Q2 2022 Compass Pathways PLC Earnings Call

Yes.

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

And on that note, generating data sets, George, you mentioned something about designing the

across those three?

be driven predominantly by strategic or financial concerns?

Our whole focus has been on scalability for this approach, hence the use of technology.

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

I think the most important element of what we're doing is actually building a learning component, and you'll be hearing much more about this on the 12th, where every session is recorded and that then provides transcripts that enable the therapist and the therapist mentors to improve the process as we move forward.

The conference will begin shortly.

Raise your hand during Q&A, you can dial star one one.

[music].

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

The conference will begin shortly.

To raise your hand during Q&A, you can dial star 1 1.

phase 3 such that it generates data useful for payers.

In the first instance, they're similar, but I think we're doing these studies for exploratory

I'm sorry, we're really not discussing the trials in this level of detail at this point.

And so this learning that we do in the real world through all of our trials, whether it's Phase III or anorexia or PTSD, all of that gets incorporated, and then we'll be releasing iterations of how to improve the therapy and the therapist training over time.

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

The conference will begin shortly.

Can you elaborate on that a little bit?

reasons to establish just how much and how little they can remain the same.

I think we've explained, we see ourselves as in an important confidential process with

So this is really an important element of what we're doing in terms of scalability, and our goal is to make this just the right size and to continue development over time, providing people feedback from the real world.

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

To raise your hand during Q&A, you can dial star 1

And then I've got a question on the anorexia trial.

So I think that, in a sense, is the objective, a partial objective of the, of both the studies

the FDA.

So those are the key elements of it.

Stephen Schultz you may begin.

Welcome all of you and thank you for joining us today for our second quarter 2022 results Conference call. We hope you've had a chance to review the press release issued earlier today summarizing our accomplishments.

that we're undertaking.

1.

Great.

And obviously, patients have, hi, Patrick, and patients in the past, if they need more

We will tell you the conclusions on the October the 12th.

We'll talk more about the program as it's agreed.

Again my name is Steve Schultz Senior Vice President of Investor Relations at Compass pathways and today I'm joined by George Goldsmith, Our co founder and Executive Chairman, Dr. Scott Goodwin, our Chief Medical Officer, and Mike <unk>, Our Chief Financial Officer.

Thank you, Ritu, and thanks for the question.

support, they receive it as part of the protocol.

I'm sorry to sound like a broken record, but that's just, I guess I'm a broken record.

All right.

The conference will begin shortly.

I'm also pleased to introduce our new Chief Executive officer could be on that.

The call is being recorded and will be available on the compass pathways Investor Relations website. Shortly after the conclusion of the call before we begin let me remind everyone that during the call today the team will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 as amended.

To raise your hand during Q&A, you can dial star 1-1.

You should not place undue reliance on these forward looking statements.

Actual events or results could differ materially from those expressed or implied by any forward looking statements.

As a result of various risks uncertainties and other factors, including those risks and uncertainties described under the heading risk factors in our quarterly report on Form 10-Q filed with the Europe U S Securities and Exchange Commission and in subsequent filings made by <unk> with the SEC.

Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date we.

We specifically disclaim any obligation to update or revise any forward looking statements, even if our estimates or assumptions change.

I'll now hand, the call over to George Goldsmith.

The conference will begin shortly.

I think that we will continue to keep things as we've disclosed so far and not go into

So that's, you know, clearly patient first here.

No problem, some broken records can be good.

Thank you very much.

Thank you, Steve and welcome everyone I'm excited to begin today's call by introducing our new CEO compare now to its first compass quarterly results call. As he officially just started on August one I won't press them into heavy service, but instead will ask him to provide some background and thoughtful as move to Congress.

Good day, ladies and gentlemen, and welcome to the COMPASS conference call.

deeper details.

Yeah.

So on the anorexia phase two, do you expect the ratio of female to male participants to

And just one more follow-up.

And then continue with the business update Guy will cover our clinical progress and Mike will provide a financial review after our prepared comments, we will open the call to questions.

At this time, all participants are in a listen-only mode.

Again, what we're aiming to do here is to share everything after we have full sign-off

And then if I could, if that's helpful, if I could just ask one on the commercialization

mimic real-world distribution?

As a reminder, this call is being recorded.

from the FDA, and that process is underway.

side.

And are there any confounding gender-based differences in the EDE score, either at baseline

Let me explain why this is the right time to welcome <unk> CEO and why I'm. So excited about what's next for corpus pathways.

So, you know, just looking, looking far ahead, I'm wondering if you can discuss the build

You mentioned layering in the anorexia program coming in from your investigator-initiated study pipeline, and you have quite a few more.

<unk> was created when my wife, and cofounder of <unk> and I experienced firsthand, how even the best institutions in the psychiatrist could fail to help people in need I've told this story many times, so I won't repeat it here except to say for the past six years compas pathways has been laser focused on our <unk>.

out of the mental health care clinic infrastructure in the U.S. and Europe.

I think that we, as you know, on the payer side and reimbursement information, we've

What preparations, if any, are underway at, you know, COMPASS to prepare for this potential

or in its clinical relevance at an end point?

Should we think of this as kind of the primary vector for label expansion for COMP360, and can you point to any other investigator-initiated studies that are expected to read out in the near-to-medium term?

even included things like quality of life measures in our phase 2 study.

for COMP360?

That's a good question.

Sure.

To accelerate patient access to evidence based innovation in mental health care.

That's been going on since 2016 in Europe and 2018 in the U.S.

And, you know, and then I guess just separately, how, you know, there could be an approval

I mean, most studies actually include only women.

So, yes, you've caught our plan.

The first of all the foundries to articulate and evolve a vision for what is possible, but does not yet exist.

So we are going to be including endpoints in all of our studies that enable us to accelerate

It's to really use these.

Surprisingly, that's the easy part visions without talent and capability are nothing but dreams.

the reimbursement discussions on both sides of the Atlantic.

Since our founding we've grown from two people to almost 150 with every new employee addition, the concrete steps to achieve our collective vision became clearer Kabir joining as CEO is to start the next chapter for Compass.

When companies grow and become more successful they require expanded and more diverse leadership talent.

In terms of more details and study design, we're going to just ask people to hold off

of MDMA and PTSD in 2023.

So you know, we're in an exploratory stage with this trial, and we'll let you know as

Obviously, these are independent investigator-initiated trials, but we choose ones that we think would make a significant contribution to unmet patient need.

As we embark on this next phase of company development. It is important that Comcast is led by someone who has experience with this next part of our journey.

until October 12th, which is a time we expect to have everything dealt with.

How, how might that contribute to the build out in a way that could be helpful to COMPASS's

Fair enough, George.

commercial efforts as we look ahead to COMP360 initially, perhaps in TRD?

As we prepare for our phase III program, we have been devoting our efforts to designing and building the regulatory and commercial elements of our business. It became clear to cartoon is co founders that we needed to find an inspirational leader who not only believed in our vision and values that have the experiences and capabilities to carry us forward.

But are you finding that like payers are more interested in further

Sure.

out time points than the regulatory guidance?

I'll take that.

it develops on issues like that.

We look closely at the results, and as we did with anorexia, if we see something positive and have patient benefit, we will look at prioritizing those for development.

So our focus is to leverage existing infrastructure wherever possible.

Thank you.

We found the right leader in career.

And I think we've seen nearly 1,000 sites of delivery for esketamine, for example, in

On August 1st our executive team began reporting to <unk> I will serve as executive chairman through the end of the year to ensure a smooth transition and continue to serve as chairman thereafter.

This is a wonderful place to be for me. It doesn't meet my cofounder role is completed instead I'll be shifting my attention to the next area of contribution to help nurture and achieve our mission.

This is what I mean by adding more leadership talent as we continue to grow.

I would now like to introduce your host for today's conference.

I'll now ask <unk> to say a few words overtime you are many opportunities to get better career.

George Thank you very much and good day to everyone.

Stephen Schultz, you may begin.

I think that, you know, we see that there is variation in that, depending on the systems.

the United States.

Thank you, one moment.

As I mentioned, these are independent investigator-initiated trials, so it's hard for us to know when things will report out.

As we embark on our next chapter at Compass pathways I'm truly honored to have been selected as campus next Chief Executive Officer.

Welcome all of you and thank you for joining us today for our second quarter 2022 results, conference call.

