Q2 2021 Compass Pathways PLC Earnings Call

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Unknown Speaker: Thank you, and so on the other than the other, and the Thee, and so on. Thank you. Good day, ladies and gentlemen.

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Operator: Good morning, ladies and gentlemen. Welcome to the Compass Pathway second quarter 2021 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0.

Operator: As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Stephen Schultz. Senior Vice President of Investor Relations, you may begin. Thank you, operator.

Good day, ladies and gentlemen, and welcome to the Compass pathways second quarter 2021 conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone if you recall.

Stephen D. Schultz: Welcome all of you, and thank you for joining us today for our second quarter 2021 results call. My name is Steve Schult, Senior Vice President of Investor Relations at Compass Pathways. Today I'm joined by George Goldsmith, Chairman and Chief Executive Officer, and Pierce Morgan, our chief financial officer. George will begin today's call with a business update on our recent progress, and Pierce will follow with a review of our financial results. We will then open the line to questions.

Any further assistance. Please press star Zero as a reminder, this call is being recorded I would now like to introduce your host for todays conference Stephen Schultz Senior Vice President of Investor Relations you may begin.

Thank you operator welcome all of you and thank you for joining us today for our second quarter 2021 results call.

Stephen D. Schultz: The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call. We hope you've had a chance to review our results, issued earlier today. 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 statement.

My name is Steve Schultz Senior Vice President of Investor Relations at Compass pathways and today I'm joined by George Goldsmith, Chairman and Chief Executive Officer, and Piers Morgan, Our Chief Financial Officer.

George will begin today's call with a business update on our recent progress and peers will follow with a review of our financial results.

We will then open the line for questions.

Call's being recorded and will be available on the compass pathways Investor Relations website. Shortly after the conclusion of the call.

We hope you've had a chance to review our results press release issued earlier today before.

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.

Stephen D. Schultz: 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 20F filed with the U.S. Securities and Exchange Commission earlier today and in subsequent filings made by Compass with the SEA. Additionally, these forward-looking statements represent our views only as of today and should not be relied on as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement.

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 Andy.

Our report on form 20-F filed with the U S Securities and Exchange Commission.

Stephen D. Schultz: With that, I now hand the call over to our Chairman and CEO, George. Thank you, Steve, and welcome everyone. This quarter, I'm pleased to report that we continue to make great progress in all aspects of our business. On July 8th, we announced that our lead development program for our Comp 360 psilocybin therapy and treatment-resistant depression, or TRD, reached a significant milestone as the last participant completed their psilocybin session. With this milestone, the trial is now fully recruited at 233 individuals, exceeding our original goal of 216.

Earlier today and in subsequent filings made by Compass with the SEC additions.

Additionally, these forward looking statements represent our views only as of today and should not be relied on as representing our views as of any subsequent date, we specifically disclaim any obligation to update or revise any forward looking statement with that.

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

Thank you, Steve and welcome everyone. This quarter I'm pleased to report that we continue to make great progress in all aspects of our business.

Stephen D. Schultz: This Phase 2B trial is the largest clinical trial of psilocybin in history, and we expect data from this trial by the end of the year. I want to remind you that the primary objective of this trial is to identify the target dose of our planned Phase 3 clinical trials and inform other aspects of the design. This important step in the development process is one that was a requirement prior to progressing to Phase 3, based on our interactions with regulators.

On July eight we announced that our lead development program of our comp 360 suicide in therapy in treatment resistant depression or T. R. D reached a significant milestone as the last participant completed their psilocybin session.

With this milestone the trial is now fully recruited at 200 and thirty-three individuals' exceeding our original goal of 216. This phase two b trial is the largest clinical trial of psilocybin in history, and we expect data from this trial by the end of the year.

Stephen D. Schultz: In this study, we are comparing a 25 milligram dose and a 10 milligram dose of Comp 360 psilocybin with a 1 milligram dose given to the patient in conjunction with psychological support from specially trained therapists. The primary endpoint of the trial is a reduction in depression symptoms as measured on the Madras scale at three weeks. We will also be looking at the durability of response at numerous points, up to 12 weeks, as well as safety and tolerability.

I want to remind you that the primary objective of this trial is to identify the target dose of our planned phase III clinical trials and inform other aspects of the design. This important step in the development process is one that was a requirement prior to progressing to phase III based on her interactions with regulators.

In this study we are comparing a 25 milligram dose and a 10 milligram dose comp 360, psilocybin with a one milligram dose given to the patient in conjunction with psychological support from specially trained therapists.

Unknown Executive: We believe that our comp 360 psilocybin therapy has the potential to provide a rapid and sustained treatment effect with a well-tolerated safety profile. Once we have the data, in addition to those arising from our extensive pre-clinical studies, we plan to meet regulators at an end of phase two meeting. The information we obtain from this trial will inform the design of our Phase 3 Pivotal Program, which we expect to begin as quickly as possible.

The primary endpoint of the trial is a reduction in depression symptoms as measured on the Madras scale at three weeks, we will be also looking at the durability of response at numerous points up to 12 weeks as well as safety and Tolerability.

We believe that our comp 360, psilocybin therapy has the potential to provide a rapid and sustained treatment effect with a well tolerated safety profile.

Once we have the data in addition to those arising from our extensive preclinical studies, we plan to meet regulators in an end of phase two meeting.

Unknown Executive: In addition to our TRD study, we continue to invest in the expansion of our portfolio through new indications and new compounds. We supply Comp 360 free of charge to investigator-initiated studies, exploring a range of indications in areas of unmet mental health need, including anorexia nervosa, bipolar disorder 2, and severe TRD. Any positive signals from these small studies would offer Compass the option to elevate the research into large late-stage clinical programs. A number of these studies are currently underway.

The information we obtained from this trial will inform the design of our phase three pivotal program, which we expect to begin as quickly as possible.

In addition to our T. R. D study, we continue to invest in the expansion of our portfolio through new indications and new compounds, we supply comp 360 free of charge two investigator initiated studies exploring a range of indications in areas of unmet mental health need, including anorexia nervosa bipolar disorder.

Two and severe T R D.

Any positive signals from these small studies would offer compass the option to elevate the research into large late stage clinical programs.

Unknown Executive: One in particular is being carried out by the Aquino Cancer Center in Maryland, the United States, where they are finishing a small open-label study of Comp 360 psilocybin therapy in cancer patients. We expect data from this study later this year. We also plan to begin a number of new studies and new indications over the next few months. We continue to be active in pre-clinical research, exploring new psychedelic compounds. These studies are being done through the Compass Discovery Center, a network of leading scientists from the University of Sciences, Philadelphia, UC San Diego School of Medicine, and the Medical College of Wisconsin. This early stage work should enable us to broaden our portfolio beyond Com 360 psilocybin therapy.

Number of these studies are currently underway one in particular is being performed by the accurately know cancer Center in Maryland, the United States.

Where they are finishing a small open label study of comp 360, psilocybin therapy in cancer patients.

We expect data from this study later this year. We also plan to begin a number of new studies and new indications over the next few months.

We continue to be active in preclinical research exploring new psychedelic compounds. These studies are being done through the Compass Discovery Center, our network of leading scientists from the University of Sciences, Philadelphia, UC, San Diego School of Medicine, and the medical College of Wisconsin. This early stage work should enable us to broaden our portfolio.

Leo beyond Com $3.60 psilocybin therapy.

In the U K, we are developing a research partnership with a couple of leading institutions, South London, and Mozley NHS Foundation Trust and the Institute of Psychiatry Psychology, and neuroscience at King's College, London.

Unknown Executive: In the UK, we are developing a research partnership with a couple of leading institutions, South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology, and Neuroscience at King's College London. We have signed a memorandum of understanding, setting out our joint intent to work together to accelerate psychedelic research and develop new models of mental health care in the UK, particularly in areas of unmet needs, such as depression, PTSD, and anorexia nervosa. We are facing an urgent global crisis in mental health care made worse by the COVID pandemic and need to work collaboratively to address this.

We have signed a memorandum of understanding sitting on our joint intend to work together to accelerate psychedelic research and developed new models of mental health care in the U K, particularly in areas of unmet need such as depression, PTSD and anorexia nervosa.

We are facing an urgent global crisis in mental health care made worse by the Covid pandemic the need to work collaboratively to address this compass was honored to be part of a working group that helped to establish mental health is one seven critical missions in the U K government's life Science strategy announced last month also in the U.

Unknown Executive: Compass was honored to be part of a working group that helped to establish mental health as one of the seven critical missions in the UK government's life science strategy announced last month. Also in the UK, we are proud to be a founding supporter of the British Neuroscience Association's inaugural Scholars Program, which launched earlier this year and aims to support students from underrepresented ethnic groups to thrive in neuroscience.

