COMPASS Pathways Plc

Ladies and gentlemen, thank you for standing by and welcome to the Compass Pathfinders Limited fourth quarter 2024 investor call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star followed by the number one. I will now hand today's call over to Steve Schultz. Senior Vice President of Investor Relations. Please go ahead, sir.

Welcome, all of you, and thank you for joining us today for our fourth quarter 2024 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, Laurie Engelbert, our chief commercial 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, 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 most recent 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.

Thank you, Steve. Good day, everyone, and thank you for joining us. Let me begin by thanking our existing and new investors who participated in our financing last month. This not only positions us to complete the Comp360 program in TRD, but also importantly allows us to progress a PTSD development program beyond the encouraging results from our open-label phase 2A study that we received last May. This will be an exciting couple of years for Compass with multiple upcoming data readouts and the January financing positions us well for success. As we've guided to on the third quarter earnings call, we eagerly await the top line results from the six-week primary endpoint from the 005 trial in the second quarter of this year. We've recruited over 90% of patients in the trial, so we're within sight of the end of recruitment, which we'll announce once enrollment is complete. As a reminder, when the top line results become available in the second quarter, we'll be disclosing three key efficacy measures for the six-week primary endpoint. The mattress affects difference between the arms, the associated p-value, and confidence intervals. We believe that these data should provide investors with a clear understanding of the treatment effect, and if positive, together with our Phase 2b results, provide a strong validation for the treatment potential for Comp360 in TRD. From a safety standpoint, given that the trial is continuing blinded through 26 weeks, we'll provide a high-level assessment from the independent DSMB, which reviews unblinded safety data on a regular basis. For the 006 trial, which is the second phase three trial, enrollment is going well. And the high throughput 005 sites will convert over to 006 sites upon completing enrollment in 005. So we're gaining momentum and we're excited for the 26-week results of 006 to read out in the second half of 2026. As mentioned earlier, given the recent financing, we're now able to resume the development of Comp360 for PTSD, and we're in the process of refining our plans for a late-stage clinical program. We're working through the various questions to address, as well as potential clinical designs, the scope of which is under discussion both internally and with external advisors. Our primary goals are to maximize the probability of success and to get COM360 to those who suffer from PTSD as quickly as possible. We look forward to updating you on our plans as they progress. Finally, on the commercial front, our strategic collaborations with select healthcare delivery organizations, including interventional psychiatry networks, are providing important insights into the various care settings. Insights which we're using to inform our strategy for launch and post-launch scalings. Many of these organizations are delivering Spravato now, which is particularly helpful as we identify Comp360 opportunities to scale within their operating models. While our phase three data will give us full clarity on the Comp360 profile, based on our data to date, we believe we will have a clinically differentiated treatment that is rapid acting with meaningful durability. Let me now hand the call over to Terry for the financial update.