COMPASS Pathways Plc

Good day, ladies and gentlemen, and welcome to the Compass Pathways third quarter 2023 conference call. At this time, all participants are in a 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 third quarter 2023 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, Mary Rose Hughes, our Interim 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 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 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 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 welcoming Mary Rose Hughes to our call as Interim Chief Financial Officer. Mary Rose has been with Compass since May 2020 when she joined as our second finance team member. She's been instrumental in laying the foundation for our finance organization and led the finance team through our NASDAQ IPO and three subsequent equity and debt financings. Mary Rose leads and manages all aspects of our finance operation, with the exception of investor relations, where she's begun to partner more extensively with Steve. I want to thank Mike Falvey for his service and contributions as CFO, and in particular for the significant financing we executed in August. We've now initiated an active search for a new CFO, and you should expect a smooth transition as we're in discussions with several strong candidates. After some introductory remarks about the business in the third quarter, I will hand the call over to Guy to provide clinical and regulatory updates. and then to Mary Rose for the financial update. COMP005 and COMP006, our phase three trials in treatment-resistant depression, or TRD, remain on track, and we continue to expect primary endpoint readouts in summer 2024 and mid-2025, respectively. Guy will provide more detail on our TRD trials and our other clinical programs in a moment. Looking at the external environment, we also continue to see strong esketamine sales sold under the brand name Spravato, which achieved global sales of $183 million this quarter, an increase of 82% compared to the third quarter of last year. This puts Bravato on a run rate of well over $600 million for 2023, continuing to demonstrate the unmet need in TRD. We believe this growth continues to be an important driver for the infrastructure of interventional psychiatry facilities and other treatment centers that we expect will be capable of delivering Comp360 treatment if approved. We find this continued development very encouraging. This quarter, we also welcomed Daphne Caridas to the Compass Board of Directors. Currently President and Chief Financial Officer at Flare Therapeutics, Daphne is a terrific addition to our board, as her biotech experience includes corporate financial management, investment management, and investment banking. Her deep biopharma industry experience and her understanding of investor priorities will help ensure that Compass remains on firm financial and strategic ground. Finally, in August, we completed an up to $285 million private placement financing, with $125 million in gross proceeds up front and up to an additional approximately $160 million in proceeds if the warrants are fully exercised. The financing structure was dictated by the investors involved and was very attractive for Compass, with the upfront investment accompanied by a warrant at a 30% premium to the last sale price. This effectively functions as an additional financing vehicle if and when the investors exercise their warrants. This financing, supported by a group of premier specialist biotech investors, extends our cash runway to late 2025 through multiple planned pivotal readouts. This strong financial foundation permits Compass to move forward confidently with our clinical programs, as well as all supporting studies for potential new drug application filing with the FDA. We also continue to invest in our pre-commercial work to ensure we're prepared for a successful Comp360 launch if approved, all with the aim of providing broad and equitable access to patients in need of better treatments. With that, let me now hand the call to Guy to update you on regulatory and clinical news during the quarter. Guy? Thank you, Kabir.