Short answer
Spero Therapeutics Inc (SPRO) filed its Q3 2017 10-Q quarterly report on Dec 14, 2017 for the quarter ended Sep 30, 2017.
Spero Therapeutics Inc Q3 2017 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Quarterly revenue $0.5M, versus $0 in Q3 2016, primarily CARB-X, DoD and NIAID reimbursements
- Operating margin not disclosed, operating loss $10.0M versus $7.9M YoY
- SPR994 largest R&D program at $1.8M, SPR741 $2.4M
- Cash $25.4M, operating cash use $26.4M for nine months, IPO net proceeds $77.7M
- Funding expected through Q2 2019, but insufficient for SPR994 Phase 3 and additional capital required
Risk Factors
- Newly triggered regulatory risk: December 2016 Cures Act and August 2017 FDA antibacterial guidance create uncertainty over SPR994 development requirements
- Most materially updated clinical risk: SPR994 Phase 3 plan relies on Japanese Phase 2 trials not aligned with FDA cUTI guidance
- Government funding risk: CARB-X and NIAID may terminate awards, with future funding beyond base periods discretionary
- Near-term operational risk: competitor trials may slow enrollment for planned SPR994 and SPR741 studies
- Liquidity risk: net loss $26.0 million for nine months ended September 30, 2017, with funding projected into second quarter 2019
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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