Earnings Call Transcript
COMPASS Pathways plc (CMPS)
Earnings Call Transcript - CMPS Q2 2022
Operator, Operator
Good day, ladies and gentlemen, and welcome to COMPASS Conference Call. At this time, all 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, Steven Schultz. You may begin.
Steven Schultz, Senior Vice President of Investor Relations
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 Chief Executive Officer; Dr. Guy Goodwin, our Chief Medical Officer; and Mike Falvey, our Chief Financial Officer. I am 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 with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements even if our estimates or assumptions change. I’ll now hand the call over to George Goldsmith.
George Goldsmith, Co-Founder and CEO
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 1st, I won’t press him into heavy service, but instead, we’ll ask him to provide some background and thoughts on his move to COMPASS. I will 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. 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 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 the 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 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 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 that 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 1st, 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 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 will now ask Kabir to say a few words. Over time, you will have many opportunities to get to know him better. Kabir?
Kabir Nath, CEO
George, thank you very much and good day to everyone. Today, as we embark on our next chapter of 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 have 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 that 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. And 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 America 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 as Head of COMPASS, especially as we embark on our Phase III program for patients suffering from treatment-resistant depression. One of my main priorities will be moving COMP360 psilocybin therapy successfully through the clinical trials, 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 am excited to be leading this critically important endeavor in continued partnership with George. Together, I believe we can realize COMPASS's vision 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.
George Goldsmith, Co-Founder and CEO
Thank you, Kabir, and again, welcome. We are thrilled to have you at the helm. I’m also pleased to report that during this quarter, COMPASS 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, 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 commence 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?
Dr. Guy Goodwin, Chief Medical Officer
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 control 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’s 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 the 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 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 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's primary endpoint is change from baseline in the EDE Global Score at week four 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% to 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 My Pathfinder, a COMPASS-developed educational digital app for supporting patient participation in COMP360's psilocybin therapy trials. The app provides engaging education about the therapy model and, with participant consents, we’ll 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 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 12th. 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, Mt. 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.
Mike Falvey, Chief Financial Officer
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 and other expenses, as we continue to investigate COMP360's 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. 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.
George Goldsmith, Co-Founder and CEO
Thank you, Mike. In closing, I look forward to Kabir employing 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. Importantly, Kabir shares our deep commitment to transforming the patient experience of mental health care. 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, 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, 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 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, Operator
Thank you. Our first question comes from Ritu Baral of Cowen. Please go ahead.
Ritu Baral, Analyst
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 going to 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. And 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? And then I’ve got a question on the anorexia trial.
George Goldsmith, Co-Founder and CEO
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. So 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 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.
Ritu Baral, Analyst
Fair enough, George. Are you finding that like payers are more interested in further-out time points than the regulatory guidance?
George Goldsmith, Co-Founder and CEO
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 again, we’ll be able to report more on the 12th as we share the entire program.
Ritu Baral, Analyst
Got it. Regarding the anorexia program briefly, I'm not very familiar with the EDE scale; are there any important sub-scales for regulators, and is this a key endpoint? I believe SSRIs are approved, but I'm not sure what they were approved based on.
Dr. Guy Goodwin, Chief Medical Officer
That’s a great question. This is Guy here. I mean, the EDE is certainly been the measure that has been used in the main psychotherapy trials. And since psychotherapy is the main way in which anorexia has been treated in the past, we regarded 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, in all of our 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 there are obviously taking advice from the FDA and other regulatory bodies as we go forward with this program.
Ritu Baral, Analyst
Great. Thanks for taking all the questions.
George Goldsmith, Co-Founder and CEO
Thanks, Ritu.
Operator, Operator
Thank you. One moment. Our next question comes from Neena Bitritto-Garg of Citi. Please proceed.
Neena Bitritto-Garg, Analyst
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? And then I know you’re also planning on reporting out the one-year long-term follow-up data for the Phase IIb and patients in the Phase II adjunctive SSRI study. And I’m just wondering if you could give us a sense of 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 expect to see on that readout? Thanks.
