Q1 2024 COMPASS Pathways PLC Earnings Call
Operator: Thank you for standing by, and welcome to the COMPASS Pathways first quarter 2024 earnings investor call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Mr. Stephen Schultz, Senior Vice President, Investor Relations. Please go ahead, sir.
Thank you for standing by and welcome to the Compass pathways first quarter 2024 Investor call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone if your question has.
Been answered I do like to remove yourself from the queue simply press Star One again as a reminder, today's program is being recorded.
I would like to introduce your host for today's program, Mr. Stephen Schultz Senior Vice President of Investor Relations. Please go ahead Sir.
Stephen D. Schultz: Welcome all of you and thank you for joining us today for our first quarter 2024 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways, and today I'm joined by Kabir Nath, our Chief Executive Officer, Dr. Guy Goodwin, our Chief Medical Officer, and Terry Luxem, our Chief Financial Officer.
Stephen D. Schultz: Welcome all of you and thank you for joining us today for our first quarter 'twenty 'twenty four results conference call.
Stephen D. Schultz: Again my name is Steve Schultz Senior Vice President of Investor Relations accomplished pathways and today I'm joined by can be on that our chief Executive Officer, I forgot Goodwin, our Chief Medical Officer, Terry <unk>, our Chief Financial Officer.
Stephen D. Schultz: 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.
Stephen D. Schultz: The call is being recorded and will be available on the company's pathways Investor Relations website. Shortly after the conclusion of the call and will be archived for a period of 30 days.
Stephen D. Schultz: 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 statement, even if our estimates or assumptions change. I'll now hand the call over to Kabir Nath. Thanks, Steve. Good day, everyone.
Stephen D. Schultz: 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.
Stephen D. Schultz: 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.
Stephen D. Schultz: Commission and in subsequent filings made by Congress with the SEC.
Stephen D. Schultz: 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.
Kabir Nath: Thanks, Steve. Good day, everyone, and thank you for joining us. First, let me report that COMPASS continues to execute on both of the Phase III COMP360 trials in treatment-resistant depression. We're on track to deliver top-line data for the COMP005 single-dose placebo-controlled study in the fourth quarter of this year and for the COMP006 fixed repeat-dose trial in mid-2025. We're also actively working on completing all necessary preclinical and clinical pharmacology studies required for a COMP360 NDA document.
Speaker Change: To give you on that.
Speaker Change: Thanks, Steve and good day, everyone and thank you for joining us.
Speaker Change: Uh huh.
Speaker Change: We report the company continues to execute on both of the Phase III Cop 360 trial increased resistant depression.
Speaker Change: We're on track to deliver top line data for the <unk>.
Speaker Change: Dose placebo controlled study in the fourth quarter of this year and for the company. There are six fixed repeat dose trial in mid 2025.
Speaker Change: We're also actively working on completing all necessary preclinical and clinical pharmacology studies.
Speaker Change: For our concrete 60 NDA dossier.
Kabir Nath: Also in this quarter, we announced additional commercial collaborations with leading mental health care providers designed to inform the development of scalable and cost-effective delivery models for COMP360 psilocybin treatment if approved for treatment-resistant depression. The most recent announcements of the Journey Clinical and Mindful Health Solutions collaborations add to those we already have in place with Reliance Medical Group, part of OptumCare, Greenbrook TMS, and Hackensack Meridian Each of these partners represents very different but equally important commercial models and settings of care for patients.
Speaker Change: Also in this quarter, we announced additional commercial collaborations with leading mental health care provider design.
Speaker Change: Designed to inform the development of scalable and cost effective delivery models for cop 365 treatments.
Speaker Change: Treatment if approved for treatment resistant depression.
Speaker Change: The most recent announcements have been fairly critical and mindful health solutions collaborations.
Speaker Change: Add to those we already have in place with reliant medical group part of Optum Cat Greenberg Tms at Hackensack Meridian health.
Speaker Change: Each of these partners represent is very different.
Speaker Change: Really important commercial model and setting the path for patients.
Kabir Nath: These collaborations are focused on investigating challenges with the current patient care experience. They will assist COMPASS and these leading mental health care providers to better understand how COMP360 may best fit into diverse care settings and also enable COMPASS to develop commercial delivery templates for these different care settings. These collaborations, plus the CPT-3 tracking code that went into effect in January, are important steps towards preparing the market for a COMP360 psilocybin treatment option, if approved. I will now hand the call over to Dr. Guy Goodwin for a clinical update. Thank you, Kabir.
Speaker Change: These collaborations are focused on investigating challenges with the current patient care experience.
Speaker Change: This accomplished in these leading muscle health care providers.
Speaker Change: Better understand how come 360, <unk> may best fit into diverse cat.
Speaker Change: And also enabled us to develop commercial delivery campaign in these different care settings.
Speaker Change: These collaborations plus the CPT III tracking codes that went into effect in January are important steps towards preparing the market for a 360 psilocybin treatment option if approved.
Guy Goodwin: Let me now on the call over to got a guy goodwill for a clinical update guidance.
Guy Goodwin: It's a pleasure to speak to everyone today and review the positive data generated from the COMP360 Phase 2 clinical study in PTSD. We hope you have the opportunity to review the press release from this morning, summarizing the results. This study included three clinical sites in the U.S. and U.K. The Icahn School of Medicine at Mount Sinai in New York.
Guy Goodwin: Thank you David.
Guy Goodwin: Our pleasure to speak to everyone today and review the positive data generated from the country 60 phase II clinical study in PTSD.
Guy Goodwin: We hope you have the opportunity to review the press release from this morning summarizing our results.
Speaker Change: This study in 33 clinical sites in the U S UK.
Speaker Change: The Icahn school of Medicine at Mount Sinai in New York.
Guy Goodwin: Sunstone Therapies in Rockville, Maryland, and the Institute of Psychiatry, Psychology, and Neuroscience at King's College London. Now, let me go through some of the specific results we saw with this PTSD study. The study was an open-label, multi-center, phase 2 exploratory study evaluating COMP360 psilocybin treatment in 22 patients with PTSD resulting from trauma in adults. Participants received a single 25 milligram dose along with psychological support. Psychological support was provided by a licensed medical professional to ensure patient safety by preparing participants for the treatment session, observing and being present with patients during the session, and supporting them afterwards.
Speaker Change: Sunstone therapy in Rockville, Maryland.
Speaker Change: The country psychology and neuroscience.
Speaker Change: In London.