K, we are proud to be a founding supporter of the British neuroscience associations inaugural scholars program, which launched earlier this year and aims to support students from underrepresented ethnic groups to thrive in neuroscience. This fits well with our ongoing commitment to fostering and maintaining a bold culture of equity diversity and inclusion within <unk>.

Unknown Executive: This fits well with our ongoing commitment to fostering and maintaining a bold culture of equity, diversity, and inclusion within our company and in the wider neuroscience and healthcare community. Our Compass team continues to grow in all areas in support of our goal to transform the patient experience in mental health care. We have made important leadership hires in clinical science, regulatory affairs, clinical safety, quality, and CMC as we develop new compounds, additional indications, and prepare for a Phase 3 program. Notably, we announced two senior team members, Guy Goodwin, our new chief medical officer, and Danielle Schlosser, our senior vice president of clinical innovation. Professor Guy Goodwin is Emeritus Professor of Psychiatry at the University of Oxford.

Company and in the wider neuroscience and healthcare communities.

Our compass team continues to grow in all areas in support of our goal to transform the patient experience and mental health care. We have made important leadership hires in clinical science regulatory affairs clinical safety quality and C. M. C. As we develop new compounds additional indications and prepare for a phase III program.

Notably we announced two senior team members Guy good move on our new Chief Medical Officer, and Daniel Schlosser, Our senior Vice President of clinical innovation.

Professor Guy Goodwin is emeritus professor of psychiatry at the University of Oxford is a deeply experienced psychiatrist and an outstanding leader in the field, who is wholly committed to patient care. He has been working with us on an advisory capacity since the beginning of the phase two b trial, and we're delighted to welcome him in a more active and full time role.

Unknown Executive: He is a deeply experienced psychiatrist and an outstanding leader in the field who is wholly committed to patient care. He's been working with us in an advisory capacity since the beginning of the Phase to Be trial, and we're delighted to welcome him in a more active and full-time role. Dr. Danielle Schlosser joined us from Verily Life Sciences, the sister company to Google, where she was the behavioral health lead, overseeing the launch of several products, including digital measurement capabilities and clinical care initiatives.

Dr. Daniel Schlosser joined US from Verily Life Sciences, the sister company to Google, where she was behavioral health lead overseeing the launch of several products, including digital measurement capabilities and clinical care initiatives. Danielle is now leading our therapy research and training team her clinical and digital innovation experience will accelerate on.

Unknown Executive: Danielle is now leading our therapy research and training team. Her clinical and digital innovation experience will accelerate our work as we move toward phase three and adds to the tremendous strength we are building in our digital team. Our work is in developing new models of care with psychedelic therapies, but our focus is firmly on mental health and transforming mental health care for patients. As we lead in the science, so must we lead in trying to eliminate the stigma associated with mental health illness.

Our work as we move toward phase three and adds to the tremendous strength, we are building in our digital team.

Our workers and developing new models of care with psychedelic therapies, but our focus is firmly on mental health and transforming mental health care for patients as we lead from the science Soma, we lead in trying to eliminate the stigma associated with mental health illness with this in mind. We recently launched a podcast called everyone has a story talking about mental health.

Unknown Executive: With this in mind, we recently launched a podcast called Everyone Has a Story Talking About Mental Health. The podcast features guests who talk about their mental health journeys and discuss critical issues in mental health care. Opening up a dialogue about mental health challenges inspires others to do the same. The first two episodes are available through the Compass website or any podcast app. Do listen and tell us what you think.

The podcast features guests, who talk about their mental health journeys and discuss critical issues in mental health care to open up a dialog about mental health challenges inspire others to do the same.

The first two episodes are available through the compass website or any podcast app do listen and tell us what you think.

Finally, a word on patents, we continue to build a strong IP portfolio with eight granted patents now in the U S. The U K, Germany, and Hong Kong. We recently received a non binding opinion from the U K I P office questioning aspects of some of the claims in one of our granted U K patents.

Unknown Executive: Finally, a word on Pat. We continue to build a strong IP portfolio with eight granted patents now in the U.S., the UK, Germany, and Hong Kong. We recently received a non-binding opinion from the UK IP office questioning aspects of some of the claims in one of our granted UK patents. The opinion came in response to a request for an opinion from a third party, and it's just that, a non-binding opinion. The opinion does not invalidate our patent or any of its claims, and we remain confident in the strength and defensibility of our patent. With that, I will now hand over to Pierce, who will give you an update on our financial results for the quarter. Thank you, George.

The opinion came in response to a request for opinion from a third party and it is just that a non binding opinion. The opinion does not invalidate our patent or any of its claims and we remain confident in the strength and defensibility of our patents.

With that I will now hand over to Pierce, who will give you an update of our financial results for the quarter.

Thank you George.

Unknown Executive: The company continues to maintain a strong financial position with cash and cash equivalents of $3.3 million at June 30th, 2021, compared with $190.90.20 million at December 31st, 2020. This includes the proceeds from our recent additional raise of $165.6 million before underwriter fees and expenses, which included the full exercise of the underwrite adoption to purchase additional ADFs or greenbacks. This is expected to fund operations into 2024. I will now recap our financial results for the three and six months ended June 30th, 2021.

Company continues to maintain a strong financial position with cash and cash equivalents of $316.3 million at June 30 of 2021.

Pad with $190.3 million at December 31, 2020, when we complete the proceeds while recent additional rate of 165.

In dollars per core underwriting and expense, which.

Which included the pool that coupon the underwrite adoptions approaches additional ABS or.

Green G.

This is expected to fund operations into 2020 pool.

I will now recap on financial results from the three and six months ended June 30 of 2021.

Unknown Executive: The loss from operations for the three months ended June 30th, 2021 amounted to $19.5 million, compared with $17.7 million for the prior year period. The loss from operations includes non-cash, share-based compensation of spend of $1.9 million for the three months ended June 30th, 2021, compared with $9.7 million non-cash share-based compensation in the prior period. Research and development expenses for the second quarter of 2021 amount to $11.4 million, an increase of $4.6 million compared with the second quarter of 2020.

The loss from operations from the three months ended June 32021 amounted to $19.5 million.

The $17.7 million for the prior year period.

The loss from operations include non cash share based compensation expenses of $1.9 million on the three months ended June 32020.

One had with <unk>.

$9.7 million noncash share based compensation in the price.

Research and development expenses for the second quarter, 2021, and back to $11.4 million, an increase of $4.6 million compared with the second quarter.

This increase in research and development expenses compared with the prior year period, primarily attributable to.

Unknown Executive: This increase in research and development expenses compared with the prior year period was primarily attributable to First, an increase of $4.7 million in development expenses, which principally related to an increase of $3.8 million in clinical trial expenses and an increase of $0.6 million in pre-clinical studies, supporting our investigational Comp 360 Scyllaibytherap therapy development. Firstly, an increase of $1.4 million in personal mail expenses, mainly for digital and clinical purposes; thirdly, a decrease of $1.7 million in non-cash share-based compensation; and, fourthly, an increase of $0.2 million in other expenses, which was primarily related to increases in consulting and regulatory compliance.

An increase of $4.7 million in development expenses was principally related to an increase of $3.8 million in clinical trial expenses and an increase of $6 million from preclinical studies supporting our investigational compounds.

The net five and therapy development.

Secondly, an increase of $1.4 million in personnel expenses, mainly in digital.

Thirdly, a decrease of $1.7 million in noncash share based compensation.

And hopefully an increase of $2 million in other expenses, which was primarily related to increases in consulting and regulatory compliance.

General and administrative expenses, the great point $2 million from the second quarter total 21, compared with $11 million the same day rate but.

Unknown Executive: General and administrative of $8.2 million for the second quarter of 2021 compared with $11 million for the same period in 2020. The decrease of $2.8 million in general and administrative expenses compared to the prior year period is primarily attributable to Firstly, an increase of $1.9 million in personnel costs, primarily additional personnel and general administrative and commercial functions to support our great initiatives, including our transition to a public company. Secondly, a decrease of $6.1 million in non-cash share-based compensation.

The decrease of $2.8 million general and administrative expenses.

Net prior year period, primarily attributable to book.

An increase of $1.9 million on medical.

Primarily additional personnel and general administrative muscle function without growth.

<unk> transitioned to a public company.

Secondly, a decrease of $6.1 million in noncash share based compensation.

Revenue decreased the milk on $5 million in legal and professional fees primarily related to expenses of.

Unknown Executive: Thirdly, a decrease of $0.5 million in legal and professional fees, primarily related to expenses associated with operating as a public company, and, fortunately, an increase of $2 million in facilities and other expenses, including rent, depreciation, and insurance.

It can go crazy with the public company on Courtney and increase of $2 million in facilities and other expenses.

Moving rent depreciation and insurance.

Other income from the second quarter, 'twenty, 'twenty $1 million to $2 million compared with other income of 1.5 dollars per day.

Unknown Executive: Other income for the second quarter of 2021 amounts to 2 million.

