Executive Summary

Q4 2024 showed higher operating spend as Compass advanced its pivotal Phase 3 program: quarterly net loss was $43.3M ($0.63/share) vs $38.5M ($0.56/share) in Q3 and $32.5M ($0.53/share) in Q4 2023; R&D rose to $32.1M and G&A to $16.3M for the quarter .
Cash and equivalents fell to $165.1M at year-end; management subsequently raised ~$140M net in January 2025, extending runway at least through the COMP006 26-week readout expected in H2 2026 .
Trial milestones: COMP005 6‑week top‑line remains on track for Q2 2025 with >90% of patients recruited; COMP006 26‑week data expected H2 2026, with design choices made to preserve blinding and inform durability/redosing .
FY25 guidance introduced: net cash used in operations $120–$145M; company reiterated runway and clarified it covers operations at least through the planned COMP006 26‑week readout (H2 2026). No revenue/earnings guidance provided; S&P Global consensus estimates were unavailable during this session .

What Went Well and What Went Wrong

What Went Well

Execution milestones intact: COMP005 6‑week primary endpoint remains targeted for Q2 2025; COMP006 26‑week remains H2 2026, with >90% of COMP005 recruited and high‑throughput sites slated to roll into COMP006 to maintain momentum .
Financial runway extended: Year‑end cash of $165.1M plus ~($140M) net January financing provide funding at least through COMP006 26‑week readout (H2 2026) .
Strategic clarity/expansion: Management is resuming a late‑stage PTSD program design, leveraging positive Phase 2a signal and January financing; commercial groundwork progressing (strategic collaborations, CPT coding, Spravato analog) .

Quote: “We believe we will have a clinically differentiated treatment that is rapid acting with meaningful durability.” – CEO Kabir Nath .

What Went Wrong

Higher quarterly loss: Q4 net loss increased to $43.3M from $38.5M in Q3 and $32.5M y/y, driven by R&D and G&A growth (strategic reorg, headcount, professional fees) .
Cash burn cadence: Cash and equivalents declined to $165.1M at 12/31/24 from $207.0M at 9/30/24; FY25 net cash used guidance remains sizable at $120–$145M .
Ongoing regulatory/process risks: Management emphasized suicidality is inherent to TRD and that DSMB reviews unblinded safety; functional unblinding concerns continue to shape disclosure timing and design (e.g., delaying COMP006 data to 26 weeks) .

Financial Results

Quarterly comparisons (oldest → newest):

Metric	Q4 2023	Q3 2024	Q4 2024
Net Loss ($USD Millions)	$32.532	$38.502	$43.332
EPS (Basic & Diluted)	$(0.53)	$(0.56)	$(0.63)
R&D Expense ($USD Millions)	$27.139	$32.928	$32.141
G&A Expense ($USD Millions)	$11.266	$14.968	$16.273
Total Operating Expenses ($USD Millions)	$38.405	$47.896	$48.414
Cash & Equivalents (Period-End, $USD Millions)	$220.198 (12/31/23)	$206.953 (9/30/24)	$165.081 (12/31/24)
Debt (Period-End, $USD Millions)	$28.8 (12/31/23)	$29.8 (9/30/24)	$30.2 (12/31/24)

Notes:

Consolidated Statements show operating expenses and other income/expense; no revenue line item appears, consistent with clinical‑stage status .
FY 2024 net loss: $155.1M ($2.30/share) vs $118.5M ($2.32/share) in 2023; includes $19.5M SBC in 2024 vs $17.3M in 2023 .

Segment breakdown: None disclosed (no commercial revenues) .

KPIs and operating items:

COMP005 enrollment: “over 90%” recruited as of the Q4 call; DSMB recently reviewed unblinded safety with continuation recommended .
Cash used in operations FY24: $119.2M (within prior guidance) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Net cash used in operations	FY 2025	—	$120M–$145M	New range introduced
Cash runway	Through key data	“Sufficient to fund operating expenses and capex at least into 2026” (as of 9/30/24)	“Sufficient at least through planned COMP006 26‑week readout (H2 2026)” (with Jan financing)	Clarified timeline; maintained runway
COMP005 top‑line 6‑week	Milestone timing	Q2 2025 (updated on 10/31/24)	Q2 2025 (reaffirmed)	Maintained
COMP006 data disclosure	Milestone timing	Shifted to after 26‑week time point; H2 2026 (10/31/24)	H2 2026 (reaffirmed)	Maintained