Mike Falvey, Chief Financial Officer
Yeah. Thanks, Neena. I’ll start on the cash balance and then turn it over to Guy and George. So, yeah, as you notice, our cash balance went from $244 million at the beginning of the quarter to $207 million at the end. So 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. And as we’ve noted in the past week, we hold our cash balances in both dollars and pounds to match our forecasts and spending in each currency. So 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 going to 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. And the most important thing is that our cash runway continues to last into 2024. And I should also probably add, the currency changes that we’ve seen over the first half have been unusually significant. So the dollar really strengthened against all currencies, because of the political uncertainty and a spike in energy prices, and this is something you’ll see pretty consistently. Historically, we don’t know what direction they’ll take going forward, which is why it’s important for us to put this natural hedge in place to make sure those currency impacts have very little operating impact.
George Goldsmith, Co-Founder and CEO
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 IIb study, and also 003, which was our adjunctive study, where patients continued to take SSRIs. We know that the patients are basically in the years follow-up now and the data is being analyzed. I think it will be a timely moment to discuss it when we present at the Investor Day on the 12th of October. So, I think, again, waiting for that day will be increasingly interesting when we get there.
Neena Bitritto-Garg, Analyst
Got it. Thank you.
Operator, Operator
Thank you. One moment. Our next question comes from Patrick Trucchio of H.C. Wainwright. Please proceed.
Patrick Trucchio, Analyst
Thanks. Good morning, and congrats on all the progress. Just the 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 press and integration sessions? And as well, what extent the digital therapeutics are expected to be included in these different indications and different trials evaluating these different indications?
George Goldsmith, Co-Founder and CEO
Thank you for your question, Patrick. Digital support will be incorporated into both the Phase III studies proposed and the anorexia study mentioned during this call. We view this as an opportunity to enhance current therapy delivery and to potentially refine it, thereby alleviating some of the therapy burden. Moving forward, we see digital support as a means to improve quality and reduce some of the additional costs associated with having multiple therapists. I'm not sure if that fully addresses your question; you might find the details about the digital therapeutic aspect interesting when we present again on October 12th.
Patrick Trucchio, Analyst
Okay. In terms of the level of psychological support, can we expect more psychotherapy for PTSD compared to treatment-resistant depression or anorexia, or are the therapy protocols fairly similar across these three conditions?
Dr. Guy Goodwin, Chief Medical Officer
In the first instance, they are similar, but I think we’re conducting these studies for exploratory reasons to determine the extent to which they can remain consistent. So, in a sense, that is part of the objective of both studies we’re undertaking.
Patrick Trucchio, Analyst
Okay.
George Goldsmith, Co-Founder and CEO
And obviously, these patients have received more support in the past as part of the protocol if they needed it. So that’s clearly patient-first here.
Patrick Trucchio, Analyst
Yeah. I would like to ask about the commercialization aspect. Looking ahead, can you discuss the development of mental health care clinic infrastructure in the U.S. and Europe? What preparations, if any, is COMPASS making for the potential of COMP360? Additionally, with the potential approval of MDMA for PTSD in 2023, how might that support the build-out and benefit COMPASS’s commercial efforts as we move forward with COMP360, particularly in treatment-resistant depression?
George Goldsmith, Co-Founder and CEO
Sure. I’ll take that. So our focus is to leverage existing infrastructure wherever possible, and I think we’ve seen nearly 1,000 sites of delivery for S-ketamine, 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 clinic delivery system, and 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. 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.
Patrick Trucchio, Analyst
Perfect. Thank you very much.
George Goldsmith, Co-Founder and CEO
And that’s one of the key reasons Kabir has joined us is to really focus on those issues. So there we are.
Patrick Trucchio, Analyst
Yeah. Great. Thank you.
Operator, Operator
Thank you. One moment. Our next question comes from Charles Duncan of Cantor Fitzgerald. Please proceed.
Charles Duncan, Analyst
Okay. Yeah. So, good morning, George and team. Congratulations on the completion of the end of Phase II meeting and progress with this innovative program. I have a couple of questions on it and then just one PTSD. The questions that I had on the program, I realized that you are waiting for additional feedback from the agency and we’ll share a lot of details on October 12th. 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 you think investors would note; could it be sample size, could it be dosing paradigm or control arm, etc.? Is there anything you can provide? And then with regard to the cash use, I think Mike mentioned, good through 2024; does that fully consider the design elements that you’re waiting for details on?
George Goldsmith, Co-Founder and CEO
So 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. 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 and that this is a whole new area of development and 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 COMPASS, and so from our point of view, we can share more details in October, as we said. I think it’s been a very productive set of discussions, and I think we’re all taking our responsibility very seriously in 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 about all I can say on that front. Guys, did you want to add on?
