COMPASS Pathways Plc

Hello everyone and welcome to contest pathways second quarter 2025 earnings conference call. Please note that this call is being recorded. After the speakers 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 Stephen Schultz, Senior Vice President of Investor Relations. You may now go ahead,

please. Welcome all of you and thank you for joining us today for our second 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 Luxum, our Chief Financial Officer, who will have prepared remarks. In addition, Dr. Guy Goodwin, our Chief Medical Officer, Dr. Steve Levine, our Chief Patient Officer, and Laurie Engelbert, our Chief Commercial 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, 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 in 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 10Q 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. Let me begin by welcoming Justin Gover to the Compass Board of Directors. Justin was the CEO and one of the founders of GW Pharmaceuticals, and we're truly excited to have access to his expertise. Under Justin's leadership, Epidiolex, the first cannabis plant-derived medicine to be approved by the FDA, had a successful commercial launch. I look forward to leveraging his expertise as we embark on a similar path to gain FDA approval and launch Comp360 for TRD. In addition to announcing the addition of Justin to the board earlier this week, we announced that Dr. Linda McGoldrick will be retiring from the board at the end of October after a transition period. I'd like to thank Linda for her service on the board over the last five years, where she was instrumental in supporting the growth of the company through the IPO and subsequent developments. Turning now to our operations, this has been an exciting quarter for Compass. In late June, we announced the successful achievement of the primary endpoint of the Comp360-005 trial, the first of our two pivotal Phase 3 trials. The positive results were highly statistically significant, demonstrating a clinically meaningful reduction in depression and no unexpected safety findings, based on the latest data reviewed by the independent DSMB. This assessment included all data reviewed by the DSMB to date from both the 005 and 006 trials, going beyond the six-week time point for 005 alone. There was a 3.6 point difference in change from baseline in mattress between the 25 milligram and the placebo arms at six weeks, exceeding the three point difference that is both clinically meaningful and commercially viable. While cross-trial comparisons are always challenging, this difference, sustained to six weeks with a single administration of Comp360, is similar to the difference seen at four weeks in the pivotal trials for the blockbuster drugs bravado, which required eight administrations. So we believe the result that we have seen at six weeks with Comp360 is both clinically and commercially compelling. With this positive data, Compass has delivered two for two, announcing positive, highly statistically significant results from two robust late stage studies of over 230 patients each in a very difficult to treat patient population in depression. Given the track record of previous studies in psychiatry, particularly in severe depression, our achievement of two positive late stage studies is remarkable and provides important clinical validation for Comp360's treatment potential in TRD. We plan to meet with the FDA to discuss these results and explore next steps in getting Comp360 to patients as rapidly as possible, patients who so desperately need new treatment options. The second pivotal phase three trial, Comp006, continues to recruit well, and we confirm that we're on track to disclose the 26 week data in the second half of next year. As a reminder, the protocol for this trial has a second dose after three weeks with the six week primary endpoint assessment, therefore only three weeks after the second administration. We should also get some good information on the effects of a second dose as part of the 26 week 005 data. Given that subject to specific retreatment criteria, participants can get another dose in part B, which runs from the six week time point through 26 weeks. To prepare for a potential commercial launch, our team continues to work with a broad array of mental health care providers, both through our strategic collaborations and through our field medical team to refine our understanding of how Comp360 treatment will fit into existing settings of care. We're frequently asked by investors how Comp360 will be viewed by providers who are used to the approximately three hour Spravato treatment window. Through our discussions with these providers, we know that patient preference will be a driving factor in treatment selection. As you're well aware, Spravato patients need to be driven to the clinic frequently, which is a burden to the patient and caregiver, and generally they're not able to return to work that day. In addition, we believe that the added administrative burden and the work required to turn a room potentially multiple times may actually favor Comp360 from a practice standpoint. Finally, the CPT3 codes specific to psychedelics that were put in place back in early 2024 provide for hourly reimbursement. So regardless of the length of the administration for Comp360, the provider will be covered. Steve and Laurie can go into much more detail on all of this. Beyond TRD, we're also excited about the potential for Comp360 and PTSD. We're in the final steps of designing a late stage clinical program in PTSD, and we look forward to updating you when that design is finalized and once we've reviewed it with the FDA. Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD. In addition, as you know, we had been running a small phase two study in anorexia. This was a double blind, randomized, controlled phase two clinical trial investigating the safety and efficacy of Comp360 psilocybin treatment in participants with anorexia nervosa. It was a multi-center study which enrolled 32 participants. The study has now completed and we recently received the data. From an efficacy standpoint, there was an encouraging positive signal in the reduction of eating disorder and depressive symptoms in the 25 milligram arm which was sustained through 12 weeks. However, the low overall numbers of participants and the high number of dropouts in the control arm limited statistical power. The safety profile was aligned with the high risk patient population in anorexia and no unexpected safety signals were reported. As we've discussed before, this is a difficult condition to study. We're proud of the data that we've been able to generate and we'll publish or present the full data set in future. With that, let me now hand the call to Terry to go through some financial updates before we move on to Q&A.