Other activities associated.

George Goldsmith: That work is played out very successfully in our phase to be trial, we'll be taking that forward. And when we expand sites, we'll be taking all of that learning into our phase three program. And we have done a tremendous amount of work identifying the phase three infrastructure, which will be significantly larger than our phase two infrastructure was.

With being a public company, so we're pretty confident in that runway and.

Kind of a financial market that.

Kind of financial stability, we believe it is a real strategic asset so we're going to continue to protect that.

Okay.

And India really helps patients.

Yeah, absolutely yeah. Thanks for taken the fever panel resolute in our phase III question.

George Goldsmith: And again, all these pieces will come together mid-year with an intention as we've disclosed to start phase three in the second half of 2022. Thank you. Thank you. Our next question or comment comes from the line of Patrick Trucchio from HC Wainwright. Your line is open. Hi, good morning. Hi, Patrick.

Yeah, that's alright, well, we want you to get the feedback from the agency and we'll talk soon.

Well I'm not that.

Thank you next question. Our next question or comment comes from the line of Nino Burrito Garg from Citi. Your line is open.

Operator: Sorry, this is Jason speaking for Patrick, but if you would like my question then, yeah, hi, how are you guys doing? And so I just kind of just, I have one question in terms of your phase three and then kind of just kind of got a little bit more on the IP. So can you just look a little bit on the how the potential for simultaneous treatments or group therapies could become part of the phase three program and what if any feedback at the receipt from regulators on this potential front and possibly also discuss on the digital therapeutic front and how digital therapeutics could be part of the phase three program? So. In terms of simultaneous administration, that's really, Independent of the design. So how sites will administer that is not part of the plan right now. So we're not being discussed.

Hey, guys. Thanks for taking the question.

Question on phase.

Phase three here.

I know you mentioned earlier that you are planning to do.

<unk> significantly more sites and then the phase <unk> and I guess, maybe if you can talk a little bit about how you're planning to ensure that you do have the right patients involved given given the expansion in the number of sites and.

Anything you can comment on at this point on how you plan to kind of.

Manage the placebo.

You know maybe different than what you did in the phase III.

So I'll take your second question first.

Very happy with how the phase to be played out and obviously, we will be taking those results to the FDA and discussing options for the phase three.

George Goldsmith: The design will be discussed, but obviously the FDA has enabled that in the past with our study at Aquilino Cancer Center. So, again, that will tend to be site-specific conversation. Next, with regard to the, Digital Aspects. Both the patients and the therapists have digital platforms to support them through the trial. The therapists are focused on training and adherence and receiving therapist feedback on the trials. What's important is that every single session is recorded and that provides a wealth of information as we look at understanding potential behavioral markers, changes in person's language, their narrative, etc.

And so until we do that we really will be.

No.

Kind of keeping with phase III designs to ourselves until we understand what their feedback is.

The second piece that I think is important here is that everything we're doing is looking at how do we rapidly and most rapidly get this into hands of patients as a reimbursed model of care.

George Goldsmith: So, we're doing a tremendous amount of natural language processing, etc. on those, creating a different set of exploratory endpoints, digital endpoints. In addition, we will be providing a patient platform called MyPathFinder, which will be an app that will enable patients to help navigate them through the trial, provide educational material and support material to them. So, those are core parts of the Phase 3 program that's being developed, both on the therapist side and on the... Patients. Okay, great. Thank you for the additional color.

So when we are developing our work we're doing a great deal of effort to make sure that our screening is appropriate that we have the right patients that we have this homogeneous group of patients as possible that work has played out very successfully in our phase <unk> trial will be taking that forward and when we expand.

Sites will be taking all of that learning into our phase III program.

And we have done a tremendous amount of work identifying the phase III infrastructure, which will be significantly larger than our phase two infrastructure was and again all of these pieces will come together mid year with an intention as we've disclosed to start phase III in the second half of 2022.

Got it thank you.

Thank you our next question.

A question or comment comes from the line of Patrick <unk> from H C. Wainwright. Your line is open.

George Goldsmith: And I guess kind of just the last question is, can you discuss the latest on for the IP for COMP360? And kind of like the level of confidence that the COMP360 therapy should have robust long-term protection? We are very confident in our IP position, which gets stronger over time. There has been a prior challenge, and that was actually overturned on merit, so we're not commenting on pending legal matters, but as you asked about our confidence, it is unwavering and strong.

