Due Diligence Checklists › Biotech › Growth / Pre-IPO
Biotech Startup Investment Checklist: Growth / Pre-IPO Stage (2026)
This checklist covers 24 due diligence items for Biotech startups at the Growth / Pre-IPO stage. Each item has been validated against institutional investor practice. DDR automates the majority of these checks from a single pitch deck PDF upload.
24 checklist items · 3 red flags automatically detected · See a sample DDR report
Growth / Pre-IPO Requirements
✓
$10M+ ARR with clear path to $100M+
✓
Profitability or credible path to profitability within 24 months
✓
Category leadership: top 1–2 in defined market
✓
CFO and board ready for public market scrutiny
✓
Revenue quality: multi-year contracts, low churn, high NRR
✓
Institutional governance: audit committee, independent board majority
Biotech Sector
✓
Core composition-of-matter patents verified and timeline confirmed
✓
Scientific advisory board reviewed with commitment letters
✓
In vivo efficacy data reviewed with expert scientific consultant
✓
FDA pre-IND meeting completed or scheduled
✓
CMC: manufacturing pathway documented for clinical quantities
✓
Freedom-to-operate legal opinion obtained
✓
Key scientist employment agreements with IP assignment confirmed
Deep Dive
✓
Scientific advisory board composition and engagement level
✓
Patent landscape: freedom-to-operate analysis and competitor IP
✓
Clinical trial design review with scientific expert
✓
Regulatory strategy: pre-IND meeting notes with FDA if available
✓
CMC (Chemistry, Manufacturing, and Controls) — manufacturing scalability
Regulatory
✓
Verify: FDA IND/NDA/BLA pathway: multiple review cycles, advisory committee meetings
✓
Verify: Clinical trial regulations: GCP compliance, IRB approval, informed consent
✓
Verify: Drug pricing scrutiny: IRA Medicare price negotiation for high-cost drugs
OSINT Signals
✓
Check: ClinicalTrials.gov: registered study status and enrollment progress
✓
Check: PubMed: peer-reviewed publications from founding team
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Check: USPTO patent database: core composition-of-matter patents
DDR AUTOMATES THIS CHECKLIST
Upload a Biotech startup pitch deck and DDR automatically completes 17+ of these 24 checklist items — sourcing data from 13 OSINT signals, benchmarking against 2 comparable companies, and detecting all 3 critical red flags.
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