Executive Summary

Q2 2025 delivered a pivotal clinical milestone (Phase 3 COMP005 met the 6‑week primary endpoint with a −3.6 MADRS delta vs placebo; p<0.001) and maintained FY25 cash burn guidance, but EPS missed consensus primarily due to a non-cash warrant fair value loss .
EPS (basic/diluted) was $(0.41) vs S&P Global consensus of $(0.37), a miss of $(0.04); net loss was $38.4M vs $38.1M in Q2 2024, with variance driven by a $2.5M non‑cash loss on warrant revaluation partially offset by $2.3M FX gains .
Liquidity improved year to date; cash was $221.9M at 6/30/25 (up from $165.1M at 12/31/24 on Q1 financing) and runway extended into 2027; full‑year net cash used in operations guidance held at $120–$145M .
Strategic setup strengthened: DSMB observed no unexpected safety issues or suicidality imbalance across Phase 3 programs; commercialization groundwork continued with CPT-3 psychedelic administration codes supporting hourly reimbursement; provider infrastructure viewed as ready to adopt .
Near-term catalysts: FDA engagement on potential acceleration/rolling NDA; COMP006 enrollment progressing well; 26‑week COMP005 data to follow COMP006 Part A completion (updated post‑Q2: company now plans to disclose COMP006 9‑week and COMP005 26‑week together in Q1 2026) .

What Went Well and What Went Wrong

What Went Well

Statistically robust efficacy: Single 25mg dose of COMP360 achieved a clinically meaningful −3.6 MADRS difference vs placebo at 6 weeks in COMP005 (p<0.001); DSMB reported no unexpected safety findings and no clinically meaningful suicidality imbalance across COMP005/006 .
Commercial and regulatory momentum: Management is pursuing accelerated pathways (including applying for the Commissioner’s National Priority Review Voucher) and planning FDA meetings to explore rolling/accelerated submission routes .
Liquidity and runway: Cash of $221.9M at 6/30/25 with runway into 2027; FY25 net cash used in operations expected at $120–$145M; Q2 operating cash outflow was $38.7M .

Selected quote

“We have now delivered clinically meaningful and highly statistically significant top‑line results after a single dose of COMP360 in two late‑stage studies in treatment‑resistant depression” — Kabir Nath, CEO .
“Cash and cash equivalents of $222 million… we expect to fund our operations into 2027… net cash used in operations for the full year 2025 to be within the range of $120 million–$145 million” — Teri Loxam, CFO .

What Went Wrong

EPS miss versus consensus: Q2 GAAP EPS (basic/diluted) $(0.41) vs S&P Global consensus $(0.37), primarily due to a $2.5M non‑cash loss from warrant liability fair value changes; FX gains of $2.3M partially offset the impact .
Continued elevated R&D intensity: R&D expenses increased YoY to $30.3M (vs $29.1M) as Phase 3 programs progressed; total opex remained high at $42.9M despite lower G&A .
Lack of revenue: Company remains pre‑commercial with no reported revenue, leaving P&L fully driven by opex and non‑cash items (warrants, FX, R&D tax credits) .

Financial Results

Quarterly P&L snapshot (oldest → newest)

Metric	Q2 2024	Q1 2025	Q2 2025
Net Loss ($USD Millions)	$38.1	$17.9	$38.4
EPS (Basic) ($)	$(0.56)	$(0.20)	$(0.41)
EPS (Diluted) ($)	$(0.56)	$(0.24)	$(0.41)
R&D Expense ($USD Millions)	$29.1	$30.9	$30.3
G&A Expense ($USD Millions)	$14.3	$18.7	$12.6
Total Operating Expenses ($USD Millions)	$43.3	$49.6	$42.9
Warrant FV Change ($USD Millions)	—	$19.5 gain	$(2.5) loss
R&D Tax Credit Benefit ($USD Millions)	$3.7	$8.4	$4.3
FX Gain/(Loss) ($USD Millions)	$0.2 gain	$2.1 gain	$2.3 gain

Cash and balance sheet (point-in-time; oldest → newest)

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents ($USD Millions)	$165.1	$260.1	$221.9
Debt ($USD Millions)	$30.2	—	$30.9
Total Assets ($USD Millions)	$213.7	$319.1	$293.5
Total Liabilities ($USD Millions)	$59.0	$123.7	$131.0
Shareholders’ Equity ($USD Millions)	$154.7	$195.5	$162.6

Operating cash flow and shares

KPI	Q1 2025	Q2 2025
Net Cash Used in Operations ($USD Millions)	—	$38.7
Weighted Avg Shares, Basic (Millions)	89.2	93.3

Estimate comparison (S&P Global consensus)

Metric	Q1 2025	Q2 2025
EPS Consensus (Primary)*	$(0.49)*	$(0.37)*
EPS Actual (GAAP Basic)	$(0.20)	$(0.41)
Surprise ($)	+$0.29 (beat)	–$0.04 (miss)

Values marked with * are retrieved from S&P Global (see disclaimer below).

