COMPASS Pathways Plc

Good day, ladies and gentlemen, and welcome to the Compass Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If you would like to ask a question during this session, please press star then 1 on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference call, Stephen Schultz. You may begin.

for joining us today for our fourth quarter and full year 2021 results conference call. We hope you've had a chance to review the press release issued earlier today covering our results. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. Today I'm joined by George Goldsmith, Chairman and Chief Executive Officer, Dr. Guy Goodwin, Chief Medical Officer, and Mike Falvey, Chief Financial Officer. Call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call. 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 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 at any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement. I'll now hand the call over to our Chairman and CEO, George Goldsmith.

Thank you, Steve, and welcome, everyone. Let me begin by welcoming Mike Falvey to his first COMPUS quarterly results call. Mike joined our team in December and has a track record in building strong financial teams and valuable experience in launching and commercializing products. This experience will be important as we work to bring our COMP360 psilocybin therapy through clinical trials, regulatory approval, and ultimately to patient access as a reimbursed therapy. I will begin today's call with a business update on our Rekusen progress. Guy will talk about additional data from the Phase 2b study and our open-label study with SSRIs, and Mike will provide a financial review. We will then open the call to questions. In the fourth quarter of 2021, Compass Pathways made significant progress toward our goal of accelerating patient access to evidence-based innovation in mental health. With the successful completion of our Phase 2b Trial of Comp360 Psilocybin Therapy in Treatment-Resistant Depression, or TRD. This trial is the largest randomized controlled psilocybin therapy study ever completed, and it showed rapid and sustained response after just a single 25-milligram dose of Comp360 psilocybin with psychological support. The trial provided Compass with a target dose for a planned Phase III program and a wealth of information to guide us in finalizing our trial design. which will be reviewed with the FDA in our upcoming end of phase two meeting which has been scheduled for late April. In the trial, in addition to looking at the safety and efficacy of Comp360 psilocybin therapy, we examined a number of exploratory measures recognized as being important to recovery for patients with TRD and we're pleased to see positive data. In December, we also announced results from our open label study of Comp360 Phyllis Ivan Therapy in TRD patients who remained on their SSRI antidepressants, unlike those in our Phase 2B trial in which patients were withdrawn from their antidepressants. The study results demonstrated that Comp360 has potential as an adjunctive therapy as well as a monotherapy, providing greater flexibility to patients. We believe this increase in patient choice could increase the number of prescribers and patients who would consider this therapy option. A number of patients who participated in either the Phase 2b or the open label study entered a 12-month long-term follow-up study. We will be reporting the results of this study later in the year and expect additional insight on the durability of a single Comp360 psilocybin dose with psychological support. Guy will walk through these data in more detail in a moment. Beyond TRD, we commenced a COMPUS-sponsored Phase 2 study of COMP360 psilocybin therapy for the treatment of post-traumatic stress disorder, or PTSD, another indication with significant unmet need and representing an urgent problem with few current therapeutic options. We expect to expand into a further indication over the course of this year. These COMPUS-sponsored programs are in addition to the ongoing investigator-initiated studies in a variety of therapeutic areas, including anorexia nervosa, bipolar depression, and severely resistant TRD. We continue to expand our leadership in preclinical research, exploring new psychedelic compounds through our Discovery Center and through our recently acquired intellectual property portfolio, covering a variety of psychedelic and empathogenic substances. This IP was developed together with inventor Dr. Matthias Grill who will be working with Compass on an exclusive research project to advance new product candidates. With that, let me now hand over to Guy.