Unknown Executive: amounts to $2 million compared with other income of $1.5 million for the corresponding period in 2020. The increase in other income amounting to $0.5 million compared with the prior year was primarily attributable to, firstly, a net movement of minus $1.6 million in foreign exchange, arising from a loss on foreign exchange of $0.6 million in the second quarter of 2021, compared with a gain on foreign exchange of $1 million in the second quarter of 2020.

Corresponding period.

The increase in other income momentum no point $5 million compared with the prior year was primarily attributable to firstly, a net move with the minus $1.6 million in foreign exchange arising from a loss on foreign exchange of <unk> $6 million second quarter 2021, compared with a gain on foreign exchange.

$1 billion in the second quarter of 2020.

Secondly in that moving to perhaps no point $7 million on the fair value.

Unknown Executive: Secondly, a net movement of plus $0.7 million on the fair value of convertible notes, reflecting an amount of nil dollars in the second quarter of 2021, compared with a loss of $0.7 million in the corresponding period of 2020. And thirdly, an increase of $1.4 million in other income and expenses, which was primarily related to an increase in the income from the R&D tax credit, which rose to $2.6 million in the second quarter of 2021, compared with $1 million in the second quarter of 2020.

Well notes, reflecting on the mountain mill in the second quarter 2021, compared with a loss of <unk> $7 million in the corresponding period of 2020.

And thirdly, an increase of $1.4 million and other income and expenses, which was primarily related to an increase from income from R&D tax credit, which was the $2.6 million from the second quarter of 2021, compared with $1 million in the second quarter of 2020.

The net book with $17.5 million on 44 cents.

Unknown Executive: The net loss was $17.5 million, or 44 cents a share, for the three months ended June 30th, 2021, compared with a net loss of $16.2 million, or $1.65 a share, during the same period in 2020. Roskram's operations for the six months ended June 30 of 2021 amounted to $33.1 million, compared with $26.4 million for the prior year period. The loss from operations included non-cash share-based compensation expense of $3.6 million for the six months ended June 30 in 2021, compared with $11.4 million in non-cash share-based compensation in the prior period.

Per share from the three months ended June 32021.

Compared with a net loss of $16.2 million or $1.65 loss per share during the same period in 2020.

The loss from operations. The six months ended June 30 of 2021 day.

$33.1 million compared with $26.4 million for the prior year period.

The loss from operations includes a noncash share based compensation expense of $3.6 million for the six months ended June 30 of 2021, compared with $11.4 million noncash share based compensation and the price pyramid.

The net loss of $32 million or 79 cents loss per share for the six months ended June 32021.

Unknown Executive: The net loss was $30.2 million or 79 cents a loss per share for the six months ending Sunday, June 30th, 2021, compared with a net loss of $24.8 million or $2.61 a loss per share during the corresponding period in 2020, but that's to hand you back to George.

Compared with a net loss of $24.8 million or $2.61 loss per share during the corresponding period in 2020.

With that I'll hand, you back to George Thank you. Thank.

Unknown Executive: Thank you. Thank you, fellow learners. We continue to make steady progress toward our goal of accelerating patient access to evidence-based innovation and mental health care to enable people to live happier and healthier lives. To achieve this bold mission, it takes leadership. And to us, this means building the best team and partnering with the best people, advancing the pipeline, executing on clinical trials, developing digital capabilities, ensuring a favorable commercial landscape, and above all, improving the patient experience and delivering better patient outcomes.

Thank you peers, we continue to make steady progress toward our goal of accelerating patient access to evidence based innovation in mental health care to enable people to live happier healthier lives to achieve this bold mission takes leadership and to US. This means building the best team and partnering with the best people advancing the pipeline.

<unk> on clinical trials, developing digital capabilities, ensuring a favorable commercial landscape and above all improving the patient experience and delivering better patient outcomes. Thank.

Operator: Thank you for your time today and your interest in Compass. We will now open the line for questions. Operator? As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is now open.

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

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.

On standby, while we compile the Q&A roster.

Our first question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is now open.

Charles Cliff Duncan: Yeah, good morning, George and team. Thank you.

Yeah.

George and team. Thank you for taking our questions and congratulations on great quarter of progress and the enrollment update.

Unknown Executive: And team, thank you for taking our questions and congratulations on a great quarter of progress in the enrollment update. I had a question, though, on phase 2B and how to interpret the results. I guess, kind of wondering since this is such a different paradigm, how would you compare to standard of care and perhaps maybe give a little color on what would be a win? Is it statistical significance of mean madras changes at three weeks, or would you be held by response rates and durability for a relatively large percentage of patients relative to standard of care? Hi Taz.

Question, though on that phase to be and how to interpret the.

Results I guess.

Kind of wondering since this is such a different paradigm, how would you compare it to standard of care and perhaps maybe a little color on.

What would be a win it is it.

Statistical significance.

Interest changes at three weeks or would you be compelled by response rates and durability for a relatively large percentage of patients relative to standard of care.

Hi, Charles Thanks, so much for a great questions as usual.

Unknown Executive: Thanks so much for a great question, as usual. I think that our focus on looking at phase two is really helping inform us and the field in general about the durability of response, and the extent of response for whom. And so our goal is to really understand in this study, the three-week madras, but also look at the durability. These are things that have never been looked at before in such a large systematic way.

I think that our focus on looking at phase two is really a help inform us and the field in general about the durability of response, the extent of response for whom and so our goal is to really be understanding in this study the three week Madras, but also.

So looking at the durability. These are things that have never been looked at before and such sports systematic study. So our real core focus here is to learn on both durability and the extent of difference between a 10 milligram on a 25 milligram remember the whole purpose of this study is to really define a dose to go into.

Unknown Executive: study. So our real core focus here is to learn both durability and the extent of the difference between a 10 milligram and a 25 milligram. Remember, the whole purpose of this study is to really define a dose to go into a pivotal program, and so that's really where our focus will be and also to identify the patients who are most likely to respond, again, as part of our responsible science development process. Did that answer your question?

<unk>, a pivotal program and so that's really where our focus will be and also to identify the patients who are most likely to respond again as part of our responsible science development process.

Did that answer your question.

Yes that makes sense to me it is phase two b no debt.

Charles Cliff Duncan: Yeah.

Charles Cliff Duncan: This is Phase 2B, not a pivotal program. But regarding that pivotal program, I guess I'm going to push the fast-word button here and ask you to speculate on the future. And that is regarding, you know, given the unmet need in TRD, and the fact that this is a pretty large Phase 2B, could you imagine having to conduct only one Phase 3 study, or are you planning, do you believe it's prudent to plan on two-phase? phase three studies.

On a pivotal program.

Regarding that pivotal program I guess on <unk>.

Your password button here and ask sure speculate on the teacher in that and that is regarding you know given given the unmet need in CRD. In fact that this is a pretty large phase two b could you imagine having to conduct on like one phase III study or are you planning do you believe it is.

Prudent to plan on two phase phase III studies.

Well I think you're spot on in terms of this is a different type of program. So whilst I think there might be a series of results coming out of our phase two that could lead us to treat this phase to be as a pivotal and then have one additional pivotal I'm not sure. It's prudent from a patient perspective, where we really do need to make.

Unknown Executive: Well, I think they're spot on in terms of this is a different type of program. And so whilst I think there might be a series of results coming out of our phase two that could lead us to treat this phase 2 as a pivotal and then have one additional pivotal, I'm not sure it's prudent from a patient perspective where we really do need to make sure that we have enough trained therapists, we understand how to deliver this at scale, and all of that would be really teed up by a fairly expansive phase three program.

Sure that we have enough trained therapists, we understand how to deliver this at scale and all of that would be really teed up by a fairly expansive phase III program. So I think we know we're well funded for that program and I think that this is a really.

Unknown Executive: So I think we know we're well funded for that program, and I think that this is really kind of our focus: to do the science, understand who responds, and also to prepare the commercial environment. So, you know, again, we can't foresee the future in terms of the results of the study. However, I think our goal is to proceed as quickly as possible into phase three and to have that program be a really good, important stepping stone to patient availability. Okay, I'm assuming the data work. Yeah, assuming the data is positive, I'm sure you'll be able to interpret it.

Kind of our focus is to do the science understand who responds and also to prepare the commercial environment. So.

You know again, we can't foresee the future in terms of the results of the study. However, I think our goal is to proceed as quickly as possible into phase three and to have that program be.

On a really good important stepping stones stone to patient availability.

Okay, Yeah, I'm, assuming the data work you bet.

Yes, assuming the data is positive I'm sure you'll be able to interpret it last question from appears though relative to R&D expenses I think it came in at $11 million or so a little bit higher than that which I think is a good thing because it seems like youre doing a lot of work with 360, but I guess I'm wondering.

