VivoSim Labs Inc Dossier
Qualitative Analysis
Business overview
VivoSim Labs, INC. (NASDAQ: VIVS), formerly known as Organovo Holdings, Inc. until its rebranding in April 2025, is a San Diego-based biotechnology and pharmaceutical services company specializing in New Approach Methodologies (NAMs). The company develops and commercializes three-dimensional (3D) human tissue models, specifically its proprietary NAMkind™ liver and intestinal platforms, to provide human-relevant safety, efficacy, and toxicology insights. These models utilize primary human cells to create micro-organoids that emulate native human biology, helping pharmaceutical partners evaluate drug candidates and bypass cross-species translation issues before clinical trials. Alongside its preclinical toxicology services, VivoSim continues to advance its lead clinical drug candidate, FXR314, which is in Phase 2/3 development for inflammatory bowel disease (IBD), specifically ulcerative colitis.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Development and availability of an AI prediction tool leveraging NAMkind™ intestinal models to accurately predict the potential of drug compounds to cause diarrhea in patients. The tool integrates proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity.
Expected impact: Attained a predictive accuracy of 96% for potential diarrhea using a training set of dozens of compounds, offering clients high-quality real-world 3D NAM assay results.
Validation of NAMkind™ liver and NAMkind™ intestine models for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs), representing a major new market segment.
Expected impact: Expands the addressable market to biopharma clients developing complex ADC therapies.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Expands VivoSim's footprint and access to the fast-evolving pharmaceutical landscape in South Korea, providing biotechnology organizations with faster access to advanced, human-relevant safety screening.
Terms: Not disclosed
Secures distribution and market access in China, targeting accelerated growth in the human-based toxicology market in the Asia-Pacific region.
Terms: Not disclosed
Eli Lilly acquired Organovo's (now VivoSim's) FXR program, including lead clinical candidate FXR314. VivoSim retains significant financial upside through future development, regulatory, and commercial milestones.
Terms: $10.0 million upfront cash payment ($9.0 million paid at closing, $1.0 million held in escrow for 15 months) plus up to $50.0 million in aggregate future milestone payments.