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Pre-revenue clinical-stage biotech; minimal debt, primarily equity-financed; near-zero leverage ratio, low interest rate sensitivity

Negligible direct sensitivity; higher rates increase equity dilution cost and VC discount rates, pressuring future fundraising valuations

Low intensity; China and India supply >60% of global API inputs, creating concentration risk.

1) API biologics/Treg cell manufacturing reliant on specialized US/EU CMOs; 2) GMP-grade reagent sourcing potentially exposed to China export controls

No current international revenue; clinical trials US-focused; minimal sovereign currency devaluation exposure at this stage

Primarily US-based operations and trials; no material international revenue markets; currency devaluation exposure effectively zero

Low intensity; commodities: Active Pharmaceutical Ingredients, Rare Earth Elements, Natural Gas (energy), Plastics/Resins, Ethanol, Packaging Materials; geopolitical: China and India supply >60% of global API inputs, creating concentration risk.

High dependency on single or dual contract manufacturing organizations (CMOs) for Treg cell therapy production; limited substitutable alternatives exist

Clinical-stage biopharma; no cloud-dependent revenue operations; 30-day AWS termination would disrupt data/collaboration tools but not core pipeline

Secondary operational risk: loss of bioinformatics and trial data management platforms could delay regulatory submissions by months

Low API coupling risk; primary dependencies are lab informatics tools (e.g., Veeva, Medidata) with manageable switching costs over 3–6 months

Revenue model is drug development/licensing—not a securities offering; Howey Test not applicable to core business operations

Very High

Limited GDPR/CCPA exposure currently; clinical trial patient data governed by HIPAA/ICH-GCP; EU trial expansion would require formal GDPR compliance buildout

Minimal antitrust risk; early-stage niche Treg immunotherapy company with no dominant market position in any commercial segment

Very High burden; regimes: FDA, CMS, HHS, HIPAA, EMA, OIG; Drug pricing legislation and approval delays directly compress revenue visibility.

Zero current revenue; future model expected to be milestone/royalty licensing plus eventual drug sales—predominantly transactional and milestone-based

Anticipated monetization via partnership licensing milestones, royalties, and eventual commercialization of Treg-based therapies for ALS, obesity, and pain

No commercial pricing yet; future drug pricing likely premium orphan/specialty tier ($50K–$200K+ annually), subject to payer negotiation pressure

Moderate-to-high potential pricing power if Treg therapies prove efficacious in orphan indications with limited competition; payer pushback risk remains

Projected commercial gross margins of 70–85% typical for biologics, contingent on CMO cost optimization and manufacturing scale-up

No free-rider leakage applicable; pre-commercial stage with no subscription or open-access product; patient/payer churn relevant only post-launch

Headcount-linear at current stage; R&D and clinical ops scale roughly proportionally with pipeline advancement; limited operational leverage pre-commercialization

Marginal cost of pipeline progression is high and capital-intensive; doubling pipeline programs would approximately double burn rate near-term

Not applicable; Coya Therapeutics does not operate a franchise network

At 10x scale (post-approval), CAC irrelevant in traditional sense; physician adoption and payer formulary access become key unit economic drivers

No meaningful network effects present; drug efficacy value is independent of user base size; no platform or marketplace dynamics

-42.5% Return on Assets (Negative equity)

Moderate resilience; rare/serious disease treatments maintain demand in recessions, but fundraising and partnership deal flow are cyclically sensitive

Biopharma/pharma partners and licensees as B2B customers; eventual end patients with ALS, obesity-related conditions, and chronic pain as clinical beneficiaries

Academic medical centers and KOL neurologists as clinical trial sites and early adopters; NIH/government grant agencies as non-dilutive funding sources

["11-0000 Management Occupations", "13-0000 Business and Financial Operations Occupations", "15-0000 Computer and Mathematical Occupations", "19-0000 Life, Physical, and Social Science Occupations", "21-0000 Community and Social Service Occupations", "23-0000 Legal Occupations", "29-0000 Healthcare Practitioners and Technical Occupations", "31-0000 Healthcare Support Occupations", "41-0000 Sales and Related Occupations", "43-0000 Office and Administrative Support Occupations", "51-0000 Production Occupations"]

0.32 (HIL — ~32% of characteristic roles agent-automatable)

Capital allocated almost entirely to forward-looking R&D and clinical development; no legacy infrastructure drag; typical asset-light outsourced biotech model

0001835022

COYA