Navidea Biopharmaceuticals, Inc. (NAVB): Business Model Canvas [Dec-2025 Updated]

You're looking at Navidea Biopharmaceuticals, Inc. (NAVB) in late 2025, and the Chapter 11 filing definitely colors the picture, but don't let the noise distract you from the core assets. Honestly, the real question is how they'll salvage value from the proprietary Manocept platform and the FDA-approved Lymphoseek, all while protecting that huge tax asset-roughly $170 million in Net Operating Losses. I've mapped out their entire business model, from their commercial partners like Cardinal Health to the high legal costs they're facing right now, so you can see the precise levers they have left to pull in this restructuring.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Key Partnerships

You're looking at the structure of Navidea Biopharmaceuticals, Inc. (NAVB) as it navigates a significant restructuring in late 2025. The Key Partnerships block is crucial here, as these relationships represent both legacy value and potential future revenue streams, even under Chapter 11 protection.

The most immediate and defining partnership context as of late 2025 is the legal one, following the voluntary petition for relief under Chapter 11, Subchapter V, filed on October 1, 2025, in the U.S. Bankruptcy Court for the District of Delaware. Epiq Corporate Restructuring, LLC is serving as the claims and noticing agent for this case. This means Epiq manages the official communication flow to creditors and stakeholders regarding the restructuring process.

Here are the key financial parameters associated with the Chapter 11 filing managed by Epiq Corporate Restructuring, LLC:

The commercialization and development partnerships, though established earlier, still dictate potential future value and contingent obligations that must be managed through the restructuring.

The North American commercialization rights for Lymphoseek are held by Cardinal Health. This deal, which closed in March 2017, involved an initial payment to Navidea Biopharmaceuticals, Inc. of approximately $83 million. The structure includes contingent consideration tied to milestones extending through 2026. The total potential contingent consideration was up to $227 million, with an initial guarantee of $17.1 million over the first three years post-closing in 2017.

The relationship with Sayre Therapeutics governs the development and commercialization of Tc99m tilmanocept (Lymphoaim) in India. Navidea Biopharmaceuticals, Inc. received an upfront payment upon signing the exclusive license and distribution agreement. Furthermore, Navidea remains eligible for future milestone payments and double-digit sales royalties from Sayre Therapeutics' efforts in South Asia.

The pipeline programs continue to rely on non-dilutive funding sources, such as those from the National Institutes of Health (NIH). While specific 2025 grant awards aren't detailed, historical NIH support for pipeline programs shows significant prior investment:

• NIH SBIR Grant (RA): Budget Part 2 was $1,500,000.
• NCI Grant (KS): Budget Part 2 was $1,500,000.
• Completed NIA Grant (Alzheimer's/NAV4694): Budget Part 2 was $1,572,800.

The partnership with Beijing Sinotau Medical Research Co., Ltd. for marketing and distribution in China was executed in August 2014. This agreement is a key element for international revenue potential, though specific 2025 financial contributions are not publicly itemized in the context of the recent bankruptcy filing.

To summarize the key contractual relationships and their associated financial structures:

The ability of Navidea Biopharmaceuticals, Inc. to meet obligations or realize value from these partnerships hinges on the outcome of the Chapter 11 process initiated in October 2025.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Key Activities

You're navigating a Chapter 11 process now, so the immediate key activities are all about triage and value preservation. Honestly, the focus has shifted from pure R&D acceleration to financial stabilization while keeping the core science alive.

Pursuing Orderly Financial Restructuring under Chapter 11, Subchapter V

The primary activity is managing the court-supervised process. Navidea Biopharmaceuticals, Inc. filed a voluntary petition for relief under Chapter 11, Subchapter V of the United States Bankruptcy Code on October 1, 2025, in the U.S. Bankruptcy Court for the District of Delaware. This filing is specifically intended to facilitate an orderly restructuring of the company's financial obligations. The company is continuing limited operations during this period to preserve value for creditors and stakeholders. Epiq Corporate Restructuring, LLC is serving as the claims and noticing agent for this Chapter 11 case.

