At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. Earlier this morning, Atai Life Sciences issued a press release providing the details of its strategic investment in Beckley Psytech. The press release is available in the investor relations section of the company's website. As a reminder, during today's call, Atai Life Sciences will be making certain forward-looking statements within the meanings of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials, regulatory applications, and commercial launches. Such forward-looking statements are not guarantees of future performance, and therefore, you should not put undue reliance upon them.
These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Atai refers you to the company's SEC filings for discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to Atai Life Sciences' co-founder and chairman, Christian Angermayer.
Thank you, Operator. Hello, and thank you, everyone, for joining us this morning, this afternoon, wherever you are in the world. Today, we are very thrilled to announce our strategic investment into Beckley Psytech, a private biopharmaceutical company focused on transforming short-duration psychedelics into clinical treatments for mental health conditions. I am joined today by my two dear co-founders, Florian Brand, CEO of Atai, and Dr. Srinivas Rao, Atai's Chief Scientific Officer, who both will walk you later through the strategic rationale for this investment and provide an overview of Beckley Psytech's programs. First, let me give you my thoughts. Since we founded Atai in 2018, we have, as you all know, had the bold and ambitious vision to heal mental health disorders so that everyone, everywhere, can live a more fulfilled life. When it comes to mental health, there is no one-size-fits-all solution.
With this investment and collaboration, we continue our dedication to building a diverse portfolio of therapeutics that addresses the heterogeneity in mental health patients. Most importantly, and I'm really, really proud of that, we always, since our foundation, had the ambition to be not just a psychedelics company but the psychedelics company. With this transaction, we continue now to cement and strengthen our position as the leading company focused on the renaissance of psychedelics, with a portfolio that we believe encompasses now, with this acquisition, all major psychedelics with therapeutic use case. We have DMT, as you know. Now, we have 5-MeO-DMT with today's acquisition. We have Ibogaine. We have R-MDMA. We have Psilocybin via our stake in Compass, and now Psilocin via Beckley again.
I also want to reiterate that while we take great pride that we have been the first ones who had the original idea, actually back in 2014, at the place where I'm right now, to bring back psychedelics into the medical world. Then, as you know, it took us several years to transform the idea into the seed funding of Compass and the foundation of Atai. We are indeed standing on the shoulders of giants who have been advocating for the therapeutic use case of psychedelics since the 1960s. Beckley's founder, Lady Amanda Feilding, is one of these giants. Joining forces with Amanda, her family, and her team makes me and us especially proud, also in terms of historic significance of this transaction. Back to the deal.
As you know, consistent with our vision, we are deploying an operating platform model that enables a modular and pragmatic approach to generating and capturing value for our shareholders, and most importantly, allows us to accelerate the development of therapies for patients. This includes progressing programs in-house, like, for example, our DMT program, which we own 100% of, or R-MDMA, as well as making strategic investments and acquisitions like we've done today. Especially in times like we have at the moment, when valuations of biotech companies, in my point of view, in my opinion, are distorted and artificially low, great founders usually don't want to sell out. To say it bluntly, I would actually have been worried if the Beckley founders would have wanted to sell 100%.
What they all do want and need in times like these is a well-capitalized partner who can help them achieve their goals. Our platform approach allows us to be this partner and to structure win-win deals, and by that, capture the opportunities times like the current one provides. I hope you all got that I'm really super excited about the transaction. I will now hand over to Florian to talk to you more about the details, the strategic rationale behind the investment, and to share especially an overview of Beckley Psytech's exciting programs. We have questions later. Again, thank you all for your interest. Florian, over to you.
Great. Thanks a lot, Christian. Good morning, everyone, also from my side. Today's strategic investment in Beckley Psytech really underscores our longstanding conviction in the clinical development of psychedelics. Data to date suggests that short-duration psychedelics, such as Beckley's two programs, BPL-003 and ELE-101, could offer clinical benefit comparable to longer-duration psychedelic compounds in a more efficient and scalable way. With shorter treatment times and reduced medical resource requirements, we believe that shorter-duration psychedelics could open up access to broader patient populations. Additionally, we believe the two-hour interventional treatment window that has already been established by J&J Spravato or esketamine could potentially be leveraged for commercial rollouts of shorter-duration psychedelics, if approved, in the future.
