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spk06: Good day, ladies and gentlemen, and welcome to the Compass Pathways conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Stephen Schultz. You may begin.
spk01: Welcome, all of you, and thank you for joining us today for our fourth quarter and year-end 2022 results conference call. Again, my name is Steve Schultz. I'm the Senior Vice President of Investor Relations at Compass Pathways. And today I'm joined by Kabir Nath, our Chief Executive Officer, and Mike Falvey, our Chief Financial Officer. Dr. Guy Goodwin, our Chief Medical Officer, is unable to join us today, so Kabir will be covering clinical development. The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call. Before we begin, Let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors including those risks and uncertainties described under the heading Risk Factors in our 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 at any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. I will now hand the call over to Kabir Nath.
spk11: Thank you, Steve. Good day, everyone, and thank you for joining us. We have quite a bit to share with you as we continue to make strong progress across all aspects of our business. During this past quarter, we started our Comp360 Phase III Pivotal Program in Treatment-Resistant Depression, or TRD, a unique achievement, the first ever Phase III trial of psilocybin. As you know, this is a field that holds the potential for significant advances in the treatment of mental health conditions, and we're thrilled to be at the forefront of this potential paradigm shift. Today, we're announcing an important update to the Phase III program we described last fall, starting with our COMP005 trial. As a reminder, this is the single-dose monotherapy trial comparing a 25 milligram dose of COMP360 to a true placebo. We've completed further analysis of our Phase IIb data. with specific focus on the participants in the one milligram arm who had a minimal psychedelic experience, as well as analysis of a recent data from a placebo-controlled study at the University of Zurich using Comp360 in major depressive disorder, or MDD. This data-driven analysis has led to a re-estimation of the sample size for the Comp005 trial and a revision to a lower expected response to true placebo. This allows us to reduce the number of patients required in the 005 trial to 255 from the original 378, while maintaining the power to achieve our objectives. With the reduction in the number of patients, we now expect to complete the pivotal component of this trial, the six-week primary endpoint, by summer 2024. rather than the end of 2024, as we'd previously guided. Additionally, we finalized the plans for long-term follow-up for the Phase III program. Building off the lessons from Comp 004, the long-term follow-up to our Phase IIb study, our strategy is to integrate the follow-up into the two pivotal trials, which we believe will enable a more streamlined design reduced selection bias, and the implementation burden on our patients and clinicians. Again, to remind you, the two pivotal trials are COMP005, which I described just now, and COMP006, a fixed repeat-dose monotherapy trial with three arms. comparing Comp360 doses of 25 milligrams, 10 milligrams, and one milligram, where patients will receive the same dose at day one and at week three. In both trials, we will follow patients up to 52 weeks, building on the six-week pivotal analysis of each trial, which we're calling Part A. The design follows the same principles for each trial. Part B of each trial will follow from the primary endpoint assessment at 6 weeks to 26 weeks. Patients who meet criteria for re-treatment in Part B will have the option to receive a further treatment according to their original allocation in both studies, thus preserving the randomized comparison between arms to 26 weeks. will run from 26 weeks to 52 weeks as an open label component of the trial. Importantly, all patients who meet criteria for re-treatment in Part C will have the option to receive a single 25 milligram dose of Comp360 open label. This option is expected to support patient engagement throughout the entire duration of the trials. It's important to emphasize that there's no change to the primary endpoint of either trial, which is change in mattress from baseline at six weeks, nor to our intention to announce the top line results from the primary endpoint of each trial at that time. We're confident that this trial design will provide insights to key questions on durability of effect and the value of re-treatments. Moreover, TRD often behaves like a chronic condition. By following patients with continuing randomization for 26 weeks, much longer than is conventional in other major depressive disorder trials, we have the potential to generate unique durability and retreatment data which could enhance the value of Comp360. We believe that these amendments will help to generate further evidence that enhances our phase three program and the potential benefit to patients, clinicians, regulators, and payers. We've submitted these protocol amendments to the FDA who have indicated they will come back to us by March the 20th on 005 if they have any further comments following their earlier feedback on durability and retreatment design principles. I remind you that this phase three program is already underway and that it's routine to have an ongoing dialogue with the FDA as we conduct the trials, especially with our breakthrough therapy designation. If we do receive further comments, we will of course consider that feedback. Let me now turn to the broader body of evidence we're developing for Comp360. The phase two PTSD program is progressing with Comp360 dosing of enrolled patients. In December, Data from an exploratory open-label investigator-led initiative in bipolar depression type 2 were presented by the investigator at the annual meeting of the American College of Neuropsychopharmacology. This study investigated the safety and efficacy of a single 25 milligram dose of Comp360 