Hi, good morning, Patrick.

Sorry, this is Jason speaking for that.

Thank you for taking my question then so you guys are doing.

And so I can kind of just I have one question in terms of the phase III.

Got a little bit more on the IP.

Can you just talk a little bit on how the potential for simultaneous treatment or groups therapies could become part of the phase III program and what if any feedback.

We should see from regulators on those potential front and possibly also discussed on digital on the digital therapeutic fronts and how.

George Goldsmith: Alright, thank you so much, Jen, congrats on the fantastic year, and we'll all speak soon. Thank you. We really appreciate it. Thanks. Thank you. Thanks so much for taking the questions. Question about trial protocols and maybe in the phase 2, given the potentially severe and refractory nature of the patient, being enrolled in the risk for potential suicide ideation, what are the protocols in place to detect and intervene early should a patient, Thanks. This is a really important question.

Digital therapeutics could be part of the phase III program.

So.

In terms of simultaneous administration, that's really.

Independent of the designs have house sites will administer that is not part of the plan right. Now so are not being discussed the design will be discussed.

But obviously the FDA has enabled that in the past with our study at Guizhou Cancer Center.

So again that will tend to be site specific conversation.

Next with regard to the.

Digital aspects.

Both the patients and therapists have digital platforms to support them through the trial.

George Goldsmith: And again, our focus on patient safety is very high. At the time of every interaction with the site in Phase IIb, as well as in the Phase III program, we assess suicidal ideation and any other aspects of that with the patient directly. And obviously, there's an escalation process to us should anything happen. So, I think we are putting those same processes in place. And really, to your point, this is a very, very difficult population.

The therapists are focused on training and adherence and receiving.

First the feedback on the trials, what's important is that every single session as reported and that provides a wealth of information as we look at understanding potential behavioral markers changes in person. This language there narrative et cetera. So we're doing a tremendous amount of natura.

Natural language processing et cetera on those creating a different set of exploratory endpoints digital endpoints. In addition, we will be providing patient.

George Goldsmith: People struggle a great deal. Going in, as we revealed into our Phase IIb trial, nearly two-thirds of people had prior history of suicidal ideation. Sadly, it goes with the very significant distress that people have with treatment-resistant depression. And of course, there were no suicides in Phase 2b.

Platform called my Pathfinder, which will be an app that will enable patients to help navigate them through the trial provided educational material and support material to them. So those are core parts of the phase III program is being developed.

George Goldsmith: There was just the ideation and some early behaviors that were in, you know, not serious and quite later after the dose. Are there specific algorithms for how to manage those patients or is it left to the discretion, It's a good question and right now what we're doing is obviously the sites are trained in how to handle that. I'm not aware of a special protocol other than their own clinical judgment.

Both our side and on the.

You bet.

Okay, great. Thank you for any additional color and I guess kind of just the last question is can you just touch on the latest songs for the IP for Cop 360, and kind of like the level of confidence that the accomplished T therapy should have a robust long term protection.

We are very confident.

In our IP position, which should get stronger over time.

There have been a prior challenge.

And that was actually overturned on merit.

So we're not commenting on pending legal matters, but as you asked about our confidence it is unwavering and strong.

George Goldsmith: Again, we can follow up with Guy. Thank you. Our next question or comment comes from the line of Esther Hong from Barron Perk. Your line is open.

Alright, thank you so much and congrats on the fantastic year.

All speak soon thank you.

Operator: Hi, good morning, thanks for taking my question. So MAPS is expected to launch the first psychedelic for commercial use, MDMA for PT. I was wondering what, if anything, could COMP360 leverage? from that commercial.

We really appreciate it thanks.

Thank you. Our next question or comment comes from the line of Josh <unk> from Evercore. Your line is open thanks.

So much for taking my questions just a question about us.

Question about trial protocols, and maybe in the phase II, given that potentially severe and refractory nature of the patients.

George Goldsmith: Really great question, Esther, and thank you for it. I think, obviously, there are similarities in the structure of the therapy around the medicine. The therapy is different because of the different natures, but having sites and facilities and trained therapists makes a lot of difference for both programs.

Being enrolled in the risk for.

