COMPASS Pathways has provided an update on their ongoing Phase III and Phase II clinical trials during their fourth quarter 2023 earnings call. The company, known for its COMP360 psilocybin therapy for treatment-resistant depression (TRD), has faced some delays in recruitment for its 005 trial, pushing its top-line data release to Q4 of the year. However, these delays are not expected to affect the planned submission of their New Drug Application (NDA).
COMPASS Pathways has also reported initial safety data from its Phase II trial in post-traumatic stress disorder (PTSD) and the publication of data on bipolar type II depression.
Financially, the company remains robust, with cash reserves of $220.2 million, despite reporting a net loss of $118.5 million for the year. The company's CEO, Kabir Nath, reaffirmed their commitment to advancing their clinical programs and exploring potential new indications for COMP360.
Key Takeaways
- Phase III COMP360 trials for TRD are ongoing, with top-line data expected in 2023 and 2024.
- Recruitment delays in the 005 trial will push top-line data to Q4 2023, but will not affect NDA submission timing.
- Initial safety data from the Phase II COMP360 trial in PTSD has been released.
- COMPASS Pathways reported a net loss of $118.5 million for 2023 but maintains strong cash reserves.
- R&D and G&A expenses have increased in 2023 compared to 2022.
- The company is developing a delivery network for COMP360, collaborating with Greenbrook TMS and Hackensack Meridian Health.
- CEO Kabir Nath emphasized the focus on execution in TRD and openness to exploring other indications for COMP360.
Company Outlook
- COMPASS Pathways expects net cash used in operations to be between $17 million and $23 million in Q1 2024, and between $110 million and $130 million for the full year.
- The company has sufficient funds to continue operations into 2025.
Bearish Highlights
- The company has observed a delay in enrollment for its 005 trial, which will postpone the release of top-line data.
- There has been an increase in net loss from the previous year, with R&D and G&A expenses rising.
Bullish Highlights
- COMPASS Pathways is encouraged by the growing interest in psychedelic treatments and regulatory acceptance for therapies like MDMA-assisted therapy for PTSD.
- The company has a strong cash position, with $220.2 million in cash and cash equivalents at the end of 2023.
Misses
- The company did not meet its timeline for the 005 trial top-line data due to recruitment delays.
Q&A Highlights
- CEO Kabir Nath stated the Phase III study is 100% U.S. based and follows the same inclusion criteria as Phase IIb.
- COMPASS is monitoring the regulatory process of potential competitor Lykos for insights into regulatory and commercial reimbursement strategies.
- The company has not given much consideration to licensing COMP360 for anxiety indications due to the complexities of split indications.
- Nath indicated openness to a compelling proposal for licensing COMP360 for other indications.
COMPASS Pathways (ticker: CMPS) continues to navigate the clinical and regulatory landscapes with a clear focus on bringing COMP360 to market for TRD while also maintaining an interest in expanding its potential indications. Despite some setbacks, the company's financial health and strategic partnerships position it to continue its research and development efforts. As the market for psychedelic treatments becomes increasingly receptive, COMPASS Pathways remains a company to watch in the emerging field of psychedelic-assisted therapies.
InvestingPro Insights
As COMPASS Pathways (CMPS) advances its clinical programs and manages its financial resources, real-time data from InvestingPro provides a granular view of the company's financial health and stock performance. Here are some key metrics and tips that could be relevant to investors and stakeholders following CMPS's progress:
InvestingPro Data:
- Market Cap (Adjusted): 635.68M USD, reflecting the company's current valuation in the market.
- P/E Ratio (Adjusted) as of the last twelve months of Q3 2023: -5.44, indicating the company is not currently profitable.
- 3 Month Price Total Return as of the 61st day of 2024: 68.36%, showing strong recent stock performance.
InvestingPro Tips:
1. COMPASS Pathways holds more cash than debt on its balance sheet, which is a positive sign of financial stability, especially considering the company's strong cash position reported at the end of 2023.