Guy Goodwin: A majority of patients entered the study with symptoms of PTSD categorized as severe, with a mean CAHPS-5 total score at baseline of 47.5. The CAPS-5 assessment involves a structured interview that provides a PTSD diagnosis aligned with DSM-5 and measures the average severity of 20 symptoms. The average age of participants at the time of screening was 39, and four participants had prior lifetime experience with psilocybin. Veteran status and combat exposure were evaluated, as were measures of the dissociated PTSD subtype. Patients diagnosed with complex PTSD were excluded from study eligibility.
Speaker Change: Now let me go through some of the specific results we saw with the PTSD study.
Guy Goodwin: The effects of the COMP360 treatment on the CAHPS-5 score were assessed at week 4 and again at week 12 to assess durability of the therapy. Study observations also included improvement at baseline in the mean FDF score, a measure of functional impairment in daily life. Safety over 12 weeks was the primary end point of this study, and administration of COMP360 in this patient group was well tolerated with no serious adverse events observed. We're also pleased to report impressive and sustained rates of response and remission at both Week 4 and Week 5.
Speaker Change: The study was an open label Multicenter phase two exploratory study evaluating countries 60, psilocybin treatment in 22 patients with PTSD, resulting from trauma in adulthood.
Guy Goodwin: The key findings include that administration of COMP 360 was well tolerated, and there were no treatment-allergent serious adverse events. Treatment of emergent adverse events over 10% included headaches, nausea, crying, and fatigue, predominantly on the day of drug administration. There were two events of suicidal ideation that resolved to join the study. The first was a moderate and transient event on administration day in a patient who went on to be a responder. The second event was mild and occurred at Week 7 in a non-linear fashion.
Guy Goodwin: As a reminder, suicidal ideation is a common feature of PTSD, as it is in TRD. We observed an early and durable improvement in symptoms from baseline following a single administration. Improvement in mean CAHPS 5 total score from the baseline of 47.5 was observed with a 29.9 point reduction at week 4 and 29.5 point reduction at week 12. We observed increasing improvement in disability over the 12 weeks. From a mean FDS total score of 22.7 at baseline, there was an 11.7 point reduction at week 4 and a 14.4 point reduction at week 12.
Speaker Change: <unk> received a single 25 milligram dose along with psychological support.
Guy Goodwin: We also saw high and sustained rates of response and remission relative to baseline with early onset of symptom improvement. Response, as defined by patient's experience, a greater or equal 15 point improvement on CAHPS 5 score with 81.8% at week 4 and 77.3% at week 12, remission, defined by a 5 total score of less than or equal to 20 was 63.6% at week 4 and 54.5% at week 12. No patients withdrew from the study, and none returned to antidepressant medication during the trial.
Speaker Change: Psychological support was provided by a licensed medical professional to ensure patient safety by preparing participants with the treatment session observing and be present with patients during this session.
Speaker Change: And then after the recession.
Terry Luxem: Although a small trial with an open-label design, the results exceeded our expectations and advanced our understanding of the potential application of COMP360 in PTSD. We were particularly impressed by the early onset and durability of improvement. We believe that COMP360 could provide a clinically meaningful benefit and substantially improve daily function and quality of life in patients with PTSD. We look forward to submitting the full results of this study for publication and will consider next steps for the program.
Speaker Change: The majority of patients entered the study with symptoms of PTSD categorized as severe with a leading caps five total score at baseline of 47 five.
Terry Luxem: In addition to TRD, as Kabir mentioned, we are on track for the primary six-week endpoint in COMP005 during the fourth quarter of this year. We are also seeing improvements from the actions we took to facilitate the retrieval of medical records, which created a bottleneck early in the year. We also remain on track for COMP006 for the primary six-week endpoints mid-next year. We are excited by the profile that's emerging for COMP360 across both TRD and PTSD and the potential benefits of patient care. We look forward to our Phase 3 results later this year and next year and continuing to progress the broader COMP360 program. I will now hand the court to Terry for a financial review.
Speaker Change: The cap cyber assessment involved with structured interview that provides the PTSD diagnosis aligned with DSM five and matches the average severity of <unk>.
Speaker Change: The average age of participants of the primary screening was 39.
Speaker Change: And for participants that prior lifetime experience with their assignment.
Speaker Change: Stay safe and combat exposure, we evaluated asthma measures with respective PTSD subtype.
Speaker Change: Patients diagnosed with complex PTSD were excluded from study eligibility.
Speaker Change: The effects of the country 60 treatment on the caps five score were assessed at week four and again at week 12 to effect durability of effect.
Speaker Change: Stemming observations also included improvement in baseline NIE.
Speaker Change: The score a measure of functional impairment in day one.
Speaker Change: Safety over 12 weeks with the primary endpoint of this study and administration of complex <unk> in this patient group was well tolerated with no serious adverse events.
Speaker Change: We're also pleased to report impressive sustained rates of response and remission at week, four and week 12.
Speaker Change: The key findings include administration countries six eight was well tolerated.
Speaker Change: There were no treatment emergent serious adverse event.
Speaker Change: Treatment emergent adverse events over 10% included headache, nausea and.
Speaker Change: T.
Speaker Change: Beyond the diodes drug administration.
Speaker Change: There were two events of suicidal ideation that resolved during the study.
Speaker Change: With a moderate and transient demand when administration day, and the patients who went on to be a responder.
Speaker Change: The second event was mild and occurred at week seven non responsive.
Speaker Change: As a reminder, suicidal ideation is a common feature of PTSD additive ETR.
Speaker Change: We observed an early enjoyable improvements in symptoms from baseline following a single administration.
Speaker Change: Improvement in mean tax five total score from baseline to 47, five with a third of the $29 nine point reduction at week, four and $29 five reduction at week 12.
Speaker Change: We observed increasingly prudent disability over the 12 weeks.
Speaker Change: <unk> total score of $22 seven at baseline that was.
Speaker Change: The 11, seven point reduction or and a 14.4 point reduction week 12.
Speaker Change: We also saw high and sustained rates of response and remission relative to baseline with early onset of symptom improvement.
Speaker Change: Response as defined by patients experienced a greater or equal to 58 point improvement on past five score was 81, 8% as we call. It 77, 3% at week 12.
Remission as defined by path.
Speaker Change: <unk> total score less than or equal to 20 was 63, 6% at week four and 55.
Speaker Change: 5% week trial.
Speaker Change: No patients withdrew from the study are not returned trying to depressant medications during the trial.
Speaker Change: Although a small trial open label design the results exceeded our expectation and advanced our understanding of potential application of <unk> 360 in PTSD.
Speaker Change: We've looked particularly impressed by the early onset and durability of improvement.
Speaker Change: We believe the concrete XP could provide a clinically meaningful benefit.