psilocybin therapy in 14 patients. The result showed positive early signals of efficacy with 12 of the 14 patients meeting response and remission criteria for the mattress scale at 12 weeks after Comp360 psilocybin therapy. Notably, no subject had manic or hypomanic symptoms or an increase in suicidal ideation. We believe that these are remarkable data and provide further evidence to support the potential of Comp360 psilocybin therapy for difficult to treat depression. I remind you, though, that this was a small study, and these findings now need to be validated in larger studies. Also, in December, the Zurich study in MDD, which I referenced earlier, was published. This randomized, blinded study enrolled 52 patients, comparing a weight-based variable dose of COMP360 to true placebo. and demonstrated compelling efficacy results with no new safety signal. We see this as further evidence of the potential for Comp360 to help patients living with serious mental illness. Turning to anorexia nervosa, this remains an area of critical unmet need with no FDA-approved pharmaceutical product at the highest mortality rate of any serious mental illness. We're committed to pioneering a robust phase two trial to build on the evidence already generated in investigator-initiated studies. I remind you that there is no significant body of experience available for this indication, so we are on a steep learning curve. We've learned that we need to make amendments to our protocol to better meet the needs of this highly vulnerable patient population. As a result, it's unlikely that we will see top-line data in 2023. Please note that this is a very different patient population from TRD patients, treated largely by different physicians at specialized centers, and that the need to amend this protocol has no impact on our Phase III TRD program. Let me reiterate that we believe the last quarter of 2022 was a quarter of strong progress, capping a year of extraordinary progress for Compass Pathways. Our phase three study, the largest, most robust ever study in psilocybin, is underway. And we're excited to continue the journey to bring Comp360 psilocybin therapy with psychological support to patients. subject to study results and regulatory approval. I'll now hand the call to Mike for the financial overview.
spk14: Thank you, Kabir. I will start with a brief summary of the full year results and then review the fourth quarter results in more detail. For the year ended December 31st, 2022, net loss was $91.5 million, or $2.16 per share. compared with a net loss of $71.7 million or $1.79 per share during the same period in 2021. These results include non-cash share-based compensation of $13.1 million in 2022 and $8.6 million in 2021. R&D expenses were $65.1 million compared with $44 million during the same period in 2021. And G&A expenses were $45.4 million compared with $39.2 million during the same period in 2021. Our fourth quarter results reflect the commencement of our phase three trial in TRD in a number of places. For the three months ended December 31st, 2022, net loss was $30.9 million or 73 cents per share compared with a net loss of $18.4 million or 43 cents per share for the three months ended September 30th, 2022. These results include non-cast share-based compensation of $3.3 million in the fourth quarter and $3.5 million in the third quarter. R&D expenses were $19.8 million in the fourth quarter compared with $14 million in the third quarter due to the Phase III start. The growth in R&D outside development spending and personnel expenses were due to our Phase III trial. G&A expenses were $12.4 million in the fourth quarter compared with $11.6 million in the third quarter. This increase was due to increased personnel and facility costs partially offset by decreased legal and professional fees. We believe that Compass continues to maintain a strong financial position with cash and cash equivalents of $143.2 million at December 31st, 2022, compared with $173.1 million at September 30th, 2022, and $273.2 million at December 31st of 2021. Our cash balance decreased by $29.9 million in the fourth quarter of 2022 due to using $45.3 million in operating cash, partially offset by a change of $14.9 million due to the impact of exchange rates on our cash balances held in British pounds. The movement in operating cash is largely driven by our net loss partially reduced by non-cash charges, and also increases from a number of prepaid Phase III expenses to our CRO, which will be used to support R&D expenses over the next few quarters as our program progresses. This cash usage was partially offset by $8.5 million we received this quarter for our 2021 UK R&D tax credit. Our cash balance also reflects an increase to record the impact of currency exchange rates on our cash balance. After two consecutive quarters of declines, the British pound appreciated versus the dollar in the fourth quarter. As a reminder, we hold our cash balances in dollars, pounds, and euros in proportion to our spending plans in each currency. Since we intend to spend these balances rather than exchange them, fluctuations in foreign exchange rates are not expected to significantly impact our cash runway, which continues to fund our operations for at least the next 12 months. We view our strong balance sheet as an important strategic asset, which we intend to manage carefully as we invest to advance promising potential therapies, while at the same time continuing to create value for our shareholders. As previously indicated, we are providing financial guidance for the first quarter and the full year 2023. We expect the first quarter net cash used in operating activities to be in the range of $24 million to $32 million, and the full year to be in the range of $85 million to $110 million. The first quarter range is due to the challenge in predicting the precise timing of cash outlays to support the phase three program in its startup phase. As the trial reaches steady state enrollment in future quarters, we plan to offer a narrower quarterly range. Thank you, and I'll now turn the call back to Kabir.
