COMPASS Pathways Plc

Good day, ladies and gentlemen, and welcome to the Compass Pathways fourth quarter 2023 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

Welcome, all of you, and thank you for joining us today for our fourth quarter 2023 results conference call. Again, my name is Steve Schultz. Today, I'm joined by Kabir Nath, our Chief Executive Officer, Mary Rose Hughes, our Interim Chief Financial Officer, Terry Luxem, our incoming Chief Financial Officer, and Dr. Guy Goodwin, our Chief Medical 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 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 thanking Mary Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter. And let me welcome Terry Lockson back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March the 1st. Terry brings to Compass deep, extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sectors. Her broad experience through all stages of development is precisely the expertise and leadership that Compass requires as we progress our phase three program in treatment-resistant depression. Many of you already know Terri, and I hope that over the coming months, the rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at Compass. First, though, let me report that Compass continues to actively recruit both our Phase III Comp360 trials in treatment-resistant depression, with top-line data expected this year and next. While our overall Phase III clinical program completion remains on track with top-line data from the 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top-line data from that trial into quarter four of this year. Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing. As we've consistently guided, we do expect that both trials will be required for NDA submission, consistent with the FDA's draft guidance for the development of psychedelics published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier. In parallel with the Phase 3 trial program, we continue to take the steps needed to ensure a well-developed delivery network for Comp360, if approved. This includes developing collaborations that will educate both Compass and Settings of Care on how Comp360 may fit into treatment options for appropriate patients. A key element of these research collaborations is to explore and develop multiple potential commercial delivery templates to ensure a successful rollout of Comp360 treatment subject to FDA approval in different care settings. Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are two very different but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COM360 psilocybin treatments. We also expect to announce additional research collaborations this year. In December, we announced initial safety data from our open-label phase two clinical trial of a single 25 milligram dose of Comp360 in 22 people living with post-traumatic stress disorder, or PTSD. We were also pleased to see the publication of Comp360 data from an investigator-initiated study in bipolar type 2 in JAMA psychiatry. In a moment, Guy will provide more information on both of these studies. While TRD is our lead indication for Comp360, we see logical expansion of its utilization into additional indications where there are significant co-morbidities and overlaps, such as PTSD and Bipolar II, subject to additional financing. With that, let me now ask Teri to introduce herself and share a bit about why she came to Compass. Teri.