Good day, ladies and gentlemen, and welcome to the COMPASS conference call. At this time, participants are in a listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, 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. 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. Guy Goodwin, our Chief Medical Officer, and Mike Falvey, our Chief Financial Officer. I'm also pleased to introduce our new Chief Executive Officer, Kabir Nath. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.
You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading Risk Factors in our quarterly report on Form 10-Q, filed with the U.S. Securities and Exchange Commission, and in subsequent filings made by COMPASS Pathways with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. I'll now hand the call over to George Goldsmith.
Thank you, Steve, and welcome everyone. I'm excited to begin today's call by introducing our new CEO, Kabir Nath, to his first Compass quarterly results call. As he officially just started on August first, I won't press him into heavy service, but instead will ask him to provide some background and thoughts on his move to Compass. I will then continue with a 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. 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 Pathways was created when my wife and co-founder, Ekaterina Malievskaia, and I experienced firsthand how even the best institutions and psychiatrists 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, COMPASS Pathways has been laser-focused on our mission to accelerate patient access to evidence-based innovation in mental health care. 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. Visions without talent and capability are nothing but dreams. Since our founding, we've grown from 2 people to almost 150. With every new employee addition, the concrete steps to achieve our collective vision became clearer. 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.
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. 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 Katya 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 first, our executive team began reporting to Kabir. 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 mean my co-founder 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'll now ask Kabir to say a few words. Over time, you'll have many opportunities to get to know him better. Kabir.
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's next Chief Executive Officer. I share a similar personal story to that of George and Katya and have a deep dedication to COMPASS's mission to bring forward new solutions for patients living with serious mental illness. 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. 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's series B investment round in 2020.
From the start, I was struck by their passion and determination to advance data-based and innovative solutions in mental health care. 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. I share their vision of creating 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. For myself, I have several decades of experience in the healthcare industry in both med tech 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 business.
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. There is great work to do at hand at COMPASS Pathways, especially as we embark on our phase III program for patients suffering with treatment-resistant depression. 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. I look forward to meeting and working with you. I'm excited to be leading this critically important endeavor in continued partnership with George. Together, I believe we can realize COMPASS Pathways' vision to create new integrated models of care which enable access for patients to transformative, evidence-based, innovative solutions for serious mental illness.
I'll hand it back to George.
Thank you, Kabir, and again, welcome, and we are thrilled to have you at the helm. I'm also pleased to report to you that during this quarter, COMPASS Pathways 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 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 III program will support regulatory approval and contribute evidence for reimbursement of this new therapy. 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.
Last week, we announced a new phase II 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. With that, let me now turn to Guy, who will provide his thoughts on the next steps in our planned phase III program and some more detail on the anorexia program. Guy?
Thank you, George, and good day, all. Let me echo George's confidence in the progress of our phase III program interactions with the FDA. Since the protocols are still under review, I will limit my comments on details during today's call. What I can say is our submitted design included two controlled pivotal trials and incorporated a number of the important lessons from our phase II program. 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. Again, we look forward to sharing the details of this program with you in October. Last week, we announced a third COMP360 program, a phase II 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 4 world-leading research institutes in the U.K. and the U.S., King's College London, Columbia University Irving Medical Center, University of California San Diego School of Medicine, and Sheppard Pratt. Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating Disorder Examination, EDE interview, and other measures. The trial primary endpoint is change from baseline in the EDE global score at week 4 after administration of COMP360 psilocybin therapy. 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%-40% of deaths in anorexia nervosa are thought to result from suicide, the highest suicide rate of any mental illness. Not only does it have an enormous impact on the people who live with it, but also on the people closest to them. Our interest in this indication is supported by positive early signals from an exploratory open-label investigator-initiated study conducted by Dr. Walter Kaye, Professor of Psychiatry at the University of California, San Diego, the results of which were published in May at the Society of Biological Psychiatry annual meeting. Dr. Kaye is the principal investigator on our trial. 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.
This phase II 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. We will demonstrate these tools during our Investor Day on October 12.