This investment brings BPL-003, which is an intranasal formulation of 5-MeO-DMT, and ELE-101, an intravenous formulation of psilocin, into our mental health innovation platform, reinforcing our position as the biopharmaceutical company with the largest and most diverse portfolio of clinical-stage psychedelics in development. BPL-003 and ELE-101 are on track for multiple anticipated clinical readouts within the next 12 months, importantly including a phase IIB readout of BPL-003 in treatment-resistant depression, or TRD, anticipated in the second half of this year. We are very much looking forward to collaborating with the Beckley team and to exploring together potential synergies, such as the use of digital tools for patient support, all with the goal to accelerate the development of urgently needed mental health innovations. Before we jump to more details of the two drug development programs, let's have a look at the high-level deal terms of this strategic investment.
With this transaction, we acquired 35.5% of Beckley Psytech through a total investment of $50 million, consisting of a $40 million direct investment into the company and $10 million in secondary share purchases. In addition, we receive a one-to-one warrant coverage with a 30% premium on the primary issuances, and we have the right to appoint and hold three of nine seats on Beckley Psytech's board of directors. Importantly, Atai will hold a time-limited right of first refusal and first negotiation on a future sale of the company, asset sales, or other transfers of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101. Before I will hand it over to Srini, who will dig into each program in greater detail, I will provide you with a brief overview of each asset's key features.
Let's start with BPL-003, which is an intranasal dry powder formulation of a novel patent-protected salt and crystal form of 5-MeO-DMT. Three trials are currently ongoing with BPL-003, with the phase IIB trial actively recruiting in the U.S. under an open IND that was accepted by the FDA in February of last year. The other compound, ELE-101, is an intravenous formulation of Psilocin, which is the active moiety in the body when Psilocybin is administered orally. As such, we view ELE-101 as a relatively de-risked asset for its stage of development, as it leverages the robust proof-of-concept data that has been established with Psilocybin across multiple trials. Both of these patent-protected assets are characterized by a short duration of psychedelic effect of approximately two hours or less, and both of these assets have, in our view, the potential to be first to market and best in class.
As you can see here on the right side of the slide, this transaction adds multiple near-term clinical milestones to our catalyst map. Importantly, the phase 2B trial of BPL-003 in TRD is anticipated to read out top-line results in the second half of 2024. In addition, results from two open-label trials with BPL-003, one in TRD and the other one in alcohol use disorder, are anticipated in the first half and middle of this year. The results of the combined phase I-2A trial of ELE-101 are also anticipated in the first half of this year. This compound will be tested in patients with moderate to severe MDD rather than TRD in the phase 2 portion of this trial. Srini will now contextualize these assets into our broader depression portfolio and then walk you through some clinical data and the trial design of the BPL-003 and ELE-101 programs.
Over to you, Srini.
Thanks, Florian. Thank you to the audience for joining us this morning. Both BPL-003 and ELE-101 augment our portfolio of psychedelic drug candidates aimed at addressing the treatment of major depression. As I'm sure many of you know, depression is a highly heterogeneous disorder. Two people can meet the DSM-5 diagnostic criteria for MDD, yet have completely different clinical presentations. As such, we're proud to have assembled a diverse portfolio of assets to address this prevalent yet highly underserved indication. As you can see on this slide, the four assets in our portfolio are differentiated from one another pharmacologically and by target indication, route of administration, and in-clinic duration. Compass's COMP360, a proprietary form of psilocybin, represents a first-generation psychedelic therapy for TRD. It's in advanced clinical development with two phase 3 trials currently ongoing, the first of which is anticipated to read out mid-year.
COMP360 is ingested orally, and it results in a psychedelic experience that lasts four to six hours. Existing interventional psychiatry clinics are typically configured to deliver some combination of ketamine, esketamine, or rTMS, all of which involve clinic stays of two hours or less. ELE-101 has the potential to directly utilize this existing infrastructure, as Florian indicated, providing the same active moiety as oral psilocybin but falling into that two-hour window. Further, ELE-101 is being developed for the treatment of MDD rather than TRD, as is the case with COMP360. Both BPL-003 and VLS-01 rely on transmucosal absorption, as neither moiety is orally bioavailable. As mentioned previously, BPL-003 is administered intranasally and is systemically absorbed through the nasal mucosa. As many of you are already aware, VLS-01 is an oral thin film that is applied to the buccal or internal cheek mucosa, and it's absorbed there.
