Atai Beckley N.V. (ATAI)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025: revenue of $0.75M and diluted EPS of -$0.28; EPS missed S&P Global consensus (-$0.12*) due to a $32.6M non-cash fair value charge and higher G&A tied to the Beckley combination/redomiciliation, while revenue beat a very low consensus ($0.05M*) .
• Strategic momentum: BPL-003 received U.S. FDA Breakthrough Therapy designation for TRD; positive Phase 2b OLE and Phase 2a two‑dose induction data support moving to Phase 3 with Phase 3 design guidance expected in Q1 2026 and initiation in Q2 2026, pending FDA discussions .
• Balance sheet extended: ~$150M October equity offering closed; cash and liquid assets expected to fund operations into 2029, through anticipated topline data from the first BPL‑003 Phase 3 trial .
• Near‑term stock catalysts: (1) FDA End‑of‑Phase 2 feedback/Phase 3 specifics for BPL‑003 (Q1 2026), (2) redomiciliation to the U.S. around year‑end 2025, (3) EMP‑01 Phase 2a topline in Q1 2026, and (4) financing runway clarity to 2029 .

What Went Well and What Went Wrong

• What Went Well

  • FDA Breakthrough Therapy designation for BPL‑003 in TRD, accelerating regulatory dialogue and validating the program’s potential .
  • Positive BPL‑003 data flow: Phase 2b OLE showed added and sustained antidepressant effects with a second 12 mg dose; two‑dose Phase 2a induction regimen also positive, supporting pivotal readiness .
  • Financing and runway: ~$150M offering closed in October; company expects liquidity to fund operations into 2029; CEO: “This has been a transformational quarter… Breakthrough Therapy designation… well positioned to advance BPL‑003 into pivotal development” .

• What Went Wrong

  • EPS miss driven by non‑cash items: net loss increased to $61.1M, including a $32.6M non‑cash fair value expense; diluted EPS -$0.28 vs -$0.12 consensus* .
  • Operating expense pressure: G&A rose to $14.5M (from $10.3M YoY) on legal/professional fees for the Beckley combination and U.S. redomiciliation; R&D also increased with advancing programs .
  • VLS‑01 timing remains pushed: topline now in H2 2026 after Q2 update citing slower-than-anticipated site activation; Q3 affirmed expanded sites and H2 2026 timing (maintained after the Q2 delay) .

Financial Results

P&L: Revenue and EPS (chronological: oldest → newest)

Notes: Q3 2025 net loss includes $32.6M non‑cash fair value expense .

Operating Expenses

Balance Sheet / Liquidity KPIs

Q3 2025: Actual vs S&P Global Consensus

Estimates marked with an asterisk are Values retrieved from S&P Global.

Segment breakdown: Not applicable (no material commercial product revenue reported) .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript located as of Nov 20, 2025 (we searched and found none). Findings below reflect company disclosures/press releases across periods.

Management Commentary

• CEO Srinivas Rao: “The FDA’s Breakthrough Therapy designation for BPL‑003 represents a major milestone… we believe we are well positioned to advance BPL‑003 into pivotal development pending discussions with the FDA at the upcoming End of Phase 2 Meeting.”
• Chairman Christian Angermayer: “With the creation of AtaiBeckley, the Breakthrough Therapy designation for BPL‑003, and a strengthened balance sheet, we are demonstrating the commercial scalability and scientific leadership needed to transform the mental health treatment landscape.”
• BPL‑003 Phase 2b core outcomes (July 1 release): single 8 mg and 12 mg doses showed rapid, durable MADRS reductions versus 0.3 mg comparator; majority ready for discharge at 90 minutes, supporting the two‑hour, in‑clinic paradigm .
• Breakthrough Therapy designation context: highlights potential to expedite development and review; supports plans to initiate Phase 3 in Q2 2026, subject to FDA alignment .

Q&A Highlights

• A Q3 2025 earnings call transcript was not available in our document search as of Nov 20, 2025; therefore, no Q&A excerpts could be reviewed [No earnings-call-transcript found in search].

Estimates Context

• Revenue beat: $0.75M actual vs $0.05M consensus*; EPS miss: -$0.28 actual vs -$0.12 consensus*, driven largely by a $32.6M non‑cash fair value charge and higher transaction‑related G&A .
• Estimate revisions risk: For modeling, we expect Street EPS to incorporate the non‑cash fair value impact and higher G&A from the Beckley combination and redomiciliation; revenue modeling remains de minimis pre‑commercial.
  Estimates marked with an asterisk are Values retrieved from S&P Global.

Key Takeaways for Investors

• Regulatory de‑risking for BPL‑003: FDA BTD and positive OLE/Phase 2a data sharpen the path to Phase 3 with clear timing milestones (Q1 2026 design guidance; Q2 2026 initiation pending FDA) .
• Balance sheet visibility: ~$150M offering plus ~$114.6M Q3 cash/securities supports operations into 2029, bridging to first Phase 3 topline—a critical risk‑mitigation for development execution .
• Pipeline breadth: EMP‑01 readout (Q1 2026) and VLS‑01 topline (H2 2026) create multiple shots on goal alongside BPL‑003, with non‑hallucinogenic 5‑HT2A/2C programs supported by an NIDA grant .
• Near‑term print risk skew: EPS volatility from non‑cash fair value marks and elevated G&A from integration/redomiciliation can obscure underlying R&D progression; focus on clinical/regulatory catalysts .
• Structural setup: U.S. redomiciliation and the Beckley combination should simplify operations, expand investor access, and consolidate late‑stage assets under the AtaiBeckley banner .
• Trading implications: We expect stock sensitivity to (i) FDA EOP2 feedback and Phase 3 design specifics, (ii) Phase 3 start confirmation, and (iii) on‑time EMP‑01 topline in Q1 2026—each a potential re‑rating or volatility event .

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Additional detail and source references:

• Q3 2025 press release and financials (8‑K Item 2.02 with Exhibit 99.1): operating metrics, net loss drivers, pipeline and financing updates .
• Q2 2025 press release and financials: prior guidance/updates including VLS‑01 delay and combined runway .
• Q1 2025 press release and financials: baseline guidance and pipeline milestones .
• Breakthrough Therapy designation press release (Oct 16, 2025): regulatory validation and implications for BPL‑003 .
• Positive Phase 2b core topline press release (July 1, 2025): efficacy/safety dataset and 90‑minute discharge readiness .