Unknown Executive: Last question for peers, though, relative to R&D expense, I think it came in at 11 million or so, a little bit higher than fax, which I think is a good thing, like you're doing a lot of work with 360. But I guess I'm wondering, just a little housekeeping, what would you set as kind of a run rate here for quarterly R&D? Yeah, so thanks, Jess. We don't guide to projected venture, and in particular one of the things, it's obviously going to be quite volatile as we complete phase 2b by the end of this year, and then we're going to see a significant ramp up, assuming that the end of phase two we can go as well with FTA, and we start on phase 3 in 2022.

Just a little housekeeping, what we choose.

Kind of a run rate here for our quarterly R&D expenses.

Yeah, Thanks debt we.

We don't guide to.

Projected spend share in particular, one of the thing at Compass.

Is it going to be.

Quite volatile as we complete the phase two b com.

By the end of this year.

And then.

Yeah, no ramp up assuming that they can we can get as well with FDA.

On page three in 2022.

Unknown Executive: Obviously, also, we're looking to start, as we've said, our own sponsored studies in a couple of other indications in Phase 2A within the three months. I think there will continue to be some volatility in our R&D quarterly. Okay, thanks for taking all the questions. Thanks, Cass. Thank you. Our next question comes from the line of Ritu Boral from Cowan. Your line is now open.

The sales.

Thoughts as we've said.

On our income from studies in a couple of other indications in phase Iia study.

In the coming months.

No.

I think the debt continues.

<unk> be some volatility in our R&D quarterly average.

Okay. Thanks for taking on all the questions.

Thanks Charles.

Thank you. Our next question comes from the line of Richard morale from Cowen. Your line is now open.

Good morning, guys. Thanks for thanks.

Ritu Subhalaksmi Baral: Good morning, guys. Thanks for taking the question. Just some follow-up on some of Charles' questions. George, can you please focus on the powering and the statistical plan as it stands right now for the primary analysis, especially between the two doses? Like, is it 25 versus 1 milligram and 10 versus 1 milligram, or is it sort of pooled 25 plus 10 activity versus 1 milligram?

Thanks for taking the question actually.

Actually a follow up on.

Charles's question.

George it's true.

Vault <unk>.

On the statistical plan as it stands right now.

For the primary analysis, especially between the two doses like is it 25 versus one milligram and 10 versus one milligram or is it sort of pool that 25, plus 10 activity versus what milligram and then.

Unknown Executive: And then, as has been the case for other trials in a number of novel antidepressants, there's a lot of focus on your 12-week efficacy endpoint. Can you help us frame how we should be looking at the efficacy at 12 weeks or earlier, because you mentioned multiple time points, that 12-week time point versus the primary three-week primary impact?

As has been the case.

Or other.

Other trials novel depressed entered the preference Theres a lot of focus on your 12 week efficacy endpoint can you help us frame, how we should be looking at the efficacy at 12 weeks or or earlier could you mentioned multiple time points that 12 week time point versus the primary three week.

The primary endpoint.

Sure.

Ritu Subhalaksmi Baral: Sure. So again, the statistics. I should just note that the way we developed this protocol was in close collaboration with the people who developed Stardee, which is the largest TRD trial. So those were the team that we brought together to help us create this and reviewed the protocol with the regulators on both sides of the Atlantic and have had a single protocol across 10 countries and 22 sites. As part of that, we did choose to look at 25, then to look at 10 versus 1.

So again this the statistical.

Just note that the way we develop this protocol was in close collaboration with the people who developed the star D, which is the largest T. R. D trial. So those were the team that we brought together to help us create this and reviewed the protocol with the.

Regulators on both sides of the Atlantic and have had a single protocol against across 10 countries in 22 sites as part of that we did choose to have US look at twenty-five then to look at 10 versus one.

Unknown Executive: So this is a progressive hierarchical assessment. And we're very hardened by the New England Journal data coming out, a different population, but again, an MDD population where we saw when the one milligram was given in conjunction with the dosing of a leading antidepressant, we still saw separation between 25 and 1. So we're quite excited about the possibility that we see in this design of looking at 25 versus 1 and 10 versus 1. Remember, the purpose here is to look first at the safest and tolerable dose, which leads to the greatest impact on Madras, and then also to look at durability.

So it is a progressive hierarchical assessments.

And we're very heartened by the New England Journal of.

Data coming out of different population, but again a M. D. G population, where we saw when the one milligram was given in conjunction with the dosing of the leading anti depressant, we still saw.

Separation between 25 and one so we're quite excited about the possibility that we see in this design if youre looking at 25 versus 110 versus one remember the purpose here is to look at first the most safe and tolerable dose, which leads to the greatest impact on mattress and then also to look on durability.

Unknown Executive: To your point on the 12 weeks, remember, this is a single dose. And what we're really looking at is, what is, what is? durability.

On to your point on the 12 weeks.

Remember this is a single dose and what we're really looking at is what is the durability. We've seen a fair amount of variability on the smaller studies. So what we're really trying to do is to understand durability for whom and that's why we're looking at are in.

Unknown Executive: We've seen a fair amount of variability in the smaller studies, so what we're really trying to do is understand durability for whom. And that's why we're looking at, in discussion with regulators, we agreed to look at one week, two weeks, three weeks, six weeks, nine weeks, and 12 weeks, with our secondary coming in at 12 and 12, and looking at the durability of the response. I hope that answers the question. It does. Thank you. Thanks a lot for the color.

In discussion with regulators, we agreed to look at a one week two week three week six week nine week and 12 week with our secondary coming in at 12.

Looking at the durability of the response I hope that answers the question.

Hey, guys. Thank you. Thanks, a lot for the color and then.

Ritu Subhalaksmi Baral: And then I did want to ask about something that you mentioned in your prepared remarks, the new indications that you're thinking about. I believe you mentioned anorexia, bipolar disorder, and severe TRD as investigator-sponsored studies. But sort of as you think about addiction and these indications, what does the company, from a strategic perspective, a funding perspective, an IP perspective, consider the most promising additional indication? So at this point, you know, what our True North encompasses is very simple.

I did want to ask about something that you mentioned on this in your prepared remarks.

New indications that you're thinking about I believe.

I had mentioned.

Anorexia bipolar and severe TRT as investigator sponsored studies, but sort of as you think about.

Addiction and deepen.

Mission.

What does the company.

From a strategic perspective.

Funding perspective on IP perspective concern on those promising additional indication.

So at this point you know what our true north accomplishes its very simple were looking at areas of high unmet need that exists in patient populations that are simply not addressing being addressed effectively by existing treatments and so when you look at things like PTSD anorexia.

Unknown Executive: We're looking at areas of high unmet need that exist in patient populations that are simply not being addressed effectively by existing treatments. And so when you look at things like PTSD, anorexia, severe TRD, these are all targets. We're also obviously doing some work that we've disclosed, Shepard Pratt, moving at bipolar too. So I think our.

Severe T. R. J. These are all targets. We're also obviously doing some work that we've disclosed shepherd, perhaps looking at bipolar too.

Unknown Executive: Our strategy is to generate signals. We have support for pre-clinical work in all of these areas. And our goal is to simply be driven by a huge unmet patient need and where there's scientific rationale for us to approach these areas. And we'll be disclosing more as we move forward around what those specific areas are that will be part of our sponsored research program later in the year. Got it. Looking forward to that. Thanks, George.

So I think our strategy is to generate signals, we have support in preclinical work and all of these areas on our goal is to simply be driven by a huge unmet patient need and where there is a scientific rationale for us to approach these areas and we'll be disclosing more as we move forward around what those specific areas are.

That will be part of our sponsored research program later in the year.

Got it looking forward to that thanks George.

Thank you.

Ritu Subhalaksmi Baral: Thank you. Thank you. Our next question comes from the line of Josh Schwimmer from Evercore ISI. Your line is now open.

Thank you. Our next question comes from the line of Josh Schwimmer from Evercore ISI. Your line is now open.

Great. Thanks for taking the questions maybe to follow up on the question Ritu was asking about some of the add on.

Josh Schwimmer: Thanks for taking the questions. Maybe to follow up on the question where Tua was asking about some of the additional indications you may explore, do you expect that to pursue development with Comp 360, or would you wait to see if there's another molecule in the portfolio? That may be better suited for those settings, and then separately, you can talk a little bit about your efforts to support capacity expansion in treatment centers to accommodate the eventual demand for siloside. Sure.

Additional indications you may explore do you expect debt.

Pursue development with Cop 360, or would you wait to see if there is another molecule in the portfolio debt.

May be better suited for those for those settings and then separately.

Can talk a little bit about your efforts to support capacity expansion in treatment centers to accommodate the eventual demand have come from.

Tyler Seidman therapy. Thanks.

Sure.

So with regard to the first question I think that what drives US again is this focus on unmet need and we're going to.

Unknown Executive: So with regard to the first question, I think that what drives us, again, is this focus on unmet need. And we're going to actually be progressing wherever we see that as a possibility. And so that's what's been driving the focus. I think because you asked a two-part question, I'd like you to go back and make sure I've answered the first part, Josh, knowing that you have a number of... psychedelic compounds in the portfolio. Oh, I got it.