spk11: Thank you, Mike. With our lead asset, COM360 in phase three, we continue to be an industry leader in our area of science, addressing complex therapeutic challenges. Treatment resistant depression is the first target indication, but we believe that COM360 psilocybin therapy has potential for broad application. We also continue to advance our commercial strategy. An important step towards this objective is to have reimbursement codes called CPT codes in place at launch. In February, we participated in a meeting focused on the final stages of this process, and we hope to have the new tracking CPT code available soon. And this would be the precursor to the final commercial code. Our robust and comprehensive strategy is designed to support both the Comp360 psilocybin therapy regulatory approval as well as provide the evidence needed by payers to reimburse this new therapy upon launch. We believe that this strategy can lead to significant value creation as we continue to execute successfully. Thank you once again for your participation in today's call. And we'll now turn to Q&A, so I will hand the call back to the operator. Thank you.
spk06: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. And our first question is from Charles Duncan with Kantor Fitzgerald. Your line is open.
spk12: Yeah, good morning Kabir and team. Thank you for taking our questions and thanks for the update on the phase three program. That was interesting. I did have a couple of questions to ask you on that. I guess I'm wondering if you could provide a little bit more color on what you saw out of the prior trial, the one milligram of you know, responses that you saw. And, you know, clearly that has resulted in a sample size adjustment downward. But can you also give us some thoughts on whether or not that changes your perspective on effect size ultimately that you're looking for out of this study?
spk11: Thanks for the questions, Chad. So in the Phase IIb, as you recall, the one milligram was effectively the control arm. And as we were able to do further analysis, as you'd expect, given this was a largely naive population, naive to psychedelics, we saw a range of psychedelic experience in the patients on the one milligram arm, but the majority clustered around essentially no psychedelic experience. And that, for us, kind of conforms to something that looks like a placebo response. When we actually were able to analyze that, we were able to see a strong correlation between that and lack of outcome. And that was our internal data from the Phase IIb data. We were then able to validate some of our thinking around that with the data from the Zurich study in MDD, which again used a pure placebo arm. And that, again, was able to validate our assumptions around, in fact, a likely lower difference from baseline in mattress on the true placebo arm in COM005. As you recall, COMP006, of course, uses the same three arms as the 2B, so we can assume something around the treatment difference there. We haven't disclosed and don't intend to disclose the actual treatment differences that we are powering for, but what I can confirm is that from our perspective, we are very comfortable that we are looking at a different treatment difference for the true placebo arm We're maintaining the power with the reduced size, but we are confident that that will not affect the integrity or the validity of the outcome.
spk12: That makes sense. Sounds like the delta is actually bigger. If I may just ask one brief follow-up, and then I'll hop back in the queue. And that is, in terms of the patient engagement that you mentioned with Part B, being able to take patients out through 26 weeks, I'm really intrigued with that. I guess I'm wondering if that was the result of some feedback from agency or more importantly, investigators suggesting that that's what patients wanted, or was that just some thinking on your part to suggest that you could really add some value for patients if you knew that the drug worked over time?
spk11: No, thanks. And I would say a combination of all those things. I mean, as I mentioned, partly it's a learning from 004, where we recognize that not having the option for a further dose for all patients was, you know, potentially a challenge in terms of maintaining them out for a long time. Plus, we'd actually design that as a separate study, you know, where they had to actually re-consent as opposed to integrating. But yeah, clearly from investigators as well. And I think It's very clear that understanding both durability from a single dose, but also the option for re-treatment, but in that continued randomized 26 weeks is information that I believe is relevant to regulators, clinicians, and payers, as well, of course, as patients.
