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- **Clinical Momentum:** CYB003 Phase III global expansion (330 pts) and CYB004 Phase II readout (1Q26) highlight late-stage pipeline strength.
- **Financial Strength:** $175M financing secures 2026-2027 liquidity, with 70% allocated to CYB003 execution.
- **Operational Focus:** Real-world clinic workflow design (short sessions, no new infrastructure) and durability (12-month remission data) differentiate psilocin.
- **CEO Search:** Seeking leader with commercialization, big pharma, and capital management expertise.

**【Management Opening Remarks】**
- Leadership transition: Doug Drysdale stepped down as CEO; Eric So serves as Interim CEO during permanent CEO search.
- Strategic focus: Patient-centric care, rigorous science, disciplined execution, and transparent communication.
- Pipeline progress: CYB003 (Phase III for MDD) and CYB004 (Phase II for GAD) advancing with global site activations.
- Recent $175M financing strengthens balance sheet, supporting Phase III execution and manufacturing readiness.

**【CEO Commentary】**
- **CYB003 (MDD):** EMBRACE Phase III study cleared for global启动 in US, UK, EU, and Australia; 330-patient trial with 2 active doses vs. placebo. Design emphasizes real-world clinic workflow (short sessions, staff-light) and durability (12-month remission data from Phase II). APPROACH trial on track for mid-2026 enrollment completion.
- **CYB004 (GAD):** Phase II enrollment completed; IM administration supports efficient clinic throughput. 1Q26 readout will assess 6- and 12-week HAM-A scores, with optional 12-month follow-up.
- Commercial readiness: Thermo Fisher manufacturing partnership ensures reliable supply; Osmind partnership integrates protocols into existing clinic schedules.

**【CFO Commentary】**
- Q2 2025 financials: Operating expenses $28.5M (vs. $18.2M YoY), net loss $33.7M, cash balance $83.8M post-Q2.
- $175M financing (common shares + prefunded warrants) retired $20M High Trail debt with 10% prepayment penalty.
- Capital allocation: 70% for CYB003 (global Phase III, manufacturing), 20% for CYB004 (database lock, analysis), 10% corporate use.
- Liquidity: Funds secure through 2027, with key milestones (CYB004 readout, CYB003 Phase III top line) in 2026.

**【Q&A Highlights】**
- **CYB004 Phase II (GAD):** Seeking directional data (trend in HAM-A improvement) and dose response; 12-week efficacy data to be shared in 1Q26.
- **Durability vs. SPRAVATO:** Agency guidance seeks 12-week durability; Cybin Phase II shows 12-month remission, targeting 3+ months for Phase III.
- **Site Activation (CYB003):** 45 sites onboarded globally; enrollment on track for mid-2026 completion.
- **CYB005 Preclinical:** Ongoing receptor profiling and PK/PD studies; potential neuropsychiatric indications TBD.
- **FDA Safety Database:** No minimum retreatment frequency; data sufficiency will guide NDA submission.
- **CEO Qualities:** Commercialization experience, big pharma partnerships, and capital stewardship.

Cybin Inc. (CYBN) Q2 2026 Earnings Call Transcript

Revenue

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CYBN

CYBN fundamentals

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