COMPASS Pathways - Q4 2023

Transcript

Operator (participant)

Good day, ladies and gentlemen, and welcome to the Compass Pathways fourth quarter 2023 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Steve Schultz. You may begin.

Steve Schultz (SVP of Investor Relations)

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 of the call 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 will now hand the call over to Kabir Nath.

Kabir Nath (CEO)

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. 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 requires 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, the rest of you will have the opportunity to meet her. 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 the COMP006 study expected in the middle of 2025, we are experiencing some recruitment delays in the COMP005 trial, which extends our guidance for top-line data from that trial into quarter four 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 mg 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, subject to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to Compass. Teri?

Teri Loxam (CFO)

Thanks, Kabir. Now that I'm back at C-level, I'm really happy to be joining you in this experienced and pioneering leadership team. Similar to many, I've 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 12-18 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 (CEO)

Many thanks, Teri. 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?

Guy Goodwin (Chief Medical Officer)

Thank you, Kabir. Looking at the COMP360 pivotal program, nearly all sites have been initiated for COMP005. For the COMP006 trial, we have sites initiated in the U.S., Canada, U.K., 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 COMP005 trial. As we've said before, these trials are complex. Beyond the Schedule I drug authorizations 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, as medical record keeping is decentralized in the U.S. and has slowed the pace of screening and enrolling.

However, now that nearly all COMP005 sites are open, and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrollment. 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 mg COMP360 psilocybin. We announced initial safety data in December, which demonstrated that COMP360 was well tolerated up to 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 PTSD 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 the 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 -24 points at week three.

12 participants met the criteria for response, and 11 met the criteria for remission. 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 four 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 options, so it's encouraging to see early signals 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 as a company.

Let me now hand the call to Mary-Rose for financial overview. Mary-Rose?

Mary-Rose Hughes (Interim CFO)

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-$100 million, excluding the 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 credit in the first quarter of this year. For the year ended December 31st, 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 operations to be between $17 million and $23 million, which assumes that we receive the R&D tax credit in the first quarter. However, as I've 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 31st, 2023, compared with $143.2 million at December 31st, 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 (CEO)

Thank you, Mary-Rose. I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both Compass and this 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's 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 treatments.

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 (participant)

Thank you. If you'd 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 Patrick Trucchio with H.C. Wainwright. Your line is open.

Patrick Trucchio (Biotechnology Analyst)

Thanks. Good morning. Just a couple of follow-up questions on the enrollment delay. So the first is just regarding the TRD diagnosis being necessary for enrollment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling in the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelics?

Kabir Nath (CEO)

Thanks, Patrick. Just checking that you can hear us, and I'll hand it to Guy.

Patrick Trucchio (Biotechnology Analyst)

Yep, I can hear you.

Guy Goodwin (Chief Medical Officer)

Okay. Hi, Patrick. Yes, I mean, our criteria are those with 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. The delay that you referred to is caused by the fact that we are being very rigorous in establishing this, that this has occurred through health records.

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 those are what have caused the problem. But the center patients who may have been previously taken psychedelics, 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, may be seeking psychedelics. And that's one of the reasons why we're particularly rigorous insisting on the medical records being proven and verifiable. Thanks so much.

Patrick Trucchio (Biotechnology Analyst)

Got it. If I could, just another follow-up. I'm just wondering if this just moving this top-line data back for COMP005 trial. Would that have any impact on the potential filing of an NDA for TRD? Or, you know, is the timing kind of gonna be unchanged based on the top-line data for the COMP006 trial? And, separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA. You know, specifically, would you have any you know certain amount of longer-term follow-up efficacy or safety data from these trials before that NDA is submitted? Thanks so much.

Guy Goodwin (Chief Medical Officer)

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 the initial submission. That will be a matter for 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, no, 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 an adequate or acceptable dossier. So no, we are not anticipating any change in the timing of a potential submission.

Patrick Trucchio (Biotechnology Analyst)

That's helpful. Thank you so much.

Guy Goodwin (Chief Medical Officer)

Thanks, Patrick.

Operator (participant)

Thank you. Our next question comes from Charles Duncan with Cantor. Your line is open.

Charles Duncan (Managing Director)

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, you know, what percentage of patients are you anticipating in COMP006, and why will the problem be fixed in that trial? Thanks.

Guy Goodwin (Chief Medical Officer)

I mean, I think that the problem in the U.S. is simply the nature of the healthcare system is being simply more decentralized. This is in great contrast, really, to particularly European healthcare systems, where usually healthcare records are extremely straightforward to access. For example, most patients in the U.K. have a primary care physician. To get health records, it's simply a matter of contacting the physician and with appropriate consent, getting the records. So there's a great—that's a tremendous difference from what we have to say in the States. I think in terms of your second issues about... What was the second issue?

