Short answer
Spero Therapeutics Inc (SPRO) filed its Q3 2019 10-Q quarterly report on Nov 4, 2019 for the quarter ended Sep 30, 2019.
Spero Therapeutics Inc Q3 2019 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Quarterly revenue $4.6M vs $4.0M, up $0.7M YoY, driven by BARDA funding
- Operating margin -387.3% vs -274.4% YoY, with operating loss $18.0M vs $10.9M
- SPR994 R&D spending $13.0M vs $3.2M, the largest program increase
- Cash, equivalents and marketable securities $93.9M at September 30, 2019
- Operating cash outflow $32.7M, equity proceeds $10.5M, expected funding through Phase 3 readout in third quarter 2020
Risk Factors
- Newly emphasized GDPR exposure: noncompliance fines up to €20 million or 4% of annual global revenues
- Regulatory risk: Phase 3 SPR994 trial relies on Japanese Phase 2 studies with materially different FDA-required designs
- Operational risk: small number of manufacturers and no long-term agreements for clinical supplies
- Market risk: established oral therapies and late-stage UTI competitors could limit SPR994 adoption
- Liquidity risk: existing resources expected to fund operations through pivotal SPR994 Phase 3 top-line readout
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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