Compass, Inc.

Good morning, ladies and gentlemen, and thank you for standing by. My name is Kelvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Compass Pathways third quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press star one again. Thank you. I would now like to turn the call over to Stephen Schultz, Compass Pathways Senior Vice President of Investor Relations. Please go ahead.

Welcome, all of you, and thank you for joining us today for this quarterly conference call. My name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. And today I'm joined by Kabir Nath, our Chief Executive Officer, and Terry Luxem, our Chief Financial Officer. Laurie Engelbert, our Chief Commercial 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, 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 most recent 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 will now hand the call to Kabir Nath.

Thank you, Steve, and thank you all for joining us for today's call. We are very excited that Compass continues to make excellent progress on all fronts, in particular, the potential nine to 12 month acceleration of our launch plans that we announced today. Our first phase three trial, Comp 005, demonstrated a highly statistically significant result for the primary endpoint in June, which was an important de-risking event for the company. It was also a clinically and commercially meaningful result, which points to the potentially differentiated profile that is emerging for Comp360. We're looking forward to the remaining data from our ongoing phase three trials, especially from the second phase three Comp006 trial with its two fixed doses, which will be important to help inform dosing for labeling. Enrollment for the 006 trial continued to accelerate throughout the summer. And today we're pleased to announce the completion of enrollment. This is great news since it clarifies timing for the remaining phase three data disclosures and gives us line of sight to our potential filing timeline. Following the data readout in June, we had a positive and collaborative interaction with the FDA on our filing strategy for Comp360 and TRD. We're encouraged by their support for acceleration of the planned NDA filing, including the potential for a rolling submission. To enable this, we now plan to unblind nine-week data from Part A of the 006 trial and disclose it concurrently with 26-week data from the 005 trial in Q1 which is likely to be in the later part of the quarter. The 26-week data from Comp 06 is now expected in early Q3 next year, which we anticipate will be the last gating item to complete our NDA submission. Given the accelerated timelines, we are also pulling forward our launch readiness, building on the significant progress we've already made over the last couple of years. With our strategic collaborations across a variety of care settings, and our medical science liaisons interactions with KOLs, we've been very active in developing an extensive understanding of the commercial landscape and of provider sentiment and dynamics. We've generated valuable learnings that we're incorporating into our launch plans, including insights into patient preference, patient flows, and provider economics, which have helped us understand how Comp360 will be differentiated from current and future treatment options if approved. We're encouraged by the continued increase in interventional psychiatry infrastructure over the past few years, driven both by Spravato and the excitement around the potential promise for psychedelic treatments such as CONC360 in the future. The learnings we've gained through our commercial work strengthen our confidence that Comp360, if approved, can be effectively integrated into the growing interventional psychiatry infrastructure and offer a differentiated, compelling treatment option for patients and providers. With significant learnings already incorporated, we are confident that we will be ready to launch on an accelerated timeframe which is great news for the estimated 3 million individuals in the US living with TRD. Beyond TRD, we're also finalizing the design for a late stage PTSD trial following constructive interaction with the FDA. We look forward to updating you further on that program in the near future. As you can see, these are exciting times for Compass, and we are focused on translating our progress into real-world patient impact as quickly as possible, as the need remains urgent. With that, let me turn it over to Teri.