Dr. Guy Goodwin, Chief Medical Officer
No. I don’t think so. I think just to reiterate what George has said. I mean, as we said, on the broadcast, 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. So in a sense, that’s, I think, an important part of our thinking.
George Goldsmith, Co-Founder and CEO
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 on financial modeling?
Mike Falvey, Chief Financial Officer
Sure. Charles, on 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 placeholder for a 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’ve projected.
Charles Duncan, Analyst
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 feel enrollment? Thanks.
Mike Falvey, Chief Financial Officer
It really wasn’t to do with numbers; it has to do with capitalizing on expertise, and we had two world-class centers, and two world-class centers are better than one world-class center, for sure.
Charles Duncan, Analyst
Okay. Thanks for taking my questions.
George Goldsmith, Co-Founder and CEO
Thanks, Charles.
Operator, Operator
Thank you. One moment. Our next question comes from Sumant Kulkarni of Canaccord Genuity. Please proceed.
Sumant Kulkarni, Analyst
Good morning and afternoon to the team. Thanks for taking my questions. I have two, one on TRD and one on anorexia. So 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, with that decision driven predominantly by strategic or financial considerations?
Mike Falvey, Chief Financial Officer
I’m sorry; we’re really not discussing the trials on this level of detail at this point, Sumant. I think we’ve explained we see ourselves as in an important confidential process with the FDA. We will tell you the conclusions on October 12th. I’m sorry; I sound like a broken record, but that’s just, I guess, I’m a broken record.
Sumant Kulkarni, Analyst
No problem. Some broken records can be good. So on the anorexia Phase II, do you expect the ratio of female to male participants to mimic real-world distribution, and are there any confounding gender-based differences in the EDE score either at baseline or in its clinical relevance at an endpoint?
Mike Falvey, Chief Financial Officer
That’s a good question. I mean, most studies actually include only women. So we’re in an exploratory stage with this trial, and we’ll let you know as it develops on issues like ours.
Sumant Kulkarni, Analyst
Thank you.
Operator, Operator
Thank you. One moment. Next question comes from Francois Brisebois of Oppenheimer. Please proceed.
Francois Brisebois, Analyst
Hi. Thanks for taking the questions. I look forward to October 12th for more details, so I’ll try to ask something a little bit different here. On the digital side, you are incorporating some of the digital tools you mentioned on this call. I was wondering, how much discussion occurs with regulatory bodies to ensure these tools are validated? If patients require additional preparation, do they receive it? Are there any discussions regarding usage levels and how we can distinguish whether effects are due to the drug or the digital tools? Any information on this would be helpful.
Dr. Guy Goodwin, Chief Medical Officer
Well, I think it’s clear that in the public statements and the FDA officials who have 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 site of digital support. Obviously, it’s a new area, and I think it’s obviously a growing one. The key issue, I think, is it doesn’t confuse the issues around the effects of the drug and the efficacy of the drug, which is the key objective of the program. I don’t know whether that answers your question; George may want to comment.
George Goldsmith, Co-Founder and CEO
Well, I think just in addition, we view all of these data arising from these as exploratory endpoints to help inform subsequent developments. So they don’t have any impact on the actual study, just delivery, etc.
Francois Brisebois, Analyst
Okay. That’s helpful. And then there’s been 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? 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 COMP360?
George Goldsmith, Co-Founder and CEO
We’re not solely focused on COMP360, although it is our top priority. We have reviewed various options in the field and will evaluate them based on their delivery speed to patients and their impact on patient outcomes at scale, which will always guide our decisions. If we find something that is beneficial for patients and supported by strong evidence, we will definitely take an interest. I hope this provides a comprehensive answer to your question.
Francois Brisebois, Analyst
Yeah. No. Thank you very much. I look forward to October 12th. And are you going to be sharing at all if this is potentially in-person or not?
George Goldsmith, Co-Founder and CEO
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 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 all virtual or all live. So virtual seems to be the right format.
Francois Brisebois, Analyst
Certainly. Thank you very much.
George Goldsmith, Co-Founder and CEO
We should also point out that the Investor Day will give us the opportunity, I think, to showcase the team here at COMPASS, and we’re also going to be offering up some KOL perspectives because that’s something that we’ve heard investors would really be interested in hearing. It’s best to deliver all of those through the virtual format.