Speaker Change: Substantially improved.
Speaker Change: Quality of life in patients with PTSD.
Speaker Change: We look forward to submitting the full results of this study for publication and we'll consider the next steps for the program.
Speaker Change: In addition.
<unk> the TRT African Bee had mentioned we are on track with the primary six week endpoint in commentary there is.
Speaker Change: Five during the fourth quarter of this year.
Speaker Change: We are seeing improvements from the actions we took to facilitate the retrieval of medical record, which created a bottleneck.
Speaker Change: We also remain on track with their there is fixed but the primary six week endpoint mid next year.
Speaker Change: We are excited by the profile that's emerging for country 60 occur.
Speaker Change: Ross, both CRB and PTSD and the potential benefit of patients.
Speaker Change: We look forward to a phase III results later this year and next year.
Speaker Change: Turning to progress the broader country 60 partner.
Speaker Change: Let me now hand, the call to Terry for financial review.
Terry Luxem: Thanks, guys. I'll now step through the Q1 financial results. Cash used in operations in the first quarter was $20.8 million. Within the guidance range, we provided $17 to $23 million, which assumes a 2022 R&D tax credit of approximately $15 million would be received in the first quarter. I'm pleased to confirm that HMRC paid our 2022 claim of approximately $15 million in full in the first quarter.
Terry: Thanks, Scott I will now step through the Q1 financial results.
Terry: It's used in operations in the first quarter was $20 8 million within the guidance range, we provided of $17 million to $23 million and let's assume that 2022 R&D tax credit will be received in the first quarter.
Terry: I'm pleased to confirm that HRC paid our 2020 Q claim of approximately 15 million is fall in the first quarter.
Kabir Nath: Regarding second quarter 2024 financial guidance, we expect net cash used in operations to be between $32 and $38 million. Turning to full year financial guidance, we expect cash use and operations to be between $110 and $130 million. COMPASS continues to maintain a strong financial position with cash and cash equivalents of $262.9 million at March 31, 2024. This compares with $220.2 million at December 31, 2023. The increase in cash in the first quarter is due to proceeds received through the ATM and the exercise of warrants from our August 2023 PIPE.
Terry: Regarding second quarter 2024 financial guidance, we expect net cash used in operations to be between 32 and $38 million.
Terry: Turning to full year financial guidance, we expect cash used in operations to be between 110 and $130 million.
Terry: <unk> continues to maintain a strong financial position with cash and cash equivalents of $262 9 million at March 31, 2024 that compares with $222 million.
Terry: December 31, 2023, the increase in cash in the first quarter due to proceeds received through the ATM and exercise of warrants from our August 2023.
Kabir Nath: Long-term debt under the Hercules Loan Facility was $29.1 million at the end of the first quarter. With the cash increase in the first quarter, we now expect our cash runway to fund operations into 2026. We will continue to manage our cash carefully to continue advancing our pivotal program and to achieve important milestones that we believe will create value for our shareholders. Thank you, and I'll now turn the call back to Kabir.
Terry: Long term debt under Hercules loan facility with $29 $1 million at the end of the first quarter.
Terry: With the cash increase in the first quarter, we now expect our cash runway to fund operations into 2020.
Terry: We will continue to manage our cash carefully to continue advancing our pivotal program and to achieve important milestones that we believe will create value for our shareholders.
Speaker Change: Thank you and I'll now turn the call back to Dr.
Kabir Nath: Thank you, Terry. With these strong PTSD data, we're now working to schedule a meeting with the FBA and align on potential next steps. While TRD is our lead indication for COMP360, we see logical expansion into PTSD, given the similarities in patient profiles and the potential commercial synergy. We're looking forward to disclosing our top-line data for our Phase 3 program later this year.
DR: Thank you Terry.
DR: With these strong PTSD data, we're now working to schedule a meeting with the FDA underlying on potential next steps.
Speaker Change: CRE is our lead indication for <unk> 368, we feel logical expansion into PTSD, given the similarities in patient profiles and the potential commercial synergies.
Speaker Change: We're looking forward to disclosing our top line data for our Phase III program later this year.
Kabir Nath: This will be a key milestone for COMPASS and, given our leadership, a significant event for the field of psychedelic science. We also continue to make great progress with a network of interventional psychiatry centers and mental health care providers who can administer COMP 360 treatment if approved. Our expanding collaborations are indications of interest from providers, and we'll continue to develop commercial models that enable rapid, scalable, broad, and equitable access to COMP360. I also want to welcome Dr. Mike Gold to the COMPASS team as our new Chief Research and Development Officer, effective May 20th. Mike brings more than 25 years of experience across all aspects of drug development in the Eurozone, with extensive therapeutic experience in neurological and psychiatric disorders, including depression.
Speaker Change: It will be a key milestone for campus and given our leadership a significant event for the field of psychedelic science.
Speaker Change: We also continue to make great progress with our network of interventional psychiatry centers and mental health care providers, who can administer concrete 60 treatment if approved.
Speaker Change: Our expanding collaborations are indications of interest from providers.
Speaker Change: We'll continue to develop commercial models that enable rapid scalable broad equitable access to <unk> 360.
Ritu Subhalaksmi Baral: I also want to welcome Doctor might go so the compass team as our new Chief Research and development officer effective may trend here.
Ritu Subhalaksmi Baral: Mike brings more than 25 years of experience across all aspects of drug development in neuroscience with extensive therapeutic experience and neurological and psychiatric disorders, including depression.
Kabir Nath: Mike will work with Guy to continue to develop COMP360 in TRD and other indications and to explore and advance other potential pipeline opportunities. I want to thank Trevor Mill, COMPASS's current Chief Development Officer, for his dedication and expertise in guiding the development of our COMP360 program over the past several years and exploring additional early pipeline opportunities. Trevor will leave after a transition period with Mike, and we wish him all the best in his future endeavors.
Ritu Subhalaksmi Baral: Mike will work with Guy to continue to develop cop 360 in CRB and other indications and to explore an advanced other potential pipeline opportunities.
Speaker Change: Want to thank Trevor no conferences current Chief development officer for his dedication and expertise in guiding the development of our Cop 360 program over the past several years and exploring additional early pipeline opportunities.
Speaker Change: I believe after a transition period with Mike and we wish him all the best in his future endeavors.
Kabir Nath: This is an exciting year for COMPASS Pathways, and we look forward to updating you on our continued progress. Thank you again for your participation on today's call. We'll now turn to Q&A, so we'll hand it back to the operators.
Speaker Change: This is an exciting year for campus pathways and we look forward to updating you on our continued progress.
Speaker Change: Thank you again for your participation on today's call.
