COMPASS Pathways Plc

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

Welcome, all of you, and thank you for joining us today for this conference call. I'm Steve Schultz, Senior Vice President, Investor Relations at Compass Pathways. And today I'm joined by Kabir Nat, our Chief Executive Officer, and Laurie Engelbert, our Chief Commercial Officer. Terry Luxem, our Chief Financial 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, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading risk factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and 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 to Kabir Nath.

Thank you, Steve, and thank you all for joining us today. It has been a very exciting and productive quarter for Compass. The company continues to lead the way in psychedelic science, validated by the confirmation of a rolling NDA submission and review, and the award of a Commissioner's National Priority Voucher, or CNPV. With our 005 and 006 data announcement in February, we have delivered positive data from both our Phase III studies. Comp 360 has therefore demonstrated what no approved drug for TRD offers, clinically meaningful efficacy with both rapid onset and extended durability. In fact, these extraordinary results redefine rapidity and durability for TRD patients. With only one drug approved and actually used for TRD today, we are confident that Comp360, with its differentiated and compelling profile, will be an important option for the millions of patients that have been failed by the many approved treatments for MDD. After we announced results of our first positive phase three trial last year, and based on discussions with the FDA, we began preparing for a potential accelerated launch. As we've said before, we will be launch ready by the end of this year. We've aligned with the FDA on our rolling submission and review plan and have begun submitting modules for the Comp360 NDA. We will continue to submit additional modules on a rolling basis over the coming months. Part B data from 006, which we continue to expect in early Q3, will be the final data set to complete the submission. Given the award of the CMPV, we are already working closely with the FDA to enable as much efficiency and acceleration as possible. In addition, based on the executive order, we are accelerating our engagement with the DEA, since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post-FDA approval. Our two large Phase III trials, blinded to an unprecedented 26 weeks for psychiatry trials, supported by our large Phase IIb trial, has resulted in over 1,000 patients in the program. With comprehensive and strong preclinical, toxicology, safety, and CMC data, we are confident that we will have a robust NDA submission that supports a Comp360 approval. We've also continued to make great progress in our commercial preparedness, which Laurie will cover in detail. Our strategic collaborations across diverse settings of care, including the interventional psychiatry infrastructure, have provided significant learnings. Together with our foresight in establishing CPT-3 codes, specifically for providers to get fully reimbursed for psychedelic monitoring, this has set us up well for a potential near-term launch. We are ramping up rapidly, building out the commercial team with outstanding, highly motivated talent and initiating all activities in anticipation of approval. In addition to TRD, we are also progressing our program in PTSD, which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand Comp360 to individuals that have few medical options. We believe Comp360 can be an important new treatment for PTSD and it is a very logical next target indication for Compass. Our work with the CRO and sites for our late-stage PTSD trial is underway, and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028. Let me now hand the call to Lori for more on our commercial preparations.