Organovo Holdings, Inc. (ONVO): Business Model Canvas [Dec-2025 Updated]

You're looking at a company that has made a sharp pivot, and honestly, understanding the new engine of Organovo Holdings, Inc. is key to valuing their next move. Forget the old 3D printing service days; as of late 2025, Organovo Holdings, Inc. is running a lean, asset-developer model, banking on high-value drug licensing, like that \$10.0 million upfront payment from Eli Lilly. With cash reserves around \$11.3 million as of March 31, 2025, and a clear focus on de-risking Inflammatory Bowel Disease (IBD) candidates, this canvas breaks down exactly how they plan to generate future milestone payments and royalties. Dive in below to see the nine building blocks of this focused, clinical-stage biotech strategy.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Key Partnerships

You're looking at the structure of VivoSim Labs, Inc., the entity carrying forward the legacy of Organovo Holdings, Inc. (ONVO) as of late 2025. The partnership landscape is defined by a major recent divestiture and ongoing strategic relationships that underpin the company's runway.

The most significant recent partnership event was the successful sale of the FXR Program, including the lead asset FXR314, to Eli Lilly and Company on March 25, 2025. This transaction provides immediate capital via an upfront payment and establishes a stream for future milestone payments contingent on FXR314 achieving key regulatory and commercial goals. This deal, combined with other capital sources, is expected to extend the operational runway through the end of FY2026, excluding those future milestones.

The financial impact of this shift is clear in the balance sheet update as of March 31, 2025, where preliminary cash and cash equivalents stood at approximately $11.3 million. Furthermore, the company anticipates a decrease in expenditures due to the elimination of costs related to pushing FXR314 through the clinic, regulatory issues, and drug supply.

Here's a look at the financial context surrounding the company leading up to and following this major transaction:

The strategy for future value creation is clearly tied to leveraging the success of the Lilly deal to repeat the process with other drug assets, as stated by the Executive Chairman. This suggests a continued focus on partnerships for asset licensing.

The foundation for these large pharmaceutical and biotech company deals is built on prior engagements that validated the technology's utility in drug discovery. These collaborations are pivotal for unlocking new avenues for innovative solutions.

• - Multiple collaborative research agreements with pharmaceutical corporations have been entered into historically.
• - The company has secured five federal grants in the aggregate amount of approximately $955,000.
• - Past agreements include a non-exclusive license for the foundational patent portfolio with BICO Group AB in February 2022.

The commitment to research through academic partnerships remains a core element, providing external validation and research scope expansion. These relationships help VivoSim Labs, Inc. tailor its going-forward business plan.

Strategic collaborations with academic institutions have historically included:

• - Collaboration agreement with the Knight Cancer Institute at Oregon Health & Science University starting in January 2013.
• - Expansion of a research agreement with United Therapeutics in November 2012, originally from October 2011.

The legacy 3D bioprinting technology is now explicitly carried forward by VivoSim Labs, Inc., following the corporate rebranding effective April 24, 2025, when the ticker changed from ONVO to VIVS. This entity is the direct successor responsible for leveraging the core technology platform across various applications.

Key dates in the transition to VivoSim Labs, Inc. include:

• - Rebranding to VivoSim Labs, Inc. effective April 24, 2025.
• - New ticker symbol on Nasdaq: VIVS.
• - The company's common stock continues listing on the Nasdaq Capital Market.

Finance: draft 13-week cash view by Friday.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Key Activities

Developing novel drug candidates for Inflammatory Bowel Disease (IBD).

Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing novel treatment approaches in IBD. The company sold its FXR Program (FXR314) to Eli Lilly, receiving an upfront payment of $10.0 million, with $9.0 million received and $1.0 million in escrow, plus potential milestones up to $50.0 million. Organovo expects to repeat the success of the FXR314 asset with another IBD opportunity. The company previously aimed to have multiple IND (Investigational New Drug) filings by 2025. The company's 3D human cellular models are used to evaluate therapeutic opportunities in both Crohn's disease and ulcerative colitis.

Creating and validating 3D human cellular models of IBD.

The company's proprietary technology is used to build functional 3D human tissues. Organovo Holdings, Inc.'s 3D human cellular models of both Crohn's disease and ulcerative colitis are used to evaluate therapeutic opportunities. The Crohn's disease model was utilized to identify specific gene targets, where modulating certain disease-driver genes reproducibly reduced disease in the 3D tissue model. Organovo plans to tailor its going forward business plan to leverage capital to pursue such opportunities.

