Revenue 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].

Core Insights - Organovo Holdings, Inc. has appointed Norman Staskey as Chief Financial Officer, bringing over 25 years of experience in capital markets and M&A transactions, particularly in the biotech sector [1][2][3] Company Developments - The company’s lead drug, FXR314, has shown promising results in treating liver fibrosis and inflammatory bowel disease (IBD), with significant reductions in liver fat content and improvements in epithelial barrier function in clinical studies [3][4][5] - FXR314 is expected to enter a Phase 2 study targeting moderate to severe ulcerative colitis, with potential for both monotherapy and combination therapy applications [5][6] Technology and Innovation - Organovo utilizes proprietary technology to develop three-dimensional (3D) human tissues that closely mimic native human tissue, enhancing drug development processes [6]

Core Insights - Organovo Holdings, Inc. has appointed Norman Staskey as Chief Financial Officer, bringing over 25 years of experience in capital markets and M&A transactions, particularly in the biotech sector [1][2][3] Company Developments - The company’s lead drug, FXR314, has shown promising results in treating liver fibrosis and inflammatory bowel disease (IBD), with significant reductions in liver fat content and improved epithelial barrier function in clinical studies [3][4][5] - FXR314 is expected to enter a Phase 2 study for moderate to severe ulcerative colitis, with potential for both monotherapy and combination therapy applications [5][6] Research and Clinical Trials - In 2024, Organovo demonstrated FXR314's effectiveness in 3D human cellular models for Crohn’s disease and ulcerative colitis, showing strong performance in improving key disease measures [4][5] - The Phase 2 study results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) were presented at a major conference, highlighting its safety profile and efficacy [3][4]

Core Insights - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing treatments for inflammatory bowel disease (IBD) including ulcerative colitis [1] - The company's lead drug FXR314 was presented at The Liver Meeting, highlighting its potential in treating metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Study Results - A Phase 2 study of FXR314 involved 214 patients, randomized to receive either 3 mg or 6 mg of FXR314, or a placebo [3] - FXR314 demonstrated a statistically significant reduction in liver fat content, with a 22.8% reduction for the 3 mg group (p=0.0010) and 17.5% for the 6 mg group (p=0.0267), compared to 6.1% in the placebo group [4] - The proportion of subjects achieving over 30% reduction in liver fat was 29.2% for the 3 mg group and 32.2% for the 6 mg group, compared to 9.5% in the placebo group [4] Safety Profile - FXR314 was found to be safe and well tolerated, with treatment-emergent adverse events mostly mild to moderate [5] - The incidence of pruritus was low, with 2.8% in the 3 mg group, 4.2% in the 6 mg group, and 2.8% in the placebo group [5] - Drug-related treatment discontinuation rates were low and similar across all groups [5] Future Prospects - Dr. Lawitz expressed optimism about FXR314's unique profile, indicating potential for further evaluation in treating MASH [6] - Organovo is also developing drugs that are effective in three-dimensional human tissues, with FXR314 being a candidate for both inflammatory bowel disease and metabolic liver disease [6]

SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its lead clinical stage drug, FXR314 will be featured in an oral presentation at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The presentation, by Dr. Eric Lawitz of the Texas Liver Institute, will de ...

Company Overview - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing novel treatment approaches for inflammatory bowel disease (IBD), including ulcerative colitis [1][3] - The company utilizes proprietary technology to create three-dimensional (3D) human tissues that replicate key aspects of native human tissue [3] Product Development - The lead molecule, FXR314, is currently advancing towards Phase 2 investigation for IBD and has potential applications in metabolic liver disease and oncology [3] - The company aims to demonstrate the efficacy of FXR314 in its Phase 2a trial, building on strong preclinical results and promising data from 3D human models of ulcerative colitis and Crohn's disease [2] Market Context - The market for IBD treatments is active, with significant mergers and acquisitions, exemplified by Lilly's acquisition of Morphic for $3.2 billion following strong Phase 2a results [2] - The company is optimistic about its near-term opportunities to showcase the value of FXR314 in the competitive landscape of IBD treatments [2]

SAN DIEGO, July 16, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announced that Executive Chairman Keith Murphy presented on the company's near and long-term outlook, operational plans, at the Jones Trading Healthcare Conference in Encinitas, CA. The webcast was recorded and can be viewed at https://wsw.com/webcast/jones/onvo/18487 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File No. 001-35996 ORGANOVO HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of in ...

SAN DIEGO, May 21, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company's lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical m ...

SAN DIEGO, May 21, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company's lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical m ...