And so we're accommodating all of that in our study designs.

So I think that plus TMS, and to your point, if MDMA receives regulatory approval, obviously

Our next question comes from Francois Brisbat of Oppenheimer.

All right.

We hope you've had a chance to review the press release issued earlier

And again, we'll be able

all of these are supportive therapies and centers, including those pharmacological therapies

Please proceed.

Thank you very much.

Ishares similar personal story to that of George and catch up and have a deep dedication to campus mission to bring forward new solutions for patients living with serious mental illness.

today summarizing our accomplishments.

in addition to TMS, will be sites of care that we're looking at.

Hi, thanks for taking the questions.

Thank you.

And in Europe, obviously we've been working more with the academic and clinic delivery

I look forward to October 12th for more details.

Thank you.

All too many of us have experienced with family and friends, but suffered from severe depression or other serious mental illnesses and are not helped by the current standard of care.

I would now like to turn the conference

Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways.

system.

So I'll try to ask something a little bit different here.

back to management for closing remarks.

I believed in and admired the mission of commitment of campus. Since my first match, Georgia capture what I hoped to lead Otsuka as investments encompass series B investment.

And today I'm joined by George Goldsmith, our Co-Founder and Executive Chairman, Dr.

But on the digital side, you guys are including, you know, some of these digital tools that

Round in 2020.

From the staff I was struck by the passion and determination to advanced database that innovative solutions and mental health care.

Been impressed by the scientific rigor and bonus at the Compass team.

They develop evidenced based options for some of the world's most serious mental health conditions.

As they work to get regulatory approval and make them accessible to those who are not helped by current treatments.

<unk> share that vision.

<unk> personalized predictive and preventative approaches to mental health care delivery.

In achieving this goal, we will improve patient outcomes and create value for health systems by combining pharmacological psychological and digital interventions.

Guy Goodwin, our Chief Medical Officer, and Mike Falvey, our Chief Financial Officer.

For myself.

Several of the cases of experience in the health care industry in both Med Tech and Biopharma. Most recently, serving as senior managing director for Global Pharmaceuticals, Oaxaca, and previously as president and CEO of <unk>.

I'm also pleased to introduce our new Chief, Executive Officer, Kabir Nath.

North American pharmaceutical business.

My time at Oaxaca, I led the development and commercialization of pharmaceutical products and digital solutions addressing complex mental health needs and also coordinated the companys technology partnerships and capabilities.

And as we move into phase three, you'll see us working more to build out that infrastructure.

There is great work to do ahead at campus, especially as we embark on our phase III program for patients suffering with treatment resistant depression.

One of my main priorities will be moving cop 360, <unk> therapy successfully through the clinical trial regulatory and reimbursement processes and ensuring that its delivered into health care systems, together with psychological and digital support.

<unk>, who urgently needed.

you kind of teased us with on this call.

I wanted to thank everyone for their patience

I look forward to meeting and working with you.

But I was just wondering, in order to include these, how much discussion goes in with the

with regard to the process that we're engaged in.

I'm excited to be leading this critically important endeavor and continued partnership with George <unk>.

regulatory bodies in order just to make sure that these are validated and, you know, if

This is critical because we are first

I believe we can realize compensation to create new integrated models of care, which enable access for patients to transformative evidence based solutions for serious mental illness.

I'll hand, it back to George.

The call is being recorded and will be available on the

you say the patient needs more PrEP, he gets more PrEP.

in class.

Kabir and again welcome and we are thrilled to have you at the helm.

COMPASS Pathways Investor Relations website shortly after the conclusion of the call.

Just from the regulatory body and maybe the FDA, are there any discussions where if there's

We are doing something that has not been done before, and we need to do it

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.

too much usage of this, how can we actually tell what's, you know, is it the drug, is

with the utmost care for all stakeholders.

I'm also pleased to report to you that during this quarter comp has continued to make steady progress as our phase III protocols have been submitted and are under review by the FDA. We are pleased with the progress of our discussions with the agency and we're looking forward to sharing with you. The details of this program during our Investor day, which is scheduled for Wednesday.

You should not place undue reliance on these forward-looking statements.

it the digital side?

And so we appreciate you're among them, and

Actual events or results could differ materially from those expressed or implied by any forward-looking, statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading risk factors in our quarterly report on Form 10-Q, filed with the U.S. Securities and Exchange Commission, and in subsequent filings, made by COMPASS with the SEC.

Any discussion there would be helpful.

we appreciate your patience with us.

Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

to report more on the 12th as we share the entire program.

We'll report more fully on all of this on October 12th.

This is an incredibly exciting time when we start

We specifically disclaim any obligation to update or revise any forward-looking

statement, even if our estimates or assumptions change.

Got it.

But as you know, we've been really engaging sites of delivery for quite a while to make

looking at the results we're seeing, not only from our phase two study, but also looking

October 12, we believe this phase III program will support regulatory approval and contribute evidence for reimbursement of this new therapy.

I'll now hand the call over to George Goldsmith.

sure that our phase three leads to a successful launch.

at the early signals that we have in anorexia and other things.

Most importantly, we continue active preparations for the phase III program and reaffirm our guidance to commencing the phase III program by the end of this year.

And then on the anorexia program, super quick, the EDE scale, I'm not very

Perfect.

So it's an exciting time.

Last week, we announced a new phase III program and anorexia for comp 360, psilocybin therapy to add to the TRT in PTSD programs currently underway.

Thank you very much.

All three of these therapeutic targets represent large patient populations that are underserved by existing treatment options.

Thank you, Steve, and welcome, everyone.

familiar with that.

And that's one of the key reasons Khabir has joined us, is to really focus on that, those

Well, I think it's clear that in their public statements and the FDA officials who've discussed

We're moving fast and quickly and effectively in our therapy development, in our technology

With that let me now turn to Guy who will provide his thoughts on the next steps in our planned phase III program in some more detail on the anorexia program guide.

I'm excited to begin today's call by introducing, our new CEO, Kabir Nath, to his first COMPASS quarterly results call.

Are there any key subscales of import for regulators?

issues.

the issues of psychological support have usually made clear that they're interested in the

support, our data.

As he officially just started on August 1st, I won't press him into heavy service, but instead will ask him to provide some background and thoughts on his move to COMPASS.

Thank you George and good day all.

I will then continue with the business update, Guy will cover our clinical progress, and Mike will provide a financial review.

And is this a pivotal

And here we are.

minimum amount necessary for safety.

Let me Echo Georges competence in the progress of our phase III program interactions with the FDA.

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

endpoint?

Yep.

Since the protocols are still under review I will limit my comment on details during todays call what.

I think SSRIs are approved, but I don't know what they were approved on.

Great.

What I can say is our submitted design included two controlled pivotal trials and incorporated a number of important lessons from our phase II program.

That's a great question, Ritu, Guy, here.

Thank you.

They haven't usually, as far as I know, committed themselves on issues of digital support.

We have moved ahead and developing digital tools to support therapist training patient Psycho education and subsequent follow up.

I mean, the EDE has certainly been the measure

One moment.

I would highlight patient preparation is a key element in the patient journey critical to the acceptability of the psychedelic approach to treatment.

Our next question comes from Charles Duncan of Cantor Fitzgerald.

So I think we're really excited about October 12th, and we'll look

forward to seeing many of you there.

And with that, I want to thank you for your support

Again, we look forward to sharing the details of this program with you in October .

that has been used in the main psychotherapy trials.

Please proceed.

Obviously, it's a new area.

and interest.

Last week, we announced the third comp 360 program.

As <unk> II trial and anorexia nervosa.

Okay.

And I think it's obviously a growing one.

And as always, we're available for subsequent questions as the need arise.

This study will compare the effects of 25 milligrams and one milligram of investigation will comp 360, psilocybin therapy when administered with psychological support in 60 participants with anorexia nervosa.

And since psychotherapy is the main

Yeah.

And the key issue, I think, is it doesn't confound the issues around the effects of

Thank you.

This study will take place across four world, leading research institutes in the U K and the U S. King's College, London, Columbia University Medical Center University of California, San Diego School of Medicine, and Shepherd traps.

So, morning, George and team.

the drug and the efficacy of the drug, which is the key objective of the program.

Congratulations on the completion of the phase two meeting and progress with this innovative

None of whether that answers your question.

program.

George may want to comment.

