Executive Summary

Q1 2025 was a de‑risking quarter financially (cash to $260.1M) and operationally (COMP005 Part A dosing complete) ahead of late‑June topline 6‑week data in TRD; management reiterated COMP006 26‑week data in H2 2026 .
EPS modestly beat S&P Global consensus on a primary/normalized basis, aided by a $19.5M non‑cash gain from warrant revaluation and higher R&D tax credit; IFRS basic/diluted loss per ADS improved sharply YoY/QoQ despite higher G&A tied to financing . EPS (Primary, S&P): consensus −$0.49 vs actual −$0.42*; IFRS EPS: basic −$0.20, diluted −$0.24 .
FY2025 net cash used in operations guidance maintained at $120–$145M; runway extended through COMP006 26‑week readout (H2 2026) following January financing .
Near‑term catalyst: COMP005 6‑week MADRS delta, p‑value, and CI in late June; DSMB to provide suicidality imbalance comment given ongoing 26‑week blinding, a focal narrative driver for the stock .

What Went Well and What Went Wrong

What Went Well

Cash runway strengthened: cash and equivalents rose to $260.1M (Mar 31) after Q1 financing, with CFO citing funding through COMP006 26‑week (H2 2026) .
Clinical execution milestone: COMP005 Part A dosing completed; topline 6‑week results on track for late June; CEO: “We eagerly await the upcoming topline 6‑week data readout… the first data from our pivotal phase 3 COMP360 program in treatment resistant depression” .
Non‑cash tailwinds: $19.5M gain from fair value change of warrants and higher R&D tax credit ($8.4M) reduced net loss YoY and QoQ .

What Went Wrong

Operating spend still elevated: total OpEx increased to $49.6M (vs $38.6M YoY; +28%), with G&A up to $18.7M due to financing and professional fees .
Underlying operating loss widened: loss from operations was $(49.6)M vs $(38.6)M YoY, reflecting continued Phase 3 investment despite R&D down modestly QoQ .
Persistent investor concerns: placebo variability and suicidality signal debated in Q&A; management set expectations that a MADRS delta >3 would be clinically significant and DSMB will provide qualitative suicidality assessment .

Financial Results

P&L and Cash Position (USD)

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Research & Development ($M)	$24.9	$32.9	$32.1	$30.9
General & Administrative ($M)	$13.7	$15.0	$16.3	$18.7
Total Operating Expenses ($M)	$38.6	$47.9	$48.4	$49.6
Fair Value Change – Warrants ($M)	—	—	—	$19.5
R&D Tax Credit Benefit ($M)	$3.1	$4.1	$10.2	$8.4
Interest Income ($M)	$2.3	$2.0	$1.6	$2.4
Interest Expense ($M)	$(1.1)	$(1.1)	$(1.1)	$(1.1)
Net Loss ($M)	$(35.2)	$(38.5)	$(43.3)	$(17.9)
Net Loss/Share – Basic ($)	$(0.55)	$(0.56)	$(0.63)	$(0.20)
Net Loss/Share – Diluted ($)	$(0.55)	$(0.56)	$(0.63)	$(0.24)
Cash & Equivalents (end, $M)	—	$207.0	$165.1	$260.1

Notes: “—” = not disclosed in the referenced period table.

Results vs S&P Global Consensus

Metric	Q1 2025 Consensus	Q1 2025 Actual	Surprise
EPS (Primary, S&P)	−$0.49*	−$0.42*	+$0.07*
Revenue ($M)	$0.0*	$0.0*	$0.0*

Values marked with * retrieved from S&P Global. IFRS EPS per press release was basic −$0.20 and diluted −$0.24 .

Additional KPIs

KPI	Q1 2024	Q4 2024	Q1 2025
Cash used in operations ($M)	—	—	$45.7
Share‑based compensation ($M)	$5.1	$4.5	$3.9
Debt under Hercules facility ($M)	—	$30.2	$30.5

Notes: “—” = not disclosed in cited source for that period.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Net cash used in operations	FY 2025	$120–$145M (2/27/25)	$120–$145M (5/8/25)	Maintained
Cash runway	Through milestone	At least through COMP006 26‑week readout (H2 2026) (2/27/25)	At least through COMP006 26‑week readout (H2 2026) (5/8/25)	Maintained
COMP005 topline	6‑week data	2Q 2025 (2/27/25)	Late June 2025 (5/8/25)	Narrowed timing
COMP006 topline	26‑week data	H2 2026 (10/31/24)	H2 2026 (5/8/25)	Maintained

