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- **9-12 Month Launch Acceleration**: FDA-supported rolling NDA submission and completed Phase III enrollment drive 9-12 month timeline reduction.
- **Commercial Readiness**: 6,000+ SPRAVATO-capable sites primed for COMP360, with REMS mirroring SPRAVATO protocols.
- **Financial Stability**: $186M cash on hand, maintaining runway to 2027; Q3 cash used: $35M, full-year guidance: $120-145M.
- **PTSD Trial Progress**: Protocol finalized, targeting Q1 2026 first patient enrollment.

**【CEO Summary Section】**
- **Accelerated Launch Timeline**: 9-12 month acceleration due to Phase III trial enrollment completion and FDA support for rolling NDA submission. 006 trial enrollment completed ahead of schedule, with 26-week data expected in Q3 2026.
- **FDA Interaction**: Positive dialogue with FDA on filing strategy, including potential rolling submission. 9-week data from 006 and 26-week data from 005 to be disclosed in Q1 2026.
- **Commercial Readiness**: Pulling forward commercial activities, leveraging insights from 6,000+ SPRAVATO-capable sites. Sites administering SPRAVATO are expected to easily transition to COMP360 if approved.
- **PTSD Trial Progress**: Protocol finalized for PTSD trial, with potential first patient enrollment in Q1 2026.

**【CFO Financial Commentary】**
- **Cash Position**: $186 million as of Q3 2025, maintaining cash runway to 2027. Q3 cash used in operations: $35 million; full-year guidance: $120-145 million.
- **Regulatory & Commercial Investment**: Added resources to regulatory team for NDA preparation and accelerated commercial activities. Debt under Hercules loan facility: $31.3 million.

**【Q&A Key Highlights】**
- **FDA & REMS Requirements**: FDA supportive of rolling submission; REMS likely to mirror SPRAVATO, allowing single or group administration based on clinician comfort.
- **Commercial Partner Selection**: No partner selected yet; focus on aligning with existing SPRAVATO infrastructure.
- **Durability & Efficacy**: 26-week data from 005 (single dose) and 006 (2 doses) to demonstrate durability, with potential for one-time administration efficacy.
- **VA Engagement**: VA's integrated project team actively planning for psychedelic treatment implementation post-approval.

COMPASS Pathways plc (CMPS) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

CMPS

CMPS fundamentals

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