Short answer
Spero Therapeutics Inc (SPRO) filed its Q2 2018 10-Q quarterly report on Aug 9, 2018 for the quarter ended Jun 30, 2018.
Spero Therapeutics Inc Q2 2018 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Grant revenue approximately $0.5 million, versus approximately $0.4 million YoY
- Net loss $10.0 million vs $9.8 million YoY, operating loss $10.0 million vs $10.2 million
- Best program: SPR206 R&D expense $2.3 million, worst: SPR994 expense $1.8 million, down $0.8 million YoY
- Cash, equivalents and marketable securities $66.6 million, July offering net proceeds approximately $70.5 million
- Operating cash use $20.6 million, investing cash use $17.8 million for marketable securities purchases
- Funding runway into second half of 2020, with SPR994 Phase 3 initiation expected around year-end 2018
Risk Factors
- Newly triggered GDPR compliance risk: May 2018 effective date introduced EU data-privacy requirements and fines up to €20 million or 4% of global revenue
- Most materially updated funding risk: July 2018 BARDA award committed $15.7 million over three years, with remaining funding subject to two options
- Regulatory risk: SPR994 Phase 3 relies on Japanese Phase 2 studies not aligned with FDA cUTI guidance, potentially requiring costly delays or additional trials
- Operational risk: Third-party manufacturers supply all preclinical and clinical materials without long-term agreements, creating replacement and interruption risk
- Financial risk: Existing cash, July 2018 equity proceeds and initial BARDA funding expected to support operations into the second half of 2020
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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