This phase II 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. We look forward to reporting on these programs as they progress. Let me now turn the call over to Mike for the financial review.
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. 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 in other expenses as we continue to investigate COMP360 psilocybin therapy in clinical and pre-clinical 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. 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. COMPASS continues to maintain its 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. Thank you, and I'll now turn the call back to George.
Thank you, Mike. 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 Pathways is well positioned to advance our goals of improving patient access and outcomes, and that our team will continue to thrive. Importantly, Kabir shares our deep commitment to transforming the patient experience of mental health care. This leadership transition is important priority because we are building COMPASS Pathways 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, advocacy, and policy efforts, as well as leading our board of directors in my role as chairman. 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. We look forward to having you join us.
Reinforced by our incredible team here at COMPASS Pathways 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. This is an exciting time for all of us and for those investors who support our mission. I am so grateful, though, for what we've accomplished, and I look forward to this next chapter in our journey together. Thank you for your time today. We will now open the line for questions. Operator?
Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Ritu Baral of Cowen. Please go ahead.
Good morning, guys. Thanks for taking the question. I wanted to ask about some very, very high-level aspects of the phase III. I understand there's gonna be a lot more detail coming, but you mentioned protocols, plural. I'm wondering if you're thinking about making the two phase IIIs different, whether looking at different populations or just generating different datasets. On that note, generating datasets, George, you mentioned something about designing the phase III such that it generates data useful for payers. Can you elaborate on that a little bit? Then I've got a question on the anorexia trial.
Great. Hi, Ritu, and thanks for the question. I think that we will continue to keep things as we've disclosed so far and not go into deeper details. Again, what we're aiming to do here is to share everything after we have full sign-off from the FDA, and that process is underway. 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 and 2018 in the U.S.. We are going to be including endpoints in all of our studies that enable us to accelerate the reimbursement discussions on both sides of the Atlantic.
In terms of more details and on study design, we're gonna 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, like, payers are more interested in further out time points than the regulatory guidance?
I think that, you know, we see that there is variation in that, depending on the systems, and so we're accommodating all of that in our study designs. Again, we'll be able to report more on the 12th as we share the entire program.
Got it. On the anorexia program, super quick, the EDE scale, I'm not very familiar with that. Are there any key subscales of import for regulators, and is this a pivotal endpoint? I think SSRIs are approved, but I don't know what they were approved on.
That's a great question, Ritu. Guy here. I mean, the EDE has certainly been the measure that has been used in the main psychotherapy trials. Since psychotherapy is the main way in which anorexia has been treated in the past, we regard it as the most important of the measures that we can make. We are including other secondaries, which we think will be informative and particularly relate to obsessionality and control, which is a key feature of the underlying problems that patients with anorexia have, and of course, quality of life, as George said, is something in all of our studies.
I think it's 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're obviously taking advice from the FDA and other regulatory bodies as we go forward with this program.
Great. Thanks for taking all the questions.
Thanks, Ritu.
Thank you. One moment. Our next question comes from Neena Bitritto-Garg of Citi. Please proceed.
Hey, guys. Thanks for taking my question. I just have two for me. One is just 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 would be great. I know you're also planning on reporting out the one-year long-term follow-up data for the phase II-B and patients in the phase II adjunctive SSRI study. I'm just wondering if you could give us a sense of, you know, maybe the timing for that, whether that will be at the October 12th Investor Day or before that, and what sorts of metrics we should, you know, expect to see on that readout. Thanks.
Yeah. Thanks, Nina. I'll start on the cash balance and then turn it over to Guy and George. As you noted, our cash balance went from $244 million at the beginning of the quarter to $207 million at the end. That's a change of about $37 million. 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 dollars for reporting purposes. 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.
Most of this $18 million impact is a paper loss because we intend to spend those pounds and not change them into dollars. Going forward, this is gonna be our continued strategy. 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. The most important thing is that our cash runway continues to last into 2024. I should also probably add, you know, the currency changes that we've seen over the first half have been unusually significant. The dollar really strengthened against all currencies because of the political uncertainty and the spike in energy prices. 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 important for us to put this natural hedge in place, to make sure those currency impacts have very little operating impact.
