공시 • 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. 공시 • 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 공시 • Mar 25
VivoSim Labs, Inc. Releases Antibody Drug Conjugate Data and Validates NAMkind Models for ADC Toxicity Prediction VivoSim Labs, Inc. announced at the Society of Toxicology (“SOT”) meeting in San Diego, CA, that its NAMkind™ liver and NAMkind™ Intestine models have been validated for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). When considering the hundreds of ADCs in development across the globe, the potential for off-target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the Company believes that the use of NAMkind™ models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. Testing of approved ADC therapies in NAMkind™models shows close correlation with clinical results. VivoSim NAMkind™ liver model was shown to clearly see the toxicity of liver toxic ADCs such as gemtuzumab ozogomicin and clearly showed drugs with low liver toxicity such as enfortumab vedotin as lacking liver toxicity. Issues of linker cleavage and target engagement can be studied, as differential toxicity between drugs like trastuzumab emtansine and trastuzumab deruxtecan were demonstrated with strong comparability to clinical outcomes. NAMkind™ intestine models were also validated with 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. NAMKind™ liver and small intestine toxicology services are now available in the 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. Reported Earnings • Feb 13
Third quarter 2026 earnings released: US$1.03 loss per share (vs US$2.29 loss in 3Q 2025) Third quarter 2026 results: US$1.03 loss per share (improved from US$2.29 loss in 3Q 2025). Net loss: US$2.69m (loss narrowed 22% from 3Q 2025). Over the last 3 years on average, earnings per share has increased by 67% per year but the company’s share price has fallen by 61% per year, which means it is significantly lagging earnings. 공시 • Feb 11
VivoSim to Debut Antibody Drug Conjugate Data, Representing A Major New Market for Namkind Models, At Society of Toxicology Meeting in San Diego VivoSim Labs, Inc. announced it will attend the Society of Toxicology meeting in San Diego, CA that takes place March 22-25 and present new data on its NAMkind liver and NAMkind Intestine model, including data on validating the models for use in predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). Considering the hundreds of ADCs in development across the globe, the potential for off target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the use of NAMkind models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. VivoSim NAMkind models can reveal details of target engagement in organ tissues, premature linker cleavage, biomarker effects and more in complex human cell models that replicate much of the target tissue biology in a controlled experimental setting. Testing of approved ADC therapies in NAMkind models shows close correlation with clinical results. NAMkind models have now been tested against a wide set of marketed ADC molecules, showing close correlation with clinical results in terms of the toxic impact in the liver and side effect profile in the intestine (causing diarrhea). These results will be presented for the first time at SOT in San Diego. 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. 공시 • Jan 07
VivoSim Labs, Inc. Appoints Amar Sethi as Chief Scientific Officer VivoSim Labs, Inc. has appointed Dr. Amar Sethi, M.D., Ph.D. as its Chief Scientific Officer. Dr. Sethi is a transformational R&D executive with three decades of experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation. He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies across metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular biology. His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures, scaling bioanalytical and biomarker teams, and guiding scientific strategy for both early and late-stage assets. At VivoSim, Dr. Sethi will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs) methodologies. He will expand the company’s biomarker and mechanistic insight capabilities, strengthen scientific governance for pharmaceutical sponsors, and collaborate closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems. Dr. Sethi’s career bridges drug-development leadership with biomarker innovation. At Omeros Corp, he led a pivotal global Phase 3 program for a Breakthrough Therapy/Orphan-designated biologic and supported multiple monoclonal antibody programs now approved or advancing into late stages. As President & Chief Medical Officer of Pacific Biomarkers, he drove 70% business growth, led successful M&A initiatives, and developed FDA-qualified novel biomarker platforms, including a gold-standard Acute Kidney Injury panel uniquely qualified by the FDA. His tenure at NIH and Copenhagen University Hospitals further established him as a scientific authority in clinical chemistry, cardiometabolic research, and translational diagnostics. 