Potential suicide ideation of what what are the protocols in place to detect and intervene early should a patient windup deteriorating in there and the mental status. Thank you.

Thanks. This is a really important question and given our focus on patient safety is very high at the time of every interaction with the site and phase <unk> as well as in the.

George Goldsmith: So, obviously, we are working closely to make sure that trainers, people who have been trained in MAPS therapy can also be trained in our therapy approach. So, I think having more capability, more sites, all of that does nothing but enhance our ability to reach patients faster. Got it.

The phase III program.

We assess suicidal ideation.

And any other aspects of that.

With the patient directly and obviously, there's an escalation process to us it should anything happen.

So I think we are putting those same processes in place and really to your point. This is a very very difficult population people struggle.

Operator: Thank you. Thank you. Our next question or comment comes from the line of Berg Hazlitt from BTIG. Your line is open. Yes, good morning, and thank you for taking my question. Hi, George.

George Goldsmith: Thank you very much. I was really intrigued to hear some of your focus on the additional characteristics of COMP360 in the TRD trial. You've mentioned these before, but, you know, obviously the durability of the single dose is important, but as you consider characteristics, additional characteristics that you saw in the study, like effects on anxiety, on positive affect, quality of life, and cognition, and others, are the things that rise to the four, characteristics that rise to the four, that you think would be important as you look forward either in phase three, or in your discussions with the agency.

Great deal going into as we revealed into our phase two b trial, nearly two thirds of people had prior history of suicidal ideation Sadly it goes with the very significant distress that people have with treatment resistant depression.

And of course, there were no suicides in phase two b there is just the ideation.

Some early behaviors that were either not serious.

Yeah.

Quite later after the dosing.

Okay.

Specific algorithms for how to manage those patients or is it left to the discretion of the treating physician.

It's a good question and.

Right now what we're doing is obviously the sites are trained in how to handle that.

I'm not aware of a special protocol.

George Goldsmith: Thank you. Absolutely, a great question and I think that what really rose to the fore for us was in addition to the significant relief and symptoms for many patients at the point of remission, their positive affect and most importantly their quality of life. For those who responded on 25 mg, their levels of quality of life of 12 weeks was equivalent to what a normal, quote unquote, normal person without any depression would experience.

Other than their own clinical judgment again, we can follow up with sky.

Thanks very much.

Thank you. Our next question or comment comes from the line of Esther Hong from Baron Perk. Your line is open.

Hi, good morning, Thanks for taking my question.

So maps is expected to launch the App first psychedelic for commercial use MDMA for PTSD.

Wondering what if anything Covid cop 360 leverage.

George Goldsmith: So our proposition here is a completely different model, not just of less symptoms or fewer symptoms but actually a greater connection to one's life with a broad proposition of improving quality of life and reducing total cost of care. So improving quality, reducing costs, critically important for this patient population for health systems and obviously huge patient benefit. So that's the thing that's been most interesting in addition to the very, very strong signals of durability for patients on the 25 mg dose.

That commercial lines. Thanks.

Really great question, Esther and thank you for it.

Obviously, there are similarities and the structure of the therapy.

Around the medicine, the therapy is different because of the different nature, but having sites and facilities and trained therapists.

Makes a lot of.

Benefit for both programs. So obviously, we are working closely to make sure that trainer.

People who've been trained in maps therapy can also be trades.

George Goldsmith: And obviously we're working to increase the number of patients who do enter remission and stay in remission and also looking at all the other aspects that we learn through the trial as we go into our phase 3. Thank you. We look forward to the additional data and the long-term follow-up data as well. Thank you. Thank you. Our next question or comment comes from the line of Francois Brisebois from Oppenheimer. Your line is open.

Our therapy approach, so I think having more capability more sites all of that does nothing but enhance our ability to reach patients faster.

Got it thank you.

Thank you. Our next question or comment comes from the line of Berg Hazlett from <unk>. Your line is open.

Yeah.

Yes, good morning, and thank you for taking my question Hi, George Thank you very much was really into.

Operator: Thanks for taking the questions. You know, obviously a lot's been kind of asked and you guys have discussed what you're going to talk about on the Phase 3 details, but I was just wondering, in the Phase 2b, can you just remind us how standardized the psychological support was in terms of preparing the patients and then maybe the integration part as well? Was this kind of the same amount of sessions for each patient or any color on that would be helpful?