In terms of pharmacology, DMT itself shows approximately the same 5-HT2A to 1A receptor binding ratio as Psilocin. Both primarily target the 2A receptor, and this activity is hypothesized to drive psychedelic effects. However, the pharmacology of 5-MeO-DMT is different from both Psilocin and DMT, as it binds the 5-HT1A receptor approximately 100 times more tightly than the 2A receptor. This difference potentially underlies the subjective experiential differences that have been noted with 5-MeO-DMT versus other psychedelics. These pharmacological and experiential differences may have therapeutic implications, an important consideration given the heterogeneity of the population of patients with depression. Let's dig a little deeper into BPL-003. A phase I SAD study was recently completed, in which BPL-003 was found to be safe and well tolerated across the seven doses tested. No severe or serious adverse events were noted, and the most common AEs were nasal discomfort, nausea, vomiting, and headache.
Dose proportion of PK was observed, as was a short TMAX of six to 17 minutes. The duration of exposure was short, with plasma concentrations approaching zero within 90 minutes of administration across all dose levels. From a pharmacodynamic standpoint, BPL-003 demonstrated robust psychedelic effects, as measured by the subjective drug intensity scale, or SDI, in this phase I study at doses of 6 milligrams and above. Indeed, all subjects in these dose groups achieved scores of seven or greater out of 10 on the SDI. Notably, subjective effects came on within a few minutes of administration, were prominent for 30-45 minutes, depending on dose, and generally dissipated by 90 minutes. These promising results compelled Beckley to advance BPL-003 into three phase II trials. As noted earlier, all three of these trials are underway now, with data readouts anticipated over the next year.
Let's dig into the first trial anticipated readout in TRD. In summary, this open-label phase IIA trial is exploring the safety and tolerability of 10 milligrams of BPL-003 in 12 patients diagnosed with TRD. The trial is enrolling patients presenting with moderate to severe symptoms who are willing and able to discontinue antidepressant medications prior to the dosing of BPL-003. The subjects will be followed for approximately 12 weeks, and several exploratory endpoints focused on efficacy will be collected. These include the MADRS at multiple time points, the CGI, the PGIC, and measure of quality of life, the EQ-5D. We anticipate results from this trial to be available in the first half of this year. Let's move now to the phase IIB trial, which is actually very similar to Compass's phase 2B trial of COMP360 in both size and design.
Briefly, this is a randomized, double-blind study assessing the effects of a single administration of BPL-003 in approximately 225 patients diagnosed with moderate to severe TRD. Like Compass's phase IIB, this trial is dose-controlled, with subjects randomized to receive 0.3, eight, or 12 milligrams of BPL-003. The primary endpoint of this study is the MADRS assessed at week four, with key secondary endpoints that include safety and other measures of efficacy at multiple time points. This is a global trial, with sites in the U.S., EU , and Australia. The first subject was dosed in October of last year, and as mentioned earlier, top-line results from this trial are anticipated in the second half of this year. It's also worth mentioning that patients who complete the phase IIB study will have the opportunity to enroll in an open-label extension trial.
This trial will evaluate the safety and efficacy of an additional administration of 12 milligrams of BPL-003 over a follow-up period of eight weeks. We expect these data will be highly informative to the design of future studies. With that, let's turn our attention to ELE-101. As mentioned earlier, ELE-101 is a benzoate salt formulation of Psilocin that is administered intravenously via a short infusion. There are two potential benefits of this approach. First, it's anticipated to result in less variability in systemic Psilocin concentrations compared to oral Psilocybin. Second, based on PK modeling, IV Psilocin is expected to have a much shorter exposure versus oral Psilocybin. This, in turn, should translate to a short duration of psychedelic effects lasting less than two hours. Such a profile may be more convenient for both patients and physicians compared to a four to six-hour experience.
We anticipate this may allow for increased commercial scalability and thus improved access for patients overall. Beckley is investigating ELE-101's use in MDD, and a combined phase I+IIA trial is currently ongoing. The phase I component of this combined trial involves a SAD design and is focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of IV ELE-101. Four dose cohorts are planned, but up to six cohorts are possible. The goals of this phase I trial will be to confirm the hypotheses that IV Psilocin results in reduced PK variability and a short duration of both exposure and psychedelic effects compared to oral Psilocybin. Upon successful completion of the phase I trial component, a dose will be selected and advanced into the open-label phase IIA portion of the trial. This will enroll 12 patients with moderate to severe MDD rather than TRD, as is being tested with BPL-003.
These subjects will be given a single administration of ELE-101 and then followed for four weeks. The primary objective of this phase IIA trial will be to assess the safety and tolerability of ELE-101 in an MDD patient population. However, exploratory efficacy endpoints, including the MADRS, will be measured at multiple time points. The company anticipates reporting top-line results from this trial in the first half of 2024. With that, I'll hand it back to Florian to wrap up. Florian?
