Organovo(US:ONVO)2025-11-06 21:08Revenue Performance - Total revenue for the three months ended September 30, 2025, was less than $0.1 million, with royalty revenue remaining consistent at $28,000, while product revenue dropped to zero from $2,000 in the same period of 2024[120] - Royalty revenue for the six months ended September 30, 2025, increased by $12,000 or 23% to $65,000 compared to $53,000 in the same period of 2024[126] - Total revenue for the six months ended September 30, 2025, was $0.1 million, consistent with the same period in 2024[127] Expenses - Research and development expenses for the three months ended September 30, 2025, were $923,000, a decrease of approximately $61,000 or 6% from the prior year, attributed to a reduction in average full-time staff from fourteen to nine[122] - Selling, general and administrative expenses increased by approximately $87,000 or 5% to $1,740,000 for the three months ended September 30, 2025, despite a decrease in average full-time staff from five to four[124] - Research and development expenses for the six months ended September 30, 2025, were $1,924,000, a decrease of $462,000 or 19% from $2,386,000 in the prior year[126] - Research and development expenses decreased by $0.5 million, or approximately 19%, to $1.9 million for the six months ended September 30, 2025, compared to $2.4 million in 2024[129] - Selling, general and administrative expenses remained approximately the same at $3.7 million for the six months ended September 30, 2025, compared to $3.7 million in 2024[131] Cash Flow and Financial Position - Net cash used in operating activities increased to approximately $6.3 million for the six months ended September 30, 2025, from $5.6 million in 2024[137] - Cash and cash equivalents as of September 30, 2025, were approximately $6.7 million, down from $11.3 million at March 31, 2025[134] - The accumulated deficit increased to $347.5 million as of September 30, 2025, compared to $342.2 million at March 31, 2025[134] - Total current assets were approximately $7.6 million and current liabilities were approximately $2.4 million, resulting in working capital of $5.2 million as of September 30, 2025[135] - Net cash provided by financing activities was $1.7 million for the six months ended September 30, 2025, down from $5.9 million in 2024[139] Future Outlook and Developments - The company anticipates having a product candidate ready for an Investigational New Drug (IND) application with the FDA by December 2026[112] - The liver predictive power of the company's platform was shown to be 87.5% for liver toxicity cases, with a specificity of 100%[113] - The company sold its FXR program for $10 million, with potential future milestones of up to $50 million based on key development and regulatory achievements[110] - The company plans to start a Phase 2a clinical trial for FXR314 in ulcerative colitis in the calendar year 2025[109] - The company has advanced a new chemical entity (NCE) drug program for inflammatory bowel disease, moving from in-silico to medicinal chemistry stages[109] - The company expects total operating expenses for the fiscal year ending March 31, 2026, to be between $10 million and $12 million[141] - As of September 30, 2025, approximately $140.1 million was available for future offerings under the 2024 Shelf registration[145]