Earnings Call Transcript
COMPASS Pathways plc (CMPS)
Earnings Call Transcript - CMPS Q2 2024
Operator, Operator
Good day, everyone, and welcome to COMPASS Pathways' Second Quarter 2024 Conference Call. This call is being recorded. I would like to introduce your host for today, Stephen Schultz. You may begin.
Stephen Schultz, Senior Vice President of Investor Relations
Welcome, all of you, and thank you for joining us today for our second quarter 2024 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. And today, I'm joined by Kabir Nath, our Chief Executive Officer; Dr. Guy Goodwin, our Chief Medical Officer; and Teri Loxam, our Chief Financial Officer. The call is being recorded and will be available on the COMPASS Pathways Investor Relations website shortly after the conclusion of the call, and will be available for a period of 30 days. 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 most recent 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 Kabir Nath.
Kabir Nath, CEO
Thanks, Steve. Good day, everyone, and thank you for joining us. First, let me welcome two new leaders to COMPASS Pathways. A few weeks ago, we added Lori Englebert as Chief Commercial Officer. And as you saw just this morning, we have appointed Gino Santini as the new Chairman of our Board of Directors. Lori and Gino both have strong, relevant experience that will benefit COMPASS as we continue to complete our COMP360 Phase 3 clinical trials and build our commercial capabilities. I am pleased that these exceptional leaders have chosen to be a part of our team, which is a reflection of their commitment to the field of mental health and their confidence in COMPASS. Turning to our core program in treatment-resistant depression, we're doing something that has never been done before at this scale and working with many clinical sites that are new to psilocybin research. We're making progress on recruitment in our COMP360 Phase 3 trials. As we discussed on prior quarterly calls, the resources that we added earlier in the year to help accelerate the process of confirming TRD diagnosis have been helpful. We continue to expect the readout for the 6-week primary endpoint top line data from the 005 placebo-controlled trial in quarter four this year. However, we're also needing to spend increased time and resources to support clinical sites to recruit as quickly as possible while maintaining the highest level of quality in the trials. Recruitment is, therefore, trending towards the end of the year and there's a chance that data could push into January. As a reminder, we expect to need both 005 and 006 for a regulatory submission, and we continue to expect the 6-week primary endpoint or 006 by mid-2025. On today's call, Guy will provide some thoughts on key issues that were discussed during the Lykos' AdCom, and Teri will provide the financial overview. I'll provide some closing comments, and we'll then move to Q&A. Guy?
Guy Goodwin, Chief Medical Officer
Thank you, Kabir. The Lykos advisory committee was certainly eventful and it provided some key insights into the FDA's thinking and their requirements for review of therapeutics in this new class of drugs. Three items came into focus: the therapy aspect of the clinical protocol, the issue of unblinding, and the lack of certain safety data that the FDA deemed important to understand. Let me discuss these in order. First, regarding psychotherapy, MDMA appears to increase interactive communication with the therapists during the drug experience. It truly is psychotherapy catalyzed by the drug. This is in contrast with psilocybin, which elicits a subjective inward experience for patients. With COMP360, the patient is supported by a licensed therapist or other medical professionals, mostly for safety purposes. There is no active psychotherapy on the day of drug administration. Most of the administration session is silent, and any interaction is typically to redirect the patient's focus back inwards. The pre-administration preparation ensures patients understand the trial and what to expect on the day of administration, and prepares them to be in the right frame of mind to undergo treatment, not unlike other medical procedures. Patients have two post-administration sessions to provide them with an opportunity to discuss their experience and integrate it into their lives. Second, turning to a discussion of unblinding, context is important here. It is not uncommon in neuroscience for drugs to produce effects that are detectable by patients. It is the absence of such effects that unblinds the patients in trials that are psychedelic. It is the presence of adverse effects, like nausea or somnolence, that are likely to cue the unblinding that may often occur in other trials, for example, of conventional antidepressants or antipsychotic drugs. Such unblinding has not prevented their approval as medicines. As requested by the FDA, our 005 trial is placebo controlled, which will help to characterize a safety baseline, but the lack of an active control will make potential unblinding likely. By contrast, our 006 trial was designed similar to the Phase 2b, with a strategy to minimize the potential for unblinding. 006 has three active arms, so patients know that they will receive a dose of COMP360, making it more difficult for them to discriminate, in particular, between the 10 and 25 milligram doses. In fact, most participants in the Phase 2b study reported an intensity of psychedelic effects that could have come from any of the doses. In addition, we have also put a cap of 15% on recruitment of patients with prior experience with psychedelic drugs. We believe that this design safeguards the blinding of the trial, and the two Phase 2 trials together will produce a robust package for the FDA. Finally, we are conducting the COMP360 TRD clinical program to the highest standards and we are collecting the range of safety data that would be expected of any pharmaceutical clinical development program, including positive side effect data. For example, we have collected data from the altered states of consciousness questionnaire after every drug administration. This survey comprises 94 items covering the full gamut of experiences, both positive and negative, attributable to psychedelic drugs. Looking at the FDA's guidelines and observing the discussion at the Lykos meeting, we are confident that our pivotal program will deliver what the FDA requires to effectively evaluate COMP360 treatment. Let me now hand the call to Teri for the financial overview.