Thank you, Srini. At Atai, our ambition is to build the leading mental health innovation company with a focus on differentiated assets with prior clinical evidence. Today's strategic investment underscores our longstanding conviction in developing psychedelic-based treatments, as I mentioned before. We believe that this collaboration with Beckley Psytech can lead to accelerating the development of promising, short-acting psychedelics with first-in-class potential, such as BPL-003, and that have the opportunity to drive broader patient access. As a result of this transaction and the addition of multiple meaningful clinical catalysts over the next 12 months, Atai becomes even better positioned to generate value for our shareholders and patients. We would now like to turn the call back over to the operator to open up the line for questions. As a reminder, please limit your questions to two panelists.
If we don't have time to answer all your questions, we will certainly try to schedule time with you after this call. Operator?
Thank you. If you would like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again. Our first question comes from Charles Duncan with Cantor. Your line is open.
Hey, yeah, good morning, Florian and Srini. Congratulations on this transformational transaction. And Christian, nice to hear from you. Happy New Year. Pretty interesting increase in visibility on the pipeline. I had a couple of quick questions regarding BPL-003. First of all, could you give us a sense of the enrollment thus far? I know that treatment only began in October. Have any patients actually been through treatment and have any entered the open-label extension? As a follow-up, Srini, can you give us a sense as to the effect size? Do you think short-duration psychedelic experience may increase or reduce the effect size and then the durability? Thanks.
Thanks, Charles. Also, happy.
My colleagues answer, happy New Year. Like I forgot at the beginning because we're already so in work mode with that transaction. To all of you, and especially to Charles, yeah, happy New Year. It's going to be a great one.
Indeed. Thanks for saying that. Srini, do you want to jump in on these questions?
Yeah, absolutely. Charles, as we noted, I mean, we just guided that the first patient was dosed in October, and we're guiding that the trial will read out at the end of the year. We really haven't given any more color than that on this study. You and I have had multiple conversations about the correlation between duration of psychedelic effect and either magnitude of efficacy or durability of efficacy. I mean, the short answer is I don't think that question has been fully elucidated yet. Obviously, this trial will be important to generate that data. As I've mentioned in multiple calls previously, I think we're really targeting a sweet spot with VLS-01, which we think of as a sort of a 30-45 minute psychedelic window. Not too short, not too long, sort of Goldilocks sort of territory. BPL-003 squarely hits that as well.
As you saw from the simulation slide, the PK slide with ELE-101, we anticipate that to hit something very similar as well. Obviously, this is a really important question and something that's TBD. A couple of trials that are ongoing should address this, and I think this is one of the largest. The BPL-003 trial is one of the largest and most powerful studies to really address this question.
Very good. That's helpful. If I may ask a question of you or Stephen or whoever regarding the IP, I'm wondering the kind of diligence that you did here. And do you have a sense of kind of the durability of the intellectual property protection for these two agents? Thanks.
Yeah, maybe I could. [crosstalk]
You go. [crosstalk]
No, I just wanted to say, of course, Charles, we took a very close look at the IPSA, and that was an essential part of diligence. Srini, maybe you want to kind of give some high-level comments?
Yeah. I mean, we have patents that are very similar to what Compass has generated. There are salt forms, there are crystal polymorphs, there are some formulation patents depending on the asset. Obviously, we spent a lot of time on this. As usual, there are lots of opportunities to create additional IP as clinical data comes in. That is an important question.
Thank you. Our next question comes from Ritu Baral with TD Cowen. Your line is open.
Good morning, guys. Thanks for taking the question. My first question's on the 003 phase 2B trial design. Srini, that 0.3 milligram dose, I'm assuming that that is a subclinical comparator arm, just in the landscape of psychedelic treatment. What is the placebo effect that you how did Beckley choose the 0.3, and what sort of placebo effect are you expecting from that arm? The primary endpoint here is a HAM-D, whereas most of the trials that we've seen with psychedelics have used the MADRS. Can you talk about why the HAM-D and what it might show versus other MADRS data sets?
Let me address that first, the second point first. It is MADRS at four weeks on this one?
Oh, I'm sorry. You're right.
Yeah.
Sorry about that. The inclusion question.