spk12: Very good. Thanks for taking my question. Thanks, Jess.
spk06: Thank you. One moment for our next question. And our next question comes from Ritu Baral with Cohen. Your line is open.
spk04: Good morning, guys. Thanks for taking the question. I wanted to ask about just some more details about Part B and Part C in 05. What is the, I guess, threshold for retreatment described in the protocol for Part B? And is it the same or different for Part C of O5? And then I've got a follow-up.
spk11: So it is, so what we will, we will retreat people who either did not remit or who relapse after remitting. So that is the criteria for retreatment. And there will be the option for one retreatment in Part B. Remembering that in Part B, it is in line with that original randomized assignment. So depending on what dose you are randomized to, it's the retreatment with that. And again, Part C, open label, would be the same thing.
spk04: And is there a particular madras threshold that defines relapse or is it clinician discretion?
spk11: There is a specific one, which we haven't at the moment disclosed from a competitive perspective.
spk04: Fair enough. Okay. And then the anorexia vosa protocol amendments, can you describe what they were and essentially what drove them? I think investors generally are relatively unfamiliar with this patient population. So what considerations were new to you that are very likely new to us as well?
spk11: No, it's a great question. Thank you. So what I would say is, I mean, that's Some of those amendments are straightforward. Some we're thinking more about. So I think what we learned was this is a patient population that is highly vulnerable, that in fact the openness, the willingness to even participate in a trial is very challenging. And perhaps, you know, from the IIS where clearly there's an element that investigators are able to work with patients they already know, we were not fully aware of just how challenging this would be. So some of the things we're thinking about is just number of visits and scales. Again, have we been over kind of, have we actually tried to get too much into that? I think, you know, that's the first thing, to make sure that we can actually have screening criteria and a protocol that meets the needs of some of this patient population. But I would say that we expect to continue to learn around this study as we move forward and around the challenges of working with this population.
spk04: Understood. And can you talk about, I just want to be clear, you haven't actually dosed your first patient in 05, correct? And also, can you just talk about how site activation is going?
spk11: Yes, so you are correct. And site activation is going well. We have more than a dozen sites actually now activated for both 005 and 006. Just a reminder, we know that site activation for these studies takes a long time. It's complex. Getting the individual DEA licenses, which despite all our experience, it's no quicker the second time around, unfortunately. So that is well underway. And again, we have patients in screening, but many of them need to wash out from SSRIs or whatever they're on. So the washout period is extended. But we are comfortable with where we're at, and that's why we've kind of given first the new guidance for 005 and reiterating the guidance for timing on 006.
spk04: Perfect. Thanks for taking all the questions.
spk11: Thanks, Richard.
spk06: Thank you. One moment for our next question. And our next question is from Francoise with Brisset Boys and the company's Oppenheimer. Your line is open.
spk02: All right. Thanks for taking the questions. I was just wondering, you touched on, after Mike's comments, Kabir, you touched on the CPT code and, you know, at launch and reimbursement. I was just wondering if you can add color to that, because I do think it's a very important part of the story.
spk11: Sure. I'm happy to. So, you know, we recognize from the get-go that the psilocybin administration session of kind of six to eight hours is, Essentially unprecedented and learning also from some of what happened with bravado around You know the fact that it launched from a monitoring perspective Jansen hadn't necessarily put a comprehensive strategy towards this in place we recognized that we actually needed to put in place a code that could potentially cover a that extended administration. So the team has actually been working now for a significant period of time with the necessary professional associations, both APAs, essentially both psychiatrists and psychologists and other groups, made a submission to the AMA. We've now had two meetings, and I think the latest meeting in February. We're very confident that we will get that tracking code. Now, initially, clearly, this will be a tracking code, but once it's issued, even during the conduct of the trials, we'll be able to use that to start to understand what actually the allocation of work by whom is to supporting those administration sessions, and that will allow us to build the body of evidence to turn that into a reimbursable commercial code soon after launch, at launch, or soon after. But as I say, learning from the previous experience We recognize it was essential to have that new code in place as soon as possible, and we're confident, as I say, that that should be in the next couple of months.