Notes

Company reports no revenue lines in the periods presented; operating results are driven by operating expenses and other income/expense (warrants, FX, tax credits) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Net Cash Used in Operating Activities	FY 2025	$120–$145M (as of Q1 2025)	$120–$145M (as of Q2 2025)	Maintained
Cash Runway	As of Q1 2025	Sufficient at least through planned COMP006 26‑week readout (H2 2026)	Sufficient into 2027	Raised/Extended

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024 & Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory path (FDA)	Top‑line COMP005 6‑week data expected in Q2; planning late‑stage PTSD program .	Meeting with FDA in Q3 to explore accelerated/rolling NDA; applied for Commissioner’s National Priority Program .	Increasing momentum toward potential acceleration
Clinical efficacy & safety	Awaiting first Phase 3 readout .	COMP005 met 6‑week primary endpoint (−3.6 MADRS; p<0.001); DSMB: no unexpected safety, no suicidality imbalance .	Positive validation; de‑risked efficacy
Commercial readiness	Early groundwork; cash for advancement .	Infrastructure mirrors SPRAVATO settings; CPT‑3 codes support hourly reimbursement; provider networks ready .	Readiness building; operational plans maturing
COMP006 execution	On track for 26‑week data H2’26 .	Enrollment “in the steep ascent,” tracking to timelines; data sequencing tied to Part A completion .	Steady progress; timelines reaffirmed
Financial discipline & runway	FY25 op cash use $120–$145M; runway through H2’26 data .	Guidance maintained; runway extended into 2027 .	Improved visibility
PTSD program	Late‑stage design underway .	Finalizing design incorporating FDA feedback .	Advancing toward late stage
Leadership/Board	CPO appointment (Q4) .	Added Justin Gover (ex‑GW Pharma) to Board .	Governance strengthened

Management Commentary

Key messages

CEO emphasized validation from two late‑stage studies showing statistically significant and clinically meaningful results after a single COMP360 dose in TRD and the company’s focus on accelerating access pathways with FDA .
CFO underlined liquidity and discipline: $222M cash at quarter‑end, runway into 2027, Q2 operating cash usage of $38.7M, and maintained full‑year operating cash guidance .

Selected quotes

“We are highly focused on solidifying our commercialization efforts and exploring pathways to get this potential paradigm changing treatment option to patients as quickly as possible.” — Kabir Nath, CEO .
“We expect net cash used in operations for the full year 2025 to be within the range of $120 million–$145 million… we expect to fund our operations into 2027.” — Teri Loxam, CFO .

Q&A Highlights

Accelerated path and rolling submission: Management confirmed a Q3 FDA meeting and application to the Commissioner’s National Priority Review Voucher; discussions include acceleration scenarios, potentially ahead of full COMP006 readout depending on agency feedback .
Provider readiness and reimbursement: Existing SPRAVATO infrastructure is viewed as compatible; CPT‑3 psychedelic codes support hourly reimbursement, mitigating concerns about session duration and capacity .
Safety and suicidality: DSMB review showed no unexpected safety findings and no meaningful suicidality imbalance across Phase 3 studies; anorexia Phase 2 saw higher overall suicidality consistent with disease risk but no arm imbalance .
COMP006 enrollment: Investigators responded positively to COMP005 data; COMP006 enrollment is in a strong phase, supporting guidance on timelines .
Data disclosure sequencing: Part B (26‑week) COMP005 will be released once all participants in COMP006 Part A have completed, to avoid confounding; earliest NDA timing contingent on FDA alignment .

Estimates Context

Q2 2025 GAAP EPS $(0.41) vs S&P Global consensus $(0.37) — miss of $0.04; drivers included a $2.5M non‑cash warrant fair value loss, partially offset by $2.3M FX gains, with R&D tax credit benefit of $4.3M .
Q1 2025 GAAP EPS $(0.20) vs S&P Global consensus $(0.49) — beat of $0.29, aided by a $19.5M non‑cash gain on warrant fair value and $8.4M R&D tax credit benefit .
Revenue consensus was $0 across recent quarters and remains structurally neutral given pre‑commercial status*.

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

Two late‑stage wins (Phase 2b and Phase 3 primary endpoint met) materially de‑risk TRD efficacy; DSMB feedback supports safety profile and suicidality balance — increases confidence into next data events .
EPS variability is largely a function of non‑cash warrant revaluation and FX; underlying opex trajectory improving (lower G&A YoY/QoQ) while R&D remains elevated to support pivotal trials .
Liquidity is solid with $221.9M cash and runway into 2027; FY25 net cash used in operations guidance reaffirmed at $120–$145M, supporting accelerated commercial readiness .
Regulatory catalysts loom: Q3 FDA meeting on acceleration/rolling NDA and broader stakeholder engagement (including Washington) may pull forward timelines; monitor updates on selection for priority review initiatives .
Commercial infrastructure and reimbursement mechanics (CPT‑3) appear favorable; provider networks delivering SPRAVATO indicate operational fit for COMP360 at launch .
Next data catalyst: Release of COMP005 26‑week and COMP006 9‑week data together (subsequently updated post‑Q2 to Q1 2026) and COMP006 26‑week in mid‑2026; sequential de‑risking expected if efficacy durability and redosing insights remain favorable .
Trading frame: Stock likely sensitive to regulatory signals and any changes to data timelines; investors should expect continued EPS noise from non‑cash items and focus on clinical/regulatory milestones as primary drivers .

S&P Global estimates disclaimer

Values marked with * are retrieved from S&P Global. Definitions for “Primary EPS” may differ from GAAP basic/diluted EPS reported by the company.

Sources

Q2 2025 8‑K press release and financial statements .
Q2 2025 earnings call transcript (prepared remarks & Q&A) .
Other relevant Q2 press releases/8‑Ks: DSMB/COMP005 efficacy announcement (June 23) ; Board appointment (July 29) .
Prior quarters: Q1 2025 8‑K press release and financials ; Q4 2024 8‑K press release and financials .

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