Charles Duncan (Managing Director)

In terms of the number of patients-

006.

Guy Goodwin (Chief Medical Officer)

Yeah. I mean, that issue relates. I mean, we, we think that we will be in a position, having set up the systems that we now have to facilitate getting the data, that 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, the patients entered on in ex-U.S., of course, are not subject to the problems anyway. And we think the proportions, I think you also requested, will be about 50/50.

We can, when we model it, we think that this is. We're on track, as we said, for 006, and the problems with 005 are really partly to do with the fact we started 005 first in the U.S.

Charles Duncan (Managing Director)

That makes, 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 standard of care, albeit ineffective, antidepressants before they enter COMP005?

Guy Goodwin (Chief Medical Officer)

I mean, that represents the washout represents a challenge, but the most of the problem has been with the verification of the diagnosis. So that having 001, our phase II trial, about a third of the patients in that study were already off antidepressants, 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 enrollment that has been the issue in 005.

Charles Duncan (Managing Director)

Got it. Thanks for the added color.

Guy Goodwin (Chief Medical Officer)

Thanks, Charles.

Operator (participant)

Thank you. Our next question comes from François Brisebois with Oppenheimer. Your line is open.

François Brisebois (Managing Director of Senior Biotechnology Research Analyst)

Hi, just a couple here. Just sorry to ask again about the enrollment, but is the fourth quarter guidance just a very conservative, or how do we feel comfortable that fourth quarter will be correct for COMP005, too?

Guy Goodwin (Chief Medical Officer)

Thanks, François . We feel we are very comfortable with that. We, as you would expect, have done a number of projections, looked at different scenarios, and we are very comfortable with the fourth quarter guidance.

François Brisebois (Managing Director of Senior Biotechnology Research Analyst)

Okay, and then on the commercial side, the Spravato infrastructure obviously has some read-through here. Can you just remind, you know, 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?

Guy Goodwin (Chief Medical Officer)

It's a great question. So yes, clearly the protocol for Spravato is very different from what we envisaged 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, you know, at patient and physician discretion, but typically every couple of weeks. So you can imagine, therefore, over the course of, you know, the first three months, that's something like 12-15 sessions. Each of those requires the patient in the clinic for a minimum of really three-four hours, given the intranasal administration and the two hours of monitoring. And by the way, they can't drive home afterwards either, 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 a, shall we say, a typical patient with COMP360, and the phase III is designed really to address that. But as we've said before, based on what we know, it perhaps might be two-four administrations a year for a patient. So you can see that from a patient perspective, that's a very, very different center. It's the difference between using one room for a day, once every, perhaps three-four months, and actually having multiple uses of rooms during the course of time for esketamine.

So we believe, and, you know, a big part of the reason we've signed these collaborations with entities such as Greenbrook 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 (Managing Director of Senior Biotechnology Research Analyst)

Great. Thank you very much. Congrats on the progress, sir.

Guy Goodwin (Chief Medical Officer)

Thanks, François.

Operator (participant)

Thank you. Our next question comes from Neena Bitritto-Garg with Deutsche Bank. Your line is open.

Neena Bitritto-Garg (Biopharma Equity Research Lead)

Hey, guys. Thanks for taking my question. So I just wanted to ask about the enrollment again. I just wanted to confirm, you know, what kind of, if there are any actions that you can take to really maybe accelerate the, you know, 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.? Thanks.

Guy Goodwin (Chief Medical Officer)

Yes. And we have 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 records. So what we have seen is that does enable us, certainly in some circumstances, to obtain those records much more quickly than, you know, going just through the motions ourselves or with our CRO. So yes, we have added specific paid-for vendors, a couple of different ones in fact, to enable that, at the majority of sites.

Neena Bitritto-Garg (Biopharma Equity Research Lead)

Okay, got it. Thank you. That's helpful.

Operator (participant)

Thank you. Our next question comes from Ritu Baral with TD Cowen. Your line is open.

Ritu Baral (Managing Director of Senior Biotechnology Analyst)

Good morning, guys. Thanks for taking the question. 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 this 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've just got a follow-up on the centers.

Kabir Nath (CEO)

Right. So, 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 II-B. But a couple of things to point out. First, obviously, the phase II-B was only partly in the U.S. It was ultimately a global study. Second, I think we do think it's relevant that phase II-B, 001 and 006, have three doses of active, one, 10 and 25, whereas in 005 there is a real placebo. And clearly from a patient willingness or a patient incentive to enroll, that is a significant difference between 005 and both 001 and 006.

Guy, I don't know if you want to add anything on that.