Actually be.

Progressing wherever we see that as a possibility.

So that's what's been driving the focus.

I think because you did a two part question I'd like you to go back and make sure I answered the first part.

Josh.

Yes.

Knowing that you have a number of.

Josh Schwimmer: Thank you. Yes, so thank you. So because of the level of unmet need, what drove us from the very beginning is to make sure that we can get something to patients that will help. And we have indications that psilocybin can help these patients, whether there's a more optimized approach downstream, that's a different question.

Of psychedelic compounds from the portfolio Oh got it. Thank you yeah. So thank you. So I think our our whole focus right is because of the level of unmet need what drove us from the very beginning is to make sure that we can get something to patients that will help.

And we have indication that psilocybin can help these patients whether there are some more optimized approach downstream. That's a different question, but right now we'll be exploring come through 60, because it will allow us to have the fastest access.

Unknown Executive: But right now, we'll be exploring Com 360 because it will allow us to have the fastest access for patients. And if we can improve the lives of patients, that's what we're here to do. So starting with Com 360, and then obviously, we have other things in development that we've shared coming out of our Discovery Center with different characteristics. But right now, Com 360 is the one.

For patients and if we can improve the lives of patients. That's what we're here to do so starting with <unk> 360, and then obviously we have other things in development that we've shared coming out of our discovery Center.

With different characteristics, but right now come through 60 of the one in terms of capacity building.

Unknown Executive: In terms of capacity building, it's very straightforward. As I commented about our phase three program, our goal is to be building out capacity through an expanded phase three program, as well as through exploring other indications. So that helps us build therapists. It helps us build capability.

It's very straightforward as I commented on our phase III program. Our goal is to be building out capacity through an expanded phase III program as well as exploring other indications so that helps us build therapists that helps us go capability.

And as we share more about our phase III infrastructure after phase two into phase two meeting.

Unknown Executive: And as we share more about our phase three infrastructure after our phase two end of phase two meeting, I think that'll become clear, but it's very much a focus of ours to make sure we have capacity so we don't end up having promising results but then insufficient capacity to actually improve the lives of patients. So thank you.

I think that'll become clear, but it's very much a focus of ours to make sure we have capacity and so we don't end up having promising results, but then the insufficient capacity to actually improve the lives of patients.

Thank you.

Unknown Executive: Thank you. Thank you. Our next question comes from the line of Nina Vitrudeau-Gar from City. Your line is now open.

Thank you.

Thank you. Our next question comes from the line of Neena <unk> Garg from Citi. Your line is now open.

Hey, guys. Thanks for taking my questions.

Nina Vitrudeau-Gar: Hey guys, thanks for taking my questions. So my first question is just around, I'm just curious if you can talk a little bit about how you're ensuring that patients are coming in for their follow-up visits to kind of ensure that we have a robust data set at that 12-week time point, and anything you can share as well on kind of, you know, how dropouts or patients who are lost to follow-up may be handled in the analysis.

So first question is just around.

I'm just curious if you can talk a little bit about how you're ensuring kind of that patients are coming in for their follow up visits to kind of ensure that we have a robust data set at that 12 week time point.

And anything you can share as well on kind of how dropouts are patients who are lost to follow on may be handled in the analysis and then my second question is just around some of the kind of discovery on formulation work that you're doing if you could talk a little bit about some of the key characteristics that you are looking for in some of these next generation.

Nina Vitrudeau-Gar: And then my second question is just around some of the kind of discovery and formulation and work that you're doing. If you could talk a little bit about some of the key characteristics that you are looking for in some of these next-generation molecules in terms of, you know, kind of onset of action, durability of the psychedelic experience, intensity of the experience, et cetera, that would be great.

Molecules in terms of kind of onset of action durability of the psychedelic experience intensity of the experience.

Great. Thanks.

Unknown Executive: I'll take the first question and hand it off to my colleague Lars for the second. In terms of follow-up visits and compliance, we have an unusual aspect here where we have a single dose that's provided to patients, and the follow-up has actually been quite effective. With COVID, we actually moved to quite a bit of that follow-up being conducted remotely, again, because there was a single dose provided.

I'll take the first question on hand, it off to my colleague, Florida for the second.

In terms of follow up visits and compliance we have a unusual aspect here, where we have a single dose that's provided to patients.

And a follow up has actually.

<unk> been quite effective with Covid, we actually moved to quite a bit of a follow up being conducted remotely.

Again, because there was a single dose provided.

Unknown Executive: So we don't anticipate that there will be a lot of issues relative to compliance, either in the trial or in the real world, which I think is incredibly important given the unmet need. So that's how we'll be doing that. We have not disclosed how we'll be handling some of the other aspects. So we will do that in the future in terms of loss to follow-up, et cetera. Lars, would you like to take the... On your, yeah, absolutely, your third question about our discovery work, so... As you mentioned, indeed, we're developing novel psychedelic and psychedelic-like compounds, and we're having several goals with that.

So we don't anticipate that there will be a.

Lot of issues relative to compliance either on the trial or in the real world, which I think is incredibly important given the unmet need.

So that's how we'll be doing that we have not disclosed how will it be canceling some of the other aspects. So we will do that in the future in terms of lots of follow up et cetera.

Largely jeweler to take on on your yeah, absolutely on your on your third question.

On our discovery work.

No.

As he mentioned indeed, we are developing novel psychedelic and secondary like com.

Compounds.

And were having several goals with that I think the overarching goal is actually to answer a scientific question.

Unknown Executive: I think the overarching goal is actually to answer a scientific question. As you know, there's a lot of enthusiasm in the field, but we need to caution everyone that we do not know how short an experience can be while still maintaining durable antidepressant effects. Because all the work over the past 20 years and a lot of the work in the 1950s, 60s, 70s, and 80s has been done with long-duration psychedelic compounds such as psilocybin, LFD, and maleic acid, of which psilocybin is the shortest.

As you know, there's a lot of enthusiasm.

But we need to caution.

Everyone that we do not know how short and experience can be whilst still maintaining durable anti depressant effect because all the work over the past 20 years and relative to work in the 1950.60, Seventy's and Eighty's has been done with long duration secondary compounds, such as silos, Simon and SDN mescaline.

Which segment is the shortest.

Unknown Executive: So we don't know if a significantly reduced experience might convey the same patient benefits. Therefore, we're creating different novel molecules that will have different durations from, I think, at the lowest end, potentially half an hour for an entire experience, all the way up to four hours.

So we don't know at a significantly reduced experience might convey the same patient benefits. Therefore, we're trading defend them.

Novel molecules that will have different durations from.

I think at the lowest end from potentially half an hour.

<unk> four and anti experience all the way up to four hours.

Lars: And then eventually, we need to run mechanistic trials in the form of phase zero trials to see if you can pick up typical signatures in terms of physiologic changes in human subjects that let us infer antidepressant and anxiytic benefits in patients. In terms of other properties we're looking at, the core target for us is the 5HT2A receptor, and to some extent, the 1A receptor. However, there are other receptors that modulate the experience and work in tandem in the serotonin system, such as, for example, the 2C receptor that's based on agonism, properties of molecules that can cause slight anxiety changes.

And then eventually we need to run a mechanistic trials in the formal phase zero trials to see if we can pick up typically signatures in terms of physiology.

So the allergy changes in human subjects that led us in for <unk>.

Antidepressant anxiolytic benefits in <unk>.

Patients in terms of other properties were looking at.

At the core target for US is the five <unk> receptor to some extent the one a receptor.

On the receptor that modulate the experience and work intend them.

In the serotonin system such as for example, the two C receptor. That's based on agonism properties of molecules can cause slight anxiety changes, so what Mike want to modulate activity of debt receptor, depending on the indication being treated.

Lars: One might want to modulate activity at that receptor, depending on the indication being treated. And then there's also the risk of 5H2B binding. There's a lot of, I would say, enthusiasm for the idea of microdosing and running clinical trials with microdoses. I think we need to caution everyone not to do that. LSD is most widely used for that purpose. LSD binds quite strongly to the 5HT2B receptor, and it's well understood that drugs like St. Fleurman that bind to the to B receptor at chronic dosing can lead to cardiovascular problems in terms of heart valve thickening, which can eventually lead to a heart attack.

And then there's also the risk of <unk>.

H T to be binding them, there's a lot of.

I would say.

Through the Hasnt on.

The idea of micro dosing in running clinical trials with micro dosing I think we need to caution everyone to do that LST is most widely used for that purpose.

And as Steve binds quite strongly to the <unk> receptor and it's well understood that trucks like fenfluramine that bind to the <unk> receptor at chronic dosing can lead to.

Cardiovascular problems in terms of heart valve thickening, which can eventually need to to a heart attack. Therefore, if one wanted to explore a chronic dosing regime, one would need to for example, improve to a agonism over to be agonism. On these are some of the elements where we're at.

