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COMPASS Pathways plc (CMPS)·Q3 2025 Earnings Summary

Executive Summary

  • Reported a larger-than-expected GAAP loss per share as a non-cash warrant revaluation drove a step-up in net loss; management simultaneously accelerated the potential COMP360 launch timeline by 9–12 months on FDA feedback and completed enrollment in the second Phase 3 (COMP006, n=585) .
  • Q3 GAAP diluted EPS was ($1.44) vs S&P Global consensus of ($0.405), a miss driven primarily by a $101.3M non-cash loss from the fair value change in warrant liabilities; cash used in operations was $35M and cash on hand was $185.9M, with runway into 2027 .
  • Guidance maintained: 2025 net cash used in operations of $120M–$145M; runway into 2027 reiterated; operational timelines pulled forward with potential rolling NDA submission after 9-week COMP006 Part A and 26-week COMP005 Part B data in Q1 2026 and COMP006 26-week data in early Q3 2026 .
  • Potential stock reaction catalysts: 1) Q1 2026 data package (COMP005 26-week + COMP006 9-week) to frame labeling and rolling NDA plan; 2) early Q3 2026 COMP006 26-week durability and dose insights; 3) regulatory clarity on adcom/REMS; and 4) commercial readiness milestones .

What Went Well and What Went Wrong

What Went Well

  • Enrollment completed in second Phase 3 (COMP006, n=585), tightening the timing for key readouts and supporting acceleration of NDA plans; FDA Type B meeting was “positive,” with encouragement toward a potential rolling submission .
  • Commercial readiness pulled forward 9–12 months, with deeper insights from strategic collaborations and MSL/KOL engagement; company believes Spravato-capable sites can deliver COMP360 if approved, aiding initial market access .
  • Strategic momentum beyond TRD: late-stage PTSD design finalized post-FDA feedback; external R&D collaboration with NeuroKaire (AI-powered neuronal analysis) to advance mechanistic understanding and precision psychiatry positioning .

Selected quotes:

  • “We are very excited… the potential 9–12 month acceleration of our launch plans that we announced today.” (CEO) .
  • “We are encouraged by [FDA’s] support for acceleration of the planned NDA filing, including the potential for a rolling submission.” (CEO) .
  • “Cash used in operations for the third quarter was $35 million… runway into 2027.” (CFO) .

What Went Wrong

  • GAAP EPS missed consensus due to a large non-cash warrant liability mark-to-market loss ($101.3M), driving net loss of $137.7M vs $38.5M a year ago; this masks otherwise stable operating expense trajectory .
  • Cash and cash equivalents declined sequentially as expected (Q3: $185.9M vs Q2: $221.9M vs Q1: $260.1M) due to operating spend and program execution; warrant liability volatility also increased total reported liabilities .
  • While revenue remains at zero (pre-commercial), investors may focus on the path to reimbursement and REMS/operational details; management acknowledged the need for further clarity post durability data for payer engagements .

Financial Results

P&L and Cash – Sequential Trend (oldest → newest)

MetricQ1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$30.88 $30.33 $27.33
G&A Expense ($USD Millions)$18.74 $12.61 $13.21
Total Operating Expenses ($USD Millions)$49.62 $42.93 $40.54
Net Loss ($USD Millions)$(17.86) $(38.40) $(137.72)
Diluted EPS (GAAP)$(0.24) $(0.41) $(1.44)
Cash & Cash Equivalents ($USD Millions)$260.11 $221.88 $185.94
Debt ($USD Millions)~$30.54 (sum of current $8.99 + non-current $21.55) $30.9 $31.3
Cash Used in Operations ($USD Millions)——$35.0

Notes: Q3 net loss includes a $(101.3)M non-cash loss from warrant liability fair value change .

Q3 2025 vs S&P Global Consensus

MetricQ3 2025 ActualQ3 2025 ConsensusSurprise
Diluted EPS (GAAP)$(1.44) $(0.405)*MISS: $(1.04)
Revenue ($USD Millions)$0.0 (no revenue reported) $0.0*In line

Values marked with * retrieved from S&P Global.

Year-over-Year (select items)

MetricQ3 2025Q3 2024YoY Change
R&D Expense ($USD Millions)$27.33 $32.93 Down $5.60
G&A Expense ($USD Millions)$13.21 $14.97 Down $1.76
Net Loss ($USD Millions)$(137.72) $(38.50) Down $(99.22), driven by $(101.32)M warrant loss
Diluted EPS (GAAP)$(1.44) $(0.56) Down $(0.88)

KPIs (biotech context):

  • Phase 3 COMP006 enrollment complete (n=585) .
  • Cash runway into 2027 reiterated .
  • Q3 cash used in operations: $35M (sequential, point-in-time) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Cash Used in Operating ActivitiesFY 2025$120M–$145M (Q2 guide) $120M–$145M (Q3 confirm) Maintained
Cash RunwayMulti-yearInto 2027 (as of 6/30) Into 2027 (as of 9/30) Maintained
Data Disclosure – COMP005 Part B (26 weeks) + COMP006 Part A (9 weeks)Q1 2026Previously linked to COMP006 Part A completion Combined disclosure planned for Q1 2026; likely later in the quarter Pulled forward/clarified
Data Disclosure – COMP006 Part B (26 weeks)Early Q3 20262H 2026 Early Q3 2026 Tightened window
Regulatory Path2026 NDA activitiesExploring accelerated filing Positive FDA Type B; pursuing potential rolling NDA submission Upgraded specificity

