Biotech · Series B Stage Due Diligence

Biotech Series B Due Diligence Checklist

The complete Series B due diligence checklist for Biotech startups. Prepare your data room, anticipate every investor request, and close your round faster.

All Checklists

6–12 weeks

Typical DD Timeline

5

DD Categories Covered

50+

Checklist Items Total

Biotech Regulatory DD Context

Biotech DD includes deep scientific review. Investors will engage independent scientific advisors to review your pre-clinical and clinical data. Have your complete data package ready in a secure data room.

Data Room Essentials for Series B

Documents to have ready before DD begins

  • 3 years of audited financial statements
  • Full customer list with contract terms and renewal dates
  • Complete IP portfolio with FTO opinion
  • All board materials and resolutions
  • Material subsidiary documentation
  • Insurance policies (D&O, E&O, cyber)
  • All government filings and regulatory correspondence

LEGALLegal Due Diligence

Institutional-grade legal DD covering corporate governance, regulatory risk, key contract change-of-control provisions, and cross-border compliance. Full rep and warranty review.

General Legal Items

  • Certificate of Incorporation and all amendments
  • Bylaws and any shareholder agreements
  • Cap table with fully diluted ownership by class
  • All convertible instruments (SAFEs, notes, warrants)
  • Option pool documentation and all grants
  • Founder IP assignment agreements
  • Co-founder agreements and vesting schedules
  • Material third-party agreements

Biotech-Specific Legal Items

  • Patent portfolio (granted and pending) with expiration dates
  • Freedom-to-operate (FTO) opinion from IP counsel
  • Licensing agreements (in-licensed and out-licensed IP)
  • Material transfer agreements (MTAs)
  • Clinical trial agreements and IRB approvals

FINANCIALFinancial Due Diligence

Audited financial statements (typically required). Revenue quality review by Big 4 accounting firm. Deep customer cohort and retention analysis. Cap table fully modeled through exit scenarios.

General Financial Items

  • Financial statements (P&L, balance sheet, cash flow)
  • Bank statements (12+ months)
  • Accounts receivable aging report
  • Accounts payable aging report
  • Payroll records and headcount history
  • Revenue recognition policy documentation
  • Tax returns and any outstanding tax obligations
  • Insurance policies (D&O, E&O, general liability)

Biotech-Specific Financial Items

  • Milestone-based funding schedule and triggers
  • R&D burn by program and project
  • Government grant and SBIR/STTR funding history
  • Collaboration revenue recognition methodology
  • Manufacturing cost of goods at scale (COGS projection)

PRODUCTProduct and Technical Due Diligence

  • Clinical trial protocol and amendment history
  • IND application and FDA correspondence
  • Pre-clinical data package completeness
  • CMO qualification and manufacturing readiness
  • Clinical hold risk assessment

MARKETMarket Due Diligence

  • Comparable drug approval timelines and outcomes
  • Reimbursement landscape analysis (payer coverage by indication)
  • Key opinion leader (KOL) relationships and advisory board credentials
  • Competitive landscape by indication and mechanism of action

TEAMTeam Due Diligence

Executive team professional background investigations. Non-compete and non-solicitation enforceability analysis. Board composition governance review.

  • LinkedIn profiles for all founders and officers
  • Employment agreements for key personnel
  • Equity grant history and vesting schedules
  • Any prior employer IP invention disclosure forms
  • Non-compete and non-solicitation agreements
  • Professional reference contacts (3+ per founder)
  • Advisory board agreements and equity grants
  • Organizational chart as of current date

Frequently Asked Questions

How long does Series B due diligence typically take for Biotech startups?

Biotech Series B due diligence typically takes 6–12 weeks. Institutional-grade legal DD covering corporate governance, regulatory risk, key contract change-of-control provisions, and cross-border compliance. Full rep and warranty review. Having a complete data room ready before DD kicks off can reduce this timeline by 30–50%.

What Biotech-specific items do investors review during Series B DD?

For Biotech at the Series B stage, investors focus heavily on: Patent portfolio (granted and pending) with expiration dates, Freedom-to-operate (FTO) opinion from IP counsel, and Milestone-based funding schedule and triggers, R&D burn by program and project. Biotech DD includes deep scientific review. Investors will engage independent scientific advisors to review your pre-clinical and clinical data. Have your complete data package ready in a secure data room.

What should I put in my data room?

Your Series B data room should include: 3 years of audited financial statements; Full customer list with contract terms and renewal dates; Complete IP portfolio with FTO opinion; All board materials and resolutions; Material subsidiary documentation; Insurance policies (D&O, E&O, cyber); All government filings and regulatory correspondence. Use a structured folder system that mirrors investor expectations — most institutional investors use a standard folder taxonomy.

What are the most common due diligence deal-killers?

The five most common DD deal-killers are: (1) undisclosed founder litigation or criminal history, (2) IP ownership gaps — particularly for university-origin technology, (3) customer contract terms that prevent assignment on change of control, (4) cap table math errors or undocumented equity grants, and (5) financial restatements required after revenue recognition review.

What team due diligence should I expect at the Series B stage?

Executive team professional background investigations. Non-compete and non-solicitation enforceability analysis. Board composition governance review.

Download the Full Checklist

Get the Biotech Series B due diligence checklist as a Google Sheets or Notion template. Track completion status for every item in your data room.

Includes data room folder template, investor question tracker, and reference FAQ guide

Other Biotech Stages