Lars: Therefore, if one wanted to explore a chronic dosing regime, one would need to, for example, improve 2A agonism over to B agonism. And these are some of the elements we're exploring. And then the goal is to move them very quickly through toxicology studies and basic preclinical screening and then do a lot of the mechanistic work in humans because, obviously, experience matters. And that's the last thing I'm going to say. Some of these very short acting triptamine-like compounds need full dissociation.

Exploring.

And then the goal is to move them very quickly through the toxicology studies and basic preclinical screening and then to a lot of the mechanistic work in humans, because obviously the experience matters I mean, that's the last thing I'm going to say some of these very short.

Acting at trip to midnight compounds need to full dissociation.

Lars: Where the patient doesn't have the ability to actually process deep-booted psychological issues, as happens with psilocybin. We believe that in itself has a strong therapeutic character that's worthwhile exploring and researching, and therefore we try to preserve some of these elements so that the patient actually has sufficient time in the experience to work through personal problems. We believe that this very strong dissociation might actually be traumatizing for patients. Overall, the goal is to be in the clinic with the first three to five molecules within the next 18 to 24 months, and then follow on with molecules in the years thereafter.

Where the patient doesn't have the ability to actually process deep rooted psychological issues as happens with Simon.

We believe that in itself has a strong therapeutic character.

Worthwhile exploring in researching and therefore, we try to preserve some of these elements that the patient actually has sufficient time in the experience to work through that.

Personal problems.

We believe that actually this very strong association might be.

Traumatizing to patient.

Overall the goal is to be in the clinic with the first three to five molecules within the next 18 to 24 months.

Then follow on with molecules in the years thereafter.

Perfect. Thanks.

Thank you. Our next question comes from the line.

Operator: Thank you. Our next question comes from the line of Esther Hong from Beringberg. Your line is now open.

From.

Your line is now open.

Esther Hong: Hi, good morning, congratulations on the progress. A couple of questions. Do any of them have comorbidity, so other symptoms like other indications like social anxiety, and will there be an analysis of how Comp 316 may have improved? symptoms for something such as social anxiety on top of treatment resistant depression. We have been very focused at the highest, thank you. I think that at this point, we have very clearly focused all of our PIs on the recruitment of patients with depression, and treatment resistant depression is validated through medical records.

Hi, good morning, congratulations on the progress on a couple of questions. My first question is regarding the enrolled patients in the phase <unk> study do you have any of them have on.

Comorbidities or other symptoms like our other indications like especially in society.

Will there be an analysis of how comp from 16 they have improved.

Symptoms for something such especially anxiety on top up.

Treatment resistant depression.

We have been very focused on high answer thank you.

I think that at this point, we have very clearly focused all of our P eyes on the recruiting of.

Patients with <unk> and with depression in treatment resistant depression is validated through medical records quite often there is comorbid anxiety in terms of and we are using the ham a and assessing any impact on comorbid anxiety, we've seen that in other studies that it has been significantly.

Esther Hong: Quite often there is comorbid anxiety. In terms of, and we are using the HAMA to assess any impact on comorbid anxiety, we've seen that in other studies, that it has been significantly improved, that not only suppression improved at the active dose, but also anxiety. And again, over 70% of patients have this comorbidity. In terms of looking at other things, such as social anxiety, we haven't called that out specifically. But we will have the largest data set ever created in this area, and we'll be interrogating it very carefully to learn what we can about the patients who will benefit most and also to inform our future programs. Yeah, it seems like there could be a lot from this. And then just to follow up separately.

Improve that not only suppression improved an active dose but also <unk>.

Xiety and again over 70% of patients have this comorbidity in terms of looking at other things such as social anxiety.

Haven't called that out specifically.

But we will have the largest data set ever.

Created in this area on won't be interrogating it very carefully to learn what we can about the patients who will benefit most and also to inform our future program.

Yeah, It seems like that could be a lot from this dataset.

And then just a follow up separately. It's just so on the regarding the patent challenge in the UK with wondering if you could provide any additional details.

Unknown Executive: It's just, so on the Patent Challenge in the UK, I was wondering if you could provide any additional information. So the patent challenge was made to our, it comes from the same group who initiated the post-grant review of our first U.S. patent, and that challenge was dismissed on the merits in August 2020. This new challenge to one of the U.K. patents appears to repeat many of those arguments, and that was the case in prior unsuccessful challenges.

So the patent challenge was made two hour.

It was.

Comes from the same group, who initiated the post Grant review of our first U S patents on that challenge was dismissed on the merits in August 2020. This new challenge to one of the UK patents appears to repeat many of those arguments on that was in prior unsuccessful challenges.

Unknown Executive: And the art cited in the request has been considered by the U.S. Patent Office, and it's not challenged to be a barrier to patentability. So this particular challenge, again, was about the U.K. patent. It's a non-binding opinion from the U.K. intellectual property office questioning aspects of some of the claims in one of our U.K. patents. The opinion came in response to a request for an opinion from a third party, and it's just that it's a non-binding opinion.

And the art cited in the request has been considered by the U S. Patent office on it's not trying to be a barrier of patent ability. So this particular challenge again was on the U K patent its a non binding opinion from the UK intellectual property office questioning aspects of some of the claims in one of our UK patents the opinion.

Came in response from this request for opinion from a third party and its just that a non binding opinion and it doesn't invalidate our patent or any of its claims and we remain confident I think that this is just part of this environment and so we remain confident in the strength and defensibility of our patents on.

Unknown Executive: And it doesn't invalidate our patent or any of its claims. And we remain confident, I think, that this is just part of this environment. And so we remain confident in the strength and defense of our patents. And interestingly enough, while challenging some aspects of this opinion, it also supported others. And then, may I ask who the third party is? Is it the same as the group that challenged the patent in the U.S.?

Interestingly enough while challenging from aspect in this opinion had also supported others.

Got it and then.

Through the third party is is it the same stay on.

The group that challenge in the U S. That's my last question. Thank you, yes. It is.

Esther Hong: That's my last question. Thanks. Yes, it is. Okay, great, thanks. Yes. Thank you. Our next question comes from the line of Patrick Truccio from H.C. Wainwright. Your line is now open.

Okay, great. Thanks.

Yes.

Thank you. Our next question comes from the line of Patrick <unk> from H C. Wainwright. Your line is now open.

Patrick Ralph Trucchio: Hi, thanks. Good morning.

Hi, Thanks, good morning.

Patrick Ralph Trucchio: Just a couple of follow-up questions. I guess the first one is just that, you know, it appears that MDMA is on track for approval for PTSD in 2023. And with an understanding of the differences in mechanism, delivery, and indication, I'm wondering what learnings, if any, have emerged from the MDMA Phase 3 program that Compus could apply to its potential Phase 3T program or to other potential clinical trials in a Comp 360 program.

A couple of follow up questions I guess the first one is just you know it appears the MDMA is on track for approval on PTSD in 2023, and with the understanding of the differences in mechanism delivery an indication I'm wondering what learnings if any have emerged from the MDM a phase III program that compass could apply to its potential phase III <unk> program or to other.

Potential clinical trials on a comp $3.60 per program.

Lars: At this point, we are, go ahead, Lars, why don't you take that one? Yeah, no, I'm just to say, absolutely, you know, Patrick, we're really happy with the development. Maybe on a macro level, it's another great achievement in mental health, right? We see the rollout of erosemic ketamine clinics. We saw the improvements of spravato in treatment-resistant depression and suicidal ideation, and now MDMA is moving closer to approval with a phenomenal phase three result in chronic PTSD.

Yes at this point we are.

<unk> why don't you take that one.

Yeah and I'll just.

Hey.

Patrick rehab you with the development, maybe on a macro level.

It's another great achievement in mental health right.

We see and the rollout of a racemic ketamine kidney providers, we saw the proven sales <unk> in treatment resistant depression, or suicidal ideation, and now MDMA moving closer to approval with a phenomenal phase III presented in chronic PTSD.

Lars: I think what is outstanding about the remission rates in that study were north of 60%, the P value of 1 and 10,000, and it shows you what the potential of psychedelic therapies might be. What do we learn from it?

But.

But its outstanding debt.

The remission rates in this study, we're north of 60% of the P value of <unk> one in 10000.

And it shows you.

What the potential of psychedelic.

Therapies might it might be I think what did we learn from it.

Lars: I think one of the things that we are absolutely aware of is incorporating payer requests into our study designs. As you know, one of our core objectives is to make psilocybin therapy accessible to as many patients as possible that require full reimbursement. As you know, we've worked with payer systems both in Europe and North America since the early days of the company in order to make sure we're not only developing the data required for safety efficacy and approval but also for commercialization.

I think one.

One of the things that we.

We are absolutely aware of us.

Incorporating pay.