Speaker Change: I will now turn to Q&A, so I'll hand, it back to the operator.
Operator: Certainly, one moment for our first question, and our first question comes from the line of Vikram Prohit from Morgan Stanley. Your question, please.
Speaker Change: Certainly one moment for our first question.
Speaker Change: And our first question comes from the line of Vikram <unk> from Morgan Stanley. Your question. Please.
Vikram Prohit: Hi, good morning. Thank you for taking our questions. So we had two on PTSD. So first, could you just frame for us, in terms of real world experience and real world benefit, the CAHPS 5 and SDS scores that you reported this morning, how to contextualize those in terms of the benefits that patients may observe, and then also, another company in the space recently received notice that the FDA is going to be scheduling an Adcom meeting for early June to review their application for their MDMA-assisted therapy for Just wanted to see what your thoughts were on potential implications for your program and the space more broadly. Thank you. Thanks.
Vikram: Hi, Good morning. Thank you for taking my questions. So we had two one PTSD. So first could you just frame for us.
Vikram: In terms of real world experience in real real benefit.
Vikram: What the caps five in STS STS scores that you reported this morning.
Vikram: How do you contextualize those in terms of the benefits that patients may observe and then also.
Vikram: Another company in the space recently received notice that the FDA is going to be scheduling an AD comm meeting for early June to review their application for the MDMA assisted therapy for PTSD just wanted to see what your thoughts were there on potential implications for your programming space more broadly. Thank you.
Kabir Nath: Thanks Vikram, it's good to hear from you, and as we start, I just want to make sure you can hear us clearly. Yes. Okay, great.
Speaker Change: Thanks, Vikram it sedan as we saw just to make sure you can hear us clearly.
Speaker Change: Yeah.
Guy Goodwin: So I'll hand it to Guy to take the first question and maybe the second, and I might add on to that. Yeah, so I think the way to think about these results is that they reflect a real near return to normality for a significant number of patients in the study. I mean, these rating scales are not terribly familiar, so we're all getting to understand them as we go along, but basically, the lowest scores that we see reflect essentially complete recovery.
Speaker Change: Yes, okay great.
Speaker Change: And the Guy to take the first question and then maybe the second one I might add on that.
Speaker Change: Yes, so I think the way to think about these results as they reflect the real near return to normality for a significant number of patients.
Speaker Change: The study.
Speaker Change: I mean this.
I think scale, but not terribly familiar but we're all getting to understand them as we go along but basically reflects the lowest scores that we see reflects essentially.
Guy Goodwin: The average, of course, is not that, and there's a range of outcomes, but we emphasize, I think, that these very high rates of remission, as defined by a minimum score, are high, and I think I would also draw your attention to the SDS scores. They reflect a measure of disability that is used across trials, and so that allows you to look at the impact of other treatments in other conditions as well as in general. That, again, reflects the numbers that we show reflect substantial return for patients, which is as important as the reduction of symptoms. The second question about LICOMP... Yeah, I mean, let me take that.
Speaker Change: Fleet recovery.
Speaker Change: The average of course did not pass.
Speaker Change: Range of outcomes that we emphasize I think that the.
Speaker Change: Very high rates of remission is defined by a minimum score Baja.
Speaker Change: And we think that's important also.
Speaker Change: I think I would also draw your attention to the STS score.
Speaker Change: They reflect a measure of disability that is used to cross trial.
Speaker Change: So that allows you to look at the impact of other treatments and other conditions as well as the essentially the PTSD dive again reflects the numbers that we show reflect substantial return function.
Speaker Change: <unk>, which is as important as a reduction of symptoms of accruals.
Speaker Change: The second question about <unk>.
Kabir Nath: I mean, first of all, no surprise. This is, as they've said, the first submission on PTSD for more than a quarter of a century. Number one. Second, it is currently a Schedule I drug. So in that sense, it is no surprise that there is going to be an outcome. And I would just say we wish them well. And obviously, we, like many other people, will be observing very closely how the FDA addresses a number of the key questions around that application.
Speaker Change: Yes, let me take that in itself I think first no surprise this is <unk>.
Speaker Change: Submission of <unk> for both on a quarter entry number one second it is currently a schedule one dropped so in that sense no surprise that there is going to be an outcome.
Speaker Change: And I would just say, we wish them well and obviously, we like many other people will be absorbing very closely how the.
Speaker Change: I apologize a number of the key questions around that.
Operator: Thank you. One moment for our next question, and our next question comes from the line of Ritu Baral from TD Coward. Your question, please.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: And our next question comes from the line of rich through barrel from Cowen Your question. Please.
Ritu Subhalaksmi Baral: Good morning, guys. Thanks for taking the question. Quick thing on potential positioning versus the Likos compound and MDA-assisted psychotherapy. Kabir and Guy, could you walk us through sort of the nature of the psychological support that you provide? Was there any aspect of exposure therapy, which from my understanding is sort of the basis for the psychological support provided by Likos? The Nature, and then I have a follow-up. Thank you.
Speaker Change: Good morning, guys. Thanks for taking the question.
Speaker Change: Quick thing on potential positioning versus like a compound.
Speaker Change: And MTA psychotherapy.
Speaker Change: Thank you Sir.
Rich Barrel: And finally could you could you walk us through sort of some nature of the psychological support.
Rich Barrel: That you provide.
Was there any aspect of exposure therapy, which from my understanding that sort of thing basis or the psychological support provider like us.
Rich Barrel: If you could talk to like the amount.
Rich Barrel: Sure.
Speaker Change: And then as a follow up thank you.
Kabir Nath: Thanks, I'll hand it down in a moment, but the headline, Ritu, is that it's no different from what we're doing in TRD, but Guy, please. Yes, thanks, Ritu.
Speaker Change: Thanks, I'll hand, it got amendment, but I mean, the headline rate too is this is no different from what we're doing in CRB.
Guy Goodwin: In fact, we have quite a detailed follow-up questionnaire, which we'll be publishing the results of in due course, and what that suggests is that, basically, patients do not really have the same kind of exposure experience. There's a little bit of that, but mainly, there is really just a change in the way people contextualize their memory and their experience, and that seems to be essentially driven by this inward journey that everyone has heard about in relation to psilocybin.
Speaker Change: Yes in fact, we have quite a deep out all of our questionnaire, which we'll be publishing the results from <unk>.
Speaker Change: In due course and what that suggests is essentially patients did not really have the same kind of exposure experience, there's a little bit of that but mainly there is really just the change in the way people contextualize that memory.
Speaker Change: Their experience.
Speaker Change: And that seems to be essentially driven by the inward journey that everyone has heard about in relation to the patient.