The question about the follow-up study, which we know is zero zero four. Just as a reminder, this took patients who had participated in both zero zero one, which was our main phase II-B 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 being analyzed. I think it will be a timely moment to discuss it when we present the Investor Day on the 12th of October. I think, again, waiting for that date will be increasingly interesting when we get there.
Got it. Thank you.
Thank you. One moment. Our next question comes from Patrick Trucchio of H.C. Wainwright. Please proceed.
Thanks. Good morning, and congrats on all the progress. Just a first follow-up on the COMP360 program, which is now building out to multiple indications including TRD, PTSD, and anorexia. 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 or talk therapy, how is this differing, if at all, in terms of the, you know, the prep and the integration sessions? As well, what extent the digital therapeutics are expected to be included in these different indications or these different trials evaluating these different indications?
Certainly, Patrick. Thank you for that question. The digital support will certainly be included in both the phase III studies that we're proposed 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. Going forward, we see particularly the digital support as a way of improving things in terms of quality and reducing, to some extent, some of the additional costs that are associated with multiple therapists, et cetera. I'm not sure whether that completely answers your question.
You know, I think we'll. You may be interested in the details from the digital therapeutic side when we demonstrate that again October the 12th.
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 compared to anorexia? Or are the kind of therapy protocols pretty similar across those three?
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. I think that in a sense is the objective, a partial objective of both the studies that we're undertaking.
Hi, Patrick. Patients in the past, if they need more support, they receive it as part of the protocol. That's, you know, clearly patient first here.
That's helpful. If I could just ask one on the commercialization side. You know, just looking far ahead, I'm wondering if you can discuss the build-out of the mental health care clinic infrastructure in the US and Europe. What preparations, if any, are underway at, you know, at Compass to prepare for this potential for COMP360? You know, then I guess just separately, how, you know, 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 Compass' commercial efforts as we look ahead to COMP360 initially, perhaps in TRD?
Sure. I'll take that. Our focus is to leverage existing infrastructure wherever possible, and I think we've seen nearly 1,000 sites of delivery for esketamine, for example, in the United States. I think that plus TMS, and to your point, if MDMA receives the 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. In Europe, obviously, we've been working more with the academic and clinic delivery system. As we move into phase III, you'll see us working more to build out that infrastructure. We'll report more fully on all of this on October 12th.
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.
That's one of the key reasons Kabir has joined us, is to really focus on that, those issues. Here we are.
Yep. Great. Thank you.
Thank you. One moment. Our next question comes from Charles Duncan of Cantor Fitzgerald. Please proceed.
Okay. Yeah. Morning, George and team, congratulations on the completion of the end of phase II meeting and progress with this innovative program. I had a couple of questions on it and then just one on PTSD. The questions that I had on the program, I realize that you are waiting for additional feedback from the agency, and we'll share a lot of details in October 12th. I guess I'm just wondering if you can provide any color on the points of debate or that you had with the agency, if anything, or if there are any elements of surprise that you think investors would note. Could it be sample size? Could it be dosing paradigm or, you know, control arm, et cetera? Is there anything you can provide?
With regard to the cash use, I think Mike mentioned good through 2024. Does that fully consider the design elements that you're waiting on details?
Happy to maybe kick this off and have Guy follow on. I would say that we've been incredibly encouraged by the thoroughness of our interactions with the FDA. We have to keep in mind here that when you look at, you know, what was observed in the prior question around the breadth of what we're looking at, the fact that this is first in class, and that this is a whole new area of kind of this development and evidence generation. You know, 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 Compass. You know, 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. These are huge indications, we really want to make sure we get everything right. That's about all I can say on that front. Guy, did you want to add on?
No, I don't think so. I think just to reiterate what George has said. I mean, as we said on the broadcast, you know, we've announced that we've included two pivotal trials in this program, and we just noticed that this is consistent with precedents in TRD indications where no one has actually received approval based on a single pivotal study. 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 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.