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Full transcript - Compass Pathways Plc (CMPS) Q4 2023:
Operator: Good day, ladies and gentlemen, and welcome to the COMPASS Pathways Fourth Quarter 2023 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 call, Stephen Schultz. You may begin.
Stephen Schultz: Welcome all of you, and thank you for joining us today for our fourth quarter 2023 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today, I'm joined by Kabir Nath, our Chief Executive Officer; Mary-Rose Hughes, our Interim Chief Financial Officer; Teri Loxam, our incoming Chief Financial Officer and Dr. Guy Goodwin, our Chief Medical Officer. The call is being recorded and will be available on the COMPASS Pathways' Investor Relations website shortly after the conclusion and will be archived 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 annual report on Form 10-K 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: Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by thanking Mary-Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter. And let me welcome Teri Loxam back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March 1st. Teri brings to COMPASS deep extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sectors. Her broad experience through all stages of development is precisely the expertise and leadership that COMPASS required as we progress our Phase III program in treatment-resistant depression. Many of you already know Teri, and I hope that over the coming months rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at COMPASS. First, though, let me report that COMPASS continues to actively recruit both our Phase III COMP360 trials in treatment-resistant depression with top line data expected this year and next. While our overall Phase III clinical program completion remains on track with top line data from 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top line data from that trial into Q4 of this year. Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier. In parallel with the Phase III trial program, we continue to take the steps needed to ensure a well-developed delivery network for COMP360 if approved. This includes developing collaborations that will educate both COMPASS and settings of care on how COMP360 may fit into treatment options for appropriate patients. A key element of these research collaborations is to explore and develop multiple potential commercial delivery templates to ensure a successful rollout of COMP360 treatment subject to FDA approval in different care settings. Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are two very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COMP360 psilocybin treatments. We also expect to announce additional research collaborations this year. In December, we announced initial safety data from our open label Phase II clinical trial of a single 25 milligram dose of COMP360 in 22 people living with post-traumatic stress disorder, or PTSD. We were also pleased to see the publication of COMP360 data from an investigator-initiated study in bipolar type II in JAMA Psychiatry. In a moment, Guy will provide more information on both of these studies. While TRD is our lead indication for COMP360, we see logical expansion of its utilization into additional indications where there are significant comorbidities and overlap such as PTSD and bipolar II subjects to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to companies. Teri?
Teri Loxam: Thanks, Kabir. Now that I'm back at sea level, I'm really happy to be joining you in this experience and pioneering leadership team. Similar to many, I sadly witnessed the impact of mental health issues on people close to me. So, a big draw for me to the company was seeing COMPASS fully embracing its mission with a thoughtful, innovative and data driven approach to tackling significant unmet need in this area. Psychedelics and their potential to treat mental health conditions have received significant attention in the media, but we are still very much just at the beginning of this journey. While psychedelics could be transformative to mental health, in these early days, it is critical for companies to build and execute robust clinical trial plans to realize the long-term potential. This is precisely the approach COMPASS has taken with its large Phase II and ongoing Phase III programs in TRD. There are a lot of important milestones over the next 12 to 18 months for the company. And with a strong balance sheet and an experienced team, we are well positioned for success. I'm really looking forward to working with the team to help shape the landscape and prepare for this potential important treatment option for patients. With that, let me hand the call back to Kabir.
Kabir Nath: Many thanks, Terry. Welcome once again, and it's great to have you join our leadership team. Let me now hand the call over to Guy to update you on clinical news during the quarter. Guy?