Guy Goodwin (Chief Medical Officer)

Yeah, I don't think that the trial—I mean, as you heard, the vendors that we've 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.

For the second part of the question, Ritu, as you are very well aware, this is a blinded trial through Part B, through 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 (Managing Director of Senior Biotechnology Analyst)

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, you know, 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? You know, sort of like just large phenotype, different phenotypes of delivery models that we should all be thinking about at this point.

Kabir Nath (CEO)

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 for-profit network of interventional psychiatry centers that is essentially you know, today offering TMS, esketamine, Spravato, are very interested in offering psychedelics as well, but have only kind of recently branched into this, how we say, more traditional psychiatric treatments. 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 includes one very large kind of tertiary care center with 300 beds, which is probably going to be at the heart of where they will treat psychedelics. So I think, you know, the reason we are doing this and the reason you will see a couple more collaborations, again, in very different settings of care, is exactly so that we learn what sort of different delivery models are required. And that would extend also to reimbursements. I mean, for instance, you can imagine some commercial centers might be very open to buy and bill.

That may actually fit very well with their economics and offer an attractive route. You know, health systems and so on, it's much more likely to be Part D rather than Part B. But these are the questions we want to answer.

Ritu Baral (Managing Director of Senior Biotechnology Analyst)

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?

Guy Goodwin (Chief Medical Officer)

The way to think about it is they, they are deliberate. You know, obviously, there's a limit to the number we can do in the-

Ritu Baral (Managing Director of Senior Biotechnology Analyst)

Right.

Guy Goodwin (Chief Medical Officer)

Very pre-commercial setting. Yes, they are designed to be sufficiently different, that they can, as we say, allow us to develop templates, but then in kind... where we get to formal pre-launch activities, if we're lucky enough to get there, that we can then take those templates to other examples with the similar settings, and that, that's the way the plan has been built.

Ritu Baral (Managing Director of Senior Biotechnology Analyst)

Understood. Thanks for taking the question.

Guy Goodwin (Chief Medical Officer)

Okay.

Operator (participant)

Thank you. Our next question comes from Sumant Kulkarni with Canaccord Genuity. Your line is open.

Sumant Kulkarni (Managing Director of Biotech Research Analyst)

Good morning and afternoon to the team. I'd like to welcome Teri. It's great to work with you again. Thanks for taking my questions. The question is actually on additional indications for COMP360. You've mentioned PTSD and depression and type two 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 three 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?

Guy Goodwin (Chief Medical Officer)

Yeah, 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 asked, including anxiety measures, specifically the GAD-7, in our trials, and we did in the 001, and we published data on that already. So we certainly see an anti-anxiety 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 short 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.

Kabir Nath (CEO)

Only to say, Sumant, I mean, obviously aware of this. I mean, it's a relatively small study in Australia, 72 patients, as I recall. But yeah, to acknowledge that that was published yesterday and something that we will dig into more.

Sumant Kulkarni (Managing Director of Biotech Research Analyst)

Got it. 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 (Interim CFO)

It doesn't, Sumant, and that's a great question as well. So no, I mean, clearly we've made some additional investments, because we think it's important to do that, but not a material change. We still have runway into, like, 2025.

Sumant Kulkarni (Managing Director of Biotech Research Analyst)

Thank you.

Operator (participant)

Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Michael Okunewitch (Senior Biotechnology Analyst)

Hey, guys. This is Michael Okunewitch on the line. Thank you for taking my questions today. 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 II-B? 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 (CEO)

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% US. 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.

Michael Okunewitch (Senior Biotechnology Analyst)

All right. Thank you. And then just one more from 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 or reimbursement side, that may help to inform your strategy for COMP360?

Kabir Nath (CEO)

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, you know, how they're thinking through commercial and reimbursement. But obviously, we recognize that there will be lessons from their progress, both through the regulatory and commercial, phases for us. Differences.

Michael Okunewitch (Senior Biotechnology Analyst)

All right. Thank you very much.

Operator (participant)

Thank you. Our next question comes from Elemer Piros, with Roth Capital Partners. Your line is open.

Elemer Piros (Managing Director of Senior Biotechnology Analyst)

Yes. Good morning. I don't have a question related to the delay, but I have a question about the anxiety indication that 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 (CEO)

Thank you, Elemer, and congratulations on the new gig. That's an interesting question. What I will say is, in general, split indications are enormously challenging, in my experience, 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.

Elemer Piros (Managing Director of Senior Biotechnology Analyst)

Thank you. Thank you very much, Kabir.

Operator (participant)

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.

Kabir Nath (CEO)

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 quarter four 2024 for top-line data from COMP005, 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 next. So thanks very much, everyone. Thank you for your time and attention today.