About financial modeling?
Charles, on the cash runway, we continue to affirm that we have runway into 2024. In coming up with that runway, we did put in a healthy placeholder for a phase III program. You know, as we refine the plans, we continue to make sure that we're, if anything, over-budgeted in that area. That is contemplated in the runway we've projected.
Got it. That all makes sense. Appreciate the color and look forward to October 12th. 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. Was the new site driven by, I guess, interest by the investigator or a desire to, I guess, capture a broader set of patients to fuel enrollment? Thanks.
It really wasn't to do with numbers. It was to do with capitalizing on expertise. You know, we had two world-class centers, and two world-class centers are better than one world-class center.
For sure. Okay. Thanks for taking my questions.
Thanks, Charles.
Thank you. One moment. Our next question comes from Sumant Kulkarni of Canaccord Genuity. Please proceed.
Good morning and afternoon to the team. Thanks for taking my questions. I have two, one on TRD and one on anorexia. As we sit here today, does it make sense to run both phase III trials for TRD in parallel? Or if you were to choose a staggered start, would that decision be driven predominantly by strategic or financial considerations?
I'm sorry. We're really not discussing the trials in this level of detail at this point. I think we've explained we see ourselves as in an important confidential process with the FDA, and we'll tell you the conclusions on October 12th. I'm sorry to sound like a broken record, but that's just I guess I'm a broken record.
No, no problem. Some broken records can be good. On the anorexia phase II, do you expect the ratio of female to male participants to mimic real-world distribution? Are there any confounding gender-based differences in the EDE score, either at baseline or in its clinical relevance at an endpoint?
That's a good question. I mean, most studies actually include only women. You know, we're in an exploratory stage with this trial, and we'll let you know as it develops, on issues like that.
Thank you.
Thank you. One moment. Our next question comes from Francois Brisebois of Oppenheimer. Please proceed.
Hi. Thanks for taking the questions. I look forward to October 12th for more details. I'll try to ask something a little bit different here. On the digital-
Sorry.
Aside, you guys are including, you know, some of these digital tools that you kinda teased us with on this call. 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, you know, if you say the patient needs more prep, he gets more prep. Just 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 what's, you know, is it the drug? Is it the digital side? Any discussion there would be helpful.
Well, I think it's clear that in the public statements and the FDA officials who've discussed the issues of psychological support have usually made clear that they're interested in the minimum amount necessary for safety. They haven't usually, as far as I know, committed themselves on issues of digital support. Obviously it's a new area, and I think it's obviously a growing one. 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. Don't know whether that answers your question. George may want to comment.
Well, I think just in addition, we view all of these, the data arising from these, as exploratory endpoints to help inform subsequent developments. So they don't have any impact on the actual study, delivery, et cetera.
Okay. That's helpful. Then there's been, you know, some M&A this morning in biotech, and I was just wondering, in your space, a lot of players, you guys are mostly focused on COMP360 right now, but any high-level views on potential consolidation in the field? If you were to look at some acquisitions and whatnot, was there any specific kinda criteria that you would look at, or are we just focused on COMP360?
We're never just focused on COMP360 here. Obviously, it's our top priority, but not our sole focus. As you know, obviously 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 at scale. That's always going to be our true north at COMPASS in terms of assessing. If we see something that makes sense, it will help patients, and it has a rigorous evidence base, we're gonna be interested. That probably is enough to answer the question, I hope.
Yep. No, thank you very much. I look forward to October 12th. Are you guys sharing at all if this is potentially in person or not, or?
It's gonna be a virtual event. You know, our thought is that a lot of people will be able to tune into it online. Many more will be viewing it in archive. We thought purely virtual would be the best way. Also, our experience with kinda half virtual lives is that they're not as good as either all virtual or all live. Virtual seems to be the right format.
Perfect. Thank you very much.
We should also point out that the investor day will give us the opportunity, I think, to showcase the team here at COMPASS. Also we're gonna be offering up some KOL perspectives 'cause 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.
Great. Thank you.
