If You Invested in Organovo Holding (ONVO)

Organovo Holdings, Inc. (Nasdaq: ONVO) is described as a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), including ulcerative colitis. According to company disclosures, Organovo develops drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company also states that it has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease.

In multiple company announcements, Organovo highlights its work with 3D human cellular models of both Crohn’s disease and ulcerative colitis. These models, made with primary cells from IBD patients, are used by the company to evaluate therapeutic opportunities. Organovo believes that targets and therapies it finds attractive based on predictive data from these models have a greater chance of success in clinical trials.

Organovo has also described a lead clinical stage drug candidate, FXR314, which has been investigated in areas such as inflammatory bowel disease and metabolic liver disease. Company communications note that FXR314 has been evaluated in a Phase 2 study in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH), with reported results related to liver fat reduction, safety, and tolerability. Organovo has further stated that FXR314 demonstrated potential in 3D human cellular models of Crohn’s disease and ulcerative colitis, including effects on epithelial barrier function and fibrotic activity, and that it showed a combination therapeutic benefit when paired with an approved Janus kinase (JAK) inhibitor in certain preclinical studies.

In addition to its drug development activities, Organovo has a long-standing association with 3D bioprinting and 3D human tissue technologies. Earlier descriptions of the business reference the design and creation of functional, three-dimensional human tissues for medical research and therapeutic applications, and collaborations with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have been described as having the potential to accelerate the drug discovery process by enabling treatments to be developed using human-relevant models.

More recently, Organovo announced that it will carry forward its 3D bioprinting and legacy technology under a new name. The company disclosed that it will adopt the name VivoSim Labs, Inc. and that a name change of the company to VivoSim Labs, Inc. will be effective on April 24, 2025. The announcement further states that 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, while continuing to be listed on the same market.

In connection with this transition, a separate announcement by VivoSim Labs, Inc. describes plans to provide technologies aimed at drug discovery and development, including liver and intestinal toxicology insights using models referred to as new approach methodologies (NAM). These disclosures state that VivoSim’s models include physical organoid wet lab models of liver and intestine made using cells from human donors, and that the company is developing artificial intelligence (AI) models in its NAMkind services suite, trained on proprietary real-world data from organoid models made from human donor cells. These descriptions indicate that the legacy 3D human tissue and bioprinting expertise from Organovo is intended to be carried forward under the VivoSim Labs identity.

Organovo has also reported various corporate actions related to its capital structure and listing status. The company announced a reverse stock split of its issued and outstanding common stock at a ratio of 1-for-12, with effectiveness at a specified time and trading on a reverse split-adjusted basis on the Nasdaq Capital Market under the symbol ONVO. The stated purpose of this reverse stock split was to regain compliance with the minimum bid price requirement of $1.00 per share for continued listing on the Nasdaq Capital Market.

In separate disclosures, Organovo reported on cash and cash equivalents, net cash utilization, and expectations regarding its continued listing on the Nasdaq Capital Market, including references to the minimum bid price requirement and stockholder equity requirements. The company also described capital raising activities, such as the issuance of additional shares of common stock in conjunction with warrant exercises and at-the-market stock sales.

Organovo’s communications have also described a transaction in which Eli Lilly and Company agreed to acquire Organovo’s FXR program, including the lead asset FXR314. The company stated that it would receive an upfront payment and may receive future milestone payments as FXR314 achieves key regulatory and commercial milestones, and that Lilly would acquire all commercial and intellectual property rights to the FXR program for worldwide development and be responsible for future clinical development.

Overall, based on available disclosures, Organovo (historically trading under the ticker ONVO) is presented as a clinical stage biotechnology company that combines proprietary 3D human tissue technologies with drug development efforts, particularly in inflammatory bowel disease and related areas. The company has also indicated that its 3D bioprinting and legacy technology will be carried forward under the name VivoSim Labs, Inc., with trading of its common stock transitioning from the ONVO ticker to the VIVS ticker on the Nasdaq Capital Market as of April 24, 2025.

Business focus and technology

According to repeated company descriptions, Organovo’s business focus centers on:

• Developing drugs that are demonstrated to be effective in 3D human tissues as candidates for drug development.
• Using proprietary technology to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease.
• Employing 3D human cellular models of IBD, including Crohn’s disease and ulcerative colitis, made with primary cells from IBD patients, to evaluate therapeutic opportunities.
• Leveraging these models to identify targets and therapies that the company believes have a greater chance of success in clinical trials.

Earlier descriptions of Organovo also emphasize its role in designing and creating functional, three-dimensional human tissues for medical research and therapeutic applications, and in collaborating with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These models are described as having the potential to accelerate drug discovery.

Corporate evolution and ticker transition

Organovo announced that it will carry forward its 3D bioprinting and legacy technology as VivoSim Labs, Inc.. The company has stated that a name change to VivoSim Labs, Inc. will be effective on April 24, 2025, and that its common stock will begin trading on the Nasdaq Capital Market under the new ticker symbol VIVS at market open on that date. The company also indicated that its common stock will continue to be listed on the Nasdaq Capital Market and that no action is required by existing stockholders with respect to the name and ticker symbol change.

A related announcement by VivoSim Labs, Inc. describes the company’s emergence from stealth mode and its intention to provide technologies for drug discovery and development, including liver and intestinal toxicology insights using NAM models, organoid models made from human donor cells, and AI-based computational modeling. These disclosures explicitly state that VivoSim will offer models and services based on human organ model-based lab testing and real-world human data, and that its NAMkind services suite will use AI models trained on proprietary data from organoid models.

Capital markets and corporate actions

Organovo has reported several capital markets and corporate actions in its public communications:

• A 1-for-12 reverse stock split of its issued and outstanding common stock, with the stock continuing to trade on the Nasdaq Capital Market under the symbol ONVO and a new CUSIP number after the split. The company stated that this reverse stock split was intended to help regain compliance with the Nasdaq Capital Market’s minimum bid price requirement.
• The issuance of additional shares of common stock in conjunction with warrant exercises and at-the-market stock sales, with aggregate gross proceeds described in the company’s announcement.
• Updates on Nasdaq continued listing requirements, including references to the minimum bid price requirement of $1.00 per share and minimum stockholder equity requirements, and the company’s belief that it has met these requirements over specified trading periods.
• Disclosure of preliminary cash and cash equivalents balances and net cash utilization for a fiscal period, with the caveat that such preliminary financial information may be adjusted following customary annual audit procedures.

Pipeline transactions and partnerships

Organovo has described a transaction in which Eli Lilly and Company will acquire its FXR program, including the lead asset FXR314. The company’s announcements state that:

• Organovo will receive an upfront payment and may receive future milestones as FXR314 achieves key regulatory and commercial milestones.
• Lilly is acquiring all commercial and intellectual property rights to Organovo’s FXR program for worldwide development.
• Lilly will be responsible for all future clinical development of FXR314.

Organovo has also referenced potential future milestone payments associated with the anticipated start of a Phase 2 clinical trial for the FXR agonist that it sold, and has indicated that it may receive additional milestones up to an aggregate amount as FXR314 advances in the clinic, although the company does not control the clinical development of these products.

Status of ONVO ticker

Based on the company’s own announcement, the ONVO ticker represents the historical trading symbol of Organovo Holdings, Inc. up to the effective date of the name and ticker change. The company has stated that, effective April 24, 2025, its common stock will begin trading on the Nasdaq Capital Market under the new ticker symbol VIVS, while continuing to be listed on the same market. For investors and researchers, this means that ONVO serves as the historical symbol for Organovo prior to the transition to VivoSim Labs, Inc. and the VIVS ticker.