VivoSim Labs, INC.

VivoSim Labs, Inc.

Company identity and focus

• VivoSim Labs, Inc. (formerly Organovo; name change effective April 24, 2025) is a pharmaceutical and biotechnology services company that tests drugs and drug candidates in three-dimensional human tissue models of the liver and intestine.
• Core approach uses NAM (new approach methodologies) models to provide liver and intestinal toxicology insights to pharmaceutical and biotech partners.
• The company positions these models to reduce risk and cost in regulatory pathways and drug development, with ongoing work in investigational toxicology and mechanism-of-action studies.

Products and services

• Predictive screening and research services for liver and intestinal toxicology.
• Focus on predicting and studying drug-induced liver injury and intestinal side effects across all stages of drug development.
• Proprietary 3D human tissue platforms, including organoids (spheroids), high-throughput systems, bioprinted tissues, and flow/stretch-enabled tissue constructs.
• Use of NovoGen Bioprinter® and related bioprinting technologies to create engineered tissues and tissue models for drug discovery and toxicology testing.
• Patent portfolio supporting platform applications in discovery and preclinical toxicology.

Intellectual property and technology

• In-licensed exclusive licenses (2009–2010) from University of Missouri (MU) and Medical University of South Carolina (MUSC).
• Company-owned IP includes 12 issued U.S. patents and 15 issued foreign patents related to NovoGen Bioprinter® and bioprinting methods.
• Patents for NAMkind Human Liver Tissue and Human Kidney Tissue have multiple national protections.
• Active patent families cover bioprinting devices, engineered tissues, tissue constructs, and in vitro testing applications; ongoing filings cover additional features and tissue types.
• Past patent disputes related to bioprinting patents have been resolved; the company maintains a broad portfolio to protect its platform and workflows.

Market, customers, and partners

• Serves pharmaceutical and biotechnology partners seeking safety/toxicity testing and mechanistic insights using 3D human tissue models.
• Engages in external testing and development collaborations with pharmaceutical and biotech companies.

Recent corporate developments

• Corporate name changed to VivoSim Labs, Inc., effective April 24, 2025, reflecting an expanded business model and assets (intestine and liver tox models, NAM technologies, and bioprinting IP).
• On March 25, 2025, sold an FXR program and related assets to Eli Lilly and Company for $10.0 million upfront, with $1.0 million held in escrow for 15 months and potential development and regulatory milestones up to $50.0 million; Lilly assumed related liabilities and may owe additional milestone payments.
• A $5.0 million milestone payment related to the FXR assets was received in July 2026.
• Common stock trades on the Nasdaq Capital Market under the symbol VIVS (ticker changed with the 2025 name change; previously ONVO).
• Subsidiaries include Organovo, Inc. (acquired 2012) and VivoSim, Inc. (incorporated 2025).

Corporate information and location

• Headquarters: 11555 Sorrento Valley Rd, Suite 100, San Diego, CA 92121.
• Primary business operations are conducted through Organovo, Inc. and VivoSim, Inc.

Financial snapshot (selected figures)

• Employees: 15 total as of June 1, 2026 (9 full-time), plus consultants and expert consultants.
• Operating losses: $11.5 million for the year ended March 31, 2026; $12.6 million for the year ended March 31, 2025.
• Financial position (as of March 31, 2026):
  • Total current assets: approximately $6.6 million
  • Current liabilities: approximately $2.8 million
  • Working capital: approximately $3.8 million
  • Accumulated deficit: approximately $356.0 million
  • Stockholders’ equity: negative $1.1 million
• Share and equity details (as of March 31, 2026, prior to the 2026 offering):
  • Common stock outstanding: 10,209,676
  • Common stock unissued but reserved: 196,500,934 available for future issuance
  • Outstanding warrants: 6,963,030
  • Outstanding restricted stock units and options: multiple components (e.g., 2,894,519 outstanding; 348,419 issuable upon vesting/exercise)
• Capital raising and equity strategy:
  • The company has used an at-the-market (ATM) sales program under a shelf registration; approximately 1,530,001 shares were issued and sold through the ATM for gross proceeds of about $52.0 million.
  • Potential dilution risk exists from future issuances and warrant exercises.
  • No dividends are anticipated in the foreseeable future.

Business risks and outlook

• The company reports ongoing losses and operates in a capital-intensive sector that requires external funding for continued development and commercialization.
• The business faces regulatory and commercial risks typical for an early-stage biotech services company.