Short answer
Adicet Bio Inc (ACET) filed its fiscal 2018 10-K annual report with the SEC on Mar 18, 2019.
- Top risk flagged: FDA approval risk: Phase 2b RTB101 showed a 30.6% RTI reduction only in the 10 mg once-daily cohort
FY2018 key financial metrics · XBRL
- Net income
- −$38M
- −11.4% YoY
- ROE
- -36.1%
- −141.9 pp YoY
- Operating cash flow
- −$36M
- −223.5% YoY
Source: XBRL data from the Adicet Bio Inc (ACET) FY2018 10-K on SEC EDGAR. USD.
Adicet Bio Inc FY2018 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biopharmaceutical model centered on TORC1 inhibition to target aging-related diseases and extend healthy lifespan
- 2018 Phase 2b validation of RTB101 10 mg once daily, reducing laboratory-confirmed RTIs 30.6% in 652 elderly patients
- Strategic narrowing toward Phase 3 immunotherapy trials excluding current smokers and COPD patients after nonresponse in those subgroups
- Planned 2019 expansion: two Phase 3 trials targeting approximately 2,600 subjects across southern and northern hemispheres
- Broader pipeline emphasis on Parkinson’s disease, UTIs, HFpEF, Huntington’s disease and ALS, with a Parkinson’s Phase 1b/2a planned for 2019
Management Discussion & Analysis
- Revenue $0, unchanged YoY, no product sales since inception
- Net loss $37.6M vs $33.8M; operating margin not applicable with no revenue
- Research and development $31.1M vs $16.8M, highest expense category
- Operating cash use $35.5M; IPO proceeds $89.9M, marketable-securities purchases $107.9M
- Cash $108.0M, funding expected through Q2 2020; additional capital required amid clinical and regulatory risk
Risk Factors
- FDA approval risk: Phase 2b RTB101 showed a 30.6% RTI reduction only in the 10 mg once-daily cohort
- Capital risk: $35.5 million operating cash use in 2018, with funding projected only into the second quarter of 2020
- Data-privacy risk: GDPR fines up to 4% of global revenues or €20,000,000
- Competitive risk: Navitor Pharmaceuticals directly targets the TORC1 mechanism
- Supply-chain risk: Third-party suppliers may not provide RTB101 ingredients and packaging in required quantities
Generated from the filing text; verify against the original. How to read a 10-K
Other Adicet Bio Inc annual reports
Ask about this 10-K
Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.