Conducting preclinical research and development (R&D).

The company's ongoing cash requirements include research and development expenses. Organovo Holdings, Inc. expected its total operating expense for the fiscal year ending March 31, 2025, to be between $12.0 million and $14.0 million. The preliminary net cash utilization during the fourth quarter of fiscal 2025 (January 1, 2025 to March 31, 2025) was approximately $2.0 - $2.2 million. The company expects to establish an operating cadence that leverages existing capital at a rate sufficient to push through the end of FY2026. The net income from continuing operations reflected a shortfall of $3.447M in a recent period. The company anticipates a $5 million milestone payment within the coming year tied to the start of a Phase 2 clinical trial for the FXR program.

Securing and managing intellectual property and patent portfolios.

The success of Organovo Holdings, Inc. depends in large part on protecting its proprietary bioprinting technologies and engineered tissue products. The company plans to utilize licensing revenue from its patent strength to help fund development costs of new drugs. The company relies on a combination of patents, trademarks, trade secrets, and contractual mechanisms.

The financial underpinning for sustaining these key activities is detailed below:

• Preliminary cash and cash equivalents balance was approximately $11.3 million as of March 31, 2025.
• The company's gross margins were reported near 96% in one financial overview.
• Financing activities in FY2025 to date included ATM proceeds of approximately $1.7 million through December 31, 2024.
• A May 2024 public offering provided net proceeds of approximately $4.5 million.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Key Resources

You're looking at the core assets that underpin Organovo Holdings, Inc.'s (now VivoSim Labs, following a rebranding around April 2025) ability to execute its drug development strategy. These aren't just items on a balance sheet; they are the specialized tools and intellectual property that create its value proposition in the 3D biology space.

The most tangible financial resource available from the latest reporting period is the cash position. Organovo Holdings, Inc. reported preliminary cash and cash equivalents of approximately $11.3 million as of March 31, 2025. This figure was bolstered by the upfront consideration from the sale of its FXR program to Eli Lilly, which included $10.0 million total consideration, with $9.0 million received at closing and $1.0 million placed in escrow. The preliminary net cash utilization for the fourth quarter ending March 31, 2025, was approximately $2.0 - $2.2 million. To give you a snapshot of the company's overall market valuation tied to these resources, the market capitalization as of December 2025 was reported at $3.67 Million USD.

The intellectual property surrounding the core technology is critical. This includes the proprietary NovoGen Bioprinters and the associated technology patents. The NovoGen MMX Bioprinter itself received recognition as one of TIME Magazine's "Best Inventions of 2010." The patent portfolio is actively maintained and expanded; for instance, a granted patent, US12037603B2, outlining methods for tissue fabrication, was issued on July 16, 2024, with a patent date of March 18, 2025. The company has historically held numerous patent applications globally covering bioprinter features and tissue fabrication methods.

The specialized scientific and clinical R&D personnel are the engine driving the use of these assets. While headcount figures fluctuate, a snapshot from the period leading up to the rebranding indicated a small, focused team. As of a filing context around 2024/2025, the employee count was listed as 13. This contrasts with a slightly older figure from June 1, 2022, which detailed 18 employees, 9 of whom were full-time, supplemented by expert consultants. The R&D focus is clearly on translating these models into clinical assets, evidenced by the expectation to file an Investigative New Drug (IND) application by the end of 2025 for a novel drug target validated in their Crohn's disease 3D tissue models.

The proprietary 3D human cellular models themselves represent a unique, non-financial resource. These models are specifically developed to mimic human disease states for superior drug testing. Key assets include:

• Proprietary 3D human tissue models of Crohn's disease and ulcerative colitis (UC).
• Models that have demonstrated the ability to show improved epithelial barrier function and fibrosis reduction in response to therapeutic candidates like FXR314.
• The technology is designed to use primary cells from donors with the disease, which the company positions as a "translational research gold standard" superior to animal models.

Here's a quick look at the tangible and intangible assets:

The company's ability to generate future revenue hinges on advancing these models, especially given the recent monetization of the FXR program. Finance: draft 13-week cash view by Friday.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Value Propositions

You're looking at the core value Organovo Holdings, Inc. delivered to its partners and the market as of late 2025, following the major strategic shift earlier in the year. The primary value proposition centers on the predictive power of its proprietary 3D human tissue platform.