Protecting Net Operating Losses (NOLs) via a Section 382 Rights Plan

A critical, proactive step taken before the filing was safeguarding the tax assets. As of December 31, 2024, Navidea Biopharmaceuticals, Inc. reported approximately $\$170$ million in U.S. federal Net Operating Losses (NOLs) and about $\$9$ million in R&D tax credits that can offset future taxable income. To protect these, the Board extended the Section 382 Rights Agreement on March 31, 2025, pushing the expiration date to April 7, 2027. This plan is designed to deter any single person or group from acquiring beneficial ownership of 4.99% or more of the outstanding common stock, which could trigger an ownership change under Section 382 of the Internal Revenue Code and severely limit the use of those NOLs.

Advancing the Manocept Platform Pipeline for New Indications

The underlying science activity centers on the Manocept platform, which targets the CD206 mannose receptor on activated macrophages. Navidea Biopharmaceuticals, Inc. is developing a pipeline of immunodiagnostic applications starting with rheumatoid arthritis (RA) and Kaposi's sarcoma (KS), alongside cardiovascular disease. However, the RA program saw a significant setback; an exploratory analysis of the pivotal NAV3-33 clinical trial showed the overall accuracy of early treatment response was consistently below 70%. Because predictive value below that level is not commercially viable, Navidea suspended all activities related to the RA Trial and is pivoting to focus on exploring opportunities related to its therapeutic assets.

Managing Global Licensing and Distribution Agreements for Tilmanocept

Managing existing agreements is key to realizing any residual value from commercialized products like Tc99m tilmanocept (Lymphoseek). The North American rights were sold back in 2017 for an $\$83$ million closing payment, with up to $\$227$ million earmarked based on milestones through 2026. The company holds a license to distribute Tc99m tilmanocept outside of Canada, Mexico, and the United States. The European commercialization responsibility was transferred to Navidea Europe, established in June 2020. The financial recognition from international deals is conditional.

Here's a quick look at the structure of some key international agreements:

It's important to note that up-front and milestone payments related to the agreements in India and China are deferred until Tc99m tilmanocept has been approved in those regions.

Evaluating Strategic Alternatives to Preserve Value

The Chapter 11 filing itself is the mechanism to execute this activity. Navidea Biopharmaceuticals, Inc. explicitly intends to use the bankruptcy process to evaluate strategic alternatives. This evaluation is aimed at protecting core assets and ensuring equitable treatment for all creditors and stakeholders. The company's strategy involves advancing its pipeline through global partnering and commercialization efforts, leveraging its diverse portfolio of issued U.S. and foreign patents.

• The company's strategy is to market novel products and advance the pipeline through global partnering.
• The Manocept platform is the molecular backbone for Tc99m tilmanocept, the first product commercialized by Navidea.
• The company holds a diverse portfolio of issued US and foreign patents and patent applications.

Finance: draft 13-week cash view by Friday.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Key Resources

You're looking at the core assets Navidea Biopharmaceuticals, Inc. has been counting on to drive its pipeline, even as the company navigated a Chapter 11 filing on October 1, 2025.

The foundation here is definitely the Manocept proprietary platform technology. This platform is built on the ability to specifically target the CD206 mannose receptor, which you find on activated macrophages. It serves as the molecular backbone for their lead products.

The intellectual property portfolio centers around this platform and its primary product. The U.S. patent covering tilmanocept itself had an extension that ran through May 12, 2025. Navidea Biopharmaceuticals, Inc. maintains license rights to technetium Tc 99m tilmanocept outside of North America, plus the license to the underlying Manocept platform IP.

For financial leverage, the company held significant deferred tax assets, which they've actively worked to protect via an extended Section 382 Rights Plan until April 7, 2027. Here's a snapshot of those key financial and research resources based on the latest reported figures before the restructuring filing:

The FDA-approved product, technetium Tc 99m tilmanocept (Lymphoseek), is a key tangible asset, though its North American commercialization rights were sold in 2017. Navidea Biopharmaceuticals, Inc. is still positioned to earn milestone payments tied to those North American sales, with $17.1 million guaranteed over the three years following the 2017 sale.

Beyond the existing product, the pipeline development is heavily supported by non-dilutive funding from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program. These active grants focus on expanding the utility of the platform:

• Rheumatoid Arthritis (RA) Program (R44AR067583): The Part 2 budget is $1,500,000, aiming for more accurate diagnosis to guide existing therapeutics.
• Kaposi Sarcoma (KS) Program (R44CA192859): The Part 2 budget is also $1,500,000, exploring the use of 99mTc-tilmanocept for imaging difficult-to-find KS lesions.
• Past/Related Funding Examples: A completed Fast Track SBIR for Beta Amyloid Deposits (R44AG044130) had a Part 2 budget of $1,572,800.

