COMPASS Pathways Plc

Thank you for standing by and welcome to the Compass Pathways first quarter 2024 earning investor call. At this time, all participants are in a listen-only mode. After this presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 1-1 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.

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. The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call and will be archived for a period of 30 days. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading Risk Factors in our annual report on Form 10-K, filed with the U.S. Securities and Exchange Commission, and in subsequent filings made by Compass with the SEC. Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. I'll now hand the call over to 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 dossier. 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 Health. Each of these partners represents very different, but equally important commercial models and settings of care for patients. 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 in 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. Let me now hand the call over to Dr. Guy Goodwin for a clinical update. Guy? Thank you, Kabir. It's a pleasure to speak to everyone today and review the positive data generated from the Comp360 Phase II 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 US and UK, the Icahn School of Medicine at Mount Sinai in New York, Sunstone Therapies in Rockville, Maryland, and the Institute of Psychiatry, Psychology, and Neuroscience at King's College in 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 II exploratory study evaluating Comp360 psilocybin treatment in 22 patients with PTSD resulting from trauma in adulthood. 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 after the session. The 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 CAHPS-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 dissociative PTSD subtype. Patients diagnosed with complex PTSD were excluded from study eligibility. 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 effect. Study observations also included improvement from baseline in mean SDS score, a measure of functional impairment in daily life. Safety over 12 weeks was the primary endpoint 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 12. The key findings include administration of COMP360 was well tolerated. There were no treatment emergent serious adverse events. Treatment 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 seven in a non-responder. 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 reduction at week 12. We observed increasing improvement from disability over the 12 weeks. From a mean SDS 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. We also saw high and sustained rates of response and remission relative to baseline with early onset of symptom improvement. Response as defined by patients experiencing a greater or equal 15 point improvement on CATS-5 score was 81.8% at week four and 77.3% at week 12. Remission as defined by CAST-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. Although a small trial with open label design, the results exceeded our expectations and advance our understanding of 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. In addition, for TRD, as Kabir mentioned, we are on track for the primary six-week endpoint in Comp 005 during the fourth quarter of this year. We are seeing improvements from the actions we took to facilitate the retrieval of medical records, which created a bottleneck earlier in the year. We also remain on track for Comp 006 for the primary six-week endpoint mid-next year. We are excited by the profile that's emerging for Comp 360 across both TRD and PTSD and the potential benefits for patients. We look forward to our phase three results later this year and next year and continuing to progress the broader Comp 360 program. Let me now hand the call to Terry for financial review.