Sumant Kulkarni

Charles Duncan

Gavin Clark-Gartner

Leonid Timashev

Patrick Trucchio

François Brisebois

Paul Matteis

Athena Chin

Chi Wen Chin

Elemer Piros

Judah Frommer

Kevin

Luis Santos

Michael Okunewitch

Ritu Baral

Thomas Shrader

- COMPASS Pathways is accelerating commercialization launch readiness plans by **9-12 months** and expects **9-week (Part A) data from COMP006** and **26-week (Part B) data from COMP005 in Q1 2026**, with **26-week (Part B) COMP006 data expected in early Q3 2026**.  **[0001816590_2231074:6]** 
- The company reported a **strong cash position of $185.9 million as of September 30, 2025**, providing a cash runway into **2027**, well beyond key catalysts.  **[0001816590_2231074:6]** 
- COMP360 is in **late-stage development with two Phase 3 trials (COMP005 and COMP006)** evaluating it for Treatment-Resistant Depression (TRD), a condition affecting approximately **3 million U.S. patients**.  **[0001816590_2231074:6]** 
- The **Phase 3 COMP005 trial achieved its primary endpoint** with a clinically-meaningful mean treatment difference of **-3.6 points on MADRS (p<0.001)**, and safety findings were consistent with previous studies.  **[0001816590_2231074:8]** 
- Positive discussions are ongoing with the FDA regarding **potential acceleration scenarios, including rolling submission**, for the New Drug Application (NDA) for COMP360 in TRD.  **[0001816590_2231074:6]**

COMPASS Pathways Provides Update on COMP360 Clinical Development and Financial Position

- Compass Pathways reported **$186 million** in cash and cash equivalents at the end of Q3 2025, maintaining a cash runway into **2027**, and projects net cash used in operations for FY 2025 to be between **$120 million and $145 million**.  **[0001816590_2230985_2]** 
- The company announced a potential **9-12 month acceleration** of its COMP360 launch plans, driven by the completion of enrollment for the COMP006 Phase 3 trial and positive FDA interactions supporting an accelerated NDA filing and rolling submission.  **[0001816590_2230985_1]** **[0001816590_2230985_8]** 
- Key data readouts are anticipated in **Q1 2026**, including 26-week data from the COMP005 trial and 9-week data from Part A of COMP006, with 26-week data from COMP006 expected in **early Q3 2026**.  **[0001816590_2230985_1]** 
- Additionally, Compass is finalizing the design for a late-stage PTSD trial, with the first patients anticipated in **Q1 2026**.  **[0001816590_2230985_1]** **[0001816590_2230985_8]**

Compass Pathways Accelerates COMP360 Launch Timeline and Provides Q3 2025 Financial Update

- Compass Pathways has accelerated its commercialization timeline for COM360 by **9 to 12 months**, attributing this to strong execution on the O6 study and positive dialogue with the FDA.  **[0001816590_2230880_6]** 
- The company anticipates holding another meeting with the FDA in **Q1 2026** to formalize a rolling submission plan, following the release of **26-week data from the O5 study** and **9-week data from the O6 study**.  **[0001816590_2230880_1]** **[0001816590_2230880_5]** 
- Commercial preparation activities, such as marketing, messaging, sales force structuring, and IT infrastructure setup, are being pulled forward by several months.  **[0001816590_2230880_3]** 
- Sites currently capable of administering **SPRAVATO** are expected to be able to deliver **COM360** if approved, as the physical infrastructure, staffing, and capabilities are largely transferable.  **[0001816590_2230880_0]**

Compass Pathways Accelerates COM360 Commercialization Timeline

- COMPASS Pathways plc announced its **Q3 2025 financial results** and is **accelerating commercial launch plans** for COMP360 in Treatment Resistant Depression (TRD) by **9-12 months** following positive FDA discussions and trial enrollment completion.  **[1816590_0001816590-25-000149_q32025pressrelease.htm:0]** 
- As of September 30, 2025, the company reported a **cash position of $185.9 million** and a **net loss of $137.7 million** for Q3 2025, or **$1.44 net loss per share**.  **[1816590_0001816590-25-000149_q32025pressrelease.htm:0]** **[1816590_0001816590-25-000149_q32025pressrelease.htm:1]** 
- The company expects its cash and cash equivalents to fund operating expenses and capital expenditure requirements **into 2027**, with full year 2025 net cash used in operating activities projected to be between **$120 million and $145 million**.  **[1816590_0001816590-25-000149_q32025pressrelease.htm:3]**

COMPASS Pathways Announces Q3 2025 Results and Accelerated Commercial Launch Plans

COMPASS Pathways (CMPS)