VivoSim Labs, Inc. (Nasdaq: VIVS) is a pharmaceutical and biotechnology services company that focuses on testing drugs and drug candidates in three-dimensional human tissue models of liver and intestine. This news page aggregates coverage of the company’s announcements, scientific presentations and corporate developments related to its NAMkind platform and toxicology services.
Readers can find updates on leadership changes, such as the appointment of a Chief Commercial Officer to guide go‑to‑market strategy and partnerships, and the appointment of a Chief Scientific Officer to oversee scientific strategy across toxicology, translational models, bioanalytics and next‑generation new approach methodologies. News items also highlight how VivoSim Labs combines organ‑specific 3D models with AI‑driven analytics to deliver what it describes as decision‑ready toxicology insights.
Company news includes reports of scientific results, such as presentations at conferences where VivoSim Labs has discussed the predictive performance of its NAMkind liver model against challenging liver toxicity cases. These articles describe sensitivity and specificity metrics within test sets of compounds and explain how the platform is intended to address unforeseen liver toxicity that can emerge in clinical trials or after market launch.
In addition, news releases from VivoSim Labs discuss its emergence from stealth mode, its focus on non‑animal NAM methods in the context of FDA initiatives to refine animal testing requirements, and its view of the market opportunity for liver and gastrointestinal in vitro models and toxicology services. Investors, scientists and industry professionals can use this page to follow how the company communicates its progress in AI‑enabled liver and intestine toxicology, regulatory context and corporate governance milestones over time.
VivoSim Labs (VIVS) is extending its NAMkind human tissue platform beyond toxicology with efficacy testing services using liver and intestinal disease models. The services use patient-derived cells to test drug candidates against disease features before clinical trials, alongside the company's existing safety testing.
The liver model addresses metabolic dysfunction-associated steatohepatitis (MASH), while intestinal models use cells from donors with ulcerative colitis or Crohn's disease. Studies compare client compounds with approved or clinically validated reference drugs in the same donor tissue. Biomarker profiling measures biological responses to help assess how compounds act alongside their effects on disease features.
VivoSim Labs (VIVS) welcomed an FDA regulatory update clarifying the use of non-animal methods to test drug and biological product safety.
The direct final rule replaces “animal tests” with “nonclinical tests” across the FDA’s regulatory framework. It clarifies that non-animal methods can be used where appropriate for products intended for human use, opening pathways for human cell-based tests such as VivoSim’s.
VivoSim said its long-duration models, based on primary human cells, can identify and distinguish liver injury and gastrointestinal toxicity risks earlier in development and have ranked clinical safety risks for clients’ drug candidates. Its stated aim is to help clients rule out likely failures before selecting a drug for clinical testing, avoiding spending on candidates that later fail.
VivoSim Labs (VIVS) presented new NAMkind™ liver and intestinal toxicity data at EUROTOX 2026, showing predictive performance across small molecules and antibody-drug conjugates (ADCs).
The 3D human liver platform maintained spheroid viability for up to 28 days and intestinal models preserved barrier function for about three weeks, enabling repeat-dose toxicity assessment. Studies ranked clinical safety risks for small-molecule sets, including thiazolidinediones and NSAIDs, and differentiated payload- versus linker-driven toxicities in ADCs. NAMkind™ testing identified trastuzumab deruxtecan as more hepatotoxic than trastuzumab emtansine and detected earlier GI barrier damage, with ileum tissue more sensitive to ADC-induced toxicity than colon.
VivoSim Labs (Nasdaq: VIVS) announced plans to develop a rat liver model to complement its existing NAMkind human liver platform and expand liver toxicology capabilities. The new cross-species model is intended to help distinguish rat-specific liver toxicity from risks that may be relevant to humans.
The planned rat model would enable side-by-side comparison of rat and human liver responses, supporting decisions on whether to advance, modify, or further investigate drug candidates. According to VivoSim Labs, this addition could broaden the commercial utility of NAMkind by adding human-relevant context to widely used rat toxicology workflows.
VivoSim (Nasdaq: VIVS) announced it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires minimum stockholders’ equity of $2.5 million. Nasdaq’s Listing Qualifications Staff notified the company of compliance on August 4, 2026.