The Manocept platform itself is the central intangible resource, underpinning multiple development efforts, including therapeutic line extensions being conducted through its subsidiary, Macrophage Therapeutics, Inc.

Finance: review the impact of the October 1, 2025 Chapter 11 filing on the realizability of the $170 million NOLs by next Tuesday.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Value Propositions

You're looking at the core value Navidea Biopharmaceuticals, Inc. (NAVB) offers, which centers on its precision medicine platform targeting activated macrophages.

Precision diagnosis by targeting the CD206 mannose receptor on activated macrophages.

The underlying technology, the Manocept platform, is predicated on the ability to specifically target the CD206 mannose receptor, which is expressed on activated macrophages. Preclinical data demonstrated that in Kaposi's Sarcoma (KS) tumor tissue from over 60 KS patients, greater than 91% of KS tumor cells and tumor-associated macrophages expressed CD206 and bound and internalized the targeting agent, Cy3-tilmanocept.

Improved diagnostic accuracy and clinical decision-making for cancer and inflammatory diseases.

The value proposition here is enabling better diagnostic accuracy and informing clinical decisions across various conditions. The platform's agents are designed to help identify the sites and pathways of undetected disease. The company's pipeline advancement efforts, prior to the October 8, 2025, bankruptcy filing, focused on leveraging this platform for indications like Rheumatoid Arthritis (RA) and cardiovascular disease.

Lymphatic mapping for staging of cancer (breast cancer and melanoma) using Lymphoseek.

Lymphoseek (technetium Tc 99m tilmanocept) is the first commercialized product based on the platform, designed for lymphatic mapping and lymph node biopsy for cancer staging. The North American rights for this product were sold to Cardinal Health in a deal with a total consideration capped at $310 million.

The financial structure of that asset sale provides concrete figures related to the perceived value of this specific application:

Potential for new targeted immunodiagnostic and immunotherapeutic products.

Navidea Biopharmaceuticals, Inc. retained rights to develop and sell new immunodiagnostic and immunotherapeutic products for specific purposes in North America, licensing back a portion of the intellectual property from Cardinal Health. The company's strategy was to use the financial flexibility from the sale to invest in its deep pipeline of activated macrophage targeted imaging agents and therapeutics. The platform's potential extends to therapeutic applications, with data showing the ability to induce apoptosis in CD206 positive Kaposi's Sarcoma tumor cells.

The company's focus areas for pipeline advancement included:

• Targeting Rheumatoid Arthritis (RA) via Phase 2b studies.
• Developing novel products for oncology, cardiology, and inflammation.
• Advancing therapeutics primarily through non-dilutive grants, as stated by the former CEO.

The company announced an extension of authority to implement a reverse stock split on May 21, 2025, and subsequently filed for bankruptcy on October 8, 2025. This filing is the current reality for realizing future pipeline value.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Customer Relationships

You're looking at the relationships Navidea Biopharmaceuticals, Inc. maintains with its various customer and stakeholder groups as of late 2025, a period dominated by its Chapter 11 restructuring.

Indirect relationship via commercialization partners like Cardinal Health

The primary commercial relationship for the lead product, Tc99m tilmanocept (Lymphoseek®), is indirect, managed through a prior divestiture. Navidea Biopharmaceuticals, Inc. completed the sale of the North American rights to Lymphoseek® to Cardinal Health on March 3, 2017.

This arrangement structures the customer relationship through the partner, with Navidea Biopharmaceuticals, Inc. retaining potential future value based on performance milestones.

Direct communication with investors via press releases, replacing conference calls

Following the filing for bankruptcy protection, direct communication with investors shifted heavily toward formal press releases, as evidenced by the public announcements made in 2025. The company's stock information as of October 1, 2025, showed a price of $0.00 and a 52-week range of $0.00 - $0.05.

Key investor-facing communications in 2025 included:

• Announcing the extension of authority to implement a reverse stock split on May 21, 2025.
• