{"success":true,"data":{"pressRelease":{"id":"175495","rtpr_id":"nGNX4JnjpL-20261021","ticker":"VIVS","exchange":"NASDAQ","all_tickers":["VIVS"],"title":"VivoSim Labs Extends NAMkind Platform with Human Disease Models for Efficacy Testing and Mechanistic Biomarker Profiling","author":"Globe Newswire","published_at":"2026-10-21T12:05:00.120Z","article_body":"SAN DIEGO, Oct. 21, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS)\n(the “Company” or “VivoSim”), a provider of next-generation New\nApproach Methodologies (NAM) 3d human cellular models for preclinical safety\nand efficacy, today announced that it is extending its human tissue platform\nbeyond toxicology, the core of its business today, with efficacy testing\nservices built on NAMkind™ disease models of the liver and intestine. The\ndisease models are built with cells from patient donors, so they carry\nfeatures of the disease itself. Drug developers can measure whether a\ncandidate acts on those disease features in human tissue before it enters\nclinical trials. VivoSim offers efficacy testing alongside toxicology on its\nliver and gastrointestinal (GI) models.\n\nThe move builds on demonstrated disease model excellence already demonstrated.\nIts intestinal efficacy platform, built in part from cells of patients with\nulcerative colitis or Crohn’s disease, received a “Poster of\nDistinction” award at Digestive Disease Week in May 2025, in work showing\nthat the platform responds to clinically used therapeutics. VivoSim has also\nused its human disease models to identify new molecular targets that drive\ninflammatory bowel disease (IBD) and to explore how known drugs act.\n\nLack of efficacy is the most common reason drug candidates fail in clinical\ntrials. In an analysis of more than 28,000 clinical trials stopped before\nreaching their endpoints, more than twice as many were stopped for negative\nresults or lack of efficacy as for safety (Razuvayevskaya et al., Nature\nGenetics, 2024).\n\n“Toxicology is the core of our business today, and it will remain a core\nservice,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our\ncustomers often need help with whether a candidate is likely to work, because\nthat is where many drugs fall short in the clinic. Disease models let us\naddress that question on the same human tissue platform we already use for\nsafety, but leveraging patient-derived diseased cell sources so a customer can\nlearn more before committing a program to clinical trials. We believe disease\nmodels could more than double our addressable market.”\n\nNAMkind™ Disease Models\n* Liver (MASH): The NAMkind™ MASH disease model co-cultures healthy human\nliver cells with stellate, Kupffer, and endothelial cells from a donor with\nmetabolic dysfunction-associated steatohepatitis (MASH), producing steatotic\ntissue with fibrosis. Compounds are dosed repeatedly over 14 or 21 days, with\nreadouts for fibrosis and liver function. Cell-health markers measured in the\nsame study separate an anti-fibrotic effect from cell damage.\n* Intestine (IBD): The NAMkind™ IBD disease model is built from colon and\nsmall-intestine organoids derived from donors with ulcerative colitis and\nCrohn’s disease, with twelve donors currently available. It measures barrier\nintegrity, inflammation, and fibrosis in the same well and reports results\ndonor by donor. A healthy tissue comparator arm is available.\n* Pharmacodynamic (PD) & Target Biomarker Profiling: The platform evaluates\ntarget engagement, gene expression panels, cytokine profiling, extracellular\nmatrix turnover markers, and other relevant biomarkers across donor tissues,\nenabling sponsors to map mechanism-of-action and dose-response relationships\nalongside functional efficacy readouts.\nIn both models, each study runs the client’s compound alongside an approved\nor clinically validated reference compound in the same donor tissue, such as\nresmetirom in the MASH model or tofacitinib or upadacitinib in the IBD model.\nIn results VivoSim has published for the IBD model, JAK inhibitors that look\nalike on paper had different effects on fibrosis, barrier function and\ninflammation, and methotrexate, a clinically used anti-inflammatory, reduced a\nfibrosis marker in a dose-dependent way in both Crohn’s patient models\ntested.\n\n“By leveraging patient-derived donor tissues, our disease platforms preserve\nthe complex multiomic signatures and heterogeneous phenotypes seen in\nreal-world clinical populations,” said Amar Sethi, M.D., Ph.D., Chief\nScientific Officer of VivoSim Labs. “Crucially, we can now evaluate\ncandidate compounds not only for primary disease endpoints like fibrosis and\nbarrier repair, but also for target-specific pharmacodynamic biomarkers. This\ndual capability allows drug developers to confirm both functional human\nefficacy and underlying drug mechanism on the exact same platform before\nentering clinical trials.”