Short answer
Adicet Bio Inc (ACET) filed its Q2 2018 10-Q quarterly report on Aug 9, 2018 for the quarter ended Jun 30, 2018.
Adicet Bio Inc Q2 2018 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Revenue $0, unchanged YoY, no product sales or collaboration revenue
- Net loss $13.6M vs $4.1M YoY, operating expenses $14.1M vs $4.1M
- RTB101 strongest program: 10 mg reduced laboratory-confirmed RTIs significantly, combination arm missed endpoint
- Cash, equivalents and securities $125.9M, IPO proceeds $89.4M
- Operating cash use $17.1M, investing use $74.8M, financing provided $89.9M
- Cash expected to fund operations through 2020, with additional financing required and clinical-development risks remaining
Risk Factors
- Newly added clinical-development risk: Phase 2b activity varied by cohort, with 30.6% fewer RTIs only at RTB101 10 mg once daily
- Most material efficacy change: no RTI reduction in 10 mg twice-daily or combination cohorts, weakening broad efficacy support
- Regulatory risk: FDA may require additional toxicity and metabolism studies before NDA submission
- Safety risk: 4.5% of once-daily subjects had serious adverse events, and 4.5% discontinued for adverse events
- Operational risk: CRO or collaborator failures to meet GCP requirements could delay trials and increase costs
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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