Organovo(US:ONVO)2026-02-11 21:05Revenue and Financial Performance - Royalty revenue for the three months ended December 31, 2025, was $26,000, a 73% increase from $15,000 in the same period of 2024[127] - Royalty revenue for the nine months ended December 31, 2025, was $0.091 million, an increase of $0.023 million or 34% compared to $0.068 million in 2024[134] - Net cash used in operating activities was approximately $8.589 million for the nine months ended December 31, 2025, compared to $7.426 million in 2024, reflecting an increase of $1.163 million[144] - As of December 31, 2025, the company had cash and cash equivalents of approximately $4.3 million and an accumulated deficit of $350.2 million[142] - The company expects total operating expenses for the fiscal year ending March 31, 2026, to be between $10 million and $12 million[148] Research and Development - Total research and development expenses decreased to $1.14 million for the three months ended December 31, 2025, down 36% from $1.78 million in 2024[130] - Total research and development expenses decreased to $3.064 million for the nine months ended December 31, 2025, down $1.102 million or 26% from $4.166 million in 2024[137] - The average full-time research and development staff decreased from 13 employees in Q4 2024 to 10 employees in Q4 2025[130] - The company anticipates an increase in research and development expenses as it executes its service model[138] - The company plans to start a Phase 2a clinical trial for FXR314 in ulcerative colitis in the calendar year 2025[117] Expenses - Selling, general and administrative expenses were approximately $1.64 million for the three months ended December 31, 2025, a decrease of 4% from $1.71 million in 2024[132] - Selling, general and administrative expenses were approximately $5.327 million for the nine months ended December 31, 2025, a slight decrease of $0.057 million or 1% compared to $5.384 million in 2024[139] Business Strategy and Future Plans - The company aims to have a product candidate ready for an Investigational New Drug application with the FDA by December 2026[120] - The company plans to offer liver and intestinal toxicology insights using NAM models to pharmaceutical and biotech companies, aiming to reduce risks and costs in drug development[141] - The FXR program was sold for $10 million, with potential future milestones of up to $50 million based on development and regulatory achievements[118] - The company anticipates generating service revenues related to its service model going forward, following the cessation of product revenue from the former Mosaic division[128] Corporate Changes - The company changed its name to VivoSim Labs, Inc. effective April 24, 2025, to reflect its new business model[119] - As of December 31, 2025, there was approximately $140.1 million available for future offerings under the 2024 Shelf registration[153] - The company issued 701,729 shares of common stock for net proceeds of approximately $1.8 million during the nine months ended December 31, 2025[153] - The company is classified as a smaller reporting company under Rule 12b-2 of the Securities Exchange Act of 1934, which exempts it from certain disclosures[157] Toxicology Insights - The liver toxicology platform demonstrated a predictive power of 87.5% for liver toxicity cases, with a specificity of 100%[121]