I think just in addition, we view all of these, the data arising from these as exploratory

Any changes in symptoms after country 60, psilocybin therapy will be measured using the eating disorder examination ETE interview.

endpoints to help inform subsequent developments, so they don't have any impact on the actual

study, delivery, et cetera.

The other measures.

Trial primary endpoint is changed from baseline in the EDI Global score at week four after administration of <unk> 360 psilocybin therapy.

Okay.

way in which anorexia has been treated in the past, we regard it as the most important

I have a couple of questions on it and then just one on PTSD.

That's helpful.

And then there's been, you know, some M&A this morning in biotech, and I was just wondering,

With no current FDA approved pharmacological treatment option available anorexia nervosa represents an extremely high unmet need with the highest mortality rate of all psychiatric disorders at almost 6%.

of the measures that we can make.

The questions that I had on the program, I realize that you are waiting for additional

in your space, a lot of players, you guys are mostly focused on COM 360 right now, but

This is a result of medical complications and suicide.

We are including other secondaries, which we think will be

any high-level views on potential consolidation in the field?

Approximately 20% to 40% of deaths and anorexia nervosa thought to result from suicide, the highest suicide rate of any mental illness.

And if you were to look at some acquisitions and whatnot, was there any specific kind of

criteria that you would look at, or are we just focused on COM 360?

Not only does it have an enormous impact on the people who live with it.

360.

But also on the people closest to them.

informative and particularly relate to obsessionality and control, which is a key feature of the

We're never just focused on COMP 360 here, obviously it's our top priority but not our

Our interest in this indication is supported by positive early signals from an exploratory open label investigator initiated study conducted by Dr. Walter K Professor of Psychiatry at the University of California, San Diego <unk>.

underlying problems that patients with anorexia have.

sole focus.

As you know, we've obviously, as you'd imagine, we've seen almost everything that's in the

space and we will assess that based on time to patients and impact on patient outcomes

All of which were published in May at the society of biological Psychiatry annual meeting Dr.

Dr. Quay is the principal investigator on our trial.

This is an excellent excellent example of how clinically meaningful early signals generated an investigator initiated studies can inform our commercial clinical development program to deliver benefits to patients at scale and in a timely manner. This phase two study will be the first to use my path.

at scale and that's always going to be our true north at COMPASS in terms of assessing.

So if we see something that makes sense, it will help patients and it has a rigorous evidence

base, we're going to be interested.

Our compass developed educational digital up to supporting patients participation income 360, psilocybin therapy trials. The App provides engaging education about the therapy model and with participants consent will collect real world data for research and treatment responsiveness.

So that probably is enough to answer the question, I hope.

Yep.

No, thank you very much.

We are also deploying therapist companion campus developed web application that will provide a centralized platform to recruit train and provide feedback to therapists.

This app is designed to streamline the entire training progress.

Process with custom campus specific training content, while at the same time, providing analytics to continuously update and improve the training program.

Finally, we will be introducing an automated transcription and translation feature the therapist to review their sessions after they meet with the patient to further help with training and feedback.

feedback from the agency and we'll share a lot of details in October 12th.

I look forward to October 12th.

We will demonstrate these tools during our Investor day on October 12.

But I guess I'm just wondering if you can provide any color on the points of debate

that you had with the agency, if anything, or if there are any elements of surprise that

Okay.

This phase II study and anorexia adds to our ongoing <unk> 360 development in treatment resistant depression, and posttraumatic stress disorder.

you think investors would note.

We recently added a second site to the PTSD study.

Could it be sample size?

Tanya I Hospital in New York City with internationally recognized PTSD expert Dr. Rachel Yehuda as principal investigator.

Could it be dosing paradigm or control arm, et cetera?

PTSD study at King's College is actively recruiting already.

We look forward to reporting on these programs as they progress.

Is there anything you can provide?

Are you guys sharing at all if this is potentially in person or not?

This concludes today's conference call.

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

And then with regard to the cash use, I think Mike mentioned good through 24.

It's going to be a virtual event.

Thank you for participating, and you may now disconnect.

The conference will begin shortly.

Thanks, Scott I'll now recap our financial results for the three months and six months ended June 32022.

Does that fully consider the design elements that you're waiting details?

Our thought is that a lot of people will be able to tune into it online.

To raise your hand during Q&A, you can dial star 11.

on.

For the three months ended June 32022, net loss was $21 million or <unk> 50 per share compared with a net loss of $17 5 million or <unk> 44 per share during the same period in 2021.

So I'm happy to maybe kick this off and have Guy follow on.

I would say that we've

These results include noncash share based compensation of $3 2 million in 2022, and $1 9 million in 2021.

For the six months ended June 32022, net loss was $42 2 million.

Or $1 per share compared with a net loss of $30 2 million or <unk> 79 per share during the same period in 2021.

These results include noncash share based compensation of $6 3 million in 2022, and $3 6 million in 2021.

For the three months ended June 32022, R&D expenses were $15 9 million.

Compared with $11 4 million during the same period in 2021.

These increases were due to increased personnel and noncash share based compensation costs due to additional hires as well as increased development and other expenses as we continue to investigate <unk> hundred 60, <unk> therapy, and clinical and preclinical trials.

We expect R&D expenses to increase modestly until our phase III program commences later this year.

For the six months ended June 32022, R&D expenses were $31 3 million compared with $18 $2 million during the same period in 2021.

For the three months ended June 32022, G&A expenses were $11 3 million compared with $8 2 million during the same period in 2021.

These increases were attributable to increased personnel and noncash share based compensation costs due to increased hiring and the legal and other professional fees as well as for facilities and other expenses to support our growth initiatives, including operations as a public company.

For the six months ended June 32022, G&A expenses were $21 $4 million compared with $14 9 million during the same period in 2021.

<unk> continues to maintain a strong financial position with cash and cash equivalents of $207 2 million at June 32022, compared with $273 2 million at December 31 2021.

With these resources, we expect to be able to fund our operations into 2024, we view our strong balance sheet is an important strategic asset, which we intend to manage carefully as we invest to advance these promising potential therapies, while at the same time continuing to create value for our shareholders. Thank you and I'll now turn the call back to Joe.

And of course, quality of life, as George

said, is something included in all of our studies.

Sure.

Let me explain why this is the right time to welcome Kabir as CEO and why I'm so excited about what's next for COMPASS Pathways. COMPASS was created when my wife and co-founder Ekaterina Malayevskaya and I experienced firsthand how even the best institutions and psychiatrists could fail to help people in need.

I think as far as how this will play

Many more will be viewing it in archives.

Thank you, Mike and closing I look forward to seeing Kabir employees leadership and experience to deliver our investigational comp 360, <unk> therapy to those patients who are not helped by currently available treatments I know that with his leadership compass is well positioned to advance our goals of improving patient access and outcomes.

I've told this story many times, so I won't repeat it here except to say for the past six years, COMPASS Pathways has been laser focused on our mission to accelerate patient access to evidence-based innovation in mental health care.

in the future for regulatory purposes, I think we're a little early to speculate about that.

So we thought purely virtual would be the best way.

Also, our experience with kind of half virtual, half live is that they're not as good as either

The first role of a founder is to articulate and evolve a vision for what is possible but does not yet exist.

Surprisingly, that's the easy part.

all virtual or all live.

Visions without talent and capability are nothing, but dreams.

Since our founding, we've grown from two people to almost 150.

And that our team will continue to thrive importantly career shares our deep commitment to transforming the patient experience of mental health care.

With every new employee addition, the concrete steps to achieve our collective vision became clearer.

So virtual seems to be the right format.

Kabir joining as CEO is the start of the next chapter for COMPASS. When companies grow and become more successful, they require expanded and more diverse leadership, talent.

Perfect.

This leadership transition is important priority because we are building confidence to make a difference in people's lives for generations to come we know that a well executed succession plan along with a strong focus on people development is central to the growth of every significant and successful company Kabir joining compass will enable me to <unk>.

Thank you very much.

As we embark on this next phase of company development, it's important that COMPASS, is led by someone who has experience with this next part of our journey.

Because on shaping our public private partnerships advocacy and policy efforts as well as leading our board of directors and my role as chairman.

As we prepare for our Phase 3 program, we have been devoting our efforts to designing, and building the regulatory and commercial elements of our business.

But we're obviously taking advice from the FDA and other regulatory bodies as we go forward

been incredibly encouraged by the thoroughness of our interactions with the FDA.