Teri Loxam, Chief Financial Officer
Thank you, Guy. I'll now step through the Q2 financial results. Cash used in operations in the second quarter was $34.4 million, within the guidance range we provided of $32 million to $38 million. Regarding third quarter 2024 financial guidance, we expect net cash used in operations to remain between $32 million and $38 million. Turning to full year financial guidance, we expect cash used in operations to be between $110 million and $130 million, which assumes that we will receive the 2023 R&D tax credit this year. COMPASS continues to maintain a strong financial position, with cash and cash equivalents of $228.6 million at June 30, 2024. This compares with $262.9 million at March 31, 2024. We expect our cash runway to fund operations into 2026. Long-term debt under the Hercules loan facility was $29.4 million at the end of the second quarter. We will continue to manage our cash carefully to advance our pivotal program and to achieve important milestones that we believe will create value for our shareholders. Thank you, and I'll now turn the call back over to Kabir.
Kabir Nath, CEO
Thank you, Teri. While we await the top line data readout for the primary 6-week endpoint in the 005 Phase 3 trial near the end of the fourth quarter, I want to reflect more broadly on our progress. We now have in place a senior management team of seasoned executives who have a passion for treating mental health conditions and decades of relevant collective experience in bringing innovation to patients. We continue to generate all the necessary supporting data for an NDA filing. And our pre-commercial collaborations are yielding valuable learnings, both for us and for potential future sites of care, as we continue our preparations to leverage the commercial delivery network. The commercial marketplace has seen continued growth for interventional psychiatry treatments, such as Spravato, which validates our approach. Finally, I want to thank David Norton for his guidance and commitment to COMPASS Pathways in serving as Interim Chairman of the Board, and we're pleased that he will continue to serve as a highly valued member of the Board after Gino joins us as Chairman in September. We have a strong team in place to continue to execute our Phase 3 program and build the organization for potential commercialization. With the progress we've made, we're well positioned for continued success in TRD and beyond. Thank you, again, for your participation on today's call. And we'll now turn to Q&A, so I will hand this back to the operator.
Operator, Operator
And our first question comes from the line of Ritu Baral with TD Cowen. Please proceed.
Ritu Baral, Analyst
Good morning, guys. Thanks for taking the questions. First question, Kabir, I wanted to just ask about the conduct of ongoing 005. How many DSMB looks have you had? And how is the overall suicidality rate? Looking just given the high background rate of suicides in the TRD population in general and the focus on this, can you give us a sense of conduct? And then I have a couple of follow-ups. Thanks.
Kabir Nath, CEO
Sure. Thanks, Ritu. And just checking that you can hear us?
Ritu Baral, Analyst
Yes.
Kabir Nath, CEO
Great. I'll actually hand that first question to Guy, if I may. So, Guy.
Guy Goodwin, Chief Medical Officer
Yes. Ritu. We recently had a DSMB meeting where both 005 and 006 were reviewed, and they will be evaluated quarterly as you may know. The feedback was to continue the trials as planned, with no changes to any procedures.
Ritu Baral, Analyst
Great. Another question regarding the conduct is about the Lykos AdCom. It was noted that labs were not conducted, and I want to clarify what types of labs were requested for that therapy compared to the typical labs we consider in biotech, such as liver levels and kidney function. Were there any specific labs that the FDA mentioned during the discussion about labs?
Guy Goodwin, Chief Medical Officer
My understanding was that they were conducting routine labs that were not significantly different from what is required for our drugs.
