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VivoSim to Debut Antibody Drug Conjugate Data, representing a major new market for NAMkind models, at Society of Toxicology Meeting in San Diego

MWN-AI** Summary

VivoSim Labs, Inc. (Nasdaq: VIVS) is set to showcase significant advancements in its next-generation New Approach Methodologies (NAMs) at the Society of Toxicology meeting in San Diego, taking place from March 22-25, 2026. The company will present data on its NAMkind™ liver and intestine models, focusing on their capabilities to predict the toxicity and side effect profiles of antibody drug conjugates (ADCs). As numerous ADCs are under development, the potential for off-target toxicity—especially in oncology—is a pressing concern, highlighting the need for advanced predictive tools.

VivoSim's NAMkind™ models are designed to elucidate important mechanisms such as target engagement in organ tissues, premature linker cleavage, and bystander effects in complex human cell environments. Preliminary testing using established ADC therapies has shown that VivoSim's models reliably correlate with clinical safety outcomes, particularly with liver toxicity and gastrointestinal side effects, paving the way for enhanced candidate optimization during drug development.

Amar Sethi, Chief Scientific Officer, expressed confidence in how these models can aid partners in screening for toxicities early in the development process, ultimately increasing the likelihood of clinical success. Keith Murphy, Executive Chairman, emphasized VivoSim’s leadership in generating human-relevant data that translates effectively to clinical settings.

With expanding availability of NAMkind™ liver and intestinal toxicology services across the U.S., Europe, and Asia, VivoSim aims to meet the growing global demand for innovative drug testing solutions, especially following the FDA's recent move to promote non-animal testing methodologies. This positions VivoSim as a key player in the evolution of pharmaceutical research and development, particularly within the complex landscape of ADC therapies.

MWN-AI** Analysis

As VivoSim Labs, Inc. (Nasdaq: VIVS) approaches the Society of Toxicology (SOT) meeting in March 2026, investors should recognize the promising market potential for its NAMkind™ models, particularly concerning antibody drug conjugates (ADCs). With hundreds of ADCs under development, the need for effective preclinical safety assessments remains paramount. The validation of NAMkind™ liver and intestine models for predicting ADC toxicity is a significant advancement that could attract partners and increase demand for VivoSim’s services.

The unique capability of VivoSim’s NAMkind™ models to provide insights into off-target effects in a biologically relevant context can significantly aid drug developers in optimizing ADC candidates. The close correlation between the results of the NAMkind™ tests and actual clinical outcomes demonstrates the models' potential to facilitate safer drug development, which could enhance clinical success rates while minimizing side effects.

Moreover, following the FDA's recent push towards non-animal testing methodologies, VivoSim is strategically positioned to capture a share of the burgeoning in vitro toxicology market. This shift not only legitimizes the use of its NAM systems but also aligns with the growing global focus on ethical testing practices.

Given the high cost of drug development and the potential financial ramifications of late-stage toxicities, VivoSim’s offerings are likely to become integral in the drug development pipeline. Investing in VIVS could be seen as a strategic opportunity to capitalize on a market that is expected to grow as companies increasingly adopt human-relevant testing methods.

However, investors should remain cautious. While the prospects are strong, they should monitor the execution of VivoSim's plans and the competitive landscape in the rapidly evolving biopharmaceutical space. Keeping a close eye on upcoming data releases and partnerships will be crucial in assessing the company's path forward.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

SAN DIEGO, Feb. 11, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced it will attend the Society of Toxicology (“SOT”) 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, bystander 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.

“These ADC toxicity results show a close correlation to clinical safety outcomes,” said Amar Sethi, Chief Scientific Officer at VivoSim. “We think that our partners working with our testing models will be able to screen out toxicities during lead candidate optimization, resulting in greater success in the clinic at eliminating cancers using drugs with limited side effect profiles,” he continued.

“VivoSim’s scientific leadership in the field of human-relevant NAM models with results that translate to the clinic is bolstered by these new data,” said Keith Murphy, VivoSim’s Executive Chairman. “Our ability to demonstrate results that match known clinical results of cutting-edge drug modalities confirms that our 3D human cell models have a strong ability to faithfully reproduce the complex biology of human tissues.”

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.

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”) announcement on April 10, 2025 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 NAMKind™, including target turnaround time and its potential to help users de-risk their pipelines, avoid costly downstream failures, reduce rework, prioritize the right assets, move faster, save millions and reduce risk; VivoSim’s commercial presence across Asia-Pacific; the evaluation and acceptance of scientifically robust NAM-based evidence; the Company’s ability to capture growing demand in the in vitro toxicology testing market; demand for human-relevant toxicology; the market opportunity and market size of gastrointestinal in vitro models and toxicology services; and the Company’s scaling capacity to support expanding global demand and development needs. 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 June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on November 6, 2025. 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. 

Contact(s):
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.


FAQ**

How is VivoSim Labs Inc. (VIVS) differentiating its NAMkind™ liver and intestine models from existing preclinical safety testing methodologies presented at the SOT meeting in San Diego?

VivoSim Labs Inc. is differentiating its NAMkind™ liver and intestine models by offering more physiologically relevant preclinical safety testing that enhances predictive accuracy, reduces reliance on animal models, and streamlines the drug development process, as presented at the SOT meeting.

What specific advantages do VivoSim Labs Inc. (VIVS) claim their NAMkind™ models provide in predicting toxicity for antibody drug conjugates (ADCs) over traditional methods?

VivoSim Labs Inc. claims their NAMkind™ models enhance the prediction of toxicity for antibody drug conjugates (ADCs) by offering more accurate, comprehensive, and efficient insights into complex biological interactions compared to traditional testing methods.

Given the close correlation with clinical results, how does VivoSim Labs Inc. (VIVS) plan to scale its capacity to meet the growing global demand for NAM-based toxicology testing services?

VivoSim Labs Inc. (VIVS) plans to scale its capacity for NAM-based toxicology testing services by investing in advanced technology, expanding its laboratory facilities, and enhancing workforce training to meet the increasing global demand for reliable clinical results.

What regulatory changes, such as the FDA's announcement, does VivoSim Labs Inc. (VIVS) anticipate will accelerate adoption of its 3D human tissue models in drug development?

VivoSim Labs Inc. (VIVS) anticipates that recent FDA announcements promoting advanced biotechnology and emphasizing alternatives to animal testing will accelerate the adoption of its innovative 3D human tissue models in drug development.

**MWN-AI FAQ is based on asking OpenAI questions about VivoSim Labs Inc. (NASDAQ: VIVS).

VivoSim Labs Inc.

NASDAQ: VIVS

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