As you heard from Guy we are pleased with the progress.

with this program.

And we have

We should also point out that the Investor Day will give us the opportunity, I think,

Of our FDA interactions and we look forward to sharing our phase III program in our upcoming Investor Day on October 12, which will also feature our TRT commercial strategy, our advanced suite of digital tools additional information on our PTSD and anorexia programs and perspectives from Kols, we look forward to having you join us.

It became clear to Katchi and I as co-founders that we needed to find an inspirational leader, who not only believed in our vision and values, but had the experiences and capabilities to carry us forward. We found the right leader in Kabir. On August 1st, our executive team began reporting to Kabir.

Great.

to keep in mind here that when you look at, you know, what was observed in the prior question

to showcase the team here at Compass.

And also we're going to be offering up some KOL perspectives, because that's something

Reinforced by our incredible team here at <unk> and now. The addition of our new CEO . Our leadership in this area of science continues to grow as we move closer to our goal of transforming the treatment of mental health, which has the potential to change People's lives for the better for generations to come.

Thanks for taking all the questions.

Thank you.

that we've heard investors would really be interested in hearing.

This is an exciting time for all of us and for those investors who support our mission.

I will serve as executive chairman through the end of the year to ensure a smooth transition, and continue to serve as chairman thereafter.

One moment.

around the breadth of what we're looking at, the fact that this is first in class, and

And it's best to deliver all of those through the virtual format.

This is a wonderful place to be for me.

that this is a whole new area of kind of development and evidence generation, you know,

I am so grateful for what we've accomplished and I look forward to this next chapter in our journey together.

It doesn't mean my co-founder role is completed.

Our next question comes from Nina Petrito-Garg of Citi.

we've been very encouraged by our interactions with the FDA and nothing has been a negative

Great.

Instead, I'll be shifting my attention to the next area of contribution to help nurture, and achieve our mission.

surprise at all.

Thank you for your time today.

Please proceed.

I think we're just doing the work as we do at COMPASS.

This is what I mean by adding more leadership talent as we continue to grow.

Hey, guys.

And so, you know,

We will now open the line for questions operator.

from our point of view, we can share more details in October, as we said, I think it's been a very

productive sets of discussions.

Thank you.

And I think we're all taking our responsibility very seriously and

One moment.

Thank you as a reminder to ask a question you will need to press star one one on your telephone please standby, while we compile the Q&A roster.

ensuring that we have the proper evidence to move forward at scale.

And these are huge

Our next question comes from Elmer Piros of Roth.

Yes.

Our first question comes from Ritu <unk> of Cowen. Please go ahead.

Please proceed.

I'll now ask Kabir to say a few words.

Yes.

Over time, you'll have many opportunities to get to know him better.

Thanks for taking the question.

Good morning, everyone.

Kabir?

I just have two for me.

indications.

And so we really want to make sure we get everything right.

Good morning, guys. Thanks for taking the question.

So that's about all I can

I wanted to ask about <unk>.

So very very high level.

Aspects of the phase III I understand theres going to be a lot more detail coming but you mentioned protocols floral im wondering if youre thinking about making the two phase III different whether looking at different populations or just generating different datasets and on that note generating datasets George you mentioned.

say on that front.

Something about.

Guy, did you want to add on?

Designing the phase III such that it generates data useful for payers can you elaborate on that.

Little bit and then I've got a question on the anorexia trial.

George, thank you very much and good day to everyone.

Today as we embark on our next chapter at COMPASS Pathways, I'm truly honored to have, been selected as COMPASS' next chief executive officer. I share a similar personal story to that of George and Katya and have a deep dedication, to COMPASS' mission to bring forward new solutions for patients living with serious mental illness.

For myself, I have several decades of experience in the health care industry in both medtech, and biopharma, most recently serving as Senior Managing Director for Global Pharmaceuticals at Otsuka and previously as President and CEO of Otsuka's North American Pharmaceutical

No, I don't think so.

George, you previously alluded to that the level of preparedness for the actual dosing

All too many of us have experience with family and friends that suffer from severe depression, or other serious mental illnesses and are not helped by the current standard of care.

Great Hi, Ritu and thanks for the question.

Business.

of the therapy made a difference in the outcomes.

I've believed in and admired the mission and commitment of COMPASS since I first met, George and Katya when I helped to lead Otsuka's Investment in COMPASS Series B Investment, Round in 2020. From the start, I was struck by their passion and determination to advance database and, innovative solutions in mental health care.

During my time at Otsuka, I led the development and commercialization of pharmaceutical products, and digital solutions addressing complex mental health needs and also coordinated the company's technology partnerships and capabilities.

I've been impressed by the scientific rigor and boldness of the COMPASS team as they develop, evidence-based options for some of the world's most serious mental health conditions and as they work to get regulatory approval and make them accessible to those who are not helped by current treatments.

There is great work to do ahead at COMPASS, especially as we embark on our Phase 3 program, for patients suffering with treatment-resistant depression.

I think just to reiterate

Do you plan to incorporate this almost as a selection tool in subsequent studies?

I share their vision of creating personalized, predictive, and preventative approaches to, mental health care delivery. And in achieving this goal, we will improve patient outcomes and create value for health, systems by combining pharmacological, psychological, and digital interventions.

what George has said, I mean, as we as we said on the broadcast, you know, we've announced that

I think that we will.

Continue to keep things as we've disclosed so far and not go into deeper details.

One of my main priorities will be moving COMP360 psilocybin therapy successfully through the, clinical trial regulatory and reimbursement processes and ensuring that it's delivered into healthcare systems, together with psychological and digital support, to patients who urgently need it.

we've included two pivotal trials in this program.

I look forward to meeting and working with you.

And we just noticed that this is consistent with

And I'm not asking for specifically this phase three, but just a general concept.

I'm excited to be leading this critically important endeavor in continued partnership with George. Together, I believe we can realize COMPASS' vision to create new integrated models of care, which enable access for patients to transformative, evidence-based, innovative solutions for serious mental illness.

precedence in TRD indications, where no one has actually received approval based on a single

I'll hand it back to George.

pivotal study.

Again, what we're aiming to do here is to share everything after we have full sign off from the FDA.

So in a sense, that's, I think, an important part of our thinking, which is

complemented by the fact that we're always thinking about, as we've talked about phase

three, designing backwards from a successful launch.

And therefore, we want to have the most

Mike, do you want to take the question?

therapists and so forth ready for a successful launch.

And that process is underway.

Sure.

I think that we as you know on the payer side and reimbursement information, we've been working with payers, even including things like quality of life measures in our phase II study that's been going on since 2016 in Europe in 2018 in the U S. So we are going to be including endpoints in all of our studies at AAP.

<unk> enable us to accelerate the reimbursement discussions on both sides of the Atlantic in terms of more details on study design, we're going to just ask people to hold off until October 12th which is a time, we expect to have everything dealt with.

Fair enough George.

Are you finding that payers are more interested in further out time points than the regulatory guidance.

I think probably...

Hi, Elmer.

I think that.

We see that there is variation in that depending on the systems and so we're accommodating all of that in our study designs.

And I think you know us well enough that anything we learn to improve outcomes, we're going

to do and put that to action.

And again, we will be able to report more on the 12, because we share the entire program.

Got it and then on the <unk> program Super quick the ETE scale.

I'm not very familiar with that are there any.

Key subscales of import for regulators.

And I think ssris are approved.

I don't know.

I can turn it over to Guy for any specific thoughts on that.

What they were approved.

But I think just the ethos of this organization is everything we learn that can help, we'll

use.

That's a great question Ritu Guy here.

I mean, the EDI is certainly being the measure that has been used in the main psychotherapy trials and since psychotherapy is the main way in which.

<unk> has been treated in the past we regarded as the most importance of the measures that we can make we are including other secondaries, which we think will be informative and particularly relate to obsession analogy and control, which is a key feature.

The underlying problems with patients with anorexia half and of course, the quality of life as George said.

And all of us.

Studies.

I think as far as how this will play in the future for regulatory purposes, I think we're a little early to speculate about that but we are obviously, taking advice from the FDA and other regulatory bodies as we go forward with this program.

Great. Thanks for taking all the questions.

Thank you, Kabir, and again, welcome.

Thanks for you too.

And we are thrilled to have you at the helm.

Thank you one moment.