Earnings Call Themes & Trends

Topic	Q3 2024 (10/31)	Q4 2024 (2/27)	Q1 2025 (5/8)	Trend
Phase 3 timing/disclosure	Shifted COMP005 6‑wk to 2Q25; delay COMP006 disclosure to 26‑wk to preserve blinding	Reiterated COMP005 6‑wk in late next quarter; COMP006 26‑wk H2‑26	COMP005 Part A dosing complete; 6‑wk topline late June	Execution progressing; timing firmed
DSMB/suicidality	DSMB to comment on suicidality at 6‑wk read; suicidality inherent to TRD	DSMB cadence; no change; expectation of AdCom	DSMB will provide suicidality comment; nuanced interpretation	Ongoing monitoring; narrative steady
Placebo/MADRS delta	Emphasis on unblinding risk; limit data disclosed	Use Phase IIb as powering benchmark; clinically meaningful lower in TRD	Aim for >3‑point MADRS delta considered meaningful	Expectation setting
Commercial prep	Collaborations, Spravato analog, CPT codes, state rescheduling groundwork	Strategic collaborations informing launch; PTSD commercial opportunity	Added HealthPort collab for underserved access	Building delivery footprint
Manufacturing/supply	—	—	Initial UK mfg; plan to add US capacity; tariffs viewed as manageable	De‑risking COGS/logistics
PTSD program design	Late‑stage design work; resource‑dependent	Resuming design post financing	Ongoing; will update after design finalized	Continued planning

Management Commentary

CEO: “We eagerly await the upcoming topline 6‑week data readout… the first data from our pivotal phase 3 COMP360 program in treatment resistant depression” .
CEO: “A positive treatment effect at 6 weeks based on a single dose… would represent a meaningful improvement in durability compared with the very limited options available to TRD patients today” .
CFO: “At the end of March, we had cash and cash equivalents of $260 million… we expect [this] to fund our operations at least through the planned 26‑week data readout from our second Phase III trial, COMP006… in the second half of 2026” .
CMO: “We would be very pleased to see effects of over 3 on the MADRS scale. We think that is clinically significant. Anything above that is a bonus” .
Chief Patient Officer: Collaborations (including HealthPort) are aimed at ensuring equitable access; sites already deliver Spravato, indicating operational readiness for interventional treatments .

Q&A Highlights

Durability and dose: 52‑week observational follow‑up suggests some 25mg patients maintain response up to ~6 months; 25mg remains preferred dose into Phase 3, with caveats about responder bias .
Placebo and effect size: Placebo response expected given intensive visit structure; company would be “very pleased” with >3‑point MADRS delta at 6 weeks in TRD .
Suicidality: DSMB will provide a qualitative assessment of any imbalance given the nuanced clinical context; suicidality is inherent in TRD and FDA did not raise specific concerns for Phase 3 design .
Manufacturing/tariffs: Current manufacturing in UK; plan to add US manufacturing for commercial supply; small‑molecule, low‑volume process viewed as straightforward; potential tariffs could be addressed in pricing .
Patient profile: Phase 3 criteria mirror Phase IIb; prior psychedelic experience capped at 15% (vs 6% in Phase IIb), but overall baseline characteristics expected to be similar .

Estimates Context

EPS (Primary, S&P): Q1 2025 consensus −$0.49 vs actual −$0.42*; IFRS basic/diluted loss per ADS was −$0.20/−$0.24 (press release). The delta versus consensus primarily reflects non‑cash warrant revaluation gain ($19.5M) and higher R&D tax credit benefit ($8.4M), offset by higher G&A from financing .
Revenue: Pre‑commercial; consensus $0.0 and actual effectively $0.0* (no product revenue disclosed) .
Coverage context: Q1 2025 EPS had 5 estimates; consensus target price $17 across 10 estimates*.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

Late‑June COMP005 6‑week topline (MADRS delta, p‑value, CI) is the key near‑term trading catalyst; DSMB’s suicidality comment will be scrutinized and could drive sentiment .
Balance sheet is positioned for multiple readouts: $260.1M cash (Mar 31) and FY25 cash burn guidance of $120–$145M support runway through COMP006 26‑week data in H2 2026 .
Q1 P&L benefited from non‑cash items (warrants, FX, R&D credit), masking a higher underlying operating loss YoY; expect OpEx to remain elevated as Phase 3 advances .
Management would view a >3‑point MADRS delta as clinically meaningful in TRD; set expectations accordingly for the topline framing .
Commercial groundwork is advancing (CPT codes, site collaborations, state rescheduling planning), with added focus on underserved access via HealthPort; Spravato adoption provides a relevant operational analog .
Manufacturing risk appears manageable (plans for US capacity; small‑molecule, low‑volume process); potential tariff impacts seen as addressable .
PTSD remains the most attractive next indication (unmet need, prior Phase 2a signal), with late‑stage design underway; timing updates pending .

Appendix: Source Documents Reviewed

Q1 2025 8‑K and press release (financials, business highlights, guidance) .
Q1 2025 earnings call transcript (prepared remarks and Q&A) .
Prior quarters for trend analysis: Q4 2024 8‑K and call and Q3 2024 8‑K and call .

S&P Global estimates used for consensus figures (EPS and revenue) and coverage context. Values marked with * retrieved from S&P Global.

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