Greig too.

Here are some.

Your focus on the additional characteristics of come $3 60 in the <unk> trial, you've mentioned these before but.

Obviously, the durability of the single dose is important but as you consider characteristics additional characteristics that you saw in the study like.

Effects on anxiety on.

Positive affect quality of life in cognition and others are the things that rise to the four characteristics of rise to the fore.

George Goldsmith: Sure, so there was a great deal, obviously we focused a great deal on the uniformity of this across the trial, but above everything it's patient safety and a focus on patient experience. So occasionally there may have been a bit more support for patients provided, again with patient safety and focus first and foremost. However, everything that we're doing is really looking at providing a very consistent form of support for patients, so patients can rely on a model that can be delivered, whether it is in the Netherlands or anywhere in Europe, the U.S., etc., there will be a consistent level of support that they've received.

Do you think would be important as you look forward either in phase III or in your discussions with the agency.

<unk>.

Absolutely a great question and I think that what really rose to before was for US was in addition to the significant relief in symptoms for many patients to the point of our mission.

There are positive <unk>.

<unk> and most importantly, their quality of life for those who responded on 25 milligram their levels of quality of life of 12 weeks was equivalent to what a normal quote unquote normal person without any depression would experience.

George Goldsmith: So the methods are the same and obviously clinical judgment is used, but we saw a tremendous similarity across the trial and we are looking obviously at the adherence to the model as part of our work in preparing for Phase III and the next level of training. Okay, great. And that's what we saw.

Proposition here is a completely different model not just have less symptoms or fewer symptoms, but actually a greater connection to one's life with a broad proposition of improving quality of life and reducing total quality and total cost of care.

George Goldsmith: Okay. Great, if I could just quickly follow up, this is not too much backdoor, but just kind of a follow-up on Charles' question about, you know, when you see monotherapy and then potentially combo and the answer was there's a possibility. Is there also a possibility for a repeat those things or that we just don't touch on at all?

So improving quality reducing costs critically important for this patient population for health systems, and obviously huge patient benefit.

That's that's the thing that's been most interesting in addition to the very very strong signals of durability.

For patients on the 25 milligram dose and obviously, we're working to increase the number of patients who do enter remission and stay in remission and also looking at all the other aspects that we learned through the trial as we go into a phase III.

George Goldsmith: Obviously, we're looking at all different aspects to enable people to get well and stay well, and obviously looking at redosing is one of those dimensions, and we'll be reporting out on the final design, Okay, great. And just, sorry, lastly, in terms of the conferences where you might present this data that you mentioned, any specific conferences that you would like to highlight? The APA, ANCP toward the end of the year, and I think those are the two, there will be some others, but those are the two that are top of mind right now.

Thank you we look forward to the additional data in the long term follow up data as well. Thank you.

Super.

Thank you. Our next question or comment comes from the line of Francois brief Bois from Oppenheimer. Your line is open.

Alright, thanks for taking the questions.

You know, obviously, a lot's been kind of asked and.

You guys have discussed what youre going to talk about on the phase III details, but I was just wondering arent in the phase II can you just remind us how standardized psychological support was in terms of preparing the patients and then maybe the integration part as well was this kind of the same amount of sessions for each patient or any color on that would be.

George Goldsmith: Great, thank you so much. Thank you. Oh, and just to add, we are, obviously the results will be published in a leading journal this year as well from our Phase IIb study. Thank you. Our next question or comment comes from the line of Cal Kean from Canaccord Genuity. Your line is open. Kyle speaking for Sumant. What is your conceptual take on some of the shorter acting psychedelics in the competitive pipelines? And comparatively, what is your advantage?

Helpful.

Sure.

So there was a great deal obviously, we focused a great deal on the uniformity of this across the trial, but above everything its patient safety and a focus on patient experience. So occasionally there may have been a bit more support for patients provided again at with patients.

Safety and focus first and foremost however, everything that we're doing is really looking at providing you very consistent form of support for patients. So patients can rely on a model that can be delivered whether it is in the Netherlands or anywhere in Europe . The U S et cetera, there will be a.

George Goldsmith: Would your advantage mainly be around your potential to be a first mover? Or would it be something entirely? So, a few things. One is... So, we chose Simon because of our focus on patients and getting things to patients as quickly as possible and this program enabled us to do just that. At the same time, innovation never stops here at COMPASS. We have our work with our Discovery Center, our relationship with Dr.