I'm also pleased to report to you that during this quarter, COMPASS continued to make steady progress as our Phase 3 protocols have been submitted and are under review by the FDA.

We are pleased with the progress of our discussions with the agency, and we are looking forward to sharing with you the details of this, program during our Investor Day, which is scheduled for Wednesday, October 12th. We believe this Phase 3 program will support regulatory approval and contribute evidence for reimbursement of this new therapy.

Most importantly, we continue active preparations for the Phase 3 program and reaffirm our guidance to commencing the Phase 3 program by the end of this year.

Okay.

Last week, we announced a new Phase 2 program in anorexia for COMP360, psilocybin therapy, to add to the TRD and PTSD programs currently underway. All three of these therapeutic targets represent large patient populations that are underserved by existing treatment options.

Our next question comes from Nina <unk> Garg of Citi. Please proceed.

One is just on, it

Guy?

Hey, guys. Thanks for taking my question.

I just have two for me one is just on it looks like you had a slightly higher cash burn this quarter versus historically and that may be due to some FX impact maybe if you can talk a little bit about that that would be great.

looks like you had a slightly higher cash burn this quarter versus historically, and

that may be due to some FX impact. Maybe if you can talk a little bit about that, that

would be great.

And then I know Youre also planning on reporting out the one year long term follow up data for the phase <unk> and patients in the phase two at Johnson SSRI study and I'm. Just wondering if you could give us a sense of maybe the.

And then I know you're also planning on reporting out the one-year long-term

follow-up data for the Phase 2B and patients in the Phase 2 adjunctive SSRI study.

Timing for that whether that will be at the October 12.

Investor day, or before that and what sort of metrics, we should expect.

You see on that readout.

With that, let me now turn to Guy, who will provide his thoughts on the next steps in our planned Phase 3 program and some more detail on the anorexia program.

And

I think expert opinion is increasingly focused on preparation, as you imply, Elmer.

Yes.

I'm just wondering if you could give us a sense of maybe the timing for that, whether

And I think we will certainly, as we develop the treatment and take it into real world

Yeah. Thanks Nina.

settings, we'll be looking to optimize that aspect of it.

And obviously, the way we're shaping the phase three is restricted by the need to keep

Start on the cash balance and then turn it over to Guy and George So yes. As you noted our cash balance went from $244 million at the beginning of the quarter to 207 at the end.

things simple.

Guy?

that will be at the October 12th, investor day or before that, and what sorts of metrics

But we'll certainly be looking at how we do this in the future so that it gets better

and better.

we should expect to see on that readout.

And we will be taking learnings from our phase two B into phase three as we design and develop

Thanks.

the protocols.

So thats.

A change of about $37 million and if you look at our summary, cash flow $18 million or about half of that change what's used in operations, which is about normal for our run rate.

Yeah, thanks, Nina.

Thank you so much.

I'll start on the cash balance and then turn it over to Guy and George.

Thank you.

So, yeah, as you noted, our cash balance went from $244 million at the beginning of the

The other half or $18 million came from the exchange rate impact of translating our pound denominated cash balances into dollars for reporting purposes.

quarter to $207 million at the end.

So that's a change of about $37 million.

And as we've noted in the past we hold our cash balances in both dollars and pounds to match, our forecasted spending in each currency.

So most of this $18 million impact, it's a paper loss, because we intend to spend those pounds and not change them into dollars and going forward. This is going to be our continued strategy. So we will continue to align our current see cash balances and spending plans.

And if you

look at our summary cash flow, $18 million, or about half of that change, was used in

operations, which is about normal for our run rate.

The other half, or $18 million,

came from the exchange rate impact of translating our pound-denominated cash balances into

So the operating impact of any future currency impacts continues to be small and the most important thing is that our cash runway.

dollars for reporting purposes.

On the cash runway, we continue to affirm that we have runway into 2024.

And as we've noted in the past, we hold our cash balances

And in coming up with that runway, we did put in a healthy placeholder for a phase three program.

And, you know, as we refine the plans, we continue to make sure that we're, if anything,

Continues to.

Last into 2024.

in both dollars and pounds to match our forecasted spending in each currency.

over budgeted in that area.

So that is contemplated in the runway we've projected.

I should also probably add.

Currency changes that we've seen over the first half have been unusually significance the dollar.

Really strengthened against all currencies because of the.

The political uncertainty and the spike in energy prices and so this is something you'll see pretty consistently historically.

We don't know what direction they will take.

Going forward, which is why it's important for us to put this natural hedge in place.

To make sure those currency impacts on very little very little operating impact.

So the question about the follow up study, which we know is zero zero for just as a reminder, this took patients who had participated in both series zero, one which was our main phase III <unk> study and also 003, which was our adjunctive study where patients continues to take ssrs.

Hi.

We know that the patient so basically filled the years follow up now and then.

Data is being analyzed I think it will be timely moment to discuss it when we present.

The Investor day, the 12th of October So I think again waiting for that date will be.

<unk> interesting when we get there.

Got it thank you.

One moment.

Thank you one moment.

Our next question comes from Bert Hazlett of BTIG.

Our next question comes from Patrick <unk> of H C. Wainwright. Please proceed.

Please proceed.

Thank you, and thank you for taking the questions.

Thank you, George, and good day all.

So most of this

Got it.

Congratulations on all the progress.

$18 million impact is a paper loss because we intend to spend those pounds and not change

Thanks, Good morning, and congrats on all the progress.

them into dollars.

That all makes sense.

Just one with a little bit more granularity for the anorexia nervosa program,

Appreciate the color and look forward to October 12.

Just a first follow up on the comp 360 program, which is now building out to multiple indications, including TRT PTSD and anorexia and what I'm wondering is if the treatment protocols are expected to be the same across these different indications specifically regarding the level of psychological support our talk.

With regard to the PTSD program, you added a new important clinical site.

Therapy.

How is this different if at all in terms of the.

The prep.

Integrations sessions.

And as well what extent the digital therapeutics are expected to be included in these different indications either.

Trials evaluating these different indications.

Let me echo George's confidence in the progress of our Phase 3 program interactions with the FDA.

and then maybe one or two bigger picture items.

It appeared that the earlier study, again, small N, N of 10, I guess,

but the earlier study showed data that may be strengthened a little bit further out at three months as opposed to one month.

Certainly Patrick Thank you for that question. The digital support will certainly be included in both the phase III studies that were proposed.

So I'm curious as to the week four endpoint and if you're looking at results further out.

And also in the anorexia study that we described in this call.

We think that it's an opportunity to improve the way in which therapy is currently delivered and it also is an opportunity to look at how it can be refined and some of the therapy burden reduced so going forward, we see the particularly the digital support as a way of improving things in terms of quality.

Since the protocols are still under review, I will limit my comment on details during today's call.

And going forward, this is going to be our continued strategy.

So we'll continue to align our currency cash balances and spending plans so the operating

impact of any future currency impacts continues to be small.

Reducing to some extent some of the additional costs that are associated with multiple therapists, etc.

Im not sure where that completely answers. Your question. The data I think you may be interested in the.

What I can say is our submitted design included two controlled pivotal trials and incorporated a number of the important lessons from our Phase 2 program.

And the most important thing is that our cash runway continues to last into 2024.

We have moved ahead in developing digital tools to support therapist training, patient psychoeducation, and subsequent follow-up.

I would highlight patient preparation as a key element in the patient journey, critical to the acceptability of the psychedelic approach to treatment.

The details from the digital therapeutics side, when we demonstrate that again October 12.

And I should also probably add, you know, the currency changes that we've seen over

And then secondly, are antidepressants going to be excluded in that trial for those patients?

And then just in terms of.

The level of psychological support is that is that expected to be.

We expect to have.

More psychotherapy with PTSD as compared to tid or as compared to anorexia or is it are the kind of the therapy protocols pretty similar across those three.

the first half have been unusually significant.

The dollar really strengthened against all currencies because of the, you know, the political

In the first instance, they're similar but I think we're doing these studies for exploratory reasons to establish just how much and how little they can remain the same.

uncertainty and the spike in energy prices.

And so this is something you'll see pretty consistently historically.

We don't know what direction they'll take going forward, which is why, you know, it's

So I think that in a sense is the objective partial objective of the of both the studies that we are undertaking.

China, obviously for patients.

Hi, Patrick in patients in the past if they need more support they receive it as part of the protocol. So that's.