Ritu Baral, Analyst
Got it. Helpful. And then last question. Have you seen any impact on your enrollment rates either for 005 or 006 based on the AdCom proceedings? And more specifically, maybe a little more subtly, would you expect, just given how much that's been in the news, for that to potentially impact your placebo rates, such that you might need to take another look at the stats plan or it might change powering? Thanks so much.
Guy Goodwin, Chief Medical Officer
Basically, to your last question, no, there's really no suggestion that I know that one trial influences another in quite that way. Clearly, there were a number of issues that were brought up around the use of placebo in general. And that formed part of the discussion, the background noise, if you like, that we heard following the AdCom. I mean our sense was that, actually, they were contending sounds some were positive, some were trying to, in a sense, reverse the sentiment that was expressed by the committee. But we haven't really had feedback either from the sites or less directly from patients, or in terms of changes in run rates for ourselves, that suggests any impact at all.
Ritu Baral, Analyst
That's great. Thanks for taking all the questions.
Guy Goodwin, Chief Medical Officer
Thanks, Ritu.
Operator, Operator
Thank you. Our next question comes from the line of Leonid Timashev with RBC Capital Markets. Please proceed.
Leonid Timashev, Analyst
Thanks. I had maybe one follow-up on one of Ritu's questions, and then a second question, if that's okay. So I guess just following up on sort of the discussion around the enrollment trends in the sites. I guess can you talk about how sites have been performing? I mean something that you alluded to, but I guess with respect to screen-in or screen-out periods. And I guess, any anomalies you may have seen on the blinded data from the raters that might require maybe retraining or spending some of that additional time that you referred to. I guess how are you maintaining that site quality?
Kabir Nath, CEO
Yes, I'll start. Thanks, Leonid. So as I said on the call, we are continuing to recruit successfully into both 005 and 006. As we've discussed earlier in the year, the need to actually be better and quicker at getting the TRD diagnosis confirmed and the additional resources we've put in there have been helpful to that. And really, it's just a focus on continued quality, ensuring that we do have the right patients, ensuring that sites are doing everything necessary. We're continuing to be in very close touch with them, visiting them and so on. But I wouldn't say there's anything out of the ordinary or any particular anomalies that we've identified. And certainly no trend breaks post AdCom or anything that suggests a change.
Guy Goodwin, Chief Medical Officer
I would like to add that one of the key indicators of quality for any trial is retention, which has actually been better than we expected. This is reassuring for all phases of the trial. Remember, there is a first phase for the primary outcome, followed by redosing and then open-label treatment phases. Retention has been maintained into the final phase of the trial, which is very encouraging. Although the trial is unblinded and we don't know the results yet, we do know that patients are continuing to participate. If they were dropping out, that would be a concern.
Leonid Timashev, Analyst
Got it. Thanks. Really helpful. And then just maybe a second question related to the concept of the suicidality. I guess as you've been talking to KOLs, I guess, do you have a sense of what might be an acceptable amount of suicidal ideation just given the patient population and the fact that psychiatrist often have some amount of experience managing patients, especially even that SSRIs, have some elevated risk that's on the label. I guess do you have a sense of what might be an okay signal if one does appear on suicidality?
Guy Goodwin, Chief Medical Officer
I think the truth is that clinicians who treat depressed patients simply live with suicidality as a fact of the disorder. It's a core symptom. It's therefore ever present really. And they don't actually think in terms, actually, that people looking at clinical trial data tend to do. They tend to see it more as a fact of life. So we don't get the sort of feedback as to what's acceptable and what is not acceptable. Ultimately, of course, the key observation will be the differential rate, if there are any, between the different arms of the study. And that will allow us to make a real and genuine conclusion about this risk, hypothetical risk, and then maybe higher risks in the active arms. We simply at the moment, I think, don't have sufficient data to say, but we will have that data once we have completed our studies.
Leonid Timashev, Analyst
Well, thank you, guys.
Guy Goodwin, Chief Medical Officer
Pleasure. Thank you.
Operator, Operator
Our next question comes from the line of Charles Duncan with Cantor. Please proceed.
Charles Duncan, Analyst
Yes. Good morning, Kabir and team. Thanks for taking our question. Good to hear of the progress. Especially, I'd like to hear some more from Guy on the recent AdCom. But before that, I guess I'm wondering if you can provide a little more granularity on, call it, the news flow yet this year, understand that the analysis may make December versus January a question mark. But do you plan to announce the completed enrollment in 005? And then I'll ask another question to Guy.
