COMPASS Pathways plc filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission on November 3, 2026, covering the quarterly period ended September 30, 2026.

Key Highlights

  • Shares outstanding: The registrant had 141,710,353 shares of common stock outstanding as of October 28, 2026.
  • Filer status: COMPASS Pathways is classified as a non-accelerated filer and a smaller reporting company, and is not an emerging growth company, according to the filing.
  • Primary investigational asset: The filing references COMP360 psilocybin treatment for treatment-resistant depression, or TRD, with a rolling NDA submission underway and a National Priority Voucher awarded, according to the company's disclosures.
  • PTSD program: The company disclosed an ongoing Phase 2b/3 clinical trial in post-traumatic stress disorder, with trial design discussions with the FDA referenced in the filing.
  • Rescheduling requirement: According to the filing, COMP360 psilocybin contains Schedule I controlled substances and must be rescheduled by the DEA and states before the company can commercialize it in the U.S., if approved by the FDA.
  • Regulatory uncertainty: The filing notes potential impacts of "regulatory agency staffing cuts and policy changes on regulatory feedback and timing thereof" as factors affecting its forward-looking statements.

COMPASS Pathways Reports September 30, 2026 Quarter Amid COMP360 NDA Submission Process

COMPASS Pathways plc (NASDAQ:CMPS), incorporated in England and Wales and headquartered at 33 Broadwick Street, London, W1F 0DQ, filed its Form 10-Q for the quarterly period ended September 30, 2026. The filing covers condensed consolidated financial statements for the three and nine months ended September 30, 2026 and 2025, along with management's discussion and analysis and other required disclosures. The company reported 141,710,353 shares outstanding as of October 28, 2026.

According to the filing, the company's primary clinical focus remains COMP360 psilocybin treatment for TRD. The company disclosed that it is engaged in a rolling submission of a new drug application to the FDA and that COMP360 has been granted rolling review and awarded a National Priority Voucher. The filing also states that commercialization in the U.S. is contingent on rescheduling by the DEA and individual states, as COMP360 contains Schedule I controlled substances. The company additionally referenced ongoing Phase 3 trial activity for TRD and a Phase 2b/3 trial in PTSD.

The filing includes a broad set of forward-looking statements, which the company notes are based on information available to management as of the filing date and are subject to its cautionary language. Topics covered by those statements include expected NDA review timing, commercial launch planning, capital requirements, cash runway sufficiency, manufacturing scalability, and market acceptance of psilocybin-based treatments. The company also flagged potential effects of regulatory agency staffing changes and policy shifts on the timing of regulatory feedback as a variable affecting its disclosures.

What Was Disclosed

COMPASS Pathways filed a Form 10-Q for Q3 2026, disclosing 141,710,353 shares outstanding as of October 28, 2026, its non-accelerated and smaller reporting company status, and ongoing regulatory and clinical activities related to its COMP360 psilocybin program for TRD and PTSD.