spk02: Okay, and is that code related to purely the administration, or you mentioned the word support, or is there any psychological support that could be encompassed in that, no pun intended, in that code?
spk11: Yeah, so our view is that existing codes can cover the preparation and integration sessions, which are shorter. This is for the administration session. And as you know, we define what we offer during that as psychological support, not as therapy, because it's not directed, it's not interventional. It really is there to support the patient through the experience. but it needs to be provided by trained professionals. And the code is designed to cover their services in that.
spk02: Okay, great. And just lastly on that, because it's a new field and there's a lot of unknowns here. Just to be clear, can you just talk about maybe the learnings in the past year, two years of looking at this in terms of the difference between psychological support and psychotherapy and how has that evolved in terms of your thinking of the approach?
spk11: So, and this is a topic which we could dive into much longer. I think from our perspective, from the Compass perspective, right from the start, we have seen this as psychological support. There are things that we think are absolutely critical. Clearly, preparation is critical, ensuring the right expectations for the patient, particularly acknowledging we're in a clinical trial setting where there are a variety of treatments maybe possible and so on. But we have always been clear that during the administration of psilocybin itself, this is around support rather than directed therapy. I'm very conscious of the fact that there is a very wide range of opinions across the community. But I think from Compass's point of view, we've always been clear to use the word psychological support as opposed to psychedelic-assisted therapy, and that is where our mind is.
spk02: Great. Thank you, and congrats on the court. Thanks, Frank.
spk06: Thank you. One moment for our next question. And our next question is from Patrick Truccio with HC Wainwright. Your line is open.
spk09: Thanks. Good morning. Just a clarification on the protocol changes to the Phase III TRD program. I'm wondering if you would also need the long-term outcomes component to submit an NDA for TRD, or would you be able to do that following the top line readouts from the 005 and 006 trials?
spk11: It's a great question. And clearly, as we start the phase three, it's a little premature to know what our regulatory strategy would be. We clearly see the primary endpoints still at six weeks of 005 and 006. What I will point out is that by the time we get to that primary endpoint for 006, we would actually have the entirety of 005 in hand, the full 52 weeks. And I think we would see that as a pretty robust data set from a regulatory perspective. But more than that, I think it's premature to speculate on what exactly the dialogue with the agency would be. And of course, it's data-driven.
spk09: Yeah, that's helpful. And I'm wondering if you can discuss whether you would intend to move ahead with a phase two trial in Comp360 and bipolar depression. And then I have a follow-up on that.
spk11: Thank you. So we are, like I said, I mean, the results are amazing, but it is just 14 patients and 12 out of 14 open label single sites. So we recognize that in order to really validate that, we'd have to. We are thinking around what a design would look like, what sort of control arm you would need for bipolar, what sort of size, but that thinking is right now in its relatively early stages.
spk09: Got it. Okay, that's helpful. And then I guess maybe just a separate question. Just around, you know, there's multiple programs, of course, advancing with short-acting or short-acting mechanisms action with psychoactive agents. There's also some of the longer-acting compounds that are advancing clinical development. And so I'm wondering, as the space kind of builds out, you know, how, if you can discuss the advantages of Comp360 compared to some of those other approaches, you know, including, you know, compounds like DMT or 5-Ameo DMT. And how would you expect these advantages of Comp360 to be demonstrated in the, you know, in the phase three program and some of these other trials that are now underway?
spk11: It's a good question. And I think, you know, without, you know, so, I mean, my fundamental response is data is what will determine, you know, where those agents are best used and so on. So, like everyone, we're intrigued by some of the data that's emerging from shorter acting But until it's been validated in much larger studies, and in particular, some of these questions around durability that we're attempting to answer in phase three are answered by other molecules, other mechanisms, it's kind of too early to say how the field will shake out. But I think what we'd also say is they are very different experiences from a patient perspective. And while there is obviously a school of thought that says, by definition, shorter acting has a shall we say, an easier route into commercialization. I think it's way premature before we've seen data, before we understand the experience the patients have and so on, to know whether in fact duration alone is a kind of key to differentiation. So obviously we continue to watch the space and I'm pleased that other agents are moving forward with good data. I think that's fantastic for the field and for patients. But I think we're a long way from determining, you know, what the competitive set ultimately looks like from a patient perspective and a results perspective.
spk09: That's helpful. Thank you very much. Thanks, Patrick.