\n\nAbout VivoSim Labs\n\nVivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical\nand biotechnology services company that is focused on providing testing of\ndrugs and drug candidates in three-dimensional (“3D”) human tissue models\nof liver and intestine. The Company offers partners liver and intestinal\ntoxicology insights using its new approach methodologies (“NAM”) models.\nThe Company anticipates accelerated adoption of human tissue models following\nthe U.S. Food and Drug Administration (“FDA”) Roadmap to refine animal\ntesting requirements in favor of these non-animal NAM methods. VivoSim Labs\noperates from San Diego, CA. Visit www.vivosim.ai.\n\nForward-Looking Statements\n\nAny statements contained in this press release that do not describe historical\nfacts constitute forward-looking statements as that term is defined in the\nPrivate Securities Litigation Reform Act of 1995. Any forward-looking\nstatements contained herein are based on current expectations but are subject\nto a number of risks and uncertainties. Forward-looking statements include\nstatements regarding the Company’s cash on hand, revenue growth guidance and\nthe Company’s progress in marketing contract research services using NAMs\nmodels to pharmaceutical companies. Such forward-looking statements are not\nguarantees of performance and actual actions or events could differ materially\nfrom those contained in such statements. These risks and uncertainties and\nother factors are identified and described in more detail in the Company’s\nfilings with the SEC, including its Annual Report on Form 10-K filed with\nthe SEC on July 14, 2026, as such risk factors are updated in its most\nrecently filed Quarterly Report on Form 10-Q filed with the SEC on August\n12, 2026. You should not place undue reliance on these forward-looking\nstatements, which speak only as of the date that they were made. These\ncautionary statements should be considered with any written or oral\nforward-looking statements that the Company may issue in the future. Except as\nrequired by applicable law, including the securities laws of the United\nStates, the Company does not intend to update any of the forward-looking\nstatements to conform these statements to reflect actual results, later\nevents, or circumstances or to reflect the occurrence of unanticipated\nevents. \n\nContact(s):\nInvestor Relations\ninfo@vivosim.ai\nVivoSim Labs, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/636bff82-374b-4c96-8194-5345983eb76a)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4JnjpL-20261021","title":"VivoSim Labs Extends NAMkind Platform with Human Disease Models for Efficacy Testing and Mechanistic Biomarker Profiling","author":"Globe Newswire","ticker":"VIVS","created":"2026-10-21T12:05:00.120Z","tickers":["VIVS"],"exchange":"NASDAQ","article_body":"SAN DIEGO, Oct. 21, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS)\n(the “Company” or “VivoSim”), a provider of next-generation New\nApproach Methodologies (NAM) 3d human cellular models for preclinical safety\nand efficacy, today announced that it is extending its human tissue platform\nbeyond toxicology, the core of its business today, with efficacy testing\nservices built on NAMkind™ disease models of the liver and intestine. The\ndisease models are built with cells from patient donors, so they carry\nfeatures of the disease itself. Drug developers can measure whether a\ncandidate acts on those disease features in human tissue before it enters\nclinical trials. VivoSim offers efficacy testing alongside toxicology on its\nliver and gastrointestinal (GI) models.\n\nThe move builds on demonstrated disease model excellence already demonstrated.\nIts intestinal efficacy platform, built in part from cells of patients with\nulcerative colitis or Crohn’s disease, received a “Poster of\nDistinction” award at Digestive Disease Week in May 2025, in work showing\nthat the platform responds to clinically used therapeutics. VivoSim has also\nused its human disease models to identify new molecular targets that drive\ninflammatory bowel disease (IBD) and to explore how known drugs act.\n\nLack of efficacy is the most common reason drug candidates fail in clinical\ntrials. In an analysis of more than 28,000 clinical trials stopped before\nreaching their endpoints, more than twice as many were stopped for negative\nresults or lack of efficacy as for safety (Razuvayevskaya et al., Nature\nGenetics, 2024).