COMPASS Pathways Plc

Ladies and gentlemen, thank you for standing by and welcome to the Compass Pathways first quarter 2025 earnings call. Please note that this call is being recorded. After the speaker's prepared remarks, there will be a question and answer session. If you'd like to ask a question during that time, please press star followed by one on your telephone keypad. Thank you. I'd now like to hand the call over to Steve Schultz, Senior Vice President of Investor Relations. You may now begin, sir.

Welcome all of you and thank you for joining us today for our first quarter 2025 results conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Terry Luxem, our Chief Financial Officer, who will have prepared remarks. In addition, Dr. Guy Goodwin, our Chief Medical Officer, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A. 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 available for a period of 30 days. Before we begin, you remind everyone that during the call today, the team will be making forward looking statements. Within the meeting 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 most recent quarterly report on Form 10-Q 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 will now hand the call over to Kabir Nath.

Thank you, Steve. Good day, everyone, and thank you for joining us. Recently, we announced the completion of dosing of all participants in Part A of our 005 trial, the first of two pivotal Phase III trials, which marks an important milestone in our mission to address the pressing unmet need in treatment-resistant depression, or TRD. We look forward to sharing the six-week top-line results in late June. As we've guided before, these results will include three P efficacy measures for the six-week primary endpoint. The difference between the treatment arm and the placebo arm in change from baseline on madras, the associated P value, and confidence interval. A positive treatment effect at six weeks based on a single dose of Comp360 would represent a meaningful improvement in durability compared with the very limited options available to TRD patients today. From a safety standpoint, the independent DSMB reviews unblinded safety data on a regular basis and has been doing so since the trial started. Since the trial remains blinded through 26 weeks, we have requested the DSMB to provide a comment on suicidality. We believe that these data, if positive, should provide investors with further clinical validation of COMF360's treatment potential in TRD. The second phase three trial, COM-006, which has three active arms, could further define the COM-360 profile with data on a second initial treatment, which we believe could potentially extend durability or deepen response. Enrollment is going well in 006, and I'll remind you that that is a global trial, and we're on track for the 26-week results in the second half of 2026. Also during this quarter, 52-week safety and efficacy data from the COMP-004 study was published in the Journal of Clinical Psychology. This was an observational 52-week follow-up from the Phase 2b-001 and 003 trials of COMP-360 psilocybin treatment in 252 patients with TRD. This study showed that for the full patient population, a single 25 mg Comp360 psilocybin dose offered long-term benefits with an average time to depressive event of over 12 weeks. A post hoc analysis of the subset of 58 participants that continued in the long-term follow-up study shown time to depressive event for those patients treated with 25 milligrams was substantially longer at 189 days. While there may be some responder bias associated with this subgroup, this is impressive data in a difficult-to-treat and highly refractory patient population, and we believe shows the potential of Comp360 to be a clinically differentiated treatment that is both rapid-acting and with meaningful durability. The Phase 3 program is designed to confirm the durability and safety profile, which, if successful and approved, could be a groundbreaking option for individuals who suffer from TRD. In addition, as we plan for the commercialization of Comp360, we'd be working to ensure that we understand the commercial opportunity, initially by focusing on how Comp360 will be delivered in a broad spectrum of settings of care. One way we are achieving this is through developing relationships with various provider types through our strategic collaborations, which we previously discussed. In line with this, we announced an additional strategic collaboration this quarter with Healthport. Healthport is a community health center that serves low-income individuals and is focused on providing broad and equitable access to innovative mental health treatments, which could potentially include Comp360 if approved by the FDA. HealthFord is our first collaboration that is focused on community-based delivery to underserved patient populations. Beyond this, our efforts with our existing collaborations are generating considerable value. We have gained deep insights into the patient experience and care pathways for those living with TRD within high-volume interventional psychiatry practices, hospital systems, and integrated delivery networks. we've strengthened our understanding of the clinical, operational, economic, and administrative considerations of implementing and scaling analogous interventional psychiatry treatments such as Spravato. This enables us to understand and prepare for the launch and adoption of Comp360, if approved. And we're building a strong appreciation of how training and continuing education is being delivered and how best to integrate Comp360 in the post-approval setting. These are just a few of the many examples of meaningful insights that we are using to inform our strategy for lawn and post-launch scaling. Now, let me turn the call to Teri.