Dr. Guy Goodwin: Thank you, Kabir. Looking at the COMP360 pivotal program, nearly all sites have been initiated for COMP005. For the 006 trial, we have sites initiated in the U.S, Canada, UK, Ireland, Sweden and Spain. I anticipate further progress this year. Patient demand is strong in all geographies, which as expected, reflects the degree of unmet need in this population. However, as Kabir has said, we are experiencing delays in recruitment in our 005 trial. As we've said before, these trials are complex. Beyond the Schedule I drug organizations and unique handling requirements and redosing protocol, we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program. This has been a challenge that medical record keeping is decentralized in the U.S. and has slowed the pace of screening and enrolling. However, now that nearly all 005 sites are open and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrolment. The challenges we have encountered are specific to U.S. clinical sites and as Kabir mentioned, we don't see the same impacts to COMP006, a global trial which remains on track. Separately, we're also excited by the potential for COMP360 in other indications. PTSD is an additional indication of interest which we have investigated in an exploratory Phase II safety study of 22 patients, all of whom were administered a single dose of 25 milligram COMP360 psilocybin. We announced initial safety data in December, which demonstrated that COMP360 was well tolerated up 24 hours and the safety profile was as expected with no treatment emergent serious adverse events recorded. The study participants have been followed for 12 weeks and we look forward to announcing the full PTS data set including efficacy later this Spring. In addition, as Kabir mentioned, the full results of an independent investigator led study in bipolar type II depression were published in JAMA Psychiatry. These data first announced in 2022 demonstrated potential for investigational COMP360 psilocybin treatment in another difficult to treat depressive disorder. The study was conducted by Scott Aaronson at Sheppard Pratt in Baltimore and funded by COMPASS. It investigated the safety and efficacy of a single 25 milligram dose of COMP360 psilocybin treatment with psychological support. The primary endpoint was change in MADRS total score from baseline to week three. All 15 participants had lowered MADRS scores with a mean change from baseline of minus 24 points at week three. 12 participants met the criteria for response and 11 met the criteria for admission. While this is a small trial, we see the results as extremely promising. Importantly, there was no increase in the suicidality score based on MADRS and no unexpected adverse events or difficulties with the dosing sessions over the 12 weeks of the study. We did not see the onset of a manic, hypomanic or mixed state, which is a particular concern for patients with bipolar disorder. The most common adverse event was headache reported by 4 out of 15 participants on the day of dosing with symptoms resolving within 24 hours. People living with bipolar II depression like those living with TRD have limited or no option. So, it's encouraging to see early signal that COMP360 psilocybin may have potential to help those living with these depressive conditions. As Kabir indicated, based on this study's results, bipolar type II looks to be an indication of interest for the use of COMP360 and additional larger studies are under consideration. This is a good fit with our mission for the company. Let me now hand the call to Mary-Rose for financial overview. Mary-Rose?
Mary-Rose Hughes: Thank you, Guy. I'll now step through the full year financial results. Cash used in operations in the full year 2023 was $97.4 million within the guidance range we provided for the full year last quarter of $94 million to $100 million excluding R&D tax credit. The timing of receipt of the credit is uncertain, but I'm pleased to confirm that HMRC have since approved our claim in full and we now anticipate receiving the tax credits in the first quarter of this year. For the year ended December 31, 2023, net loss was $118.5 million or $2.32 per share compared with a net loss of $91.5 million or $2.16 per share during the same period in 2022. These results include non-cash share-based compensation of $17.3 million in 2023 and $13.1 million in 2022. R&D expenses were $87.5 million in 2023 compared with $65.1 million in the prior year and G&A expenses were $49.4 million in 2023 compared to $45.4 million in the prior year. Long term debt under our Hercules loan facility was $28.8 million at the end of the fourth quarter. Regarding first quarter financial guidance, we expect net cash used in operation to be between $17 million and $23 million which assumes that we received R&D tax credit in the first quarter. However, as I mentioned already, the timing is uncertain. Turning to full year financial guidance, we expect cash used in operations to be between $110 million and $130 million. We expect to narrow this range as the year progresses. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $220.2 million at December 31, 2023 compared with $143.2 million at December 31, 2022. We will continue to manage our cash carefully to continue advancing our pivotal programs and to achieve important milestones that we believe will create value for our shareholders. Thank you. And I'll now turn the call back to Kabir.