\n\n“Toxicology is the core of our business today, and it will remain a core\nservice,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our\ncustomers often need help with whether a candidate is likely to work, because\nthat is where many drugs fall short in the clinic. Disease models let us\naddress that question on the same human tissue platform we already use for\nsafety, but leveraging patient-derived diseased cell sources so a customer can\nlearn more before committing a program to clinical trials. We believe disease\nmodels could more than double our addressable market.”\n\nNAMkind™ Disease Models\n* Liver (MASH): The NAMkind™ MASH disease model co-cultures healthy human\nliver cells with stellate, Kupffer, and endothelial cells from a donor with\nmetabolic dysfunction-associated steatohepatitis (MASH), producing steatotic\ntissue with fibrosis. Compounds are dosed repeatedly over 14 or 21 days, with\nreadouts for fibrosis and liver function. Cell-health markers measured in the\nsame study separate an anti-fibrotic effect from cell damage.\n* Intestine (IBD): The NAMkind™ IBD disease model is built from colon and\nsmall-intestine organoids derived from donors with ulcerative colitis and\nCrohn’s disease, with twelve donors currently available. It measures barrier\nintegrity, inflammation, and fibrosis in the same well and reports results\ndonor by donor. A healthy tissue comparator arm is available.\n* Pharmacodynamic (PD) & Target Biomarker Profiling: The platform evaluates\ntarget engagement, gene expression panels, cytokine profiling, extracellular\nmatrix turnover markers, and other relevant biomarkers across donor tissues,\nenabling sponsors to map mechanism-of-action and dose-response relationships\nalongside functional efficacy readouts.\nIn both models, each study runs the client’s compound alongside an approved\nor clinically validated reference compound in the same donor tissue, such as\nresmetirom in the MASH model or tofacitinib or upadacitinib in the IBD model.\nIn results VivoSim has published for the IBD model, JAK inhibitors that look\nalike on paper had different effects on fibrosis, barrier function and\ninflammation, and methotrexate, a clinically used anti-inflammatory, reduced a\nfibrosis marker in a dose-dependent way in both Crohn’s patient models\ntested.\n\n“By leveraging patient-derived donor tissues, our disease platforms preserve\nthe complex multiomic signatures and heterogeneous phenotypes seen in\nreal-world clinical populations,” said Amar Sethi, M.D., Ph.D., Chief\nScientific Officer of VivoSim Labs. “Crucially, we can now evaluate\ncandidate compounds not only for primary disease endpoints like fibrosis and\nbarrier repair, but also for target-specific pharmacodynamic biomarkers. This\ndual capability allows drug developers to confirm both functional human\nefficacy and underlying drug mechanism on the exact same platform before\nentering clinical trials.”\n\nAbout VivoSim Labs\n\nVivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical\nand biotechnology services company that is focused on providing testing of\ndrugs and drug candidates in three-dimensional (“3D”) human tissue models\nof liver and intestine. The Company offers partners liver and intestinal\ntoxicology insights using its new approach methodologies (“NAM”) models.\nThe Company anticipates accelerated adoption of human tissue models following\nthe U.S. Food and Drug Administration (“FDA”) Roadmap to refine animal\ntesting requirements in favor of these non-animal NAM methods. VivoSim Labs\noperates from San Diego, CA. Visit www.vivosim.ai.\n\nForward-Looking Statements\n\nAny statements contained in this press release that do not describe historical\nfacts constitute forward-looking statements as that term is defined in the\nPrivate Securities Litigation Reform Act of 1995. Any forward-looking\nstatements contained herein are based on current expectations but are subject\nto a number of risks and uncertainties. Forward-looking statements include\nstatements regarding the Company’s cash on hand, revenue growth guidance and\nthe Company’s progress in marketing contract research services using NAMs\nmodels to pharmaceutical companies. Such forward-looking statements are not\nguarantees of performance and actual actions or events could differ materially\nfrom those contained in such statements. These risks and uncertainties and\nother factors are identified and described in more detail in the Company’s\nfilings with the SEC, including its Annual Report on Form 10-K