De-risking drug development with highly predictive human tissue models.

Organovo Holdings, Inc. offers models that are believed to have a greater chance of success in clinical trials because they are built with primary cells from IBD patients, specifically for Crohn's disease and ulcerative colitis. This capability was instrumental in positioning the FXR program for a significant return to investors, as demonstrated by the 2024 data showing FXR314 improved epithelial barrier function and fibrotic activity in ulcerative colitis models.

High-value, clinical-stage drug candidates for IBD (e.g., FXR program).

The value proposition here is the successful monetization of a clinical-stage asset. Organovo Holdings, Inc. completed the sale of its FXR program, including the lead asset FXR314, to Eli Lilly and Company on March 25, 2025. This validated the company's ability to advance candidates through the model stage to a point of significant external value capture.

Here's a quick look at the financial realization from this core asset:

Faster, more accurate preclinical testing than traditional animal models.

The platform's value is rooted in its emulation of native human tissue composition, architecture, and function. While specific 2025 comparative metrics are not available, the historical data on liver tissue showed extended durability, with functionality sustained through 60 days post-implantation in diseased animal models, an increase from 28 days in earlier preclinical studies. This speaks to the increased duration and fidelity of the human tissue models over traditional methods.

Potential for significant return on investment for licensing partners.

The successful exit of the FXR program confirms the potential for significant return. Organovo Holdings, Inc. now expects to establish an operating cadence that leverages existing capital at a rate sufficient to push through the end of FY2026, with future milestone payments being additive to this runway. The company believes it is well-positioned to repeat the FXR success with another IBD opportunity.

The current operational snapshot reflects the post-deal focus:

• Preliminary Net Cash Utilization (Q4 FY2025): $2.0 - $2.2 million
• Market Capitalization (December 2025): $3.67 Million USD
• Q3 2025 Revenue: $0.03M
• Q3 2025 Gross Profit: -$0.03M

The value proposition is the ability to generate substantial, non-dilutive capital events from proprietary pipeline assets validated in-house.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Customer Relationships

You're looking at how Organovo Holdings, Inc. (ONVO) manages its most critical external relationships, which, as of late 2025, are heavily weighted toward strategic, high-value transactions rather than broad customer bases. This is classic, late-stage biotech relationship management, focusing on deep, specific partnerships.

Highly personalized, long-term strategic partnerships for asset licensing.

The relationship structure is defined by these singular, massive deals. Look no further than the asset sale of the FXR program, including lead asset FXR314, to Eli Lilly and Company (Lilly), which closed on March 25, 2025. This wasn't a simple vendor transaction; it was a complete transfer of worldwide commercial and intellectual property rights, demanding a highly personalized approach to negotiation and integration. The terms themselves define the long-term nature of this relationship.

Here's a quick look at the structure of that key asset monetization event:

Also, remember that ONVO maintains existing licensing arrangements, such as the paid-up, worldwide, irrevocable, perpetual, non-exclusive license granted to Viscient back on November 6, 2019, concerning certain bioprinter devices and methods. These existing, older agreements also require ongoing, personalized management to ensure royalty streams, if any, are respected.

Direct negotiation and management of complex collaboration agreements.

The complexity is inherent in the structure of these deals, which involve contingent payments tied to clinical progress. Managing the Lilly relationship means tracking the anticipated start of a Phase 2 clinical trial for the FXR agonist, which is the trigger for that expected $5 million milestone payment within the next 12 months. This requires direct, ongoing communication with Lilly's development teams, not just legal or finance departments. The negotiation process for the FXR sale itself was complex enough to warrant an Asset Purchase Agreement filed on February 25, 2025. It's all about managing the dependencies built into the contract.

• Track Phase 2 start date for FXR agonist.
• Manage the $1.0 million escrow release timing.
• Ensure compliance with the Viscient license terms.
• Monitor all $50.0 million potential milestones.

Investor relations focused on communicating clinical and financial milestones.

For investors, the relationship is managed through precise communication of financial health and regulatory hurdles. You saw this play out in early 2025 when the company communicated its preliminary cash position of approximately $11.3 million as of March 31, 2025, alongside a moderated net cash utilization of $2.0 - $2.2 million for the fourth quarter. This financial transparency directly addresses investor concerns about runway.