Kabir Nath: Thank you, Mary Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both COMPASS and its area of science. Our COMP360 Phase III program remains on track with the first trial expected to read out this year, not only a key milestone for COMPASS, but also a major event in the development of psychedelic medicines. The FDA draft guidance for clinical studies of psychedelic drugs along with the European Medicines Agency's plans to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe are important signs that regulators are preparing for the potential use of psychedelics as treatment. In a sign of the continuing unmet need in TRD, esketamine sold under the brand name Spravato achieved global sales of almost $700 million in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deliver it, which bode well for the potential of COMP360 if approved. We also welcome the news of FDA acceptance of Lykos therapeutics NDA submission for MDMA assisted therapy for PTSD. We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings. Our collaborations are indications of this interest, and we'll continue to develop commercial models that enable rapid, scalable, broad and equitable access to COMP360 if approved. In closing, with our strong balance sheet, we are focused on execution of our Phase III program in treatment resistant depression. This will be an exciting year for COMPASS Pathways and we look forward to updating you on our progress over the coming year. Thank you again for your participation on today's call. And we'll now turn to Q&A. So I will hand the call back to the operator. Thanks.
Operator: Thank you [Operator Instructions]. Our first question comes from Patrick Trucchio with H.C. Wainright. Your line is open.
Patrick Trucchio: Thanks. Good morning. Just a couple of follow-up questions on the enrolment delays. So, the first is just regarding the TRD diagnosis being necessary for enrolment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?
Kabir Nath: Thanks, Patrick. Just checking if you can hear us and I'll hand it to Guy.
Patrick Trucchio: Yes. I can hear you.
Dr. Guy Goodwin: Yes, I mean our criteria are those of treatment-resistant depression as you know and that means that patients are required to have failed at least two treatments. These treatments have to meet the criteria for adequate dose and adequate duration. And the delay that you referred to is caused by the fact that we are being rigorous in establishing this, but this has occurred through health record and that in the U.S. has proved to be difficult but not impossible and we're proceeding successfully to do that in the patients we are recruiting. I should say there's no shortage of patients, but the issues around verification have been real and that those are what have caused the problem. But the same of patients who may have been previously taken psychedelics, we were -- we've taken that number up from 10% in the Phase II to 15% in the Phase III. And just to emphasize, one of the issues that we face is that patients conceivably or patients -- people seeking treatment maybe seeking psychedelics and that's one of the reasons why we're particularly rigorous insisting on the medical records being proven and verifiable.
Patrick Trucchio: Got it. If I could just another follow-up. I'm just -- I'm wondering if this just moving this top line data back for COMP005 trial, is that would that have any impact on the potential filing of an NDA for TRD or is the timing kind of going to be unchanged based on the top line data for the 006 trial? And separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA? Specifically, would you have any certain amount of longer-term follow-up efficacy or safety data from these trials before that NDA is submitted? Thanks so much.
Kabir Nath: Thanks, Patrick. So, I'll work backwards from that question. We have not clearly guided on what we are going to expect to include in initial submission. That will be about a discussion with the agency. But as a reminder, with breakthrough designation, you can clearly envisage things like rolling submissions as well. To the first part of the question, as I said in my prepared remarks, this does not alter the potential timing of a filing. COMP006 remains on track for mid-2025, and we have always consistently guided that we do expect both trials to be needed to form [Indiscernible]. So no, we are not anticipating any change in the timing of potential submission.
Operator: Our next question comes from Charles Duncan with Cantor. Your line is open.
Charles Duncan: Good morning, Kabir and team. Thanks for taking the question. I wanted to follow-up to those last questions with regard to diagnosis of TRD. Can you help us understand how it's different in the United States versus elsewhere? And what percentage of patients are you anticipating in 006? And why will the problem be fixed in that trial? Thanks.