Kabir Nath, CEO
Thanks, Charles. So we haven't yet determined whether we will make that announcement.
Charles Duncan, Analyst
Okay. It would be great to hear more from Guy regarding the recent AdCom. You did a wonderful job outlining your thoughts after the Lykos AdCom. I'm curious if anything surprised you. These issues seem like they might have been part of your considerations, especially with respect to the guidance and design of your trial. I'm wondering if any new insights emerged from the AdCom that you are currently contemplating, or if these were aspects you already factored into the design of the 005 and 006 programs.
Guy Goodwin, Chief Medical Officer
I think speaking for ourselves, there were really no surprises in the AdCom. I mean the tone of the AdCom was surprising, as I'm sure anyone listening to it would have agreed at times. But actually, in terms of the content, the FDA's contribution, the issues that were discussed, they were not surprising. And they were not something that we hadn't, to some extent, as fully as possible, anticipated.
Charles Duncan, Analyst
So you don't feel like there was any real change in the FDA's perspective versus the guidance that was put out earlier?
Guy Goodwin, Chief Medical Officer
No, we certainly couldn't detect that, and we simply content that our trials are running as they are on track and with all the considerations that we put into designing them.
Kabir Nath, CEO
I think what this shows us is that psychedelic trials do not receive any special consideration or leniency. They are required to be conducted with the same level of rigor, safety, data collection, and other standards as any other psychiatry trials, which is something we expected.
Charles Duncan, Analyst
And probably consistent with the way you do things. Question on 005 versus 006, this may seem like naive, but can you just remind us as to what is the key question that is being asked in those trials? What would you like to see out of those trials to encourage you that you have a drug that's really novel?
Guy Goodwin, Chief Medical Officer
That is indeed a great question. For 005, we want to see a clear separation from placebo. Previous studies have shown this, and we aim to achieve similar results. Essentially, we need to continue demonstrating safety in that study and ensure it maintains safety compared to the placebo baseline. That's what we hope to achieve. Our 006 study, if successful, will replicate the findings from 001, the Phase 2 study, which showed a significant dose response effect. We want to determine if adding a second treatment will significantly improve remission and response rates. If it does, that would be fantastic news for patients.
Kabir Nath, CEO
And then taken together, Charles, is durability. Clearly, that's a question that we didn't answer in 001 beyond 12 weeks. So that's another key element, particularly out of 006.
Charles Duncan, Analyst
Yes. And that durability of interest to a lot of people. And appreciate your good retention comments to the last question. Thanks for taking our questions.
Kabir Nath, CEO
Thanks, Charles.
Operator, Operator
Thank you. Our next question comes from the line of Vikram Purohit with Morgan Stanley. Please proceed.
Vikram Purohit, Analyst
Hi, good morning. Thank you for taking our questions. We had two, one on the pivotal program in TRD and then one on the pipeline. So for 005 and 006, it sounds like near the end of the year and then middle of next year, we'll be getting the 6-week primary endpoint data. But I was curious when the longer-term follow-up data from both studies might be communicated publicly? And then secondly, on the pipeline, could you just remind us where next steps and your thoughts on development plans stand for both PTSD and also, potentially, bipolar disorder? Thank you.
Kabir Nath, CEO
Thanks, Vikram. So you're right, reconfirming those dates that you mentioned for the 6-week primary endpoints, we haven't talked about when we could expect the 26 weeks. But simply projecting the additional five to six months of data, you can imagine that that's when we would be releasing both of those, but we haven't specifically confirmed that to this point. Regarding PTSD, yes, we continue to believe that, that was a very interesting signal that we showed in what was a small open-label study. So we are developing some designs and protocols around that. We're taking external advice also. And as you're aware, though, the current runway does not contemplate an additional study or set of studies in PTSD, but we're continuing to do the work around what that could look like.
Guy Goodwin, Chief Medical Officer
Bipolar disorders obviously remains a great interest to us, but I think it's a rather lower priority at the moment compared to PTSD.
Vikram Purohit, Analyst
Understood. Thank you.
Guy Goodwin, Chief Medical Officer
Thank you.
Operator, Operator
Our next question comes from the line of Gavin Clark-Gartner with Evercore ISI. Please proceed.
Gavin Clark-Gartner, Analyst
Hi, guys. Thanks for taking the questions. First, are you able to see the rates of retreatment in Part B of both of the trials? And is that rate different between the two trials?
