Organovo Holdings, Inc., a clinical-stage biotechnology company, reported its financial results for the three and six months ended September 30, 2024, highlighting significant developments in revenue, expenses, and strategic initiatives. The company focuses on developing FXR314 for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease.

For the three months ended September 30, 2024, Organovo generated total revenues of $30,000, a notable increase from $0 in the same period of 2023. This revenue comprised $28,000 in royalty revenue and $2,000 in product revenue, marking the first product sales since the inception of its Mosaic division. In contrast, total costs and expenses decreased to $2,638,000 from $4,115,000 year-over-year, leading to a reduced loss from operations of $(2,608,000) compared to $(4,115,000) in the prior year. The net loss for the quarter was $(2,549,000), down from $(3,994,000) in the same quarter of 2023.

For the six months ended September 30, 2024, the company reported a net loss of $(5,893,000), an improvement from $(8,022,000) in the prior year. The decrease in losses was attributed to lower operating expenses, with total research and development expenses falling to $2.4 million from $3.0 million, and selling, general, and administrative expenses decreasing to $3.7 million from $5.4 million. The company also noted a significant reduction in cash used in operating activities, which was $(5.6 million) compared to $(8.5 million) in the same period of 2023.

Organovo's cash and cash equivalents increased to $3.2 million as of September 30, 2024, from $2.9 million at the end of the previous fiscal period. The company raised approximately $5.9 million through financing activities during the six months, primarily from the issuance of common stock.

Strategically, Organovo formed the Mosaic Cell Sciences division in February 2024 to optimize its supply chain for primary human cells, aiming to reduce research and development costs. The company is also preparing to initiate a Phase 2a clinical trial for FXR314 in UC in 2025, following positive Phase 2 data released in April 2024.

Despite these advancements, the company faces challenges, including a notice from Nasdaq regarding non-compliance with minimum bid price requirements, and substantial doubt about its ability to continue as a going concern. The accumulated deficit as of September 30, 2024, stood at approximately $345.6 million, underscoring the financial pressures the company faces as it seeks to advance its clinical programs and secure additional funding.