Francois Brisebois, Analyst
Great. Thank you.
Operator, Operator
Thank you. One moment. Our next question comes from Elemer Piros of ROTH. Please proceed.
Elemer Piros, Analyst
Yes. Good morning, everyone. George, you have previously alluded to that the level of preparedness for the actual dosing of the therapy had 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 specifics in this Phase III, but just a general concept?
George Goldsmith, Co-Founder and CEO
I believe, Elemer, that anything we learn to enhance outcomes will be implemented. I can let Guy share any specific thoughts on this. However, the core principle of our organization is to apply everything we learn that can be beneficial.
Dr. Guy Goodwin, Chief Medical Officer
I think expert opinion is increasingly focused on preparation, as you imply, and 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. And obviously, the way we’re 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.
George Goldsmith, Co-Founder and CEO
And we will be taking learnings from our Phase IIb into Phase III as we design and develop the protocols.
Elemer Piros, Analyst
Thank you so much.
Operator, Operator
Thank you. One moment. Our next question comes from Bert Hazlett of BTIG. Please proceed.
Bert Hazlett, Analyst
Thank you for the opportunity to ask questions and congratulations on your progress. I would like to get more details regarding the anorexia nervosa program, along with a couple of broader topics. It seems that the earlier study, while small in scale, indicated that the results might be more robust at three months compared to one month. I'm interested in the week four endpoint and whether you are considering outcomes at a later stage. Also, will antidepressants be excluded from this trial for those patients? Thank you.
Dr. Guy Goodwin, Chief Medical Officer
Thank you. It will include a 12-week observational component. We have chosen to maintain the initial four weeks because it allows us to keep conditions more stable during that time, and as we move forward, other factors may come into play. Therefore, it makes sense to utilize the first four weeks to gauge the initial treatment effect and then continue observing for 12 weeks to maximize our insights. Regarding the antidepressants, we will still withdraw patients from them using the same strategies as we did in the Phase IIb study, as that approach was effective.
Bert Hazlett, Analyst
Terrific. Thank you. I have some broader questions regarding the recently granted patents you mentioned in the press release related to composition formulation and method of use. Additionally, there are ongoing discovery efforts with novel drug candidates. Could you provide more details on both of these initiatives and when we might see visibility into the novel drug candidates? What are the goals for the novel NCEs? Thanks.
George Goldsmith, Co-Founder and CEO
Before 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, etc. But 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. 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. 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’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.
Bert Hazlett, Analyst
Thank you very much.
George Goldsmith, Co-Founder and CEO
Thank you.
Operator, Operator
Thank you. One moment. And our next question comes from Jason McCarthy of Maxim Group. Please proceed.
Michael Okunewitch, Analyst
Hey, guys. This is Michael Okunewitch on the line for Jason. Thank you for taking my questions. So, I guess, first, you mentioned refining your therapists 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 fully train and certified therapists for COMP360?
George Goldsmith, Co-Founder and CEO
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-tiered training model, as we said, that includes clinical training, providing experience to therapists with 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. 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 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. All of 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 we’ll 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. Our goal is to make this just the right size and to continue development over time providing people feedback from the real world. So those are the key elements of it. We’ll talk more about the program as it’s agreed.
Michael Okunewitch, Analyst
Thank you very much. I have a follow-up question. You mentioned introducing the anorexia program from your investigator-initiated study pipeline, and you have several others as well. Should we consider this the main avenue for label expansion for COMP360? Can you also highlight any other investigator-initiated studies that are expected to yield results in the near to medium term?
George Goldsmith, Co-Founder and CEO
Sure. So, 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. 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. But I would expect that given where some of these things are, you may be hearing more news this year.
Michael Okunewitch, Analyst
All right. Thank you very much.
George Goldsmith, Co-Founder and CEO
Thank you.
Operator, Operator
Thank you. I would now like to turn the conference back to management for closing remarks.
George Goldsmith, Co-Founder and CEO
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 II study but also looking at the early signals that we have in anorexia and other things. So it’s an exciting time; we’re moving fast and quickly and effectively in our therapy development, in our technology support, and our data. 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 and interest, and as always, we’re available for subsequent questions as the need arises. Thank you.
Operator, Operator
This concludes today’s conference call. Thank you for participating and you may now disconnect.