<unk> level of support that they perceive so the methods are the same obviously clinical judgment is used but we saw a tremendous similarity across the trial and we are looking obviously at the adherence to the model as part of our work in preparing for phase III and the next level of trading.

George Goldsmith: Grill that we announced, and are looking at a very robust program at shorter acting substances, substances that have different receptor occupancy, etc. The short answer is, we really don't know if shorter acting actually will produce the level, demonstrated in Phase 2B. So I think this is really important that we need to generate the data. We realize there's a lot of enthusiasm about shorter acting, but the enthusiasm is greatly outpacing the evidence available.

Okay, great and what we saw.

Great. If I could just quickly follow up this is not not too much back door, but just kind of a follow up on Charles' question about can.

Can you see monotherapy and then potentially combo and the answer was there as a possibility is there also a possibility for repeat dosing or that we just don't touch on at all.

George Goldsmith: So we're going into this area as we do, and we do that with a great deal of focus on developing robust evidence that we can then move forward into clinical programs. And we have a very robust pipeline looking at shorter acting and other ways of designing these to produce perhaps less anxiety, et cetera, than existing psychedelics. So we're very focused on leading the preclinical and discovery work in this area, as well as being a leader in our clinical development. Boyling.

Obviously, we're looking at all different aspects to enable people to get well and stay well and are obviously looking at re dosing is one of those dimensions and we'll be reporting out on the final design win that's agreed.

Okay, Great and then just sorry lastly in terms of the conferences, where you might present this data.

You mentioned any specific conferences that you would like to highlight.

The E P. A N C P or towards the end of the year.

And I think those are the two there will be some others, but those are the two that are top of mind right now.

Operator: Brisebois. Thank you. I'm showing no additional questions in the queue at this time. I'd like to turn the call back over to management for any closing remarks. We greatly appreciate all of your support and interest. Obviously, all eyes are focused on our Phase 3 program, which, as is our history, we will develop in a robust way, reflecting our values of being compassionate, bold, rigorous, and inclusive in the design of our trials and work. So we're looking forward to that, and we also will be sharing increased progress on other areas of our business as we progress this year, and it will be an exciting milestone-filled year for COMPASS once again.

Great. Thank you so much.

Thank you.

Just to add we are obviously the results will be published in a leading journal this year as well from our phase <unk> study.

Thank you. Our next question or comment comes from the line of Cao Kim from Canaccord Genuity. Your line is open.

Speaking first Vermont.

What is the actual 10 Hello, what is there a conceptual take on some of the shorter acting psychedelics and the competitor pipelines and comparatively what is your advantage. What's your advantage mainly be around your potential to get first mover or or would it be something entirely.

George Goldsmith: Thank you. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.

So a few things one is.

So we chose psilocybin because of our focus on patients and getting things to patients as quickly as possible. In this program enabled us to do just that.

At the same time innovation never stops here at Compass, we have our work with our discovery Center our relationship with Dr. <unk>.

Grill that we announced.

We are looking at it.

A very robust program at shorter acting substances substances that have different receptor occupancy et cetera. The short answer is we really don't know if shorter acting actually will produce the level.

That's traded in phase two big So I think this is really important that we need to generate the data we realized there's a lot of enthusiasm about shorter acting but the enthusiasm is greatly outpacing the evidence available. So we're going into this area as we do and we do that with a great deal of phone.

So in developing robust evidence that we can then move forward into clinical programs and we have a very robust pipeline looking at shorter acting and other.

Waste of designing these to produce perhaps less anxiety et cetera than existing psychedelics. So we're very focused on meeting the preclinical and discovery work in this area as well as being a leader in our clinical development.

Alright.

Yeah.

Thank you I'm showing no additional questioners in the queue at this time I'd like to turn the call back over to management for any closing remarks.

We greatly appreciate all of your support and interest obviously all eyes are focused on our phase III program, which as is our history.

We'll develop in a robust way, reflecting our values of being compassionate bold rigorous and inclusive in the design of our trials that work. So we're looking forward to that and we.

We hope that we'll be sharing increased progress on other areas of our business as we progress this year.

And it will be an exciting milestone filled year for compass. Once again, thank you.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.

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