Short answer
Adicet Bio Inc (ACET) filed its fiscal 2017 10-K annual report with the SEC on Mar 29, 2018.
- Top risk flagged: FDA approval risk: RTB101 Phase 2b and subsequent Phase 3 trials required before NDA submission
FY2017 key financial metrics · XBRL
- Net income
- −$34M
- −3377700.0% YoY
- ROE
- 105.8%
- Operating cash flow
- −$11M
Source: XBRL data from the Adicet Bio Inc (ACET) FY2017 10-K on SEC EDGAR. USD.
Adicet Bio Inc FY2017 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biopharmaceutical model focused on TORC1-targeting therapeutics for aging-related diseases, led by RTB101 immunotherapy
- March 2017 Novartis license added worldwide RTB101 rights and RTB101-everolimus combination rights
- Phase 2b RTI trial initiated in 2017, with at least 424 U.S. patients planned after October interim review
- Phase 2a results: infection reductions of 33% with RTB101 and 38% with combination therapy across 264 elderly subjects
- Strategic expansion beyond RTIs toward urinary tract infections, heart failure and neurodegenerative diseases, with at least one Phase 2 study planned for 2018
Management Discussion & Analysis
- Revenue $0, no product sales since inception
- Net loss $33.8M, operating loss $18.9M, other expense $14.9M
- Research and development highest expense at $16.8M, general and administrative expenses $2.0M
- Operating cash used $11.0M, financing cash provided $64.4M, capital expenditures $44,000
- IPO net proceeds $89.4M, funding expected through 2020, additional capital required as clinical risks persist
Risk Factors
- FDA approval risk: RTB101 Phase 2b and subsequent Phase 3 trials required before NDA submission
- UK regulatory uncertainty: Brexit could disrupt product approvals in the United Kingdom and European Union
- Supply vulnerability: Third-party suppliers may fail to provide RTB101 or everolimus ingredients in required quantities
- Competitive disruption: Navitor Pharma targets the same TORC1 mechanism, while Calico and Unity pursue alternative aging pathways
- Funding risk: $33.8 million 2017 net loss and $33.8 million accumulated deficit with no committed additional capital
Generated from the filing text; verify against the original. How to read a 10-K
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