COMPASS Pathways Plc

Good day and thank you for standing by. Welcome to the Compass Pathways first quarter 2023 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. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like to hand the conference over to you, to your speaker today. Stephen Schultz, please go ahead.

Welcome, all of you, and thank you for joining us today for our first quarter 2023 results conference call. Again, my name is Steve Schultz. I'm the Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our Chief Executive Officer, Dr. Guy Goodwin, our Chief Medical Officer, and Mike Falvey, our Chief Financial Officer. The 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 quarterly report on Form 10-Q 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 of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. And with that, I will now hand the call over to Kabir Nath.

Thank you, Steve. Good day, everyone, and thank you for joining us. During this past quarter, Compass Pathways has continued to make excellent progress with our Comp 360 Phase 3 Pivotal Program in Treatment-Resistant Depression, or TRD, with patients being treated in both trials. You may recall that on our fourth quarter conference call, we said that we expected the FDA to come back to us with comments on pivotal trial design amendments by March the 20th. We've now received comments for both the 005 and 006 trial designs. While I won't go into the details of our interactions with the FDA, I will say that the comments reflected an active and thoughtful dialogue. As you would expect, with a drug development program that has breakthrough designation, we will have ongoing engagement with the FDA more broadly over the whole course of the development program. The upshot, is that we are continuing to execute both the 005 and 006 trials as described in our February conference call, and importantly, with no changes to the trial design. We also continue to expect top-line results for the six-week primary endpoint for 005 in summer of 2024 and for 006 in mid-2025. On the reimbursement front, The American Medical Association has accepted a current procedural terminology or CPT-3 code for psychedelic therapies. This was a very welcome development and the result of a collaboration between Compass Pathways and MAPS Public Benefit Corporation. Once effective, the CPT code will provide physicians and other qualified healthcare professionals with a means to track the work involved and ultimately seek reimbursement for delivering psychedelic therapies. Existing codes can provide coverage for the preparation and integration sessions, but the new code will fill a gap and cover psychological support during administration. The full details of the code are expected to be released by the AMA in July this year, and the code will go into effect when it's published on January the 1st, 2024. Currently, clinicians are forced to use various different codes cobbled together to gain reimbursement for approved medicines that require observation or support during administration. This tracking code is a crucial step toward a single code that covers psychological support for therapies like Comp360, subject to FDA approval, and it's a critical step towards obtaining reimbursement. This helps enable broad and equitable access to psychedelic therapies. This ensures that FDA-approved psychedelic therapies could be integrated into healthcare systems, reimbursed by payers, and made available to the people who need them. Finally, we've continued our active engagement with biotech specialist investors. We've continued to communicate the depth and the progress of our programs and the strength of our value creation proposition in an area of significant unmet medical need. Since the beginning of this year, we've raised roughly $28 million from sales under our ATM facility, including a large block trade in April. With that, let me now hand the call over to Dr. Guy Goodwin to provide further clinical updates.