After filing its Form 10-K for the year ended March 31, 2026, VivoSim received a $5.0 million milestone payment and $1.0 million escrow release on July 22, 2026 related to its prior FXR program sale to Eli Lilly. On July 17, 2026, it completed a financing issuing pre-funded and common warrants at a combined purchase price of $0.85 per underlying share, generating $4.0 million gross and approximately $3.6 million net proceeds. These July events are not reflected in the March 31, 2026 audited statements or the upcoming June 30, 2026 Form 10-Q.
VivoSim reported cash of about $10.1 million as of August 3, 2026. Shares outstanding increased from 3,194,295 on June 30, 2026 to 13,390,789 on August 3, 2026, mainly from 9,896,718 warrant exercises in July. The company reiterated guidance for 500%+ revenue growth in fiscal 2027. All figures are preliminary and unaudited.
VivoSim (Nasdaq: VIVS) announced its first commercial sales of NAMkind™ liver and gastrointestinal toxicology screening and efficacy testing services in mainland China, secured via distributor Tekon with a leading Shanghai oncology biotech and a large Chengdu pharmaceutical company. These initial paid programs cover GI toxicology screening and GI efficacy profiling for oncology and other candidates and represent a meaningful share of VivoSim’s contracted revenue to date.
According to VivoSim, the addressable China market for liver and GI in vitro models and toxicology services is about $2 billion, growing at 10% CAGR. The NAMkind™ Liver model showed 91% predictive accuracy, 90% sensitivity and 95% specificity across 92 compounds, outperforming typical animal-model sensitivity. NAMkind™ services are now offered in the U.S., Europe and, with this launch, mainland China.
VivoSim (Nasdaq: VIVS) has priced a $4.0 million private placement with a single healthcare focused institutional investor, involving 4,705,883 shares of common stock (or equivalents) and accompanying warrants to purchase up to 4,705,883 shares, at an effective combined price of $0.85 per share and warrant.
The warrants will have a $0.85 exercise price, become exercisable after shareholder approval and expire five years from initial exercise. VivoSim also agreed, subject to stockholder approval, to reduce the exercise price of May 2024 warrants on 520,833 shares from $9.60 to $0.85, with a new five-year term from approval. Closing is expected on or about July 17, 2026, with net proceeds intended for working capital and general corporate purposes. The unregistered offering relies on Section 4(a)(2)/Regulation D exemptions, and VivoSim will file an SEC registration statement for resale of the shares and warrant shares.
VivoSim (Nasdaq: VIVS) reported that it has received a $5 million milestone payment from Eli Lilly tied to the first patient dosing in Eli Lilly’s Phase 2 studies of an inflammatory bowel disease drug previously sold by VivoSim. The company remains eligible for up to $45 million in additional milestones if specified regulatory and commercial goals are achieved as Eli Lilly advances and markets the drug.
VivoSim also issued FY2027 guidance, stating it anticipates over 500% revenue growth, driven by increasing adoption of its NAMkind 3D human cellular models in contract research by pharmaceutical customers. The company highlighted liver and intestine models with reported predictive accuracies around 90%+, aligning with FDA encouragement of human-relevant NAMs.
VivoSim (Nasdaq: VIVS) presented new data on its AI-enabled NAMkind Liver and NAMkind GI platforms at ESTIV 2026. In a 92-compound clinical liver dataset, NAMkind Liver showed 91% accuracy, 90% sensitivity, 95% specificity, 99% precision, and >90% sensitivity versus 50–65% for traditional methods.
The models produced <5% liver-toxicity false positives versus >10% for some current approaches and were used to characterize toxicity for small molecules, TKIs and antibody-drug conjugates, including Trastuzumab Emtansine and Trastuzumab Deruxtecan.
VivoSim (Nasdaq: VIVS) announced an AI prediction tool, VitroSense™, trained on data from its NAMkind™ ileum and colon 3D human intestinal models to predict drug-induced diarrhea. VivoSim reports the model attained 96% predictive accuracy using a training set of dozens of compounds. The platform supports oral and IV dosing simulations and detected differential effects from antibody-drug conjugates (ADCs). NAMkind™ liver and small-intestine services are offered in the US, Europe, Korea, and China as the company scales capacity.