spk06: Thank you. One moment for our next question. And our next question is from Elamir Pyros with EF Hunting Group. Your line is open.
spk10: Yes, good morning. Thank you for taking my question, Kabir. What I'd like to, if you could clarify, please, that would there be a retreatment paradigm in Part B, both in the 005 and the 006 trials?
spk11: Yes. So, as we said earlier, for those who do not respond, who after remission relapse, there is the option for retreatment in Part B. Clearly, it's the patient's choice. remembering that it will be in their original assigned treatment.
spk10: So it is true, so re-treatment will occur even in the 005 trial.
spk11: So re-treatment either with 25 milligram or placebo at patient choice, yes.
spk10: Okay. And I think you just clarified, but I just want to make sure that I understand that even those who are not responding well, would have the option to be retreated. So it's not only those who went into remission and fell out of remission. Correct. And is this a single retreatment, Kabir? Yes. Yes. Okay. I think I got that. And in your effort to establish a code, are you working together with MAPS in that endeavor to potentially harmonize activities? Yes, we are.
spk11: Yes, we are, as we've said before. Yes, we are working with MAPS.
spk10: Okay. And one last question, please. When would you be able to provide an update on your internal R&D programs into other psychoactive agents?
spk11: That's a very good question. We actually haven't landed on that, but we'll... As you mentioned, we did say at Capital Markets Day we would do that in due course. We'll take that internally and come back to you. Okay.
spk10: Well, thank you so much for the update. Thank you, Eleanor.
spk06: Thank you. One moment for our next question. And our next question is from Nina Vidrido-Gard with Citi. Your line is open.
spk03: Hey, guys. Thanks for taking my questions. So I just have two. So first one, just going back to the retreatment in Part B and Part C in the 05 and 06 studies, can you just clarify, is it only at the six-month time point, so week 26 and then week 52 in Part C, that patients can go through this second or possibly third treatment? like a dosing session, or could a patient be retreated earlier during Part B and Part C? And then my second question is just on cash and the balance sheet. It looks like you're going to end this year with maybe a couple quarters of cash, so it just carries how you're planning on dealing with the cash runway. Thanks.
spk11: Thanks, Nina. So, yes, sorry. And I know doing this all verbally is hard. So, to be clear, in Part B, the option for retreatment would be between weeks 6 and 26, depending on relapse or failure to respond. And then in Part C, we would expect that to be pretty early in Part C for those patients who are eligible and chose to have a COMP360 dose. So, that would be you know, soon after the start of the final 26 week open label section.
spk14: And then on the runway, yes, we're looking at it from a couple of perspectives, sort of the financing front and also operating moves that we could make to further lengthen our runway on the financing front. You know, it remains a difficult market environment for financing biotechs. But having said that, we have had a lot of interest from investors really since we announced the phase three at our capital markets day last fall. And it's a very serious attention from sophisticated biotech investors. So as I mentioned, it's a challenging environment, but there's still an opportunity that under the right circumstances, we could do an equity offering with those interested investors. Secondly, we do have an ATM in place, so if a new investor were to want to take up a position, that's potentially a way for us to issue equity and raise cash. And then lastly, you know, I think there's an opportunity with debt. Now, in the past, we've stated that, you know, we think we're a little bit early stage to be considering forms of debt, but I think in these kinds of market environments, we do have to be flexible. So under the right circumstances, that would be another way to continue to lengthen the runway via financing. And then lastly, on the operating side, you know, we've been very disciplined in the way that we've grown the company really since we announced the phase two results at the end of 2021 and really have just focused on making sure we prepare and start to execute on the phase three, as well as our two advanced phase two programs, and really have gated all further investments on being able to continue to have a strong balance sheet and a long runway. And so those efforts will continue. And we've always said we view our strong balance sheet as an important strategic asset. And while we want to pursue these breakthrough potential therapies, We want to do it in a way that's going to create value for our shareholders. And to date, I think we've done that pretty successfully, and that's going to be a key for us going forward.
spk03: Thank you. That's helpful.
spk05: Thank you. One moment for our next question.
spk06: And we have our next question from Bert Haslett with BTIG. Your line is open.