Payor requests each on a study designs and as you know one of our core objectives is to make satisfied in therapy and accessible to as many patients in need as possible that requires full reimbursement.

As you know we work with payer systems, both in Europe, and North America.

Since the early days of the company in order to make sure we're not only developing the data required for safety or efficacy is on approval.

So for commercialization I think that is something that we're learning from MD&A.

Lars: I think that is something that we're learning from MDMA, where you see that in these studies, it's a very therapy-heavy approach. We focused on the core elements for efficacy in our study. I think what we also achieved and learned is that we are able to reduce the number of therapists required. We reduced the number of therapists from two therapists per patient to one therapist per patient.

Where do you see that in these studies, it's a very had a.

Therapy heavy approach.

Focused on the core elements for efficacy in our study.

I think what we also achieved and learned this debt.

Able to reduce the number of therapists required.

Reduced the amount of therapy from two therapy for patient to one therapist for patients we believe debt as a scalable model. We're also looking at the merits of eventually simultaneous group administration and we have delivered great safety data in the face of one 4% to six participants at the same time.

Lars: We believe that this is a scalable model, and we're also looking at the merits of eventually simultaneous group administration. We have delivered great safety data in phase one for up to six participants at the same time. We're now involved in a study with patients under our IND for major depressive disorder in the United States and patients with a cancer diagnosis. Again, they were treating, We're running a group of four patients through preparation, the actual dosing day, and then the integration session in group four. That seems to be going really well.

We're now involved in the study with patients on <unk>.

And day in major depressive disorder.

In the United States in patients with a cancer diagnosis.

They were treating.

Uh huh.

Running most of four patients through preparation the extra dosing day and then the integration session in groups of four that seems to be going really well and so we're absolutely moving from that.

Lars: And so we're absolutely emerging from that. I think when you look at the numbers required for these astonishing phase three results, they only had 80 patients in that study. The second phase three has a similar number of patients. Obviously, we are running a very large phase-to-b study, and I think we're going to learn a lot from the data set and the analysis to decide just how large our phase three actually has to be. I hope this answers your question. Yeah.

I think when you look at the numbers required for this astonishing phase III results.

They only had 80 patients in that study.

The second phase III Hasnt similar patient number.

Obviously, we are running at very large phase II B study.

And I think we can learn a lot from the data certainty analysis too and then decide of how large off pace.

<unk> actually has to be I hope this answers your question.

Unknown Executive: Yeah, yeah, that's helpful. And then just, you know, in the press release, it highlighted hires in clinical science, regulatory affairs, clinical safety, quality, manufacturing, and preparation for phase three new compounds and additional indications. So I'm wondering if you can give us some additional details on these new hires and on those preparations that are underway for the phase three program and on the potential studies in the additional indications.

Yeah, Yeah. That's helpful. And then just you know on the press release.

Delighted hires in clinical science regulatory affairs clinical safety quality and manufacturing in preparation for phase III new compounds on additional indications. So I'm wondering if you can give us some additional details on these new hires and on those preparations that are underway for the phase III program add on my potential studies and additional indications.

Sure I think that our whole focus here is on world class talent and that continues.

Unknown Executive: Sure, I think that our whole focus here is on world-class talent, and that continues. So we have our new head of safety, clinical safety, comes with background from the FDA, psychiatrists, etc. Very, very strong background in drug development. Our head of quality, again, someone who's been leading in terms of how to design quality into the functioning of the entire organization. So we have hired all of these people at DEP level or above, and I think this is really about strengthening the ability to execute rapidly as we go into our studies.

So we have our new head of safety.

Clinical safety comes with backlog from the F D a psychiatrist et cetera.

Very very strong background in drug development.

Head of quality again, someone who has been leading in terms of how to design quality into the functioning of the entire organization.

So we have hired all of these people on GP level or above and I think this is really about how do we strengthen the ability to execute rapidly as we go into our studies when we look at tie on Danielle I think that our guide Goodwin coming in as our CMO speaks to our focus on academic rig.

Unknown Executive: When we look at Dye and Danielle, I think that Guy Goodwin coming in as our CMO speaks to our focus on academic rigor and the ability to have someone deeply, deeply respected in the area of depression, bipolar, etc., former chairman of Oxford to come and work with us is, I think it's critically important. Danielle brings kind of the whole focus of Verily and Google to us and how we think about therapy development.

<unk>.

And the ability to have someone deeply deeply worse.

Respected in that area of depression, bipolar et cetera.

On former chairman of Oxford to come and work with US I think it's critically important Danielle brings kind of the whole focus of generally on Google to us and how we think about therapy development remember, we're pulling all of these pieces together the digital day medicinal and the therapeutic and we need world class talent to do that.

Unknown Executive: Remember, we're pulling all of these pieces together, the digital, the medicinal, and the therapeutic. And we need world-class talent to do that in every area we're focused on. So really looking at how we define these new clinical care pathways for patients who are not served by existing ones. That's what the team is doing. is focused on. So I think hopefully that will give you a little bit more detail. And we'll be sharing a little bit more on everyone else's background, but we're now over 100 people, and it's been as full-time employees, and I think it's been really gratifying to see the team build. There really is no one like us in terms of that capability across the breadth of the project.

In every area, which we're focused on so really looking at how do we define these new critical care pathways for patients who are not served by existing months. That's what the team is focused on.

So I think hopefully that will give you a little bit more detail and will be.

Sure a little bit more on everyone else's.

Background, but we're now over 100 people and it's been as full time employees and I think it's been really gratifying just simple team build there really is no one like us in terms of that capability on the bracket that.

Unknown Executive: Yeah, and then just one quick follow-up on just Com 360 and TRD. I'm just wondering how soon after the Phase 2B top line data could you or would you expect the end of Phase 2 meeting? And what, from your perspective, would be the ideal outcome from that meeting?

Yeah, and then just just one quick follow up on just comp 360, <unk> I'm just I'm just wondering how soon after the phase <unk> top line data could you or would you expect the end of phase two meeting.

And what from your perspective would be the ideal outcome from that meeting.

Unknown Executive: You know, we've been reviewing our phase three program with regulators based on different scenarios for over a year now. And so our goal in the phase two thing is to bring all of the data to bear, not only at the phase two meeting, but all the safety data will be in additional studies we've done, and bring it to bear on the FDA. As you've gotten to know us, we're all about execution, so our goal is to do that as quickly as possible, but not faster. So we are all well prepared for that.

You know we've been reviewing our phase III programs with our regulators based on different scenarios for over a year now and so our goal on the phage thing is to bring all of the day to to bear on not only the phase two meeting, but all the safety data on additional studies we've done.

And bring it to bear to the FTA.

As you've gotten to know us we're all about execution. So our goal is to do that as quickly as possible, but not faster. So we are well prepared for that.

Unknown Executive: And our goal is to minimize, like any patient-oriented company, the time between the end of phase two and the start of phase three. We've also worked with the CRO, and we're developing our infrastructure for phase three again. So following the meeting with the FDA, which we'd expect to be early next year, certainly in the first quarter, that's where we're going to go and build upon to get to phase three as quickly as possible. Again, it's all about the data. These dates may change depending on what we learn from the data. That's why we're doing the study. That's why we're an evidence-based company.

And our goal is to minimize like any patient oriented company. The time between the end of phase II on the startup of our phase III.

Also worked with the CRO and you're developing our infrastructure for phase III again, so following the meeting with the FDA, which we would expect to be early next year a.

Certainly in the first quarter, that's where we're going to go on.

Built upon to get to phase III as quickly as possible again, it's all about the data. These data may change depending on what we learned in the data and that's why we're doing the study that's why we're an evidence based company.

Patrick Ralph Trucchio: Yep, terrific. Thank you very much.

Terrific. Thank you very much.

Operator: Thank you. Our next question comes from the line of Bert Haslitt from BTIG. Your line is now open.

Thank you. Our next question comes from the line of Bert Hazlett from <unk>. Your line is now from.

Bert Haslitt: Thank you, thank you for taking the time to answer the question and congratulations on the

Thank you. Thank you for taking the question and congratulations on the progress and look forward to the to be data coming.

Bert Haslitt: Congratulations on the progress. Look forward to the 2B data coming soon. Just with regard to the additional indications that you were mentioning, anorexia, PTSD, and others down the road, do you envision patients being managed similarly to TRD in that with regard to the preparation, the administration with therapist support, and then the integration afterwards?

In regard to the additional indications that you were mentioning anorexia PTSD and others done down the road.

Do you envision patients being managed similarly to CRD.

With regard to the preparation administration with therapy support and then the integration afterwards, you spoke to it a little bit earlier, but can there be on.

Unknown Executive: You spoke about it a little bit earlier, but can there be potentially group integration sessions or just any changes as you, any potential changes as you might consider additional indications and then one follow-up with regard to the patent? Would this discussion that you have, this non-binding opinion, have any effect on pending applications? Okay, so I think I'll start with the first question, and certainly Lars can weigh in on the IP issue as well after that.

