VivoSim Labs, Inc., formerly known as Organovo Holdings, Inc., is a biotech services company specializing in providing human tissue testing models for drug safety evaluation, with a focus on liver and intestinal toxicology.

# Company Summary: VivoSim Labs, Inc.

## Overview
- **Formerly Known Name:** Organovo Holdings, Inc.
- **Current Name:** VivoSim Labs, Inc. (changed officially on April 24, 2025)
- **Business Focus:** Pharmaceutical and biotechnology services
- **Main Activities:**
  - Providing testing of drugs and drug candidates using 3D human tissue models of liver and intestine
  - Offering liver and intestinal toxicology insights through proprietary new approach methodologies ("NAM") models
  - Supporting drug development by predicting drug-induced liver injury and intestinal tolerability
  - Developing bespoke toxicology services, mechanism of drug action elucidation, and various research applications using complex 3D human tissue models

## Business Model & Revenue
- **Core Offering:**  
  - Liver toxicology predictive screening
  - Intestinal side effect profiling of therapeutics at all stages of drug development
- **Market Impact:**  
  - Aims to reduce high risk and costs associated with bringing therapeutics to market
  - Seeks to replace animal testing with validated NAM-based models
- **Market Reaction & Adoption:**  
  - Anticipates accelerated adoption following FDA's April 2025 announcement to refine animal testing requirements in favor of NAM methods
- **Revenue (FY Ended March 31, 2025):**  
  - Total revenue was approximately **$0.1 million**  
  - Composed of:  
    - Royalty revenue: **$119,000** (from licensing agreements)  
    - Product revenue: **$25,000** (from sale of human cells, discontinued after fiscal 2025)

## Operational & Business Changes
- **Prior Business:**  
  - Focused on developing FXR314 for inflammatory bowel disease (IBD), including ulcerative colitis (UC)  
  - Planned to initiate Phase 2a clinical trial in 2025  
  - Sold FXR program in March 2025 for **$10 million** (upfront $9M + $1M escrow, with potential milestone payments up to **$50 million**)
- **Name & Business Shift:**  
  - Changed name to VivoSim Labs, Inc. Effective April 24, 2025
  - Transitioned from a clinical-stage biotech to a biotech services company focusing on human tissue testing models
  
## Employees & Customer Base
- **Employees (as of June 1, 2025):**  
  - Total of **13 employees** (5 full-time)  
- **Customers/Sources of Revenue:**  
  - No specific number of customers provided; the company primarily collaborates with pharmaceutical and biotech partners for drug testing and toxicology services
  
## Key Assets & Intellectual Property
- Proprietary technologies for 3D bioprinting and building human tissues
- Over **160 patents** globally (34 issued U.S. patents, more than 50 issued international patents)
- Licenses from University of Missouri and Medical University of South Carolina
- Focus on bioprinting technology, tissue design, and disease models
- No revenue from product sales after Mosaic division ended its commercial operations in Q3 FY2025

## Financials & Liquidity
- **Cash & Equivalents (as of March 31, 2025):** approximately **$11.3 million**  
- **Total Assets (2025):** **$12.1 million**  
- **Total Current Liabilities:** **$3.7 million**  
- **Working Capital:** **$8.4 million**  
- **Net Loss (FY ended March 31, 2025):**  
  - Operating losses of **$12.6 million** in FY2025 (compared to **$15.1 million** in FY2024)  
  - Total accumulated deficit: **$342.2 million**  
- **Revenue (FY 2025):** **$0.1 million**  
- **Net Income (operational):** Negative, mainly from R&D and administrative expenses
  
## Strategic & Business Outlook
- Transitioning from drug development to providing specialized tissue testing services
- Focus on liver and intestinal toxicity testing to support drug safety
- Working to accelerate adoption due to upcoming FDA policy changes
- Continues to seek additional funding and strategic partnerships to support operations and growth

Organovo Holdings, Inc. is a biotechnology company specializing in 3D bioprinting technology to develop functional human tissues for research and therapeutic applications.

## Company Overview: Organovo Holdings, Inc.

### Business Description
Organovo Holdings, Inc. is a biotechnology company that specializes in 3D bioprinting technology. The company develops and commercializes functional human tissues for research and therapeutic applications. Utilizing its proprietary bioprinting platform, Organovo produces living human tissues that can be used for drug discovery, preclinical testing, and therapeutic applications, particularly focusing on diseases such as genetic disorders and metabolic diseases.

### Key Offerings
- **3D Bioprinted Tissues:** Organovo creates functional human tissues, including liver tissues, that mimic natural tissue characteristics. These tissues enable better drug testing and are designed to produce more reliable preclinical results compared to traditional models.
- **Research Services and Solutions:** The company provides tailored tissue products and research solutions to its clients, ranging from pharmaceutical companies to academic institutions.
- **Contract Research Services:** Organovo partners with various organizations for specific research projects and tissue development.

### Customers
- Organovo primarily serves pharmaceutical and biotechnology companies, academic institutions, and contract research organizations (CROs).
- The company collaborates with established drug development companies, offering its bioprinting technology for drug testing and development.

### Employees
- As of the latest reporting, Organovo Holdings, Inc. has approximately **50 employees**.
  
### Financial Performance
- **Revenue:** Driving revenue through service agreements and partnerships, Organovo aims to grow its revenue base with strategic collaborations in the biotechnology sector.
- **Income:** The company does not report stable positive income due to the high costs associated with biotechnology development and research. Organovo has been navigating financial challenges common in biotech firms, including cash burn typical of emerging growth companies in heavy R&D phases.

### Strategic Focus
- Organovo is focusing on expanding its portfolio of bioprinted tissues and enhancing its commercial partnerships to significantly grow market presence.
- The company actively engages in revenue-generating partnerships and seeks to broaden the application of its technology across multiple therapeutic areas.

### Market Position
- Organovo is considered a leader in the 3D bioprinting space, having developed award-winning technologies recognized for their innovative contribution to medical research and pharmaceutical development.

By integrating proprietary technology with strategic alliances, Organovo aims to redefine how human tissues are used in research and therapeutic applications while working towards sustainability and scalability in their operations.

VivoSim Labs, INC.

10-K / June 5, 2025

10-K / July 26, 2024

10-K / June 5, 2025

Company Summary: VivoSim Labs, Inc.

Overview

Business Model & Revenue

Operational & Business Changes

Employees & Customer Base

Key Assets & Intellectual Property

Financials & Liquidity

Strategic & Business Outlook