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, 2025 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 VIVOSIM LABS, INC. (Exact name of registrant as specified in its charter) | Delaware 27-1488943 | | | --- | --- | | (State or other j ...

SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (NASDAQ:VIVS) (the "Company") announced that it has emerged from stealth mode to dramatically impact drug discovery and development. VivoSim will offer liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of the FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA's push to phase out animal models, announced on April 10, is expec ...

SAN DIEGO, April 23, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (the “Company”) announced that it will carry forward its 3D bioprinting and legacy technology as VivoSim Labs, Inc. A name change of the Company to VivoSim Labs, Inc. will be effective on April 24, 2025, and the Company’s common stock will begin trading on the Nasdaq Capital Market under the new ticker symbol “VIVS” at market open on April 24, 2025. No action is required by existing stockholders with respect to the name and ...

Financial Performance and Compliance - Organovo Holdings reported preliminary unaudited cash for the fiscal year ending March 31, 2025, and expects to meet all requirements for continued listing on the Nasdaq Capital Market[6]. - The company had stockholders' equity of $364,000 as of December 31, 2024, which did not meet Nasdaq's minimum requirement of $2,500,000[10]. - Following the asset sale and other financial activities, the company believes it has a minimum of $2,500,000 in stockholders' equity as of April 2, 2025[12]. - The company received a notice from Nasdaq indicating it did not meet the minimum bid price requirement of $1.00 per share[10]. - The company presented its compliance plan to the Nasdaq Hearings Panel on February 27, 2025, and was granted an exception until April 15, 2025, to demonstrate compliance[10]. - Forward-looking statements indicate potential risks and uncertainties regarding compliance with Nasdaq listing requirements[13]. Asset Sale - On March 25, 2025, Organovo completed the sale of its FXR program to Eli Lilly for an upfront cash payment of $10.0 million, with potential milestone payments of up to $50.0 million[11]. Financial Strategy - The company has engaged in warrant exercises and sales of common stock to improve its financial position[12]. - Organovo's financial information is subject to adjustments based on the completion of customary annual audit procedures[6]. Company Classification - The company is classified as an emerging growth company under the Securities Act[5].

SAN DIEGO, April 02, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), today reported preliminary unaudited cash for the fiscal year ending March 31, 2025, 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 Compa ...

Core Insights - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing novel treatment approaches for inflammatory bowel disease (IBD) [1] Group 1: Business Update - The company has completed the sale of its FXR Program to Lilly, receiving upfront payments and anticipating future milestone payments [2] - Organovo expects a decrease in expenditures in the coming year due to the elimination of costs associated with the FXR314 program, allowing for a more efficient use of existing capital [2] - The company plans to report its full year financials for the fiscal year ended March 31, 2025, around June 6-10, 2025 [2] Group 2: Research and Development - Organovo utilizes 3D human cellular models of Crohn's disease and ulcerative colitis to evaluate therapeutic opportunities, believing these models increase the likelihood of success in clinical trials [3] - In 2024, FXR314 showed strong performance in improving epithelial barrier function and fibrotic activity in ulcerative colitis models, as presented at the Crohn's and Colitis Congress [3] - FXR314 demonstrated synergistic benefits when paired with an approved Janus kinase (JAK) inhibitor, indicating potential for combination therapies [3] Group 3: Company Overview - Organovo is developing drugs that are effective in 3D human tissues, utilizing proprietary technology to create tissues that mimic native human tissue characteristics [4]

Core Insights - Organovo Holdings, Inc. has successfully closed the sale of its FXR program, including the lead asset FXR314, to Eli Lilly and Company on March 25, 2025 [1][2] Company Overview - Organovo is a clinical stage biotechnology company focused on developing drugs that are effective in three-dimensional (3D) human tissues, utilizing proprietary technology to create 3D human tissues that replicate key aspects of native human tissue [3]

Core Points - Organovo Holdings, Inc. announced a 1-for-12 reverse stock split effective March 20, 2025, to comply with Nasdaq's minimum bid price requirement of $1.00 per share [1][5]. - The reverse stock split will reduce the number of issued and outstanding shares from approximately 21.4 million to about 1.8 million, without changing the par value of $0.001 per share [3][5]. - The company will continue trading under the symbol "ONVO" on the Nasdaq Capital Market with a new CUSIP number [2]. Company Information - Organovo is a clinical stage biotechnology company focused on developing novel treatment approaches for inflammatory bowel disease (IBD) and utilizes proprietary technology to create 3D human tissues for drug development [7]. - The reverse stock split was approved by stockholders at the annual meeting on November 20, 2024, allowing the board to select a split ratio between 1-for-5 and 1-for-20 [5]. - Following the reverse split, the number of shares available under equity incentive plans will be proportionately adjusted [4].

Company Overview - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing novel treatment approaches for inflammatory bowel disease (IBD) [1] - The company utilizes proprietary technology to create three-dimensional (3D) human tissues that replicate key aspects of native human tissue composition, architecture, function, and disease [2] Recent Developments - Organovo announced the issuance of an additional 2,967,144 shares of common stock due to warrant exercises by investors and at-the-market stock sales [1] - The gross proceeds from these activities are expected to total approximately $2.3 million before financial advisory fees and commissions [1] - Following this issuance, the total number of outstanding shares of common stock will be 20,421,617 [1]

Core Insights - Organovo Holdings, Inc. is set to be acquired by Eli Lilly and Company, specifically for its FXR program, which includes the lead asset FXR314 [1][2] - This acquisition represents a significant milestone in advancing treatments for inflammatory bowel disease (IBD) using Organovo's proprietary 3D human tissue models [2] Company Overview - Organovo is a clinical stage biotechnology company focused on developing drugs that are effective in three-dimensional (3D) human tissues [3] - The company utilizes proprietary technology to create 3D human tissues that replicate key aspects of native human tissue composition, architecture, function, and disease [3] Transaction Details - Under the terms of the acquisition, Organovo will receive an upfront payment along with milestone payments as FXR314 meets key regulatory and commercial milestones [2] - Eli Lilly will acquire all commercial and intellectual property rights to Organovo's FXR program for worldwide development [2]