Short answer
Assembly Biosciences Inc (ASMB) filed its fiscal 2016 10-K annual report with the SEC on Mar 2, 2017. It reported revenue of $0 and net income of −$44M.
- Top risk flagged: FDA approval risk for ABI-H0731 and ABI-M101: both remained pre-commercial, with Phase 1b trials planned for 2017
FY2016 key financial metrics · XBRL
- Revenue
- $0
- Net income
- −$44M
- ROE
- -55.4%
- Operating cash flow
- −$35M
Source: XBRL data from the Assembly Biosciences Inc (ASMB) FY2016 10-K on SEC EDGAR. USD.
Assembly Biosciences Inc FY2016 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biotech focused on oral HBV-cure therapeutics and synthetic live biotherapeutics restoring dysbiotic microbiomes
- ABI-H0731 completed Phase 1a, with Phase 1b/2a planned for Q2 2017; ABI-M101 IND-enabling studies targeted for 2017
- Strategic shift toward partnered microbiome development: Allergan collaboration covering up to six indications
- R&D spending doubled to $30.1M from $15.1M, with $20.0M allocated to HBV and $10.0M to Microbiome
- Allergan agreement added $50M upfront, up to approximately $2.78B in milestones, and tiered royalties in early 2017
Management Discussion & Analysis
- Revenue $0, unchanged, no approved products or product sales
- Net loss approximately $44.3M, accumulated deficit approximately $208.2M
- HBV best-performing program: R&D expense $20.0M vs $10.8M; Diltiazem lowest at $0
- Operating cash use $34.9M; investing provided $36.2M from $44.3M securities redemption
- Outlook: substantial losses and funding needs, Phase 1b/2a ABI-H0731 trial planned for Q2 2017
Risk Factors
- FDA approval risk for ABI-H0731 and ABI-M101: both remained pre-commercial, with Phase 1b trials planned for 2017
- International exposure: planned China operations faced weaker intellectual-property enforcement and counterfeit-pharmaceutical risks
- Manufacturing vulnerability: no internal facilities, with third parties supplying ABI-H0731 and ABI-M101 clinical materials
- Competitive disruption: emerging HBV, CDI, UC, IBS and IBD therapies could make candidates obsolete or non-competitive
- Funding risk: accumulated deficit $208.2 million and 2016 net loss $44.2 million required additional capital
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