Guy Goodwin: So patients are prepared in the same way as we prepare the TRD group, as you've heard. There are no specific exposure exercises as would occur with conventional psychotherapy, and patients, who have had previous psychotherapy, in contrast to that, say that they feel that they are, in a sense, doing their own work, that they are leading themselves, and they're not being driven by an external interactive force, which would be the therapist in conventional psychotherapy. So it's a very interesting contrast between the preparation, of course, in terms of hours and so on, and subsequent integration is relatively short. And we think that the efficacy is remarkable given that it's been sustained out.
Speaker Change: Patients.
Speaker Change: And the same way.
Speaker Change: Great. Thank you.
Speaker Change: With no exposure to specific exposure exercises is worth it to them with a.
Speaker Change: <unk> psychotherapy.
Speaker Change: I should've been a remark.
Speaker Change: Previous brachytherapy in contrast to that but they feel that they are just.
Speaker Change: And doing their own work, but they are leaving themselves and then not being written by an external interact six or so which would be the fact that in conventional soccer therapy. So it's a very.
Speaker Change: Any interest in contrast of the preparation of course in terms of hours and Saum and subsequent integration is relatively short.
Speaker Change: And we think that the efficacy is remarkable.
Speaker Change: Sustained problem.
Guy Goodwin: Very helpful. And then, can you just talk about some of the exclusion criteria as it relates to suicidality? Were you able to exclude patients with a history of suicidality? Was there anything unique in the history of those two patients that experienced suicidality?
Speaker Change: Very helpful. And then can you just talk about some of the exclusion criteria as it relates to Suicidality did you were you able to exclude patients with a history of suicidal already was there anything unique in history with expectations. Thank you Gary.
Guy Goodwin: Yeah, I mean, this is a group, even though this is not complex PTSD. Because this was really a first study, we wanted to be careful not to recruit too vulnerable patients, and the severe, pardon me, the complex PTSD group would be that. So this is a single trauma, which also simplifies the measure of outcome.
Gary: Yes, I mean this is a group even though it's not complex PTSD.
Gary: Because this was really a first study we wanted to be careful not to recruit to vulnerable patients when they cynthia.
Gary: The complex PTSD.
Gary: With beta. So this is a single trauma, which also simplifies the measure of outcome, but these patients also showed significant history.
Guy Goodwin: But these patients also show a significant history of suicidality. For example, 70% of them have expressed in their lifetimes a wish to be dead, and as many as 30% of them have expressed active suicidal ideation with specific plans and intent. So this is a group that has lifetime suicidality as a feature of the illness. This particular group was obviously recruited at a stage where they were not suicidal, and therefore, what we're seeing is relatively sub-threshold effects. So there were no serious adverse events, and, of course, there were no attempted suicides or suicides, which unfortunately is a risk in this condition.
Gary: So 70% of them.
Gary: For having trust in their lifetime.
Gary: And as many as 30%.
Gary: And express.
Gary: Total aviation with specific plans and intent.
Gary: As a group that has a lifetime certify the app is a feature of the illness.
Gary: Particular group, where obviously recruited at the place where they were not pure Basel.
Gary: And therefore, we are therefore, what we're seeing is relatively soft threshold effects the alert serious adverse event. Unfortunately.
Gary: Tempted suicide.
Gary: Which unfortunately is the risk in this condition.
Kabir Nath: Got it. And if I could have just one quick follow-up, and a follow-up to the first question, Kabir, you left us hanging when you said you would have some key questions that you'd love to have answered by the Lycos adcom. Can you elaborate a little further on that? What questions do you have that you hope the adcom addresses?
Speaker Change: Got it and if I could have just one quick follow up and a follow up to the first question to be are you left with hanging. When you said you have some key questions that you'd love to have answer by the lighthouse AD Com can you can you elaborate a little sharper on that what what questions do you have that.
Kabir Nath: So, once again, it's up to them to comment on how they think that will go, but clearly, and as we've said this before... The MICOS protocol is therapy, and in fact, your question itself proved that with the fact that there is a significant therapeutic component, and that clearly is something that will be interesting to see how the FDA understands that, how it treats that, and ultimately, if that's successful, how that will be reflected in labeling and so on. I think that's probably the key. As well as clearly stating the overall assessment of benefit and risk for what is generally categorized as a psychedelic. I think again how the FDA's approach here will benefit risks.
Speaker Change: You hope the common shareholders.
Speaker Change: And again, it's up to us.
Speaker Change: That is a comment on how they think that will go but clearly and as we've said this before.
Speaker Change: The <unk> protocol.
Speaker Change: And then back to your question.
Speaker Change: Further after the fact that there is a significant therapeutic components in that.
Really is something that will be interesting to see how the FDA understands that causes that and ultimately if that's successful that will be reflected in labeling themselves I think that's probably the key question.
Speaker Change: As well as clearly overall.
Speaker Change: Second the benefit risk for what is generally categorized as a hypothetical if I look at retail.
Speaker Change: I'll take that.
Speaker Change: Again, how the FDA approach if you have a little downside risks.
Speaker Change: Okay.
Kabir Nath: Great! Thank you so much.
Speaker Change: Oh, great. Thank you so much.
Operator: Thank you one moment for our next question. And our next question comes from the line of Charles Duncan from Canter. Your question, please.
Speaker Change: Yes.
Speaker Change: Thank you one moment for our next question.
And our next question comes from the line of Charles Duncan from Cantor. Your question. Please.
Charles Cliff Duncan: Good morning, Kabir and team. Congratulations on the progress. I had a question on PTSD and then one on TRD. The PTSD data seems fairly robust, so I guess, you know, at the risk of jumping the gun, I know that you are seeking FDA input, but could you imagine a relatively capital-efficient Phase III program, maybe including one or two studies, both with less than, say, roughly 90 patients, given the, you know, call it, magnitude of change that you're seeing in CAPS 5
Speaker Change: Okay.
Charles Cliff Duncan: Hey, good morning.
The beer and team congrats on the progress I had a question on PTSD and then one on TRP.
Charles Cliff Duncan: On the PTSD data seeds.
Speaker Change: Fairly robust so I guess.
Speaker Change: The risk of jumping the gun I noted that you are seeking FDA input, but could you imagine a relatively capitalization phase III program may be including one or two studies, both with less than save roughly 90 patients given day.
Speaker Change: I'll call it magnitude of change that you're seeing in cap Scott.
