Organovo(ONVO)2025-02-19 14:00Revenue Performance - For the three months ended December 31, 2024, royalty revenue increased to $15,000 from $5,000, representing a 200% increase year-over-year[137]. - Product revenue for the same period was $9,000, a 100% increase compared to $0 in the prior year[137]. - For the nine months ended December 31, 2024, total revenue was $0.1 million, with royalty revenue decreasing by $12,000, or 15%, to $68,000, while product revenue increased by $25,000, or 100%[144][145]. Research and Development - Research and development expenses rose to $1.78 million, an increase of $346,000 or approximately 24% from the previous year[141]. - Total research and development expenses for the nine months ended December 31, 2024, were $4.2 million, a decrease of $0.3 million, or approximately 6%, from the prior year period[148]. - Total research and development expenses included a $369,000 increase in material-related costs, primarily due to the write-off of Mosaic's inventory[141]. - The company intends to continue advancing the clinical drug development of FXR314 and its 3D models for target discovery and drug development[141]. - FXR314 has received FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis[122]. - The company plans to initiate a Phase 2a clinical trial for FXR314 in ulcerative colitis in 2025[123]. - The company plans to start a Phase 2a clinical trial for FXR314 in ulcerative colitis (UC) in the calendar year 2025[152]. Expenses - The cost of revenues for the three months ended December 31, 2024, was $2,000, compared to $0 in the prior year[139]. - Total selling, general and administrative expenses for the three months ended December 31, 2024, were approximately $1.7 million, a decrease of $0.5 million, or approximately 24%, compared to the prior year period[142]. - Total selling, general and administrative expenses for the nine months ended December 31, 2024, were approximately $5.4 million, a decrease of $2.3 million, or approximately 29%, compared to the prior year period[149]. - The company expects total operating expenses for the fiscal year ending March 31, 2025, to be between $12.0 million and $14.0 million[159]. Cash Flow and Financing - Cash and cash equivalents at December 31, 2024, were approximately $1.2 million, with an accumulated deficit of approximately $349.0 million[153]. - Net cash used in operating activities for the nine months ended December 31, 2024, was approximately $7.4 million, a decrease of $4.6 million from $12.0 million used in the prior year[155]. - Net cash provided by financing activities was $5.7 million for the nine months ended December 31, 2024, compared to $1.2 million for the same period in 2023[157]. - The company has filed a new shelf registration statement to register $150.0 million of common stock, preferred stock, debt securities, warrants, and units[160]. - The company filed a prospectus for the 2024 Shelf, allowing for the sale of common stock with an aggregate offering price of up to $2,605,728[162]. - During the three months ended December 31, 2024, the company issued 52,628 shares in ATM offerings for net proceeds of approximately less than $0.1 million[163]. - As of December 31, 2024, the company has sold a total of 1,441,630 shares in ATM offerings under the 2024 ATM Prospectus, generating gross and net proceeds of approximately $1.8 million[163]. - The company priced a public offering on May 8, 2024, for 1,562,500 shares at a combined public offering price of $0.80 per share, resulting in net proceeds of approximately $4.5 million[164]. - A registration statement was filed on October 25, 2024, for a potential offering of shares and warrants, with proceeds expected to be used for working capital and general corporate purposes[165]. - The company has approximately $100.0 million available for future offerings under the 2024 Shelf[163]. - As of December 31, 2024, approximately $0.8 million is available for future offerings through the ATM program under the 2024 ATM Prospectus[163]. - The company acknowledges that failure to obtain adequate financing could adversely affect its ability to operate as a going concern[167]. - The company may face significant dilution to existing stockholders if additional funds are raised through equity securities[167]. Compliance and Operations - The company received a Nasdaq minimum bid notice on July 18, 2024, indicating non-compliance with the minimum bid price requirement[131]. - The Mosaic Cell Sciences division, which provided human cells for research, ceased operations in the third quarter of fiscal 2025[130]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[168].