Compass Pathways — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the three months ended September 30, 2026, was $9.8 million ($0.07 basic, $0.31 diluted per share), compared to a net loss of $137.7 million ($1.44 per share) in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $172.4 million ($1.35 per share), compared to a net loss of $194.0 million ($2.09 per share) in the same period in 2025.
• Research and development expenses were $23.5 million for the three months ended September 30, 2026, down from $27.3 million in 2025; for the nine months, expenses were $79.1 million, down from $88.5 million in 2025.
• Selling, general and administrative expenses were $33.0 million for the three months ended September 30, 2026, up from $13.2 million in 2025; for the nine months, expenses were $72.6 million, up from $44.6 million in 2025.
• Cash and cash equivalents totaled $444.0 million as of September 30, 2026, an increase from $149.6 million as of December 31, 2025.
• Total debt was $51.0 million as of September 30, 2026, compared to $31.6 million as of December 31, 2025.
• The decrease in net loss was primarily driven by a $40.8 million non-cash gain on fair value adjustments related to warrant liabilities for the three months ended September 30, 2026, compared to a $101.3 million loss in the same period in 2025.

Guidance and Future Outlook:

• The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028.
• Final NDA submission is nearing completion and will be filed within the next two weeks.
• Launch readiness is on track for the first half of 2027, subject to FDA approval.
• Potential for accelerated review and approval exists due to the National Priority Voucher (NPV), which could shorten review times to 1-2 months, and a White House Executive Order directing the DEA to conduct a timely review for rescheduling.

Business Segments and Product Lines:

• COMP360 data from two positive Phase 3 trials reinforces a profile of rapid onset and durability of effect.
• 52-week open-label data from COMP005 showed notable added benefit from an additional 25 mg dose of COMP360, extending durability to one year.
• A late-stage PTSD trial is ongoing, designed to be registration-enabling.
• Compass is working with the U.S. Department of Veterans Affairs on a multi-site randomized controlled clinical trial evaluating COMP360 psilocybin for TRD in veterans, including those with concurrent PTSD.
• Commercial readiness activities are advancing, including sales team selection, provider training, patient access, reimbursement, and supply chain readiness.
• COMP360 is expected to fit into an existing infrastructure of more than 8,500 treatment centers.

Market and Competitive Landscape:

• The U.S. market for Treatment-Resistant Depression (TRD) is estimated to include 4 million people, a significantly underserved market where the only marketed medicine has captured less than 3% market share.
• COMP360 is expected to be a blockbuster opportunity with the potential to establish a new standard of care by moving from daily administration to a few treatments per year.
• PTSD affects approximately 13 million people in the U.S. annually, with only two FDA-approved medications currently available.

Risks and Challenges:

• Clinical development involves lengthy and expensive processes with uncertain outcomes; trials may be delayed, terminated, or cost more than expected.
• Full results and safety data from Phase 3 trials may not be consistent with preliminary results.
• Additional funding may be required; failure to obtain funding could force delays, limitations, or termination of clinical trials.
• The rolling review process and National Priority Voucher program may not lead to faster FDA review or approval.
• Regulatory approval for COMP360 in the U.S. or other jurisdictions may be unsuccessful.
• Commercialization efforts, including obtaining coverage and reimbursement, may be unsuccessful.
• Risks include the potential failure of strategic collaborations and the ability to retain key personnel.

Management Commentary and Tone:

• CEO Kabir Nath stated the company is leading "one of the most important advances in mental health care in decades" and is executing with "urgency and discipline."
• Management expressed confidence that COMP360 has the potential to change the paradigm for TRD patients and establish a new standard of care.
• The company highlighted a "robust clinical package," a "clear path forward," and a "launch-ready organization" as key positioning factors.

Other Key Points:

• Compass Pathways plc (Nasdaq: CMPS) holds Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK for COMP360 in TRD.
• The company is leading the world's largest classic psychedelic clinical program in TRD.
• A conference call with management is scheduled for November 3 at 8:00 am ET.
• The decrease in R&D expenses was driven by reduced clinical trial costs following the completion of the Phase 3 program for TRD and reduced discovery expenses following program terminations in 2024 and 2025.
• The increase in SG&A expenses was driven by costs to support commercial preparedness, including investments in commercial infrastructure, market access, and launch preparation activities.