Yeah, yeah. No worries. Yeah. The question around dosing is an important one. In the slides, kind of pointed out the fact that seven doses were tested. The lowest in that context was one. There were some perceptual observations there. That was the reason for the decision to go to one-third of that dose, the 0.3. They actually did generate some clinical data with that dose as well. It just was not presented today. These are all psychedelic naive patients. There is obviously going to be some expectation. Nonetheless, in this context, there was essentially no significant sort of perceptual perceptions of alteration, perceptual alterations with that 0.3 milligram dose. Again, very analogous to how Compass approached it.
Would you expect a similar placebo effect on the MADRS versus other depression studies with that 0.3 in this trial design?
I mean, broadly, again, I think that we are expecting something very similar in terms of magnitude, etc., to what compass saw, right? There really isn't much of any effect at 0.3 milligrams. I think it's functionally very much a placebo in this context.
Got it. The next question is 101. Could you disclose which dose cohort are you at between the four per slide 15? I'm just wondering how we should be thinking about the side effects of usual suspicion with Psilocin, the nausea, the headache, etc., maybe blood pressure, and what you're seeing to date at which dose?
Yeah. We haven't really provided any more color on that other than to say that we do anticipate the whole trial wrapping up certainly by the end of this, the middle of this year, so the first half of this year. You're absolutely right. I mean, those are the side effects that one would anticipate with Psilocin. It's an IV infusion, so you have a little bit more latitude there than oral administration in terms of duration of infusion, for example. Yeah, it's the same as you see with other psychedelic compounds. The headache, the nausea, vomiting are the main ones that we're watching out for.
You personally can see the tolerability profile being kicked off and have seen it before the deal?
We've seen some data, yes. Yet again, we're not guiding on that. Yep.
Thank you. Our next question comes from Andrew Tsai with Jefferies. Your line is open.
Thanks. Good morning and congratulations on the deal. Maybe two questions for me on 003. For the data set, the phase IIB data set coming up, what would you want to see on MADRS efficacy drug versus 0.3 dose, high and mid-dose versus, sorry, not placebo, but the 0.3 dose as the primary endpoint at day 28? Why did you choose day 28 as a primary endpoint as opposed to, let's just say, day seven, for instance? Secondly, just a higher-level question for 003. Can you also help us reconcile why you guys are running both an open-label study as well as this phase IIB study in parallel? Just trying to understand how you plan to leverage the open-label data set as it relates to the phase IIB data set. Thank you.
Yeah. Andrew, great to hear from you. Let's answer the second question first. Obviously, we've literally inherited these trials, right? We didn't have anything to really do with them in terms of Atai itself. There are different questions, of course. The first thing is just around safety and tolerability. That trial was kicked off earlier, the open-label bit. Obviously, made the decision to get that phase IIB up and running as well. I think the focus is around safety and tolerability in this patient population with the phase IIA. There's going to be then obviously the phase IIB is already running, and that's really the focus of the program at this point. Sorry, what was the first question again?
Sure. [crosstalk]
A little early on the West Coast. [crosstalk]
No problem. Day 28 expectations and why day 28 as well. Yeah.
Yeah. Expectations, not guiding a lot there. You can sort of surmise where one's head would be at as a general statement. This is a really well-powered study, as I mentioned. Obviously, anticipating STAT-SIG. Beyond that, in terms of effect size, in terms of magnitude of change, I mean, that's just not something that we're going to get into at this point. Part of this was in terms of the four-week versus three-week was really kind of, or one-week for that matter, really driven sort of by internal decisions and thoughts around existing data, albeit all open-label data around 5-MeO-DMT. That's what really kind of guided that. That also was then reflected in the size of the trial, right? Again, this is a pretty substantial trial to really make sure that that four-week endpoint is nailed.
Thanks very much.
Absolutely.
Thank you. Our next question comes from Sumant Kulkarni with Canaccord Genuity. Your line is open.
Good morning. Happy New Year. Thanks for taking my question. My question is on 003. How do you expect the eventual battle for new chemical entity exclusivity for Firmier DMT to play out if and when the molecule gets approved in the U.S.? Asking because Beckley has one in development and GH also has one roughly at similar stages. Thanks.
Yeah. Got to be first, right? That's the key there. It's literally NCE, new chemical entity exclusivity. Definitely have to be first. Now, there's a lot of reasons why we have conviction in this asset, not the least of which is this is the most substantial trial. GH, as an example, at this moment is obviously on clinical hold in the United States. This trial is apparently running primarily, GH's trial is apparently running primarily in New York. It's a much more limited trial in terms of the number of patients as well. Our expectation is considering where Beckley is, it seems to be the furthest along, IND is enabled in the United States, etc. With our investment, with the team that's there, we have a lot of conviction that this will be the first to market.