Kabir Nath: So Charles, you're not going to trick me into designing a phase 3 study on this call. Suffice to say, obviously, you know, we are encouraged by this data. As I said, we clearly are working on plans and development plans. We will need to take a robust outline of that to the agency, together with this data, to have that discussion. What that number of trials is, the sizing and so on, is still very much to be determined, but you have my assurance we will be doing it. Appropriately trading off robust evidence and capital, both of those will be gold and one out of the
Speaker Change: Charles Correct me onto designing a phase III study on their scope, but nice to say obviously, we are encouraged by this data as I said, we clearly are working on plans our development plans.
Speaker Change: We will need to take a robust bottom line of that to the agency together with its stated to have that discussion.
Speaker Change: That number of trials is besides maintenance on it still very much to be determined how much shirts, we were doing it appropriately trading off robust evidence capital efficiency.
Speaker Change: Both of those will go and what are the design we put forward.
Kabir Nath: I appreciate that. Confident in it. Moving on to TRD. Another question you're probably not going to be interested in answering, but I'll ask it anyway. Can you provide any color on the number of patients or, at least, the kind of pacing of patients into Part B and even Part C in terms of retreatment on a blinded basis in Part B and then open label? Thanks. Hello.
Speaker Change: I appreciate that confident in it.
Speaker Change: Moving on to Tiara D.
Speaker Change: Another question, you're probably not going to be.
Speaker Change: Interest Sydney, and ensuring better Lionsgate anyway can you provide any color on the number of patients or at least the kind of pacing of patients into part b and even part C. In terms of re treatment on a blinded basis and part B is an open label. Thanks.
Kabir Nath: So, you were right. The answer is no. I'm not going to give specifics except to say, as you said, we clearly have patients on both paths, but also importantly, as we've also said, the dropouts are running significantly lower than what we had potentially anticipated in the trial.
Speaker Change: Thanks.
Speaker Change: So.
Speaker Change: You are right. The answer is no I'm not going to give specifics except to say that we clearly have patients in both up but also importantly, as we've also.
Speaker Change: The dropouts are running significantly lower than what we had potentially anticipated in the trial.
Kabir Nath: Again, a good
Speaker Change: Okay.
Speaker Change: Syed.
Charles Cliff Duncan: Got it. Thanks for taking the questions.
Speaker Change: Yes.
Syed: Got it thanks for taking the questions.
Operator: Thank you. One moment for our next question, and our next question comes from the line of Patrick Trucchio from H.C. Wainwright. Your question, please.
Syed: Charles.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from the line of Patrick <unk> from H C. Wainwright Your question. Please.
Patrick Ralph Trucchio: Thanks. Good morning and congratulations on this very positive outcome in PTSD. I'm wondering if you can talk a little bit about the trial design for the Phase 2 study in PTSD relative to the FDA guidance for psychedelic drug development and, you know, discuss any of the learnings that have emerged that could have an impact on or inform the potential Phase 3 trial in PTSD. And then secondly, regarding the pivotal Phase 1 trial in TRD with top-line data expected in the fourth quarter, can you frame for us what data you would expect to include in that top-line release and how we should think about the outcome from this study relative to both the Phase 2B trial in TRD as well as possible read-through to the outcome from the pivotal trial 2 in TRD where the top-line data is expected in mid-2025?
Patrick: Thanks, Good morning, and congrats on this very positive outcome in PTSD.
Patrick: I'm wondering if you can talk a little bit about the trial design for the phase III study in PTSD relative to the FDA guidance for psychedelic drug development and discuss any of the learnings that have emerged that could have an impact or inform a potential phase III trial in PTSD and.
Patrick: And then secondly, I'm wondering regarding the pivotal phase one trial in CRD with topline data expected in the fourth quarter can you frame for US what data you would expect to include in that top line release, and how we should think about that.
Patrick: Outcome from the study relative to both the phase III trial in CRT as well as possible read through to the outcome from our pivotal trial two in CRD, where the top line data is expected mid 2025.
Kabir Nath: Thanks, Patrick. So I'll hand over to Guy in a moment, but I guess just the first thing to say is a reminder that this phase two was an open-label, 22-patient study. But let me hand it to Guy to say anything around the FDA guidance that will inform how we think about further design. Yeah, I mean, the FDA has obviously expressed an interest in seeing comparisons with another treatment, and that can be placebo, or it can be another dose of the active treatment, or even an active placebo.
Speaker Change: Thanks, Patrick so.
Speaker Change: And the guidance document, but I guess, just the first thing to say.
Speaker Change: This phase II open label 22 patient study.
Speaker Change: But let me hand, the guy to say.
Speaker Change: Anything around the FDA guidance that will inform how we think about some of it does not.
Speaker Change: Yes.
Speaker Change: I mean, the FDA are obviously expressed an interest in seeing comparisons with another three point that can be placebo or it can be.
Speaker Change: Another dose of the active treatment or even an active placebo.
Kabir Nath: So they've left really quite a wide range of options for anyone developing a drug in this space, and we'll take that into account when we think carefully about how we design our Phase 2 and indeed Phase 3 programs for PTSD. I don't think there are tremendous differences between TRD and PTSD from what we've seen. But, of course, there'll be the advantage of a shared safety database with TRD, which is no reason not to read across to PTSD.
Speaker Change: Really quite a wide range of options for anyone developing a drug in this space than.
Speaker Change: We will take that into account when we think carefully about how we design our share in the phase III.
Speaker Change: Program for PTSD.
Speaker Change: There are tremendous differences between CRB in PTSD more we've seen.
Speaker Change: But of course, there will be.
Speaker Change: Advantage.
Speaker Change: Safety database with TRP written.
Speaker Change: Not to read across particularly FDA indication.
Kabir Nath: And on your second question, Patrick, again, we have not been guided as to what exactly we'll be in a position to release. As you know, Part B runs to 26 weeks blinded, so we're going to have to be sensitive around that in terms of that. And look, no weed. COMPASS has designed this study for success clearly, and we believe that any significant result will be very positive and further evidence of the potential for COMP360 in TRD.
Speaker Change: And on your second question Patrick again.
Speaker Change: Guidance.
Speaker Change: What exactly will be in a position to release with top line as you are aware.
Speaker Change: Yes.
Speaker Change: Heartbeat runs to 26 weeks blinded so we're going to have to be sensitive around that in terms of that.
Speaker Change: And look.
Speaker Change: <unk>.
Speaker Change: Powered and designed the study for success clearly we believe that any significant result will be very positive.
Speaker Change: Evidence of the potential for comp for <unk> and CRB.