spk08: Thank you. Thank you for taking the question. I've covered a lot of ground on this call, and I'll just ask, I think, on intellectual property, if I might, on Comp 360. You've talked about your protection and patents that expire to 2038. There were a number of pending applications. Has there been any evolution with regard to IP for Comp 360 or other elements that are of material importance? Thanks.
spk11: Thanks, Bert. So, no, nothing new to disclose here, except one note. You'll recall that three of our patents were challenged by another organization. That challenge was rejected. They appealed, and that appeal was also rejected in February. So, that's actually the only update. We continue to be confident that we have a robust estate of protection out to 2038.
spk07: Thank you. And thank you for the additional clarity on the retreatment. Very helpful. Thanks.
spk11: Thanks, Luke.
spk06: Thank you. One moment for our next question. And our next question is from Kyle Quinn with CGF. Your line is open.
spk13: Oh, this is Kyle speaking for Sumant Kulkarni. Maybe a few from us. On the open label retreatment, in the development process for that retreatment paradigm, has a company thought of doing retreatment on an as-needed basis for maybe a longer term duration? And I'm curious why that has not been implemented. Thanks.
spk11: No, thank you, Kyle. And when you say as needed, just to clarify, you're proposing multiple retreatments, yes?
spk13: Yeah, for example, over like a year duration and potentially more than one retreatment.
spk11: No, it's a fair question. And yes is the answer. We considered a variety of designs in terms of how we extend this out. And I think, you know, The reality is we know that our phase three program, however we design it, is not going to answer all those questions to the satisfaction of all of regulators, payers, clinicians, and so on as well. Ultimately, the trade-off we arrived at was that in terms of getting clarity on durability of a single dose or potentially two doses in 006, and what happens with one re-treatment, recognizing also that per protocol, as you'd expect, as we did in 2b, at some point you have to allow patients to go back onto antidepressants or something, because ethically you cannot expect to sustain them without that. So ultimately, the interpretability of multiple doses if they're actually already on background SSRI is going to be challenging. I think in this case with the single redose in the open label, that is again interesting data from the perspective of clinicians and so on as to the impact of that on a background of other therapy. But no, I acknowledge there are different designs we could have gone for. We think in terms of interpretability and also balancing the needs of the different stakeholders, this was the right choice.
spk13: Got it. Thanks. And maybe one more. In all of the non-TRD studies, such as in bipolar, anorexia nervosa, or MDT, how many incidents of suicidal ideation have you observed as of today? And what percent of total would that be?
spk11: So, we will have to get back to you with that data. I actually don't have those. I'm not aware. of any specific finding, but I would need to come back to you with anything particularly in the MDD study from Xero, which I covered. As I mentioned in the bipolar study, we saw none. There were no examples of that among those 14 patients. And I think Steve is reminding me that some of these are in our investor presentation.
spk05: Okay, thank you. One moment for our next question.
spk06: And we have a follow-up question from Frank Brissebois with Oppenheimer. Your line is open.
spk02: All right, thanks. Just a quick one here. You mentioned March 20th, maybe getting feedback from the FDA in terms of your amendments. Is this something that, you know, on 005, is this something that you would disclose, or you'll hear the feedback and adjust accordingly, or just, I'm just trying to figure out what we should be waiting for in terms of expectations of that date?
spk11: Yeah, so as you know, I mean, typically we have not actually disclosed the to and fro of our correspondence with the FDA, because as you would expect for any phase two company, we have a lot of to and fro, including protocol amendments and so on. We recognize, though, that this was sufficiently significant, both in terms of OO5 and the integration of the long-term follow-up that we wanted to flag it. That said, we believe, first in terms of the sizing and powering OO5, ultimately that's a sponsor decision based on our analysis of the data and what we believe around treatment difference. And for the long-term follow-up, that's clearly aligned with the design principles that we had worked through with the FDA. So I think, you know, we do not see that as a particular clearing event, but we also wanted to acknowledge, given the significance of the changes we're making, that there is a date at which they've said they will get back to us with comments, if any.
spk12: Perfect. Thank you.
spk06: And I'm showing no further questions at this time. I would now like to turn the conference back to management for closing remarks.
spk11: Thank you, Amy. So thanks, everyone. Thank you very much for your participation today. Thanks for the many questions. And as always, you know where to find us, and we're always happy to take more. So thanks, everyone. Have a great day.
spk06: And this concludes today's conference call. Thank you for participating. You may now disconnect.
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