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
FDA interactions / NDA planExploring accelerated filing; BTD allows dialogue Positive Type B; considering rolling submission; plan to meet FDA again post Q1 2026 data Improving regulatory visibility
Phase 3 execution (TRD)COMP005 6-week positive; COMP006 26-week expected 2H26 COMP006 enrollment complete (n=585); COMP005 26-week + COMP006 9-week in Q1 2026; COMP006 26-week in early Q3 2026 Timelines accelerated/clarified
Commercial readinessBuilding strategy; into 2027 runway supports prep Pulling forward marketing, sales force design, IT, payer engagement; Spravato-site readiness emphasized Acceleration of go-to-market
Cash runway & burnCash $260.1M (Q1); $221.9M (Q2); guide $120–$145M net cash used in ops Cash $185.9M; Q3 cash used in ops $35M; FY guide maintained; runway into 2027 On track with spend discipline
PTSD programLate-stage design in development Late-stage design finalized post FDA interaction; CRO selected; potential first patients in Q1 next year Advancing toward execution
REMS / delivery modelN/AExpect conservative initial setup similar to Spravato; efficiencies may evolve (group admin, bays) Practical commercialization detail emerging
Warrant liability volatilityNot a focus previously$(101.3)M non-cash loss drove EPS miss vs consensus New P&L volatility factor

Management Commentary

  • “We are encouraged by [FDA’s] support for acceleration of the planned NDA filing, including the potential for a rolling submission.” (CEO) .
  • “We are pulling forward our launch readiness… building on the significant progress we have already made… [and] insights into patient preference, patient flows, and provider economics.” (CEO) .
  • “Cash used in operations for the third quarter was $35 million… we expect net cash used in operations for the full year 2025 to be between $120 million and $145 million… cash runway into 2027.” (CFO) .
  • “Any site delivering Spravato today would be capable of delivering COMP360 if approved… infrastructure, staffing, capabilities port over directly.” (Chief Patient Officer) .
  • “We have finalized the [PTSD] protocol… selected a CRO… potential to have first patients in [Q1 next year].” (CEO) .

Q&A Highlights

  • Distribution/patient access: Specialty pharma partner not yet selected; framework and requirements being scoped with acceleration of activities .
  • Site readiness: Spravato-capable centers expected to deliver COMP360; early delivery to be conservative with potential efficiencies over time (group rooms, bays) .
  • FDA path: Additional meeting anticipated after Q1 2026 data to align on rolling submission and review sequencing; potential for adcom acknowledged and company preparing accordingly .
  • Data disclosures: Company will disclose COMP006 Part A (9-week) with COMP005 Part B (26-week) in Q1 2026; believes disclosing Part A then will not compromise Part B integrity; COMP006 remains double-blinded through 26 weeks .
  • Commercial prep: Pulling forward marketing, sales force design, IT systems, and payer engagement contingent on full durability profile; broad access across diverse sites of care envisioned .

Estimates Context

  • EPS: Q3 2025 GAAP diluted EPS of ($1.44) vs S&P Global consensus Primary EPS of ($0.405)*; miss primarily reflects $(101.3)M non-cash warrant liability loss, overshadowing lower operating expenses YoY .
  • Revenue: In line with $0.0* as the company remains pre-revenue .
  • Estimate depth: Q3 2025 EPS estimate count = 2*, revenue estimate count = 9*.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • The core narrative improved: regulatory tone and timelines strengthened with a credible plan toward rolling NDA submission and durability readouts to support labeling in 2026 .
  • The EPS miss is a non-operational artifact: a large, non-cash warrant liability revaluation drove reported loss; operating spend trended down sequentially and YoY on R&D and G&A .
  • Cash runway into 2027 provides sufficient capital to reach pivotal readouts and regulatory milestones, with Q3 operating cash burn of $35M consistent with the full-year cash-use guide .
  • Commercialization is being pulled forward; Spravato infrastructure suggests practical launch pathways and an initial delivery model that can later scale efficiencies post-launch .
  • Upcoming catalysts (Q1 2026 combined data; early Q3 2026 durability) will likely drive estimate revisions, label expectations, and payer discussions—key for sentiment and stock volatility .
  • Watch for FDA engagement updates (rolling NDA acceptance, potential adcom scope) and early payer signals post-durability data, which will shape medium-term revenue ramp assumptions .
  • External R&D collaboration (NeuroKaire) supports precision psychiatry positioning and could differentiate the scientific narrative ahead of commercialization .

Citations:

  • Q3 2025 8-K press release and financial statements .
  • Q3 2025 earnings call transcript .
  • Q2 2025 8-K press release and financials .
  • Q1 2025 8-K press release and financials .
  • NeuroKaire collaboration press release .