Furthermore, investor communications centered on regaining Nasdaq compliance. The market was keenly aware of the 1-for-12 reverse stock split effective March 20, 2025, which reduced outstanding shares from approximately 21.4 million to about 1.8 million post-split. This action was explicitly tied to the clinical/financial milestone of maintaining a stock bid price above $1.00 for 10 consecutive days, a level sustained since March 21, 2025. The expectation to meet the minimum stockholders' equity requirement of $\geq$$2.5 million was also a key communication point pending Nasdaq confirmation. Finance: draft the Q2 2025 cash flow projection by next Wednesday.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Channels

You're looking at how Organovo Holdings, Inc. (ONVO) gets its value proposition-advanced 3D human tissue models for drug development-into the hands of customers, especially given their strategic pivot away from therapeutics toward ex-vivo services following the November 2019 shift. The channels reflect a high-touch, partnership-driven approach.

Direct outreach by executive and business defintely development teams.

This channel is heavily reliant on executive-level engagement, which is logical when dealing with multi-million dollar asset sales and strategic collaborations. The most significant recent event demonstrating the success of this high-level channel was the monetization of their pipeline assets. For instance, the FXR program, including FXR314, was sold to Eli Lilly and Company on March 25, 2025. This deal structure provides concrete financial outcomes that flow through these direct channels.

• Upfront payment from Eli Lilly: $10.0 million total consideration.
• Cash received at closing (March 2025): $9.0 million.
• Amount placed in escrow (for 15 months): $1.0 million.
• Potential future milestone payments: Up to $50.0 million.

The company's recent financial health is tied to these direct deals. Preliminary cash and equivalents as of March 31, 2025, stood at approximately $11.3 million, bolstered by this transaction. The net cash utilization for the quarter was moderated to about $2.0 - $2.2 million.

Exclusive licensing agreements with major pharmaceutical companies.

Licensing and strategic sales represent a core path to realizing the value of their intellectual property, particularly following the divestiture of the FXR program. Before this, Organovo Holdings, Inc. had established foundational licensing deals to monetize their core bioprinting technology.

Here's a look at the quantitative evidence supporting the licensing and partnership channel's importance:

The company's revenue from operations remains modest, with the last twelve months' revenue reported at $122.00K as of April 2025, underscoring that the primary channel value realization comes from large, infrequent licensing or sale events rather than high-volume product sales.

Scientific publications and industry conferences for validation.

Validation through scientific rigor is crucial for adoption in the preclinical research space. This channel builds credibility, which then feeds back into the direct outreach and licensing efforts. Organovo Holdings, Inc. has historically invested heavily in this area to prove the functionality of its tissue models.

• R&D investment in FY 2024: Approximately $8.2 million.
• Active patents related to tissue engineering: 12.
• Expected near-term catalyst: A $5 million milestone payment anticipated within 12 months, tied to the start of a Phase 2 clinical trial for the FXR agonist sold to Lilly.

These scientific efforts, often presented at industry conferences and published, serve to de-risk the technology for potential licensees and partners, making the direct sales process more efficient.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Customer Segments

You're looking at the customer base for Organovo Holdings, Inc. as of late 2025; it's a mix of big pharma interest, smaller biotech needs, and the speculative eye of the market.

For large pharmaceutical companies seeking de-risked clinical assets, the deal with Eli Lilly on the FXR program is a clear data point; that transaction involved an upfront payment of $10.0 million, with $9.0 million received at close and $1.0 million held in escrow. Furthermore, Organovo Holdings, Inc. has an expected milestone payment of $5 million within the next 12 months tied directly to the commencement of a Phase 2 clinical trial related to that asset.

Biotechnology firms looking for novel drug targets and platforms are engaging with a company whose preliminary cash and cash equivalents stood at approximately $11.3 million as of March 31, 2025. This financial footing supports the development of their 3D human tissue platform, which includes proprietary NovoGen Bioprinters.

Institutional investors focused on clinical-stage biotech growth are reacting to volatility; on February 25, 2025, the stock traded up by 252.3 percent. The company's financial structure as of that period showed total liabilities hitting $3.48M against total equity of just $373,000.