filed with\nthe SEC on July 14, 2026, as such risk factors are updated in its most\nrecently filed Quarterly Report on Form 10-Q filed with the SEC on August\n12, 2026. You should not place undue reliance on these forward-looking\nstatements, which speak only as of the date that they were made. These\ncautionary statements should be considered with any written or oral\nforward-looking statements that the Company may issue in the future. Except as\nrequired by applicable law, including the securities laws of the United\nStates, the Company does not intend to update any of the forward-looking\nstatements to conform these statements to reflect actual results, later\nevents, or circumstances or to reflect the occurrence of unanticipated\nevents. \n\nContact(s):\nInvestor Relations\ninfo@vivosim.ai\nVivoSim Labs, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/636bff82-374b-4c96-8194-5345983eb76a)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-21T12:05:00.156043302Z","server_sent_at_ms":1792584300156},"received_at":"2026-10-21T12:05:00.214Z","source_url":null},"analysis":{"id":"163508","press_release_id":"175495","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"product_launch","narrative":"VivoSim Labs is extending its NAMkind human tissue platform beyond toxicology into efficacy testing, launching patient-derived disease models of the liver (MASH) and intestine (IBD).\n\nThe move targets the leading cause of clinical-trial failure — lack of efficacy — letting drug developers test candidate compounds in diseased human tissue, with pharmacodynamic and biomarker profiling on the same platform.\n\nManagement believes disease models could more than double the company's addressable market, while toxicology remains the core service; no revenue figures or customer contracts were disclosed in the release.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Small-cap CRO expands TAM with patient-derived efficacy models — watch for early contract wins to validate the claim."},"keyFigures":{"customDimensions":{"ibd_donor_count":12,"mash_study_duration":"14 or 21 days","clinical_trials_analyzed":"28,000+"}},"quotedText":"We believe disease models could more than double our addressable market.","namedEntities":{"people":[{"name":"Keith Murphy","role":"Executive Chairman"},{"name":"Amar Sethi, M.D., Ph.D.","role":"Chief Scientific Officer"}],"products":["NAMkind™","NAMkind™ MASH disease model","NAMkind™ IBD disease model"],"companies":[{"name":"VivoSim Labs, Inc.","ticker":"VIVS","relationship":"filer"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Platform extension adding efficacy-testing disease models (MASH, IBD) to an existing toxicology CRO business. Management claims it could more than double the addressable market, but it is a service expansion with no revenue figures or contracts announced yet."},"tickerRelevance":{"others":[],"primary":"VIVS"},"globalImportance":18,"audienceRelevance":12,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"service platform expansion, no financials","sectorWeight":"biotech services, niche audience","issuerAuthored":true}},"event_type":"product_launch","event_type_secondary":["operations_update"],"sentiment":"bullish","material_impact_score":2,"narrative":"VivoSim Labs is extending its NAMkind human tissue platform beyond toxicology into efficacy testing, launching patient-derived disease models of the liver (MASH) and intestine (IBD).\n\nThe move targets the leading cause of clinical-trial failure — lack of efficacy — letting drug developers test candidate compounds in diseased human tissue, with pharmacodynamic and biomarker profiling on the same platform.\n\nManagement believes disease models could more than double the company's addressable market, while toxicology remains the core service; no revenue figures or customer contracts were disclosed in the release.","key_figures":{"customDimensions":{"ibd_donor_count":12,"mash_study_duration":"14 or 21 days","clinical_trials_analyzed":"28,000+"}},"named_entities":{"people":[{"name":"Keith Murphy","role":"Executive Chairman"},{"name":"Amar Sethi, M.D., Ph.D.","role":"Chief Scientific Officer"}],"products":["NAMkind™","NAMkind™ MASH disease model","NAMkind™ IBD disease model"],"companies":[{"name":"VivoSim Labs, Inc.","ticker":"VIVS","relationship":"filer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-21T12:05:05.793Z","global_importance":18,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","eventGravity":"service platform expansion, no financials","sectorWeight":"biotech services, niche audience","issuerAuthored":true}},"durationMs":5564,"modelName":"glm-5.3-flashx"}}