Kabir Nath: I mean I think that the problem in the U.S. is simply the nature of the health care system is being simply more decentralized. This is in great contrast really to particularly European health care systems where usually health care records are extremely straightforward to access. For example, most patients in the UK have a primary care physician to get health records is simply a matter of contacting the physician with appropriate consent getting the record. So there's a great that's a tremendous difference from what we have to say for each day. I think in terms of your second issue is about what was the second issue? So, in terms of the number of patients. Yes. I mean that issue relates -- I mean we think that we will be in a position having set up the systems that we now have to facilitate getting the data. The fact that 006 is taking place subsequent in most centers to 005 means that everything will really be running optimally by the time many of the U.S. sites switch to 006. The patients entered in ex U.S. of course are not subject to the problems anyway. And we think the proportion, I think you also requested, will be about fifty-fifty. And we can -- when we model it we think that this is we're on track as we said for 006. And the problems of 005 are really hard to do with the fact we started 005 first in U.S.
Charles Duncan: That That makes sense. If I could ask one follow-up, and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before of standard of care, albeit ineffective, antidepressants before they enter 005?
Kabir Nath: I mean, there are that represents -- the washout represents a challenge, but the most of the problem has been with the verification for diagnosis. So that's having 001, our Phase II trial, about a third of the patients in that study were already off antidepressant, so 2/3 required washing out and the majority -- great majority, were able to do so once they had been enrolled in the study. But it's enrolment that has been the issue in 005.
Operator: Our next question comes from François Brisebois with Oppenheimer.
François Brisebois: Hi. Just a couple here. Just sorry to ask again about the enrolment. But, is the fourth quarter guidance just a very conservative? Or how do we feel comfortable that fourth quarter will be correct for 005?
Kabir Nath: We are very comfortable with that. As you would expect, we've done a number of projections, looked at different scenarios, and we are very comfortable with the fourth quarter guidance.
François Brisebois: Okay. And then on the commercial side, the Spravato infrastructure obviously has some read through here. Can you just remind maybe us, the listeners that how Spravato works, how many times people come in and are there any efficiencies maybe for these centers that would put you in a situation that might be superior to Spravato? Just any learnings there? How has that evolved as you guys look into the commercial opportunity?
Kabir Nath: It's a great question. So yes, clearly the protocol for Spravato is very different from what we envisage to be a final protocol for COMP360. So as a reminder, the Spravato label actually requires eight administrations in the first month, four in the second month and maintenance thereafter patients in physician discretion, but typically every couple of weeks. So, you can imagine therefore over the course of the first three months that something like 12 to 15 sessions, each of those requires the patients in the clinic for a minimum of really 3 to 4 hours given the intranasal administration and the two hours of monitoring. And by the way they can't drive a home afterwards, so it actually requires a caregiver for each of those as well. In contrast, obviously, we don't yet know what the durability will be for, shall we say, a typical patient with COMP360 and the Phase III is designed ready to address that. But as we've said before, based on what we know, it perhaps might be 2 to 4 administrations a year for a patient. So you can see that from a patient perspective, that's a very, very different from center-to-center, it's the difference between using one room for a day, once every perhaps three to four months and actually having multiple uses of rooms during the course of time for [Indiscernible]. So we believe and we have a big part of the reason we've signed these collaborations with entities such as Greenberg and Hackensack and we'll do more is exactly to understand how we are going to integrate psilocybin differentially from Spravato into those workflows and think of how they address reimbursement.
François Brisebois: Great. Thank you very much. Congrats on the progress, sir.
Operator: Our next question comes from Neena Bitritto-Garg with Deutsche Bank.
Neena Bitritto-Garg: Hey, guys. Thanks for taking my question. So, I just wanted to ask about the enrolment again. And, I just wanted to confirm, what kind of -- if there are any actions that you can take to really maybe accelerate the reviews that you're doing, to confirm diagnosis? Is there anything that you've actually been able to do that you found has been helpful in accelerating that process in the U.S.?
Kabir Nath: Thanks. Yes. In a word that had and we've taken those mitigating actions. So, we have added specific vendors who are able with patient consent to work directly with patients and to obtain the medical record. So what we have seen is that that does enable us certainly in some circumstances to obtain those records much more quickly than going just through the motions ourselves or with our CRM. So yes, we have added specific paid for vendors, a couple of different ones in fact to enable that at the majority of sites.