Clearly patient first here.

important for us to put this natural hedge in place to make sure those currency impacts

Yes, and then if I could that's helpful. If I could just ask one on the commercialization side. So.

have very little operating impact.

Just looking looking far ahead I'm wondering if you can discuss the buildout of the mental health care clinic infrastructure in the U S and Europe .

So the question about the follow-up study, which we know is 004, just as a reminder,

this took patients who had participated in both 001, which was our main Phase 2B study,

and also 003, which was our adjunctive study, where patients continued to take SSRIs.

We know that the patients have basically filled the year's follow-up now, and the data is

What preparations that are underway compass to prepare for this potential for <unk> hundred 60.

being analyzed.

I think it will be a timely moment to discuss it when we present the Investor Day on the

And then I guess just separately.

There could be an approval of MDMA and PTSD in 2023.

How might that contribute to the build out in a way that could be helpful to you.

<unk> commercial efforts as we look ahead to.

360, initially perhaps in PRT.

Sure ill take that.

So our focus is to leverage existing infrastructure wherever possible and I think we've seen.

Nearly 1000 sites a delivery first academy in for example in the United States. So I think that plus Tms and to your point, if MDMA receives regulatory approval. Obviously all of these are supportive therapies and centers, including those.

Pharmacological therapies. In addition to Tms will be sites of care that we're looking at.

And in Europe , obviously, we've been working more with the academic and clinical delivery system and as we move into phase III, you will see us working more to build out that infrastructure will report more fully on all of this and on October 12.

Again, we look forward to sharing the details of this program with you in October.

12th of October.

Last week, we announced the third COMP360 program, a Phase 2 trial in anorexia nervosa. This study will compare the effects of 25 milligrams and 1 milligram of investigational COMP360 psilocybin therapy when administered with psychological support in 60 participants with anorexia nervosa.

This study will take place across four world leading research institutes in the UK and, the US.

But as you know we've been really engaging sites of delivery for quite a while to make sure that our phase III leads to a successful launch.

Terrific. Thank you very much.

And Thats one of the key reasons <unk> joined US is to really focus on that those issues, so where we are.

So I think, again, waiting for that date will be increasingly interesting when we get there.

Yep great.

Thanks.

Thank you.

Thank you one moment.

Okay.

Our next question comes from Charles Duncan of Cantor Fitzgerald. Please proceed.

King's College London, Columbia University Medical Center, University of California San, Diego School of Medicine, and Sheppard Pratt.

Got it.

Yeah, thank you.

Okay.

Yeah, it's going to be a 12-week observational component.

I mean, we've kept it four weeks because, you know, we, in many ways,

So.

George and team congratulations on the completion of the phase II meeting and progress with this innovative program I have a couple of questions on it and then just one on PTSD.

Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating, Disorder Examination, EDE, interview and other measures.

Thank you.

you can keep things most constant for those first four weeks, and as time goes on, other things intervene.

The trial primary endpoint is changed from baseline in the EDE global score at week, four after administration of COMP360 psilocybin therapy.

So I think keeping it to four weeks makes sense as an initial treatment effect,

With no current FDA approved pharmacological treatment option available, anorexia nervosa, represents an extremely high unmet need with the highest mortality rate of all psychiatric disorders at almost 6%. This is a result of medical complications and suicide. Approximately 20 to 40% of deaths in anorexia nervosa are thought to result from suicide, the highest suicide rate of any mental illness.

and then continuing to observe over 12 weeks optimizes what we can see.

Not only does it have an enormous impact on the people who live with it, but also on the, people closest to them.

In terms of the antidepressants, we still will continue to withdraw patients from antidepressants

Our interest in this indication is supported by positive early signals from an exploratory, open-label investigator-initiated study conducted by Dr. Walter Kay, Professor of Psychiatry at the University of California, San Diego, the results of which were published in May of the Society of Biological Psychiatry annual meeting.

This is an excellent example of how clinically meaningful early signals generated in investigator-initiated, studies can inform a commercial clinical development program to deliver benefits to patients at scale and in a timely manner.

and with the same strategy as we used in the Phase 2B since it worked well there.

Dr. Kay is the principal investigator on our trial.

This phase two study will be the first to use MyPathFinder, a compass-developed educational, digital app for supporting patients' participation in COMP360 psilocybin therapy trials. The app provides engaging education about the therapy model and with participant consent, will collect real-world data for research on treatment responsiveness.

We are also deploying Therapist Companion, a compass-developed web application that will, provide a centralized platform to recruit, train, and provide feedback to therapists. This app is designed to streamline the entire training process with custom compass-specific, training content while at the same time providing analytics to continuously update and improve the training program.

Finally, we will be introducing an automated transcription and translation feature for, therapists to review their sessions after they meet with the patient to further help with training and feedback.

The question that I had on the program I realize that you are waiting for additional feedback from the agency, we'll share a lot of details in October 12.

We will demonstrate these tools during our investor day on October 12.

And I guess I'm

But I guess I'm just wondering if you can provide any color on the points of debate.

That you had with the agency if anything or is there any element of surprise that you think investors would would now.

Could it be sample size could it be dosing paradigm or control arm et cetera is there anything you can provide and then with regard to the cash use I think Mike mentioned good through 'twenty four kids that fully consider the.

The design elements at year waiting details on.

One moment.

Terrific.

So I'm happy to maybe kick this off and have got a follow on.

Our next question comes from Patrick Tuchio of H.C.

Thank you.

Wainwright.

And then just kind of bigger picture questions.

I would say that we've been incredibly encouraged by the thoroughness of our interactions with the FDA and we have to keep in mind here that when you look at what was observed in the prior question around the breadth of what we're looking at the fact that this is first in class.

Please proceed.

You've had some granted patents, you mentioned in the press release,

Thanks.

with regard to composition formulation and method of use.

And there's some continued, obviously, discovery work with novel drug candidates.

Could you elaborate maybe a little bit more on both of those efforts

Good morning, and congrats on all the progress.

Sure, I can start there.

and when actually we should see maybe visibility of the novel drug candidates

Again, some of this will be part of the discussion we have on the 12th

and what the goals are there for the novel NCEs?

Thanks.

Just a first follow-up on the COMP360 program, which is now building out to multiple indications,

to shine a light on some of our discovery efforts, et cetera.

But I think we've always been clear that what we're looking to do is to develop novel chemical entities

And that this is a whole new area of underserved.

<unk> development.

that will enable us to enhance the patient experience.

Evidence generation.

We've been very encouraged by our interactions with the FDA and nothing has been a negative surprise at all I think we're just doing the work as we do at Congress and so.

And so right now there's precious little data on shorter acting,

but obviously we need to look at that to help more patients over the same unit of time.

From our point of view, we can share more details in October as we said I think it's been a very productive sets of discussions and I think we're all taking our responsibility very seriously and ensuring that we have the proper evidence to move forward at scale and these are huge indications and so we really want to make sure we get everything right.

So that's one of the design elements of these.

But we have a lot of efforts in our discovery program looking at different dimensions,

So that's about all I can say on that front guy to do you want to add on.

and we'll certainly report out on that.

I don't think so I think just to reiterate what Joe just said.

Obviously intellectual property is important,

As we said on the broadcast we've announced that we've included two pivotal trials in this program and we've just noticed that this is consistent with precedent and TRT indications while no. One has actually received approval based on a single pivotal study so in a sense.

I think an important part of our thinking.

and we'll continue to integrate that thinking into the selection of future compounds and approaches.

Which is complemented by the fact that we're always thinking about as we have talked about phase III designing backwards from a successful launch and therefore, we want to have the most therapists and so forth ready for a successful launch Mike do you want to take the question sure.

Modeling such as on the.

The cash runway, we continue to affirm that we have runway into 2024 and in coming up with that runway. We did put in a healthy place holder for.

Our phase III program.

And as we refine the plans we continue to make sure that we're if anything over budgeted in that area. So that is contemplated in the runway we projected.

Got it that all makes sense appreciate the color and look forward to October to us with regard to the PTSD program you added a new important clinical site and I guess I'm wondering if you can provide any additional color on enrollment trends in the PTSD program. Please state new site driven by.

wondering if you can provide any additional color on enrollment trends in the PTSD program.

Was the new site driven by, I guess, interest by the investigator or a desire to, I guess,

I guess interest by the investigator or desire to I guess capture a broader set of patients to feel enrollment. Thanks.

capture a broader set of patients to fuel enrollment?