Kabir Nath: I don't know, Guy, in terms of any weeds from 05 to 06, if you have any comment you want to make? Not really. I mean, I think we see OO6, as we said before, Patrick, OO6 as being particularly informative from a clinical perspective rather than simply a regulatory one, you know, in that it will help us to understand the number of treatments that are probably required in ordinary practice potentially going forward, which Commercial Model, and to the acceptability by clinicians and patients as well.
Speaker Change: I know a guy in Cincinnati, we tripled our refinery in all aspects of the current enrollment rate.
Speaker Change: <unk>.
Speaker Change: No not really I mean, I think if we see fit so I think as we've said before Patrick.
Speaker Change: This is particularly informative from a clinical perspective since the regulatory one.
Speaker Change: In the middle.
Speaker Change: That will help us to understand the number of treatments that are probably require.
Speaker Change: In all of REIT practice, potentially going forward, which is essential to the commercial model.
Speaker Change: <unk> ability to clinicians inspection.
Kabir Nath: Right, that's helpful. And if I
Speaker Change: Yes.
Speaker Change: Alright, that's helpful and if I could just on these on the commercial collaborations following another announced today I'm wondering if do you have an estimate or an expectation for the proportion of the CRD population you may be able to reach at the time of the potential launch based on these commercial collaborations or how significant should we think about.
Speaker Change: These collaborations in preparation for possible rollout of cop 360 and CRD.
Kabir Nath: Thanks Patrick, it's a great question. So to be clear, these collaborations are really learning exercises. They are just examples...
Speaker Change: Thanks, Patrick its a great question so to be clear. These collaborations already learning exercise. They are examples of different settings of care and while some like for instance, Greenberg Tms, we would expect potentially that would be.
Speaker Change: A significant contributor so commercial rollout others. This is a little more about building 10 understanding delivery models that we will then need to apply to a wide range of other health care settings. So what I would say at this stage as you think of them really as this learning experience really to deepen our understanding of it.
Speaker Change: Potential to deepen our understanding these different areas, but assuming we're fortunate enough to follow you can imagine the PDI pre launches when we will be ready space in those 10 fleets across a number of those different settings with different health care providers.
Patrick Ralph Trucchio: Thanks so much.
Speaker Change: Great. Thanks, so much.
Operator: Thank you. One moment for our next question, and our next question comes from the line of Tom Shrader from BTIG. Your question, please.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from the line of Tom Shrader from <unk>. Your question. Please.
Thomas Eugene Shrader: Good morning. Thanks for taking the question. It's a remedial one on PTSD. So patients with your baseline score, what level of impairment do they have? What level of medical care are they using? And would a group like this, at some level, support the same price as your TRD patients? Thank you.
Thomas Eugene Shrader: Good morning, Thanks for taking the question its a remedial one on PTSD.
Thomas Eugene Shrader: Patients with your baseline score what level of impairment do they have what level of medical care are they using and what a group like this at some level support the same price as your T. R. D patients. Thanks.
Guy Goodwin: So it's basically classified as severe, and one of the criteria for the way in which one scores the CAPS-5 is that it would merit intervention or require intervention when people score 2 or 3, particularly on the scales that are used for each item of symptom. It's a complicated scale, I'm afraid, so we will be unpacking it a little more in the future, but that gives you some idea that these are a group who would need treatment. They're not a group who are sort of mild and are coming in for the experience.
Thomas Eugene Shrader: So steady classified as severe.
Thomas Eugene Shrader: One of the criteria towards the way in which one scores rig count slide.
Thomas Eugene Shrader: It would merit intervention would require intervention when people score two or three particularly on the scales that are used for each item. It's.
Thomas Eugene Shrader: It's a complicated.
Thomas Eugene Shrader: So it needs a little we will be unpacking, it a little more in the future.
Thomas Eugene Shrader: That gives you some idea that these are a group who would need treatment.
Thomas Eugene Shrader: The group, who are sort of mild and coming in for the experience.
Thomas Eugene Shrader: Any background on how much they're hospitalized?
Thomas Eugene Shrader: Yes.
Thomas Eugene Shrader: Background on how much they're hospitalized.
Guy Goodwin: We don't have all of the data on these patients yet, but this is very much a top line, so when we get all the tables in, we'll be able to give you that. That included psychotherapy as well as drug treatment, and about half were actively still on drugs which we then discontinued. And Tom, to your second question, I would say we still have a lot of work to do to actually finalize the profile for TRD, let alone PTSD.
Thomas Eugene Shrader: We don't have all of the data on these patients. Yes. This is very much top lines, but when we get all the table then we'll be able to give you that color.
Thomas Eugene Shrader: Roughly half quarter on something in Africa.
Thomas Eugene Shrader: Joseph I think all have received previous treatment with some time, sorry, if that was the question.
Thomas Eugene Shrader: That included psychotherapy, as well as drug treatment and about half were actively stephane.
Thomas Eugene Shrader: On drugs, which we then discontinued.
Guy Goodwin: So again, Out. Genuinely couldn't comment on how many administrations we would see for PTSD, what durability we might expect to see in a subsequent trial, and so on. So, honestly, it's premature to comment on how these would relate to each other commercially.
Speaker Change: And Tom to your second question I would say they still have a lot of work to do so actually finalize the profile for TRP.
Speaker Change: Let alone TSB so again.
Thomas Eugene Shrader: We couldnt.
Speaker Change: In January we Couldnt comment on how many administrations, we would see for PTSD durability, we might expect to see.
Speaker Change: Subsequent trial and so on so on our fleet premature to comment on how these would relate to each other commercially.
Speaker Change: Perfect. Thank you.
Operator: Thank you. One moment for our next question, and our next question comes from the line of Sumant Kulkarni from Canaccord Genuity. Your question, please.
Speaker Change: Okay.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Okay.
Speaker Change: And our next question comes from the line of <unk> Kulkarni from Canaccord Genuity. Your question. Please.
Sumant Satchidanand Kulkarni: Morning and afternoon. Thanks for taking my questions and nice to see the PTSD data. I have two.
Sumant Satchidanand Kulkarni: Good morning, and afternoon, Thanks for taking my questions and nice to see the PTSD data.
Sumant Satchidanand Kulkarni: So first on comp 360, how can the company optimally mitigate the risk associated with suicidal ideation.
Sumant Satchidanand Kulkarni: In trials, given both <unk> high background rates of this type of event and patients to start with and second it's very nice to see Dr. Michael Goldenberg, given Michael the extensive experience that might be asset companies. How do you think the study of compass might evolve going forward in terms of the types of compounds that companies might be looking at.
Michael Goldenberg: Well, thanks a lot.
Michael Goldenberg: I think started answer this is really we don't recruit patients who are actively suicidal because it really doesn't seem ethical to randomize them no treatment of low treatment.