Operator: Our next question comes from Ritu Baral with TD Cowen.
Ritu Baral: Kabir, are you anticipating that this delay and this sort of going back and reconfirming TRD is going to change the patient demographic in any way shape or form? Is that sort of coming out different and how might that affect the potential powering or potential perceived expected placebo effect in the study and the follow-up to that is have you determined what you are going to release with top line data at the end of the year, specifically longer-term follow-up and durability? And then I just got a follow-up on the centers.
Kabir Nath: So let me start, but I'll also ask Guy to weigh in on the third part of the question. So, to be clear, this does not in any way represent a change to the inclusion criteria nor in fact is this a change from what we needed to do in Phase IIb. But a couple of things to point out first obviously the Phase IIb was only partly in the U.S. It was ultimately a global study. Second, I think we do think it's relevant that Phase 2b 001 and 006 have three doses of active 110 and 25 whereas in 005 there is a real placebo and clearly from a patient willingness or a patient incentive to enrol, that is a significant difference between 005 and both 001 and 006. So I don't know if you want to add anything on that.
Dr. Guy Goodwin: Yeah, I don't think that the track -- I mean as you heard the vendors that we hired are there because this is a general problem, it isn't just our problem. Our definition hasn't changed and so our considerations around power and placebo response are unchanged as well. So it's just a delay and we think we've overcome some of the factors that contributed to it now. And for the second part of the question, Ritu, as you are very well aware, this is a blinded trial through Part B through the 26 weeks and therefore determining what we will be able to announce with top line is something that will be a matter of review at that time.
Ritu Baral: Got it. And then a follow-up question. You mentioned multiple delivery templates when you speak of your collaborations with Greenbrook and Hackensack, and you mentioned that you're working through options. Are there any sort of buckets of different templates or particular aspects of delivery that you are, I guess, building out and investigating with those two, sort of like just large different phenotypes of delivery models that we should all be thinking about at this point?
Kabir Nath: It's a great question. And what I would say is the work we're doing is precisely to understand how many different phenotypes of delivery, shall we say, that we're going to need. And so, if we take these first two, obviously, Greenbrook and Hackensack are very different. Greenbrook is a full profit network of interventional psychiatry centers that is essentially today offering TMS, Ketamine, Spravato, but very interested in offering psychedelics as well, but have only kind of recently grasped into I would say more traditional psychiatric treatment. And therefore, how this will fit they already have physical infrastructure for the delivery of these things. So working out what works for them in that context may be very different from someone like Hackensack, which is an integrated regional health system with multiple sites that currently have different specialisms, but also very large kind of tertiary care center with 300 beds which will probably going to be at the heart of where they will treat psychedelics. So, I think the reason we are doing this and the reason we you will see a couple more collaborations again in very different settings of care. It's exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursement. I mean, for instance, you can imagine some commercial centers might be very open to buy and bill. They actually fit very well with their economics and offer an attractive route. Health systems and so on, it's much more likely to be Part B rather than Part B. But these are the questions we want to answer.
Ritu Baral: Got it. So, each collaboration is going to represent a type of setting that is that has significant use in the U.S. or EU. Is that the way to think about each of these individual collaborations?
Kabir Nath: The way to think about it is they are deliberate. You know, obviously, there's a limit to the number we can do in this very pre commercial setting. And yes, they are designed to be sufficiently different that they can as we say allow us to develop template for them in when we get to formal pre-launch activities that we're lucky enough to get there, that we can then take those templates to other examples of the similar settings. And that's the way the plan has been built.
Operator: Our next question comes from Sumant Kulkarni with Canaccord Genuity.
Sumant Kulkarni: Good morning and afternoon to the team. I'll add my welcome to Teri. It's great to work with you again. Thanks for taking my questions. The question is actually an additional indications for COMP360. You've mentioned PTSD and depression in type II bipolar disorder, but is there a reason why you've not specifically mentioned anxiety, especially given comorbidity depression? And are you collecting any anxiety related measures in your Phase II program? And just a bit of a follow on to that, how closely are you watching a potential competitor Incannex’s program with psilocybin and GAD that reported Phase II data yesterday?
