ONVO News & Events

Organovo reported preliminary unaudited cash for the fiscal year ending March 31, and net cash utilization results for the fiscal fourth quarter of 2025. The Company expects to release full fiscal second-quarter financial results the week of June 9-13, 2025. The Company also gave guidance that, as its common stock has been trading above the $1.00 minimum bid price required, it expects to meet the requirements for continued listing on the Nasdaq Capital Market should the closing price of its common stock remain at similar levels. The Company's preliminary cash and cash equivalents balance was approximately $11.3M as of the end of the fiscal year on March 31, 2025. Organovo's preliminary net cash utilization during the fourth quarter from January 1, 2025 to March 31, 2025 was approximately $2M - $2.2M. The Company further clarified it expects to meet all requirements for continued listing on the Nasdaq Capital Market. The Company's common stock has closed above the $1.00 minimum bid price requirement since March 21, 2025 and believes it has met the minimum stockholder equity requirements of continued listing, pending Nasdaq confirmation. Nasdaq requires a minimum of 10 consecutive trading days where the stock closes at a minimum bid price of $1.00, and the Company has closed above $1.00 since March 21, 2025. Although the Company does not control the clinical development of products for which it may receive milestone payments, it currently reasonably expects to receive a $5M milestone payment within the next 12 months associated with the anticipated start of a Phase 2 clinical trial for the FXR agonist that it recently sold. In connection with the sale of the FXR agonist, the Company may receive future milestones of up to an aggregate of $50M, which is inclusive of the $5M milestone payment that would be received upon the commencement of a Phase 2 clinical trial.

Organovo Holdings (ONVO) provided a business update. With the closing of the sale of its FXR Program to Lilly (LLY), Organovo has received upfront payments and anticipates future milestone payments. When combined with funding from previously reported warrant exercises and additional monies raised through equity sales, the company believes it is well-positioned to repeat the FXR314 success with another IBD opportunity. The company expects an overall decrease in expenditures in the coming year, due to the elimination of costs related to pushing FXR314 into and through the clinic, as well as from eliminating spending relating to regulatory issues, drug supply, intellectual property, and other aspects of the FXR program. Organovo now expects to establish an operating cadence that leverages existing capital at a rate sufficient to push through the end of FY2026. For clarity, capital from future milestone payments expected as FXR314 advances in the clinic would be in addition to this, allowing for longer runway or increased expenditures. The Company expects to report its full year financials for the fiscal year ended March 31, 2025, on or about June 6-10, 2025. Organovo's 3D human cellular models of both Crohn's disease and ulcerative colitis are used by the company to evaluate therapeutic opportunities. Organovo believes that targets and therapies that it finds attractive based on predictive date from these models, made with primary cells from IBD patients, have a greater chance of success in clinical trials.