VivoSim Labs Unveils New NAMkind™ Drug Toxicity Data at EUROTOX 2026, Demonstrating Predictive Superiority in Liver and Gastrointestinal Safety Across Small Molecules and ADCs

New data presented in Vienna highlights long-term repeat-dose modeling, mechanistic GI barrier profiling, and deconvolution of payload- and linker-dependent toxicities for complex modalities

SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (NASDAQ: VIVS) (“VivoSim” or the “Company”) unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).

The new data strengthens VivoSim's positioning in the growing market for human-relevant predictive toxicology and New Approach Methodologies (NAMs), as pharmaceutical companies increasingly look for better ways to identify safety risks before drug candidates enter expensive human clinical trials.

Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition, while ADC therapies introduce additional safety challenges involving payload toxicity, linker behavior and off-target exposure. VivoSim's EUROTOX findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for small-molecule reference sets such as thiazolidinediones and NSAIDs, while deconvoluting complex structural toxicities in advanced ADC modalities.

NAMkind™ Targets Liver and GI Toxicity Before the Clinic

VivoSim's NAMkind™ Liver platform supports up to 28-day liver spheroid viability, while its intestinal models maintain barrier integrity for up to three weeks, allowing researchers to evaluate repeat-dose effects that shorter-duration laboratory assays may not capture.

In studies being presented at EUROTOX, VivoSim's repeat-dose testing framework successfully ranked clinical safety risks across small-molecule reference compounds while also distinguishing payload- and linker-dependent toxicities in ADCs. The NAMkind™ Liver platform ranked trastuzumab deruxtecan as significantly more hepatotoxic than trastuzumab emtansine in the presented testing. In the NAMkind™ Intestine model, transepithelial electrical resistance (TEER) identified mucosal barrier deterioration before overt tissue cytotoxicity, with human ileum tissue demonstrating greater sensitivity to ADC-induced toxicity than colon tissue.

The findings carry particular weight as ADC development expands across oncology and other therapeutic areas, sharpening demand for technologies capable of determining where toxicity originates and which component of a complex drug is responsible.

Moving Beyond Detecting Toxicity

The broader commercial opportunity for VivoSim goes beyond simply detecting whether a drug candidate is toxic: it lies in helping pharmaceutical developers understand why toxicity occurs and whether it is likely to matter in humans.

“As global regulators like the FDA accelerate the transition away from traditional animal testing, biopharma leaders are seeking predictive human tools that eliminate translational surprises before clinical entry,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our latest data presented at EUROTOX demonstrate that the NAMkind™ platform doesn't just evaluate traditional small molecules with exceptional fidelity, it successfully deconvolutes the complex safety liabilities of next-generation modalities like ADCs. By identifying payload and linker toxicities early, we provide our commercial partners with the actionable intelligence needed to save years of development and millions in potential clinical failure.”

“Predicting organ-specific toxicity requires capturing the biology of chronic, repeat-dose exposure,” said Amar Sethi, M.D., Ph.D., Chief Scientific Officer of VivoSim Labs. “With our extended-culture platforms, we observe micro-architectural and functional degradation that traditional short-term assays may miss. Whether ranking clinical DILI risk across small-molecule analogs or pinpointing why trastuzumab deruxtecan exhibits distinct hepatic and ileal liabilities compared to emtansine, our multi-endpoint profiling gives biopharma teams human-relevant translational signatures to optimize compound selection and de-risk pipelines.”

FDA NAM Momentum Adds to the Opportunity

The EUROTOX presentation arrives as regulators, including the U.S. Food and Drug Administration (FDA), continue advancing frameworks for New Approach Methodologies and human-relevant alternatives to traditional animal testing.

That regulatory shift does not represent an endorsement of VivoSim specifically, but it creates a potentially favorable industry backdrop for validated technologies capable of generating predictive human safety information before clinical development.

The opportunity extends beyond detecting toxicity. If broader validation and pharmaceutical adoption follow, NAMkind™ and VitroSense™ could become part of the decision layer between drug discovery and human clinical trials, helping pharmaceutical companies determine which programs deserve additional time and development capital.

For VivoSim investors, the EUROTOX data mark a meaningful validation point in the developing commercial thesis behind NAMkind™ using 3D human biology and predictive toxicology to help pharmaceutical companies identify safety liabilities earlier, select stronger drug candidates and reduce costly failures later in development.

VivoSim's demonstrated ability to evaluate both traditional small molecules and increasingly important complex modalities such as ADCs positions its NAMkind™ platform to broaden its applications across pharmaceutical R&D.

About VivoSim Labs

VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) Roadmap to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding the Company’s cash on hand, revenue growth guidance and the Company’s progress in marketing contract research services using NAMs models to pharmaceutical companies. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on July 14, 2026, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on August 12, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

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VivoSim Labs, Inc.