Kabir Nath: Yes. Thanks, Sumant. Great question. I mean there's a tremendous -- I mean there's a shared genetic origins for depression and anxiety and so they're closely related and most patients with depression have anxiety levels at least to some degree. We are as you've asked including anxiety measures specifically the GAD7 in our trials needed in 001 and we have published data on that already. So, we certainly see an antianxiety and anxiolytic potential with COMP360. But in many ways the presentation of anxiety is usually in primary care and we can't really see how COMP360 would be kind of the treatment of choice under those circumstances. And for that reason, we have not gone for that in the first instance. But clearly patients who have both depression and anxiety are probably the commonest phenotype around and we think that there will be an advantage in treating that population on the basis of their depressive symptoms, but incidentally treating their anxiety. I don't know whether you want to comment on the competitive difference.
Dr. Guy Goodwin: Only to say, I mean obviously aware of this. I mean it's a relatively small study in Australia, 72 patients as I recall, but yet to acknowledge that that was published yesterday and something that we will dig into more.
Sumant Kulkarni: Correct. Do the logistical hurdles in the U.S. That are leading to the slight delay contribute to a meaningful change in the financial outlay required for 005 and 006?
Mary-Rose Hughes: That's a great question. So no, I mean clearly we've made some additional investments and we think it's important to do that. But not a material change. We still have runway into 2025.
Operator: Our next question comes from Jason McCarthy with Maxim Group. Your line is open.
Jason McCarthy: Hey, guys. This is Michael Okunewitch on the line. Thank you for taking my questions today. So I guess to start off, I'd just like to ask, are you using a more rigorous verification of the TRD diagnosis compared to the Phase IIb? And if so, what is the reason? Does this have to do with greater public awareness of psychedelics and their efficacy? Or just a factor of a larger U.S. portion for the study?
Kabir Nath: So no, we're not it is exactly the same inclusion criteria. It is the same population. It is as I said in answer to an earlier question. I mean partly it is the fact that this is 100% U.S. and also I do think the nature of the arms of the study this being true placebo as opposed to both 001 and 006 that have three doses of active drug, I think that also is a contributing factor.
Jason McCarthy: All right. And then just one more for me. I just wanted to see how closely you would be watching the Lykos NDA process and potential subsequent approval. Is there anything in particular that you're looking for on the commercial reimbursement side that may help to inform your strategy for COMP360?
Kabir Nath: So yes, we will clearly be observing the regulatory process for Lykos very closely. We wish them well and I think it's clearly premature to see how they're thinking through commercial reimbursement. But obviously, we recognize that there will be lessons from that progress both through the regulatory and commercial basis for us.
Operator: Our next question comes from Elemer Piros with Rodman & Renshaw.
Elemer Piros: I don't have a question related to the delay, but I have a question about the anxiety indication was mentioned that you are not focusing on it necessarily. But would you be interested in licensing COMP360 to indications that are potentially of no interest to you?
Kabir Nath: That's an interesting question. What I will say is, in general, split indications are enormously challenging in my experience. If you could particularly if you can't clearly identify a very different dosing paradigm and so on. So that's not something we have given any great consideration to. Clearly, if somebody comes with a very compelling proposal, we would listen to it. But it's not in general, it's pretty hard with a single molecule in my experience.
Operator: Thank you. There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.
A - Kabir Nath: Thanks, everyone, for joining. In conclusion, let me just say, again, our guidance for the overall timing of our Phase II program in TRD is unchanged. We are acknowledging and giving guidance around a slight delay into Q4 2024 for top line data from 005, but our overall guidance remains unchanged. We continue to be very focused on execution in TRD. And also as we said, continuing to think about which other indications of interest would be the most compelling places to take COMP360 there. So thank you very much everyone. Thank you for your time and attention today. Thank you for your participation.
Operator: This concludes your conference call for today. [Operator Closing Remarks].
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