VivoSim Labs VIVS

VivoSim Labs, Inc. is a pharmaceutical and biotechnology services company specializing in the development and application of three-dimensional (3D) human tissue models for drug testing and toxicology assessment. The company focuses on providing advanced new approach methodologies (NAM) models, particularly for liver and intestinal toxicology, to pharmaceutical and biotech partners. By leveraging proprietary 3D bioprinting and tissue engineering technologies, VivoSim Labs aims to enhance the predictive accuracy of drug safety evaluations, reducing the risk and cost associated with drug development failures.

VivoSim Labs generates revenue primarily through service-based offerings, including liver and intestinal toxicology screening, investigational toxicology, and mechanism-of-action studies for drug candidates. The company also earns milestone payments from partnered drug development programs, such as the $10.0 million upfront payment and potential $50.0 million in future milestones from the sale of its FXR314 program to Eli Lilly and Company. Additionally, the company may derive income from early-stage internal drug discovery programs and licensing opportunities.

The company operates through the following segments:

• Drug Testing and Toxicology Services: This segment provides predictive screening and research services using 3D human tissue models to assess liver and intestinal toxicity of drug candidates. The platform, NAMkind™, demonstrates an 87.5% sensitivity and 100% specificity in identifying liver-toxic compounds, positioning it as a best-in-class solution for pharmaceutical and biotech companies seeking to mitigate development risks.

• Internal Research and Development: This segment focuses on early-stage drug discovery, target validation, and the evaluation of external drug compounds for potential licensing or internal development. The company continues to explore therapeutic areas such as inflammatory bowel disease (IBD) through its proprietary disease models, though its primary clinical program, FXR314, was divested in March 2025.

VivoSim Labs holds a competitive position in the biotechnology services industry, particularly in the niche of 3D human tissue modeling for drug safety assessment. The company’s proprietary NAMkind™ platform distinguishes itself with industry-leading predictive accuracy, addressing a critical gap in traditional preclinical testing methods. Key competitors include companies like BICO Group AB, which operates in the broader 3D bioprinting and bioengineering space. VivoSim Labs’ intellectual property portfolio, comprising over 160 patents and pending applications worldwide, provides a significant barrier to entry and reinforces its technological leadership. The recent FDA announcement favoring non-animal testing methods further strengthens the company’s market opportunity, as demand for human-relevant tissue models is expected to accelerate.

VivoSim Labs serves pharmaceutical and biotechnology companies at all stages of drug development, from early discovery to late-stage clinical trials. The company’s services are particularly valuable to clients seeking to identify liver toxicity and intestinal side effects before advancing candidates into costly clinical phases. While specific customer names are not disclosed, the company’s target market includes large pharmaceutical firms, mid-sized biotech companies, and academic research institutions engaged in drug development and toxicology studies.