Thank you. One moment. Our next question comes from Elemer Piros of Roth. Please proceed.
Yes, good morning, everyone. George, you previously alluded to that the level of preparedness for the actual dosing of the therapy. It made a difference in the outcomes. Do you plan to incorporate this almost as a selection tool in subsequent studies? I'm not asking for it specifically this phase III, but just a general concept.
I think probably. Hi, Elemer, 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. I can turn it over to Guy for any specific thoughts on that, but I think just the ethos of this organization is everything we learn that can help, we'll use. Guy?
I think expert opinion is increasingly focused on preparation, as you imply, Elmer. I think we will certainly, as we develop the treatment and take it into real-world settings, we'll be looking to optimize that aspect of it. Obviously with the way we're shaping the phase III is restricted by the need to keep things simple. We'll certainly be looking at how we do this in the future so that it gets better and better.
We will be taking learnings from our phase II-B into phase III, as we design and develop the protocols.
Thank you so much.
Thank you. One moment. Our next question comes from Bert Hazlett of BTIG. 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 n of 10, I guess. The earlier study showed data that may be strengthened a little bit further out at 3 months as opposed to 1 month. I'm curious as to the week 4 endpoint and if you're looking at results further out. Secondly, are antidepressants going to be excluded in that trial for those patients? Thanks.
Yeah, thank you. Yeah, yeah, it's going to be a 12-week observational component. We kept it 4 weeks because, you know, in many ways you can keep things most constant for those first 4 weeks, and as time goes on, other things intervene. I think keeping it to 4 weeks makes sense as an initial treatment effect, and then continuing to observe over 12 weeks optimizes what we can see. In terms of the antidepressants, we still will continue to withdraw patients from antidepressants, and with the same strategies we used in the phase II-B since it worked well there.
Terrific. Thank you. 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. There's 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 when actually we should see maybe visibility of the novel drug candidates and what the goals are there for the novel NCEs? Thanks.
Sure, I can start there. Again, some of this will be part of the discussion we have on the 12th, to shine a light on some of our discovery efforts, et cetera. I think we've always been clear that what we're looking to do is to develop novel chemical entities that will enable us to enhance the patient experience. 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. That's one of the design elements of these. We have a lot of efforts in our discovery program, looking at different dimensions, and we'll certainly report out on that. Obviously, intellectual property is important, and we'll continue to integrate that thinking into the selection of future compounds and approaches.
Thank you very much.
Thank you.
Thank you.
One moment. Our next question comes from Jason McCarthy of Maxim Group. Please proceed.
Hey, guys. This is Michael Okunewitch on the line for Jason. Thank you for taking my questions. I guess first, you mentioned refining your therapist training strategies. 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 COMP360?
I think, again, we're in the process of finalizing that as part of the phase III design. I think that will be more comprehensively shared on the 12th. Our view is that we have a multi-tiered training model, as we said, that includes clinical training that provides experience to therapists, then the ability for them to work under supervision in clinical settings and then to move on their own. 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 in, 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 therapists and the therapist mentors to improve the process as we move forward. 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. 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. Those are the key elements of it.
We'll talk more about the program as it's agreed.
All right. Thank you very much. Just one more follow-up.
Sure.
You mentioned layering in, the anorexia program coming in from your investigator-initiated study pipeline, and you have quite a few more. Should we think of this as kind of the primary, vector for label expansion and for COMP360? Can you point to any other investigator-initiated studies that are expected to read out in the near-to-medium term?
Sure. Yes, you've caught our plan. It's to really use these. Obviously, these are independent investigator-initiated trials. We choose ones that we think would make a significant contribution to unmet patient need. 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. As I mentioned, these are independent investigator-initiated trials, so it's hard for us to know when things will report out. I would expect that, given where some of these things are, you may be hearing more news this year.
All right. Thank you very much.
Thank you.
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. We appreciate you're 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 II study, but also looking at the early signals that we have in anorexia and other things. It's an exciting time. We're moving fast and, you know, quickly and effectively in our therapy development, in our technology support, our data. 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. 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.