Thanks.

It really wasn't to do with numbers.

It really wasn't to do with numbers do with capitalizing on expertise and we have two world class centers in two world class ended better than one world class vendor.

For sure Okay. Thanks for taking my questions.

It was to do with capitalizing on expertise.

Thanks, Chad.

Thank you one moment.

Okay.

And,

Thank you very much.

Our next question comes from Sumit Kulkarni of Canaccord Genuity. Please proceed.

you know, we had two world-class centers, and two world-class centers are better than

Thank you.

Good morning, and afternoon to the team. Thanks for taking my questions I have two one on tid and one another.

including TRD, PTSD, and anorexia.

one world-class center.

For sure.

So as we sit here today does it make sense to run both P&C trials, but tid tablet.

What I'm wondering is if the treatment protocols are expected to be the same across these different

Okay.

If you were to choose a staggered start that position to be driven predominantly by strategic or financial consideration.

Okay.

I am sorry, we are really not discussing.

And this level of detail at this point, Oklahoma I think we've explained we see ourselves as an in an important.

Confidential process with the FDA and we will tell you the conclusions on the October 12, I'm, sorry to sound like a broken record, but thats, just I guess I'm a broken record.

Yeah.

No problem some broken back is going to be good.

This phase two study in anorexia adds to our ongoing COMP360 development in treatment-resistant, depression and post-traumatic stress disorder.

We recently added a second site to the PTSD study, Mount Sinai Hospital in New York City, with internationally recognized PTSD expert, Dr. Rachel Yehuda, as principal investigator.

The PTSD study at King's College is actively recruiting already.

So on the anorexia fees do you expect the ratio of female to male participants to mimic real world of distribution and Danny compounding gender differences in the east core EDA at baseline.

We look forward to reporting on these programs as they progress.

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

Chemicals element at the endpoint.

Thanks, Guy.

I'll now recap our financial results for the three months and the six months ended June 30, 2022. For the three months ended June 30, 2022, net loss was $21 million, or $0.50 per share, compared with a net loss of $17.5 million, or $0.44 per share, during the same period in 2021. These results include non-cash share-based compensation of $3.2 million in 2022 and $1.9 million in 2021.

That's a good question I mean, most studies actually include only women.

For the six months ended June 30, 2022, net loss was $42.2 million, or $1 per share, compared with a net loss of $30.2 million, or $0.79 per share, during the same period in 2021. These results include non-cash share-based compensation of $6.3 million in 2022 and $3.6 million in 2021.

For the three months ended June 30, 2022, R&D expenses were $15.9 million, compared with $11.4 million during the same, period in 2021. These increases were due to increased personnel and non-cash share-based compensation costs due to additional hires, as well as increased development and other expenses as we continue to investigate COMP360 psilocybin therapy in clinical and preclinical trials.

We expect R&D expenses to increase modestly until our Phase III program commences later this year. For the six months ended June 30, 2022, R&D expenses were $31.3 million, compared with $18.2 million during the same period in 2021.

For the three months ended June 30, 2022, G&A expenses were $11.3 million, compared with $8.2, million during the same period in 2021. These increases were attributable to increased personnel and non-cash share-based compensation costs due to increased hiring and legal and other professional fees, as well as facilities and other expenses to support our growth initiatives, including operations as a public company.

So we're in an exploratory stage with this trial.

We'll let you know as it develops.

Only seems like that.

Thank you.

One moment.

Thank you one moment.

Okay.

For the six months ended June 30, 2022, G&A expenses were $21.4 million, compared with $14.9 million during the same period in 2021.

indications, specifically regarding the level of psychological support or talk therapy.

And our next question comes from Jason McCarthy of Maxim Group.

Compass continues to maintain a strong financial position with cash and cash equivalents of $207.2, million at June 30, 2022, compared with $273.2 million at December 31, 2021. With these resources, we expect to be able to fund our operations into 2024. We view our strong balance sheet as an important strategic asset, which we intend to manage carefully as we invest to advance these promising potential therapies, while at the same time continuing to create value for our shareholders.

Our next question comes from French Swab response of Oppenheimer. Please proceed.

Please proceed.

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

How is this differing, if at all, in terms of the PrEP and the integration sessions?

Thanks for taking my questions.

Hey guys, this is Michael Okunewitch on the line for Jason.

Thanks, Joe.

Thank you.

Alright, thanks for taking the questions I look forward to October 12.

Thank you for taking my questions.

For more details so I'll try to ask something a little bit different here, but on the right side you guys are.

And as well, what extent the digital therapeutics are expected to be included in these different

So I guess first, you mentioned refining your therapist training strategies.

So could you just comment on how comprehensive of a training program is needed and how long you would expect it to take to actually, you know, fully train and certify a therapist for COMP 360?

Guys are you including.

indications, these different trials evaluating these different indications?

Some of these digital tools that you kind of teased us with on this call, but I was just wondering in order to include these how much discussion goes in with the regulatory bodies in order just to make sure that these are validated and would you say that patient needs more prep he gets more prep.

Certainly, Patrick, thank you for that question.

From the regulatory body and maybe the FDA are there any discussions where if there's too much usage of this how can we actually tell whats.

The drug is it the digital side any discussion there would be helpful.

Well I think I think it's clear that in the in their public statements and the FDA officials. We've discussed the issues of psychological support of usually made clear that they are interested in the minimum amount necessary for safety.

The digital support will certainly be included in both the Phase III studies that were proposed

and also in the anorexia study that we described in this call.

They haven't usually as far as I know committed themselves on issues.

We think that it's an opportunity to improve the way in which therapy is currently delivered,

A digital support.

and it also is an opportunity to look at how it can be refined and some of the therapy

Obviously, it's a new area and I think it's.

Obviously, a growing one.

burden reduced.

Going forward, we see particularly the digital support as a way of improving things in terms

And the key issue I think is it doesn't confound the issues around the effects of the drug and the efficacy of the drug which is the key objective of the program.

of quality and reducing, to some extent, some of the additional costs that are associated

None of whether that answers your question George May want to comment.

So I think, again, we're in the process of finalizing that as part of the Phase III design.

I think just in addition, we view all of these data arising from this as exploratory endpoints to help inform subsequent developments.

So they don't have any impact on the actual study.

This delivery et cetera.

Okay. That's helpful and then Theres been some M&A. This morning in biotech and I was just wondering in your space a lot of players you guys are mostly focus on comp 360, right now, but any high level views on potential consolidation in the field.

You were to look at some acquisitions and whatnot.

Any specific kind of criteria that you would look at where are we just focus on income through 16.

We're never just focused on <unk> 360 here, obviously, it's our top priority, but not our sole focus.

As you know, we've obviously you would imagine we've seen almost everything that's in the space and we will assess that based on time to patients and impact on patient outcomes at scale.

That's always going to be our true north campus in terms of assessing so if we see something that makes sense it will help patients.

And it has a rigorous evidence space, we're going to be interested.

So that probably is enough to answer the question I hope.

Thank you, Mike.

So I think that that will be more comprehensively shared on the 12th.

Yes, thank you very much.

In closing, I look forward to seeing Kabir employ his leadership and experience to deliver, our investigational COMP360 psilocybin therapy to those patients who are not helped by currently available treatments.

I know that with his leadership, COMPASS is well-positioned to advance our goals of improving, patient access and outcomes, and that our team will continue to thrive.

As you heard from Guy, we are pleased with the progress of our FDA interactions, and, we look forward to sharing our Phase III program in our upcoming Investor Day on October 12th, which will also feature our TRD commercial strategy, our advanced suite of digital tools, additional information on our PTSD and anorexia programs, and perspectives from KOLs.

Importantly, Kabir shares our deep commitment to transforming the patient experience of, mental health care.

October 12 are you guys sharing at all if this is potentially in person or not or.

This leadership transition is an important priority because we are building COMPASS, to make a difference in people's lives for generations to come. We know that a well-executed succession plan, along with a strong focus on people development, is central to the growth of every significant and successful company.

Kabir joining COMPASS will enable me to focus on shaping our public-private partnerships, policy and policy efforts, as well as leading our Board of Directors in my role as Chairman.

We look forward to having you join us.

