Capital Exhaustion
Biotech downturns and strategic reprioritizations force sponsors to mothball viable Phase 1/2 assets as balance sheets deplete ahead of pivotal trial readouts.
Runway Clinical Intelligence correlates real-time clinical trial velocity with SEC financial burn to identify mispriced, stalled biopharma assets. Through automated PK/PD mathematical reconstruction, we confirm viable drug biology, acquire programs into liability-isolated Single-Asset Vehicles (SAVs), and execute capital-efficient clinical turnarounds.
- 21 CFR Part 11
- Audit Trail Integrity
- Delaware C-Corp
- Ring-Fenced SAVs
- Continuous SEC
- CIK Burn Surveillance
14-Day SAB Workbench Preview High Salvage Potential
Pharmacometric Target MetricSteady-State Occupancy >= 85%
Observed Trough Exposure (Ctrough)Target Saturation Maintained
Algorithmic Triage Verdict
REGIMEN_FAILURE (Salvageable)
Primary endpoint missed due to sub-optimal dosing intervals rather than target invalidation. Candidate for SAV acquisition and revised clinical schedule.
- Corporate Recourse
- $0 Parent Liability
- Tranche Financing
- Milestone-Gated
The Macro Disconnect
Clinical Programs are Frequently Abandoned for Operational, Not Biological, Reasons
Regimen vs. Biology Failure
A notable proportion of early trial failures result from faulty dosing intervals, narrow exposure windows, or inadequate PK/PD modeling rather than defective target biology.
Valuation Arbitrage
Runway acquires historical R&D at conservative initial entry valuations, structuring payouts via contingent clinical milestones and protecting syndicate downside.
The Complete Operating Model
From Algorithmic Triage to Acquisition and Commercial Exit
STAGE 01
Continuous Surveillance
Ingests global trial registries and SEC filings (10-K, 10-Q, 8-K) to flag trial velocity deceleration and corporate burn rate divergences before public announcements.
- Registry Velocity Tracking
- Cash‑Zero Date Modeling
- Corporate Debt Stack Audit
STAGE 02
14‑Day SAB Diligence
Evaluates raw CSR tables through our strict pharmacometric engine. Confirms target saturation and determines whether failure was biological or schedule-driven.
- PK/PD Mathematical Model
- CMC Stability Review
- FTO Exclusivity Audit
STAGE 03
The SAV Acquisition
Assets are acquired into isolated Delaware Single-Asset Vehicles (SAVs). Acquired via 90-day option windows and structured via 50% Cash / 50% SAV Equity to align sellers.
- Complete Parent Liability Ring‑Fence
- Milestone‑Gated Earn‑Outs
- Anti‑Stacking Covenants
STAGE 04
Execution & Out‑Licensing
The SAV conducts targeted formulation work or Phase 1b/2 bridging studies. Once de-risked, the asset is out-licensed or acquired by commercial pharmaceutical partners.
- Phase 1b/2 Proof‑of‑Concept
- Global Pharma Out‑Licensing
- 80%‑90% Net Syndicate Payout
Capital Architecture
The Single-Asset Vehicle (SAV) Waterfall Simulator
Model how Runway aligns capital, isolates corporate operational liability, and distributes downstream out-licensing proceeds.
Model Parameters
Conserves initial vehicle liquidity by issuing preferred equity in the SAV to the original sponsor.
Defines the seller’s agreed cut of downstream licensing proceeds, superseding prior milestone claims.
Target share of syndicate capital dedicated directly to bridging trial and CMC operations.
Capital & Proceeds Waterfall
SAV Syndicate & Platform Distribution85%
Net cash returned to outside investors, co-syndicates, and the platform upon execution of a major out-license or acquisition.
Original Seller Sublicense Allocation15%
Contractual pass-through percentage extinguishing all unaccrued historical milestone claims.
PARENT COMPANY RECOURSEQuarantined to Asset Vehicle
$0 Parent LiabilityOperational Playbook
Post-Acquisition De-Risking & Clinical Execution
MILESTONE 01
Regulatory Protocol Realignment
Filing amended IND protocols and safety updates with the FDA/EMA, establishing optimized dosing schedules (e.g., Q2W to weekly QW).
MILESTONE 02
Targeted CMC & Stability
Executing drug substance (DS) and drug product (DP) inventory audits, qualification batches, and real-time release assays with partner CDMOs.
MILESTONE 03
Phase 1b/2 Proof‑of‑Concept
Running lean clinical bridging cohorts to demonstrate therapeutic coverage and clear primary efficacy biomarker endpoints.
MILESTONE 04
Global Pharma Out‑Licensing
Partnering de-risked assets with commercial-stage biopharma organizations, generating upfront fees, milestones, and running net sales royalties.
Institutional Rigor
Governed for High-Stakes Clinical Diligence
Every triage recommendation and diligence decision generated on the Runway platform operates under strict regulatory controls, formal electronic signature verifications, and complete legal separation between software and asset operations.
21 CFR Part 11
Cryptographic audit trails and formal review sign-off ceremonies.
Delaware SAV Ring-Fence
Clinical risks and operational vendor payables isolated by entity.
GCP / ICH Compliance
Institutional data handling protocols for clinical trial evaluation.
Anti-Stacking IP Covenants
Standardized contractual protection against third-party royalty claims.
21 CFR Part 11
Electronic Records & Signatures
HIPAA / HITECH
Security Standards
SOC 2 Type II
Alignment
Partner with Runway Clinical Intelligence
Whether evaluating co-investment into active Single-Asset Vehicles, exploring strategic advisory alignment, or submitting a shelved biopharma asset for triage, reach out directly to our executive team.