Michael Goldenberg: I think everyone's flexpath approach ultimately impossible to completely exclude the existence of suicide in these sorts of patient populations, otherwise youre not studying a truly generalizable sample.
Michael Goldenberg: But we insist that our preparation and the support during the administration optimizes the preparedness of patients.
Michael Goldenberg: We think for that reason, we're seeing these relatively minor changes in our racing bear in mind that we have attempted suicides all suicide than any of our studies.
Michael Goldenberg: What we're seeing in describing here are changes on a scale, which is the threshold for action events that you would classify clinically serious particularly in this study.
Guy Goodwin: So first, on COMP360, how can the company optimally mitigate the risk associated with suicidal ideation in trials, given both TRD and PTSD have high background rates of this type of event in patients to start with? And second, it's very nice to see Dr. Michael Gold on board. Given Michael's extensive experience with multi-asset companies, how do you think the strategy of COMPASS might evolve going forward in terms of the types of compounds that COMPASS might be looking at?
Kabir Nath: Well, I think the standard answer to this is really that we don't recruit patients who are actively suicidal because it really doesn't seem ethical to randomize them to no treatment or low treatment, and I think everyone takes that approach. However, ultimately, it's impossible to completely exclude the existence of suicidality in these sorts of patient populations. Otherwise, you're not studying a truly generalizable sample. But, you know, we insist that our preparation and the support during the administration optimize the preparedness of patients.
Speaker Change: And some answer your question yes.
Kabir Nath: And we think for that reason, we're seeing these relatively minor changes on a rating scale. Bear in mind that we have had no attempted suicides or suicides in any of our studies. And what we're seeing and describing here are changes on a scale that is sub-threshold for actual events that you would classify as clinically serious, particularly in this case.
Michael Goldenberg: I think first we've always said.
Michael Goldenberg: That huge credibility with countries 60.
Guy Goodwin: Thanks Sumant for your question. I think first what we've always said is that we need to establish credibility with COMPASS. I believe with our progress with TRV and what we've announced today with PCSB, we're well on the way to doing that. We do have discovery assets, some of which we could be in a position to advance into first-in-human in a relatively short time frame. But I think having established ourselves as a credible developer, a late-stage developer of drugs, it absolutely is part of our thoughtful strategy to think about how we might expand into other assets over time. But, recognizing again, that's not a given. We have to demonstrate credibility and success with our lead assets. There are a lot of ways to do that.
Michael Goldenberg: Without prejudice with CRB and what we've announced today with PTSD, where we're on the way to doing that we do have discovery assets some of which we could be in a position to advance into first in human in the relatively short timeframe, but I think having established ourselves as a credible developer late.
Operator: Thank you, and as a reminder, if you do have a question at this time, please press star 11. And our next question comes from the line of Elemer Piros from Rodman. Your question, please.
Michael Goldenberg: Late states about Trump it absolutely is part at all from our strategy to how we might expand into other assets over time, but recognizing again.
Michael Goldenberg: Thats another given we have to demonstrate success.
Michael Goldenberg: Success with all of these assets and I think that while Hawaii students.
Speaker Change: Got it thanks.
Speaker Change: Thank you and as a reminder, if you do have a question at this time. Please press star one one.
Michael Goldenberg: And our next question comes from the line of Al <unk> from Rodman. Your question. Please.
Elemer Piros: Yes, good morning. Maybe I have a question for Guy.
al: Yes, good morning.
Elemer Piros: Maybe a question to guide.
Elemer Piros: I'm looking at the PTSD.
Guy Goodwin: Guy, I'm looking at the PTSD results with MDMA from the phase 3 trial, and it appears that it takes about 12 weeks to reach maximal benefit with MDMA plus therapy. How does that compare to what you observed with a single dose of COMPASS 360?
Elemer Piros: Results with MDMA from the Phase III trial.
Guy Goodwin: Where is that.
Guy Goodwin: <unk>.
al: It takes about 12 weeks to reach maximum benefit with MDMA plus therapy, how does that compare to what you observed.
Guy Goodwin: The single dose of <unk>.
Guy Goodwin: Our CAS-5 number is taken at 4 weeks. It's the first measure we take because it's a 4-week measurement. And of course, that shows the full effect at 4 weeks, and it's sustained out at 12 weeks. So that's what we appear to see. We will have even finer-grained evidence for early, very speedy onset from other measures that we took from patients that we don't yet have available to show you, but we will.
al: Steve.
Guy Goodwin: No.
Guy Goodwin: Comcast three tests.
Guy Goodwin: Numbers, taking that four weeks since the first measure we take because all we measure and of course that shows the full effect at four weeks.
Guy Goodwin: To stand up at 12 weeks using the same measure.
Guy Goodwin: That's what we see we will have an even finer grind.
Guy Goodwin: Evidence early very speedy onset from other measures that we took in patients, but we don't yet have a valuable to show you that we will happen just grows so do you believe that the results with MDMA.
Elemer Piros: So, do you believe that the results with MDMA are probably due to the second dose, the third dose amplifying the effect, and, you know, with the end results being about the same reduction in CAHPS-5?
Elemer Piros: Probably due to the second dose the third dose.
Elemer Piros: Amplifying the effect and with the end results being about the same reduction.
Elemer Piros: The reduction in caps five.
Guy Goodwin: Yeah, that's what we all see.
Guy Goodwin: Yes.
Guy Goodwin: That's what we all see.
Elemer Piros: Thank you. Thank you very much.
Speaker Change: Okay. Thank you. Thank you very much.
Operator: Thank you. This does conclude the question and answer session for today's program. I'd like to hand the program back to management for any further remarks.
Speaker Change: Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to management for any further remarks.
Kabir Nath: So just to say thanks to you all for your participation. As I say, and as we've heard also during the questions, we're very encouraged by this robust signal we've seen in PTSD. We are working to look at what a future plan for the program might be. We continue to execute on the timelines we established in February for COMP005 and COMP006 in TRD, and I think, therefore, we are looking forward to exciting news later in the year. So thank you everyone for your participation. Thanks for your support. I wish everyone a very good rest of the day.
Speaker Change: So just to say thanks, all for your participation as I say I think as we've hurdles that during the questions.
Kabir Nath: Very encouraged by this robust signal received in PTSD, we are working to look up what our future plans for the program might be we continue to execute on the timelines. We established in February four comes there is a revival comes <unk> six in CRB and I think therefore, we are looking forward to exciting news late.
Speaker Change: So thanks, everyone for your participation. Thanks sales of book I wish everyone. A good rest of the day.
Operator: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.
Speaker Change: Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: Okay.
Operator: [music].