Announcement • 3h
Vivosim Labs Demonstrates Superiority of Ai-Enabled Namkind Liver and Intestine Platforms in Liver Toxicity Prediction At European Toxicology Meeting VivoSim Labs, Inc. announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind Liver and NAMkind GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50% to 65% sensitivity, VivoSim’s models provided greater than 90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in greater than 10% false positives, VivoSim’s liver toxicology methods result in fewer than 5% false positives. The United States Food and Drug Administration is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. The company has done extensive testing of Antibody Drug Conjugates (ADCs), with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. The findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan. Announcement • Apr 30
VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal Models VivoSim Labs, Inc. had announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense. The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. VitroSense – the use of NAMkind-produced data to train predictive machine learning models. NAMkind intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing. Because of the advanced nature of the NAMkind intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer. As recently demonstrated at Society of Toxicology, NAMkind intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates. NAMKind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs. Announcement • Mar 28
VivoSim Labs, Inc. has filed a Follow-on Equity Offering. VivoSim Labs, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,366,862
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,550,293 