Here's a quick look at some key financial metrics relevant to the business operations supporting these segments:

The customer and market engagement is reflected in these operational statistics:

• - Stock closed above the $1.00 minimum bid requirement since March 21, 2025.
• - Preliminary unaudited cash balance was $11.3 million at the fiscal year-end March 31, 2025.
• - The company reported quarterly revenue figures around $109,000 in February 2025 reports.
• - Total equity was reported at $0.364M at December 31, 2024.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Cost Structure

You're looking at the core expenditures that kept Organovo Holdings, Inc. running through late 2025, especially after the strategic shift following the FXR program sale. The cost structure is heavily weighted toward the science, which is typical for a clinical-stage biotech, but you can see management actively working to moderate the outflow.

The Research and Development (R&D) expenses, which are the lifeblood of any drug developer, showed a specific quarterly spend. For the second quarter of fiscal year 2025 (Q2 FY2025), R&D expenses were reported at $984,000.

Supporting the operational side, the Selling, General, and Administrative (SG&A) expenses for that same period, Q2 FY2025, totaled $1,653,000. This category covers the overhead necessary to run the business outside of direct research.

Personnel costs were definitely a focus area for expense management. Following significant corporate restructuring and the divestiture of certain programs, the company signaled an expectation for an overall decrease in expenditures in the coming year, which included eliminating costs related to the FXR314 program's clinical advancement, regulatory, and supply needs. This streamlining effort was intended to lower the overall operating expense base.

The net result of these activities, combined with the upfront payment from the Eli Lilly transaction, was a moderated cash burn rate. Organovo Holdings, Inc.'s preliminary net cash utilization (burn) for the fourth quarter of fiscal year 2025 (Q4 FY2025) was approximately $2.0 - $2.2 million.

Here's a quick look at how those key operating costs stacked up for the quarter ending in question, alongside the recent cash burn metric:

To give you a bit more context on the operating expense trajectory before this, the loss from operations for the three months ended December 31, 2024, was ($3.447) million, with operating expenses for that quarter reported at $3.49 million, which included nearly $1.78 million in R&D alone. The expected total operating expense for the full fiscal year ending March 31, 2025, was guided to be between $13.0 million and $15.0 million.

The cost structure is clearly centered on maintaining the core R&D engine while aggressively trimming non-essential overhead to extend the runway. Finance: draft 13-week cash view by Friday.

Organovo Holdings, Inc. (ONVO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Organovo Holdings, Inc. (ONVO) as of late 2025, which, honestly, has been dramatically reshaped by a major asset sale. The primary focus shifted from product sales to capturing value from past development work through upfront and milestone payments.

The most significant recent cash infusion came from the disposition of the FXR program to Eli Lilly and Company, which closed on March 25, 2025. This deal establishes the core of the current revenue stream structure.

The revenue streams for Organovo Holdings, Inc. (ONVO) are centered on these key areas:

• - Upfront payments from the sale of drug programs, like the $10.0 million from Eli Lilly.
• - Contingent milestone payments upon clinical advancement (e.g., expected $5 million).
• - Royalty revenue from existing or future licensed intellectual property.
• - Minimal product revenue from the former Mosaic Cell Sciences division (ended Q3 FY2025).

Let's break down the financial reality of the major transaction that defines this period.

The upfront component of the FXR Asset Sale was structured precisely:

Contingent milestone payments represent the potential upside, which you need to track closely. The total potential is substantial, but the near-term expectation is more concrete.

• Total potential milestone payments aggregate up to $50.0 million contingent upon development, regulatory, and commercial achievements of FXR314.
• Management guided that they 'reasonably' expect a $5 million milestone payment within 12 months, tied to the expected Phase II start of the FXR agonist sold to Lilly.

Here's the quick math on the deal structure:

Before the FXR sale, the company's operating revenue was quite small. For the trailing twelve months (TTM) ending in 2025, the reported revenue was $0.14 Million USD. For the quarter ended December 31, 2024 (Q3 FY2025), the reported revenue was $24.00 thousand, which analysts expected to be $44.00 thousand.

The minimal product revenue stream, which came from the former Mosaic Cell Sciences division, was noted as being de minimis, alongside small royalty receipts, leading up to its cessation after Q3 FY2025. This means that going forward, any revenue from this legacy source is expected to be negligible or zero, as the focus shifted entirely to R&D and the milestone-driven partnership income.

Royalty revenue is still a potential stream, though it was grouped with the de minimis product sales in prior reporting. Any future royalty revenue would stem from other licensed intellectual property outside the FXR program, but concrete, current figures aren't the main story here; the deal payments are. Finance: draft 13-week cash view by Friday.