Earnings Call Themes & Trends

Topic	Q2 2024 (prior)	Q3 2024 (prior)	Q4 2024 (current)	Trend
Trial timing & design	Guided COMP005 6‑week in Q4 2024; COMP006 mid‑2025; emphasized minimizing unblinding via multi‑dose arm design	Pushed COMP005 to Q2 2025; delayed COMP006 to 26‑week/H2 2026 to protect blinding	Reaffirmed COMP005 Q2 2025; COMP006 H2 2026; >90% COMP005 enrolled; DSMB oversight ongoing	Timing stabilized after Q3 reset; execution progressing
Safety/DSMB & suicidality	DSMB quarterly reviews; trials continue as planned	Framed suicidality as inherent to TRD; DSMB to comment on any imbalance at top‑line	DSMB most recently in Feb; will provide high‑level safety assessment at top‑line	Consistent vigilance; communication plan defined
Commercial prep & reimbursement	Leveraging Spravato growth; building commercial capabilities	Strategic collaborations; site flow optimization; education	CPT Category III codes highlight reimbursement path; not constrained to therapists	Increasing operational detail
PTSD program	Open‑label Phase 2a signal; planning options (not in runway)	Reiterated interest; capital constrained	Resuming late‑stage program design post‑financing	Re‑accelerating
Workforce/cost actions	—	~30% workforce reduction to focus on COMP360	FY24 cash used in ops $119.2M; FY25 guide $120–$145M; runway through H2 2026	Cost focus + added capital support runway

Management Commentary

“We’ve recruited over 90% of patients in [COMP005]… we expect to report the top‑line 6‑week primary endpoint data towards the end of next quarter.” – CEO Kabir Nath .
“Cash used in operations for the full year was $119.2M… January financing resulted in net proceeds of ~ $140M… provides us runway at least through the planned 26‑week data readout from COMP006 in H2 2026.” – CFO Teri Loxam .
“Depression inherently carries suicidality… any study that enrolls a large number of patients with TRD… is running that risk… DSMB… unblinded… decide that there is no clear reason to think… a signal of danger.” – CMO Guy Goodwin .
“We believe we will have a clinically differentiated treatment that is rapid acting with meaningful durability.” – CEO Kabir Nath .

Q&A Highlights

Top‑line disclosure scope: 6‑week data will include only MADRS difference between arms, p‑value, and confidence intervals; no secondary endpoints (no remission/response) until later reads .
DSMB and suicidality: Regular DSMB reviews (most recently in February) will provide high‑level safety assessment and comment on any suicidal ideation imbalance at top‑line .
Durability measurement: Company will assess maintenance of effect on MADRS and time‑to‑new‑treatment; patients remain in 52‑week protocol; co‑medication tracked observationally .
Commercial model and economics: Category III CPT codes support reimbursement for administration day on an hourly basis; many prospective sites already deliver Spravato; launch not constrained to therapists .
PTSD prioritization: Large unmet need and positive Phase 2a signal drive prioritization; scope and design under discussion with planned FDA interactions .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable during this session; we were unable to retrieve valid S&P Global estimate data to compare against actuals. As a result, estimate comparisons are not shown.

Key Takeaways for Investors

Near‑term catalyst: COMP005 6‑week top‑line in Q2 2025 will be the key event; disclosure will be limited to MADRS difference, p‑value, and CIs, but should frame efficacy effect size and statistical significance .
Runway secured through H2 2026 readout: Year‑end cash plus January net proceeds (~$140M) support operations at least through COMP006 26‑week readout; watch FY25 net cash used range ($120–$145M) vs program cadence .
Program design mitigates regulatory risks: COMP006’s multi‑dose‑arm design seeks to minimize functional unblinding; delayed disclosure to 26 weeks preserves blinding integrity—important given FDA focus observed in peer AdComs .
Commercial path increasingly defined: Category III CPT codes and Spravato center overlap should aid adoption and reimbursement if approved; strategic collaborations aim to optimize site throughput .
PTSD optionality returns: With financing complete, Compass is planning a late‑stage PTSD program, broadening potential value creation beyond TRD .
Execution watch‑items: Enrollment completion and top‑line timing for COMP005; DSMB commentary at readout; cash burn relative to guidance; and clarity on PTSD program timeline in 2025 updates .

Citations:

Q4 2024 8‑K press release and financials: .
Q4 2024 earnings call transcript: .
Q3 2024 8‑K and call: .
Q2 2024 8‑K and call: .

COMPASS Pathways plc (CMPS)·Q4 2024 Earnings Summary