Reinforced by our incredible team here at COMPASS and now the addition of our new CEO, our leadership in this area of science continues to grow as we move closer to our goal of transforming the treatment of mental health, which has the potential to change people's lives for the better for generations to come.

It is going to be it's going to be a virtual event.

Our thought is that a lot of people will be able to tune into it online many more will be viewing it in archive. So we thought up purely virtual would be the best way also our experience with kind of half virtual half life is that they're not as good as either all virtual or all of our lives.

Virtual seems to be the right format.

This is an exciting time for all of us and for those investors who support our mission.

Thank you Anna we should also point out that the Investor day will give.

I am so grateful for what we've accomplished, and I look forward to this next chapter in, our journey together.

Thank you for your time today.

Give us the opportunity I think to showcase the team here at Compass and also we're going to be offering up some kols perspective, because that's something that we've heard investors would really be interested in hearing and it's best to deliver all of those through the virtual format.

We will now open the line for questions.

One moment.

Great. Thank you.

Our next question comes from Sumant Kulkarni of Canaccord Genuity.

Okay.

Thank you one moment.

Okay.

Our next question comes from Al <unk>.

Please proceed.

Ross. Please proceed.

Operator?

Good morning and afternoon to the team.

Thanks for taking my question.

Yes, good morning, everyone.

George you previously alluded to.

And that the level of preparedness.

For the actual.

Dosing of the therapy.

Made a difference.

And the outcomes.

Do you plan to incorporate this almost as a selection tool.

In subsequent studies.

It's going for a specific mandate phase III, but just a general concept.

Thank you.

I have two,

I think probably the hi, Oliver and I think you know us well enough that anything we learn to improve outcomes, we're going to do and put that to action.

As a reminder, to ask a question, you will need to press star 1-1 on your telephone.

one on TRD and one on anorexia.

I can turn it over to guy for any specific thoughts on that but I.

I think just the ethos of this organization is everything we learned that can help us.

Please stand by while we compile the Q&A roster.

Our first question comes from Ritu Burrell of Cohen.

I think expert opinion is increasingly focused on preparation as you as you imply on alright, I think we will certainly as we develop the treatments and take it into real world setting, we'll be looking to optimize that aspect of it.

Please go ahead.

Obviously with the way with shaping the phase III is restricted by the need to keep things simple, but we'll certainly be looking at how we do this in the future so that it gets better and better.

But we will be taking learnings from our phase <unk> into phase III as we.

We design and develop the protocols.

Good morning, guys.

Thank you so much.

Thanks for taking the question.

Thank you one moment.

Okay.

Yes.

I wanted to ask about some very, very high-level aspects of the phase 3.

Our next question comes from Bert Hazlett of BTG. Please proceed.

Thank you and thank you for taking the questions. Congratulations on all the progress just one with a little bit more granularity for the anorexia nervosa.

Program, and then maybe one or two bigger picture items.

It appeared that the earlier study.

Again, small and <unk> I guess the earlier study showed data that may be strengthened.

A little bit further out in three months as opposed to one month. So I'm curious as to the week for endpoint and if youre looking at.

Results further out and then secondly are ended depressant is going to be excluded in that trial for those patients.

Yes. Thank you yes. It is.

And to be a 12 week observational component.

We've kept the four weeks because we in many ways you can keep things most constant for those that first four weeks and as time goes on.

Other things intervene so I think keeping it to four weeks makes sense as an initial treatment effect and then continuing to observe over 12 weeks Optimizes, what we can see.

In terms of antidepressants, we still will continue to withdraw patients' from antidepressants.

With the same strategy as we used in the phase III since it worked well.

Terrific. Thank you.

And then just kind of bigger picture questions you've had some.

Granted patents you mentioned in the press release with regard to composition formulation and method of use.

And there is some.

Continued obviously discovery work with novel drug candidates could you elaborate maybe a little bit more on both of those efforts and whether we should actually we should see maybe visibility of the novel drug candidates and what the goals are therefore for the novel and CES.

Sure I can start there again some of this will be a part of the discussion we have on the trough to shine a light on some of our discovery efforts et cetera.

with multiple therapists, et cetera.

But I think we've always been clear that what we're looking to do is to develop novel.

Chemical entity as it will enable us to enhance the patient experience and so right now there's precious little data on shorter acting, but obviously, we need to look at that to help more patients over the same period of time. So that's one of the design elements of these but we have a lot of.

Efforts in our discovery program looking at different dimensions, and we will certainly report out on that obviously intellectual property is important.

We will continue to integrate that thinking into the selection of future compounds that approaches.

Thank you very much.

Thank you.

One moment.

And our next question comes from.

Jason Mccarthy of Maxim Group.

Please proceed.

Hey, guys. This is Michael <unk> on the line for Jason. Thank you for taking my questions.

So I guess versus.

You mentioned refining your therapists training strategies. So could you just comment on how comprehensive training.

Training program is needed and how long you would expect it to take to actually fully trained and certified therapist for comp 360.

So I think again, we're in the process of finalizing that as part of the phase III design. So I think that that will be.

More comprehensively shared on the 12th our view is that we have a multi tier training model as we've said that includes clinical training.

Our view is that we have a multi-tiered training model, as we've said, that includes clinical training that provides experience to therapists with then the ability for them to work under supervision in clinical settings and then to move on their own.

That provides experienced two therapists with then the ability for them to work under supervision.

In clinical settings, and then to move on their own so it's a very comprehensive process.

So it's a very comprehensive process.

It's approximately 40 hours, but looking at being optimized right now our whole focus has been on scalability for this approach hence the use of technology I think the most important element of what we're doing is actually building a learning component and youll be hearing much more about this on the 12 where ever.

Session is recorded.

And that then provides transcripts that enabled a therapist and the therapists mentors to improve the process as we move forward and so this learning that we do in the real world through all of our trials, whether it's phase III or anorexia or PTSD all of that gets incorporated and then we will be releasing iterations of how to improve the therapy.

And the therapist training over time. So this is really an important element of what we're doing in terms of scalability and our goal is to make this.

Just the right size and to continue development over times, providing people feedback from the real world. So those are the key elements of it we'll talk more about the program as its agreed.

Alright. Thank you very much and then just one more follow up.

Layering in.

Anorexia program coming in from your investigator initiated study pipeline and you are quite a few more should we think of this as kind of the primary vector for label expansion for <unk> 360, and can you point to any other investigator initiated studies that are expected to read out in the near term.

Medium term.

Sure so yes.

Yes, you've caught our plan is to really use these.

Obviously these are independent investigator initiated trials.

But we choose ones that we think would make a significant contribution to unmet patient need.

Closely at the results and as we did with under Rex here.

If we see something positive and patient benefit we will look at prioritizing those for development.

As I mentioned these are independent investigator initiated trials. So it's hard for us to know when things will report out.

But I would expect that given where some of these things are you may be hearing more news this year.

Sure.

Alright, Thank you very much.

Sure.

Thank you I would now like to turn the conference back to management for closing remarks.

I wanted to thank everyone for their patience with regard to the process that we're engaged in this is critical because we are first in class. We are doing something that has not been done before and we need to do it with the utmost care.

For all stakeholders and so we appreciate your among them and we appreciate your patience with us.

This is an incredibly exciting time when we start looking at the results, we're seeing not only from our phase two study, but also looking at the early signals that we have and anorexia and other things. So it's an exciting time, we're moving fast.

Quickly and effectively in our therapy development in our technology support our data. So I think we're really excited about October 12th and we'll look forward to seeing many of you there.

With that I want to thank you for your support and interest and as always we're available for subsequent questions as the need arise. Thank you.

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

I understand there's going to be a lot more detail coming, but you mentioned protocols,

I'm not sure whether that completely answers your question.

So, as we sit here today, does it make sense to run both phase

It's approximately 40 hours, but looking at being optimized right now.

I'm wondering if you're thinking about making the two phase 3s different, whether looking

I think you may be interested in the details from the digital therapeutics side when we

three trials for TRD in parallel?

at different populations or just generating different data sets.

demonstrate that again on October the 12th.

Or if you were to choose a staggered start, would that decision

The conference will begin shortly.

And then just in terms of the level of psychological support, is that expected to be, you know,

would we expect to have, you know, more psychotherapy with, you know, PTSD as compared to TRD or

As Johan during Q&A, you can dial star one one.

as compared to anorexia, or is it, are the kind of the therapy protocols pretty similar

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Okay.

Yes.

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