Guy Goodwin, Chief Medical Officer
We can see the raw rates in principle, but we haven't compared them at this point.
Gavin Clark-Gartner, Analyst
Okay. Are you planning to share the overall rates of retreatment at any point prior to the top line? And should we also expect that with the top line release?
Guy Goodwin, Chief Medical Officer
I don't think so. These are details that we'll obviously make available in due course, but there are considerations around announcing the top line data relating to blinding, which make it important that we don't cause too much interest in the data, for example, from patients themselves.
Gavin Clark-Gartner, Analyst
Got it. What is the overall rescue rate or the use of rescue therapy? How is that progressing in both of the trials?
Guy Goodwin, Chief Medical Officer
You mean rescue on the day of administration of the drug?
Gavin Clark-Gartner, Analyst
No, just during the blinded portion of the trial, like starting another medication.
Guy Goodwin, Chief Medical Officer
We are not tracking that as a group. Essentially, we are unaware of the details of the study for obvious reasons.
Gavin Clark-Gartner, Analyst
Got it. Thanks.
Guy Goodwin, Chief Medical Officer
Thanks.
Operator, Operator
One moment for our next question. And it comes from the line of François Brisebois with Oppenheimer. Please proceed.
Unidentified Analyst, Analyst
Hi. This is Dan on for Frank. Thanks for taking my question. Just a quick one from us. Regarding the Lykos AdCom, one of the focuses was the challenge of disentangling the contribution of psychotherapy to the efficacy of the drug in Lykos' case. In the case of COMP 005 and 206, of course, there's no formal psychotherapy in the trial. Could you talk about your thoughts regarding the FDA commentary around that?
Guy Goodwin, Chief Medical Officer
Yes. I mean my understanding originally was that the FDA had approved the design of the study, which, of course, was placebo versus the doses that were eventually used. And so they were accepting the idea that a drug could enhance psychotherapy. I think it introduces complexity, which is what was discussed in the AdCom. But I think, frankly, we have to wait for what the FDA actually decides. We don't really have clear guidance on what that will be, obviously. We think that we're in a different category; we are not providing a psychotherapy. And so the question of whether a drug versus placebo or one dose versus another is a much simpler decision in terms of deciding efficacy. And I think that's where we rest our current understanding.
Unidentified Analyst, Analyst
Thank you.
Guy Goodwin, Chief Medical Officer
Thank you.
Operator, Operator
Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed.
Sumant Kulkarni, Analyst
Hi. Thanks for taking our questions. I have two. So given how important the durability of treatment effect is, especially within the psychedelic therapeutics context, how is COMPASS specifically ensuring that patients don't have any unused use of other treatment modalities or therapeutic post dosing in your Phase 3 trials, because such instances have the potential to obscure durability that could be directly attributable to COMP360 treatment?
Guy Goodwin, Chief Medical Officer
Yes. I mean that's a great question. I mean I think we await to see. We are collecting data about co-administration of other drugs throughout the follow-up phase. So we will be able to observationally tell you what the rates are. Actually actively preventing or discouraging patients is obviously difficult. It's simply understood in terms of how the patients get consent, but that's not an objective of the study. But clearly, if there is a clinical need, patients will receive other treatments. And the thing we have to do is to follow what they are, and really work out to the extent to which it really is something that is required for the group of patients we saw. In the highly responsive patients in 001, we did not see high rates of treatment-seeking outside of the trial in up to 12 weeks. We obviously are going much longer, and we will be better informed when we complete the current study.
Kabir Nath, CEO
And just to be clear, Sumant, I mean, patients do in theory commit to no subsequent use of psychedelics. I mean that is an inclusion criteria and it's part of the informed consent. But clearly, we need to monitor that.
Sumant Kulkarni, Analyst
Understood. And the second question is more because investors tend to be hyper-focused on the topic of suicidal ideation. So how well studied is this topic when it comes to recreational users of psilocybin? For example, there was a 2022 paper out of Howard on 400,000 or so U.S. adults, that when the U.S. national survey of drug use that are characterized as 'lifetime users' of MDMA or psilocybin, and both psychological distress and suicidal thoughts were found to have reduced odds in that population.
