Short answer
Spero Therapeutics Inc (SPRO) filed its fiscal 2018 10-K annual report with the SEC on Mar 14, 2019. It reported revenue of $4M (+100.4% year over year) and net income of −$42M.
- Top risk flagged: FDA approval risk: SPR994 Phase 2 Japanese studies lacked randomization, comparator arms and FDA-aligned cUTI endpoints
FY2018 key financial metrics · XBRL
- Revenue
- $4M
- +100.4% YoY
- Net income
- −$42M
- −7.5% YoY
- Operating margin
- -1079.3%
- +1029.3 pp YoY
- ROE
- -36.1%
- +9.7 pp YoY
- Operating cash flow
- −$40M
- −1.3% YoY
Source: XBRL data from the Spero Therapeutics Inc (SPRO) FY2018 10-K on SEC EDGAR. USD.
Spero Therapeutics Inc FY2018 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage antibiotic company targeting MDR bacterial infections, centered on oral, hospital, and orphan-disease therapies
- SPR206 advanced into Phase 1 in December 2018, while SPR720 entered Phase 1 in January 2019 for pulmonary NTM infections
- SPR994 moved toward a single pivotal Phase 3 cUTI trial at 600 mg TID after positive Phase 1 results and FDA guidance
- Everest license expanded SPR206 reach into Greater China, South Korea, and Southeast Asia, with $3.0 million upfront and up to $59.5 million milestones
- Pipeline supported by up to $25.2 million committed non-dilutive funding, potentially reaching $54.3 million with options exercised
Management Discussion & Analysis
- Grant revenue $3.97M, up $1.99M YoY, with no product sales revenue
- Net loss $41.66M vs $39.89M, operating loss $42.81M vs $41.73M
- Best program SPR994 R&D spend $11.41M, worst Potentiator Platform spend $8.27M vs $11.82M
- Operating cash use $39.63M, investing cash use $83.16M, financing cash provided $69.52M
- Cash, equivalents and securities $115.4M, funding expected into second half of 2020, with additional capital required thereafter
Risk Factors
- FDA approval risk: SPR994 Phase 2 Japanese studies lacked randomization, comparator arms and FDA-aligned cUTI endpoints
- Government funding exposure: BARDA award provides $15.7 million base funding through June 30, 2021, with additional options
- Manufacturing vulnerability: small number of third-party manufacturers supply all preclinical and clinical materials without long-term agreements
- Competitive disruption: oral UTI candidates C-Scape, sulopenem and omadacycline could reach market before SPR994
- Financial risk: $41.7 million 2018 net loss with cash resources projected only through the second half of 2020
Generated from the filing text; verify against the original. How to read a 10-K
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