Due Diligence Checklists › Biotech › Series A
Biotech Startup Investment Checklist: Series A Stage (2026)
This checklist covers 24 due diligence items for Biotech startups at the Series A 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
Series A Requirements
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$1M+ ARR or strong path within 12 months
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Proven repeatable go-to-market motion
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Net Revenue Retention >100% (expansion > churn)
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Gross margins indicating sustainable unit economics
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Management team capable of scaling to $10M ARR
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Clear competitive differentiation and moat building
Biotech Sector
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Core composition-of-matter patents verified and timeline confirmed
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Scientific advisory board reviewed with commitment letters
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In vivo efficacy data reviewed with expert scientific consultant
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FDA pre-IND meeting completed or scheduled
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CMC: manufacturing pathway documented for clinical quantities
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Freedom-to-operate legal opinion obtained
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Key scientist employment agreements with IP assignment confirmed
Deep Dive
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Scientific advisory board composition and engagement level
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Patent landscape: freedom-to-operate analysis and competitor IP
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Clinical trial design review with scientific expert
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Regulatory strategy: pre-IND meeting notes with FDA if available
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CMC (Chemistry, Manufacturing, and Controls) — manufacturing scalability
Regulatory
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Verify: FDA IND/NDA/BLA pathway: multiple review cycles, advisory committee meetings
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Verify: Clinical trial regulations: GCP compliance, IRB approval, informed consent
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Verify: Drug pricing scrutiny: IRA Medicare price negotiation for high-cost drugs
OSINT Signals
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Check: ClinicalTrials.gov: registered study status and enrollment progress
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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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