Guy Goodwin, Chief Medical Officer
Yes, I couldn't summarize the data better than you just did. That is what the finding indicates and is widely accepted. There are smaller studies focused on identifying individuals who will have psychedelic experiences multiple times, and those studies have similarly shown a reduction in distress associated with the acute use of these substances, not just lifetime recreational use. However, our main interest lies in how to effectively deliver this treatment to patients who have struggled to improve with other methods. Our emphasis is more on the clinical experience, as you can understand, but this background information is useful for safety considerations.
Sumant Kulkarni, Analyst
Thank you.
Guy Goodwin, Chief Medical Officer
Thank you.
Operator, Operator
Our next question comes from the line of Tom Shrader with BTIG. Please proceed.
Tom Shrader, Analyst
Good morning. Thanks for taking the questions. I wanted to ask Charles' question in a slightly different way. As we've talked to people about the panel, there was a fair bit of surprise with all the focus on unblinding. A lot of people thought the FDA is pretty comfortable with that, and you certainly gave a very clean description. Do you agree with that, that maybe that wasn't expected?
Guy Goodwin, Chief Medical Officer
Well, I think I can only answer whether I expected it. And to be honest, I did expect that to come up. Because it so frequently comes up when I hear, frankly, nonexperts discussing these trials. It is something that a lot of people have got their teeth into, and so it's something that people want to discuss. As you may be well aware, it's not an exact science to define what the effect of unblinding is in different studies. And so it's often an argument based on very unsecure basis, in fact. But it's certainly something that gets people's energies up. And as you see, it certainly caused a lot of energy to be expanded in that meeting.
Tom Shrader, Analyst
And I had a quick PTSD follow-up. As we've talked to people, how derisking do you think the PTSD data is on the safety front? People think that the likelihood of a bad experience is much higher in PTSD. So are you confident that you've seen really negative experiences and negotiated your way through them? Or is 22 patients still too small? Thank you.
Guy Goodwin, Chief Medical Officer
I believe that 22 patients is still a relatively small sample size. Furthermore, they were a highly selective group, specifically patients with adult trauma, excluding those with developmental or childhood trauma. Those individuals often face much more challenging life circumstances and chronic issues. Some of these patients were indeed included in the Lykos studies. We should be cautious in how we proceed with our program, which is why we plan to seek advice on it. However, what we observed was quite promising in terms of efficacy and safety. At this time, that is all we can share. Nonetheless, we believe that there is significant potential for some patients with PTSD.
Tom Shrader, Analyst
Great. Thank you for the answers.
Guy Goodwin, Chief Medical Officer
Thank you.
Operator, Operator
Our next question comes from the line of Elemer Piros with Rodman. Please proceed.
Elemer Piros, Analyst
Good morning. Kabir, you initially aimed to identify and engage 150 sites across 12 different countries. What is your progress regarding that number? Do you believe you have the appropriate number of sites to successfully complete these two trials?
Kabir Nath, CEO
Thank you. The number of sites is distributed between 005 and 006, with approximately 40 in 005 and the remainder in 006. It's important to note that 005 is solely focused on the U.S., and all U.S. sites for 005 are operational. Some U.S. sites for 006 are also active, but many of the 005 sites will transition to 006 over time. Internationally, we have sites operational in the U.K., Ireland, Canada, France, Spain, and Sweden, with more countries expected to follow. As we reaffirm our six-week endpoint expectation for 006, we are precisely on track for bringing these sites online. Ultimately, we anticipate patient distribution in 006 to be about 50% from the U.S. and 50% from outside the U.S.
Elemer Piros, Analyst
Thank you very much for that detail. And you also have an MDD trial ongoing. Is there a chance that, that trial, I think it's roughly 100 patients, would read out before 005?
Kabir Nath, CEO
I don't think that's very likely, Elemer. But you never know. If recruitment goes very well, it's possible. But as you know, it's primarily designed to look at PK/PD in this population. I mean it will be of great interest as an MDD study, but I think it's unlikely to read out before 005.
Elemer Piros, Analyst
Thank you very much, Kabir.
Kabir Nath, CEO
Thank you.
Operator, Operator
And as I see no further questions in the queue, I will turn the call back to management for closing remarks.
Kabir Nath, CEO
Thank you, everyone, for your participation on today's call. As we said, we continue to make good progress. We are very focused, as you can understand, on 005 and 006. And continuing to do everything we can to ensure quality execution, that we have the right patients in those trials and that we are able to bring forth really robust data at the appropriate time point. So thank you for your participation and look forward to seeing you all in the next quarter.
Operator, Operator
And thank you all for participating in today's conference. You may now disconnect.