Thanks.
Sumant, maybe just to add to this. We discussed it earlier, but there's an additional differentiation on the route of administration, of course, which we believe is also another key point to highlight. Inhalation versus the intranasal delivery of BPL-003.
Yeah. Good point. I mean, I've personally been burned in the past with inhaled and the FDA's kind of take on this. I don't know what's going on there specifically, but yeah.
Right. A bigger picture question. As you looked at the assets, Beckley specifically, was it the proximity of data that drove this? What was the thought process behind owning a part of Beckley versus internalizing it wholly?
If I can start here, as I said, sometimes you want to own things fully, but the other side doesn't. I'm actually kind of happy because I think valuations in biotech are super low at the moment. I think they're kind of artificially depressed low. If companies, if you don't have to, you don't want to sell your company now. You want to wait till markets recover. What you want, you want to raise money. We had actually this discussion because we're also looking on some other stuff. Before I either cannot have a deal or I have a market for lemon, where just the sort of not-so-good founders want to sell out now in the worst moment of all times, yeah, I'd rather take a smaller stake.
As you know, we have warrants, which would bring us close to 50% in case of exercise. I would rather have sort of half of something amazing, at very good terms, than owning 100% of something not so amazing or of not getting the deal at all. We are very pragmatic. For us, the most important thing is IRR and sort of making the right decisions and then getting sort of the right assets onto our platform. Additionally, the team is amazing. I want to reiterate that. Cosmo, all the people around him. I also think we not just acquired two great sort of therapeutics, but we also acquired some very smart brains, which we are also very friendly with each other since a very long time. We also like to work together.
I think given times, given markets, given mutual interests and win-win situations, that is sort of the best deal structure.
Sumant, maybe just to add to this, it's also in line with kind of how we've done the structured deal historically. We've been always, as Christian said, pragmatic. It was really the excitement around the data that drove, yeah, our conviction here and in also the potential for scalability and patient access, in addition to some synergies that we see also with some of our enabling technologies, as I mentioned earlier, with the digital patient support that we will explore together and other synergies. This is really a very collaborative approach with them over the last weeks. We're looking very much forward to explore this further.
If you noticed, or as I said earlier, there's also a ROFN and the ROFR in place that allow also more for, I guess, a more formal, closer collaboration, adding to Christian's point between our two firms in the future.
Thank you. Our next question comes from Patrick Trucchio with H.C. Wainwright. Your line is open.
Hi. Good morning and congrats on the deal. I have a couple of follow-up questions on the BPL-003 program. Just first, for clarification, is BPL-003 being administered by a third-party device, or was this device designed by Beckley? Just on the trial design for the phase IIB trial, regarding the inclusion criteria, it's based on the HAM-D, and then the primary endpoint is based on the MADRS. I guess I'm just curious, why is there a difference there? How is treatment resistance being defined in this study in terms of number of prior treatments failed? How does that compare to some of these other TRD trials that we've seen?
Yeah. It's done in trials sometimes to prevent sort of grade inflation or, sorry, the HAM-D bit, right? You use a different endpoint or a different criterion for inclusion. There's good correlation between the two endpoints, but then you use a separate one for the primary. That is done. It's been done in multiple trials in the past, again, just to prevent any kind of grade inflation by the site, including patients and us getting more of a regression of the mean. That's why that was done in this context.
And then. [crosstalk]
Hello?
Thank you. I'm throwing no further questions at this time. I will now turn the call back over to Atai Life Sciences CEO, Florian Brand, for closing remarks.
Thank you. Patrick, you cut out there, I think. Happy to follow up, of course, after this call. To the rest of you, thanks a lot for dialing in today. We wish you, as Christian said, continued Happy New Year and appreciate your support and really look forward to our continued progress throughout this year. Operator, you can now.
Oh, over to you, Christian.
No, I just want to say whoever is also at J.P. Morgan Conference next week, both Srini, Florian, and I are there together, and we would love to see you. Either drop one of us, yeah, drop one of us an email. You have our contact details, and then we can schedule something. We are all in town for the whole week. Hope to see you in person. Again, Happy New Year.
Thanks to you, Operator. Thank you.
Thank you, Operator.
Thank you.
Bye, everybody.
You're welcome. Thank you for your participation. This does include the program, and you may now disconnect. Everyone, have a great day.
Thank you.