Potentially group integration sessions or just any changes as you any potential changes as you might consider additional indications and then one follow up with regard to the patent.

With this discussion that you have this non binding opinion have any effect on the pending applications. Thank you.

Okay. So I think I'll start with the first question on certainly Lars can weigh on on VIP issue as well after that so.

Unknown Executive: So on the first question, you know, the reason we're doing these smaller studies with independent investigators and we'll be starting smaller sponsors to learn about what patients need broadly, we absolutely will have to prepare, we'll absolutely support people through the dosing session and the administration of psilocybin therapy and integration. What happens specifically in a patient population suffering with PTSD as opposed to with anorexia will obviously need to be calibrated.

On the first question you know the reason we're doing these smaller studies with independent investigators and we'll be starting smaller sponsored studies to learn about what the patients need broadly we absolutely will have to prepare will absolutely support people through the dosing session.

The administration of suicide on therapy.

And the integration what happened specifically in that patient population suffering with.

<unk> as opposed to with anorexia, we'll obviously need to be calibrated on that's really what we're doing it's part of the responsibility of the Daniela we'll have as we really look at how to take the broad structure and customize it for different patient populations working closely with our subject matter experts key opinion leaders in these.

Unknown Executive: And that's really what we're doing. It's part of the responsibility that Danielle will have is that we really look at how to take the broad structure and customize it for different patient populations, working closely with subject matter experts and key opinion leaders in these areas, as we're already starting in our IIS studies. So this is clearly a core program that will be optimized for those patients based on what we learn through working with external experts, as we have all along. I hope that answers that part of the question. Yes, it does, thanks.

Areas as we're already starting in our Iis studies. So this is currently a core program that will be then optimized for those patients based on what we learned through working with external experts as we have all along.

I hope that answers that part of the question Bert.

Yes. It does thanks, and then just regard to the patents and whether this might have any impact on pending applications.

Lars: And the disregard for patents and whether this might have any effect on pending applications. Again, I will turn that over to Lars and Lars, if you want to answer that question. Yeah, absolutely. Hi, Bird.

Again, its I will turn it over to Lars.

Lars if you want to answer that question.

Yes, absolutely.

Hybrid I hope you understand that we do not comment on ongoing patent prosecution.

Lars: I hope you understand that we do not comment on ongoing patent prosecution in detail. Of course, we're very confident in our strategy. We have several patent grants pending. We don't expect any major impact from the current non-binding challenge.

In detail of course, we're very confident in our strategy.

We have separate patent grants depending.

We don't expect any major impact from the current non binding challenge.

Bert Haslitt: Thank you very much. Thank you. Our next question comes from the line of Jason McCarthy from Maxim Group. Your line is now open.

Thank you very much.

Thank you. Our next question comes from the line of Jason Mccarthy from Maxim Group. Your line is now open.

Jason Mccarthy: Hi guys, a lot of questions and answers, but I want to go back to something, I think it was Josh's question about capacity. Can you talk about if there will be any role for third-party clinics in terms of acquiring or rolling them up to bring them under the Compass umbrella or be purely building out infrastructure on your own the way Compass sees fit? So, very clearly, we plan to work closely with delivery partners. We do not want to be a, given our mission, we certainly do not want to be a bottleneck to any kind of deployment.

Hi, guys a lot of questions asked and answered, but I want to go back to something I think from it.

His question about <unk>.

Capacity can you talk about if there'll be any role or third party clinics in terms of acquiring or rolling them up.

Bring them under the compass umbrella on the purely.

Building out infrastructure on your on the way competencies.

Yeah.

So just.

Very clearly we plan to work closely with delivery partners, we do not want to be a given our mission, we certainly don't want to be a bottleneck too.

Any kind of deployment, hence we wanted to have a vigorous group of partners to deliver the care.

Unknown Executive: Hence, we want to have a vigorous group of partners to deliver the care. Our goal is to work with those partners so that we can actually make the care better through our understanding of how that's progressing and ongoing data. I think that the, So that's critical to our strategy.

Our goal is to work with those partners. So that we can actually make the care better through our understanding of how that's progressing and are ongoing data I think that the.

So that's critical to our strategy, it's to be working with a vibrant group partners and I think this points to the need for a broad ecosystem, whether it's for MDMA, whether it is for.

Unknown Executive: It's to be working with a vibrant group of partners, and I think this points to the need for a broad ecosystem, whether it's for MDMA, whether it's for ketamine, and other administered care models in this new paradigm of clinical care for psychiatrists. So we expect to work vigorously and effectively with a whole group of partners. Great, thank you. And in terms of our future commercial plans, we cannot comment on that beyond making sure that we're never a bottleneck. Got it.

Ketamine other administered care models in this new paradigm of clinical care for psychiatry. So.

We expect to work vigorously on effectively with a whole group of partners.

Great. Thank you.

And in terms of our future commercial plans, we cannot comment on that.

Beyond making sure that we're never a bottleneck.

Jason Mccarthy: Thank you. Thank you. Our next question comes from the line of Eleanor Peerose from Roth Capital Partners. Your line is now open.

Got it thank you.

Thank you. Our next question comes from the line of LNR Piero from Roth Capital Partners. Your line is now open.

Eleanor Peerose: Yes, good morning, everyone. Thanks for taking my questions. I was wondering if you could spend just a couple of minutes on the cancer study, the investigator, on what sort of bench you would invest in the problem, and it was poured. The question is, have you explored their regulatory framework? of endpoints here and what sort of durate do they have?

Yes, good morning, everyone. Thanks for taking my questions.

Just wondering if you could spend just a couple of minutes on the cancer.

Got it.

The investigator initiated trial.

What sort of benchmark when would you have to see on George for you to invest in the program.

And then part B to this question is have you explored the regulatory framework on what kind of endpoints, maybe your vote here and what sort of duration of treatment.

Unknown Executive: or observation to have from the regular. Yeah, so obviously we are very focused on working with regulators about how to think about these new areas. Obviously, these patients are suffering from MDD, often with comorbid anxiety, as we hear. And in many ways, these are patients who are very difficult to treat, right, given their other physical issues.

Our observation would you have to have for them.

From the regular income perspective.

Yeah. So obviously we.

Very focused on working with regulators about how to think about these new areas.

Obviously these patients are suffering with M. D D often with comorbid anxiety as we here.

And in many ways. These are patients who are very difficult to treat right given their other physical issues. So I think our goal in this was to see if in fact, we could make a durable impact in a study with a different delivery model and this is the first patient.

Unknown Executive: So I think our goal in this was to see if, in fact, we could make a durable impact in a study with a different delivery model. And this is the first patient study that actually did simultaneous preparation, administration of psilocybin therapy among four people in separate rooms, but simultaneously, and integration. So this is a pretty different delivery model that is actually not terribly distinct from models and other forms of cancer care and support groups. We will be seeing those data later, and I think what we are looking for is movement in all of the traditional measures. Again, we have a madras measure here.

That actually did simultaneous preparation administration of suicide on therapy for.

For people on separate rooms, but simultaneously.

Integration. So this is a pretty different delivery model that is actually not terribly distinct from models and other forms of cancer care and support groups.

We will be seeing those data later on I think what we are looking for is movement in all of the traditional measures again, we have a mattress measure here.

Unknown Executive: There's a three-week and an eight-week end point. And we're also going to be looking at qualitative changes in patient experience. And that will help inform an ongoing program following a set of discussions with regulars based on the data. Again, it's sort of boring, but we're all about evidence. And I think there have been interesting small studies at this point.

There's a three week on an eight week endpoint.

And we're going to also be looking at the qualitative changes in patient experience and that will help inform and ongoing program. Following a set of discussions with regulators based on the data again, sorry to be boring, but we're all about evidence and I think there have been interesting small studies at this point, what we wanted to start.

Unknown Executive: What we want to do is to start the conversation about bringing this model to patients at scale, and that study is a first step in doing so, working closely with the Maryland Oncology hematology group at Aquino Cancer.

The conversation about bringing this model to patients at scale on that study as a first step in doing so working closely with the Maryland oncology Hematology group debt.

Operator: Thank you. At this time, I'm asking no further questions. I would like to turn the call back over to management for closing remarks. I'd very much like to thank all our investors for their questions and their support in making a difference in patients' lives. We're very much focused on this and greatly appreciative of your support and appreciate the very thoughtful questions today. So with that, and my colleagues from the Compass, thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.

Moving on cancer Center.

Thank you very much.

Thank you at this time I'm showing no further questions I would like to turn the call back over to management for closing remarks.

I'd very much like to thank all our investors for the questions to support.

And making a difference in patients' lives.

We're very much focused on this and are greatly appreciative of your support.

And I appreciate the very thoughtful questions today, so without Oh.

I and my colleagues compass. Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect.

[music].

Operator: and the