VivoSim Presents Best-in-Class Liver Toxicology Prediction Results at Digestive Disease Week Conference

Rhea-AI Summary

VivoSim Labs (NASDAQ: VIVS) presented groundbreaking results for its NAMkind™ liver toxicology prediction platform at the Digestive Disease Week Conference. The platform demonstrated 87.5% sensitivity in predicting liver toxicity cases and 100% specificity in avoiding false positives. NAMkind™ uses physical organoid wet lab models from human donor cells and is developing AI-enhanced in silico predictions. This advancement aligns with FDA's recent initiative to phase out animal testing, targeting a >$10B market. VivoSim claims its technology could reduce drug development costs by 50% and significantly decrease late-stage clinical trial failures due to liver toxicity. The company's platform also addresses intestinal toxicity issues in cancer treatments, potentially improving chemotherapy dosing and reducing side effects.

Positive

• Achieved 87.5% sensitivity in liver toxicity prediction and 100% specificity, setting a world-leading benchmark
• Platform could reduce drug development costs by 50% across the industry
• Targets disruption of >$10B animal testing market with more predictive methods
• Aligns with FDA's recent initiative to phase out animal testing requirements
• Technology could reduce late-stage clinical trial failures by 50% or more

Negative

• None.

Insights

Biotechnology and Pharmaceutical Innovation Expert

VivoSim's liver toxicity platform shows 87.5% sensitivity with 100% specificity, potentially reducing late-stage drug failures as FDA phases out animal testing.

VivoSim's NAMkind™ platform has demonstrated 87.5% sensitivity in predicting liver toxicity with 100% specificity - an impressive technical achievement that positions the company favorably in the emerging non-animal testing landscape. The perfect specificity is particularly valuable as it eliminates false positives that could unnecessarily halt development of promising drug candidates.

The timing couldn't be better for VivoSim, with the FDA's April announcement to phase out animal testing requirements in favor of New Approach Methodologies (NAM). This regulatory shift could accelerate adoption of VivoSim's technology while disrupting a $10+ billion animal testing market.

What makes the company's approach compelling is their combination of physical organoid models using human donor cells with AI prediction capabilities. This dual-pronged strategy addresses a critical industry pain point - liver toxicity remains one of the leading causes of late-stage clinical failures and post-market withdrawals, each costing pharmaceutical companies hundreds of millions in wasted R&D.

The company's claims about reducing drug development costs by 50% and cutting failure rates by 50% are ambitious but grounded in addressing a genuine industry problem. Liver toxicity issues are typically discovered late in development or even post-approval, making earlier, more accurate prediction tremendously valuable.

VivoSim's expansion into intestinal toxicity models further broadens their market opportunity, potentially improving cancer treatment tolerability and effectiveness by predicting and mitigating gastrointestinal side effects.

For investors, this announcement represents promising technology advancement, though commercial adoption metrics and revenue projections are notably absent. The transition from scientific validation to pharmaceutical industry integration will be the true test of VivoSim's market potential.

SAN DIEGO, May 07, 2025 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company”) announced today that its world-leading NAMkind™ platform for liver toxicology prediction, provided as a commercial service to pharma companies, was featured in an oral presentation at the Digestive Disease Week Conference (San Diego, CA, May 2-6, 2025) showing best-in-class predictive power against a set of test liver compounds.

VivoSim’s liver predictive power was shown to be 87.5% for a set of challenging liver toxicity cases – inclusive of classic cases of “liver tox misses” drugs with unforeseen liver toxicity found in clinical trials or drugs that were withdrawn from the market after liver toxicity issues emerged later. The platform identified correctly that 87.5% of the known liver-toxic drugs could be seen as liver toxic using NAMkind™ liver. This is known as the sensitivity of the platform, which at 87.5% is a world’s best. Importantly, the specificity was 100%, meaning that none of the compounds tested that are not liver toxic were incorrectly identified as having liver toxicity issues by the platform.

VivoSim’s NAMkind™ liver model is a physical organoid wet lab model of liver made using cells from human donors. VivoSim is also developing what it believes will be industry-best in silico predictions of liver tox. Artificial intelligence (AI) models in VivoSim’s NAMkind™ services suite will be trained on extensive set of proprietary, real-world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials.

VivoSim offers liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA’s push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim’s market adoption, disrupting a >$10B animal testing market with models that are more predictive and ethically sound.  

VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry. As a result of the inability to fully predict liver toxicity, a number of drugs today still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more.

VivoSim’s NAMkind™ intestine models can also deliver readouts on endpoints that are today not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient’s needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges.

The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve according to FDA Commissioner Marty A. Makary’s vision, which he expressed in March 2025 with the rollout of FDA’s push to move away from animal testing and towards NAM models. “By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices,” Makary noted. By leveraging AI-based computational modeling, human organ model-based lab testing, and. VivoSim is delivering on the promise of this technology, and will use its proprietary methods and cutting-edge capabilities for NAMkind models that displace use of animals and provide superior outcomes for its pharmaceutical customers, ultimately delivering for on the end goal of providing better solutions for patients.

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 belief that it is developing an industry-best in silico predictions of liver tox, that it can help reduce the cost of development per approved drug by 50% across the industry and that it can cut the incidence of drugs failing clinical trial at late stages or being pulled from the market after launch due to unforeseen liver toxicity by 50% or more, the Company’s expectations about its AI models in the Company’s NAMkind™ services suite, the Company’s capability to help transform the way drug development is done, the Company’s plan to provide transformative solutions for certain challenges, including that a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient’s needed chemotherapy dose might be lower than it could be and the Company’s expectations that it can provide superior outcomes for its pharmaceutical customers and better solutions for patients. 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 May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 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
Investor Relations
info@vivosim.ai

FAQ

What are the key performance metrics of VivoSim's (VIVS) NAMkind liver toxicology platform?

VivoSim's NAMkind platform achieved 87.5% sensitivity in predicting liver toxicity cases and 100% specificity in avoiding false positives, making it a world-leading solution.

How could VivoSim's (VIVS) technology impact drug development costs?

VivoSim claims its technology could reduce drug development costs by 50% across the industry by reducing late-stage clinical trial failures due to liver toxicity.

What market opportunity is VivoSim (VIVS) targeting with its NAMkind platform?

VivoSim is targeting disruption of the >$10B animal testing market with its NAMkind platform, aligned with FDA's initiative to phase out animal testing requirements.

How does VivoSim's (VIVS) NAMkind platform work?

NAMkind uses physical organoid wet lab models made from human donor cells and is developing AI-enhanced in silico predictions for liver toxicity testing.

What additional benefits does VivoSim's (VIVS) technology offer for cancer treatment?

The platform can help optimize chemotherapy dosing and reduce side effects like nausea, vomiting, and intestinal problems through its intestinal toxicity prediction capabilities.