VivoSim Labs, INC.

VivoSim Labs, Inc. has undergone a significant strategic pivot, changing its name from a clinical-stage biotech to focus on providing pharmaceutical and biotechnology services using proprietary 3D human tissue models for drug testing. This shift followed the sale of its FXR program to Eli Lilly and Company in March 2025 for an upfront $10.0 million and potential milestones. The company recently received a $5.0 million milestone payment in July 2026 related to the FXR314 development. Despite this, both management and auditors have expressed substantial doubt about the company's ability to continue as a going concern, highlighting the risks of its new unproven business strategy and ongoing operating losses.

VivoSim Labs announced that its advanced 3D human tissue models, NAMkind™ Liver and NAMkind™ GI, demonstrated superior predictive power for preclinical safety at a European toxicology conference. The NAMkind™ Liver model achieved over 90% sensitivity in detecting liver toxicity, significantly outperforming animal models (50-65% sensitivity) and reducing false positives to under 5%. These models also accurately predict GI toxicity for both small molecules and complex antibody-drug conjugates (ADCs), aligning with FDA's push for human-relevant alternatives in drug development.

VivoSim Labs, Inc. announced the launch of an AI prediction tool that leverages its NAMkind ™ intestinal models to accurately predict drug-induced diarrhea with 96% accuracy. The VitroSense ™ tool integrates proprietary NAMkind ™ ileum and colon tissues with advanced machine-learning analytics, trained on dozens of compounds. This breakthrough aims to transform cancer treatments by reducing reliance on animal models and identifying toxic liabilities in novel compounds.

VivoSim Labs announced the pricing of a best efforts public offering of up to 3,508,772 shares of common stock or pre-funded warrants, along with accompanying common warrants to purchase up to 5,263,159 shares. The initial tranche closed on April 1, 2026, issuing shares and pre-funded warrants with accompanying warrants at a combined price of $1.14 and $1.139, respectively, potentially providing the company with significant capital.

VivoSim Labs announced the pricing of a best efforts public offering of up to 3,508,772 shares of common stock and accompanying warrants. The offering is comprised of two tranches, with the initial tranche closing on April 1, 2026, and is expected to generate gross proceeds of up to $4 million, which will provide the company with additional capital.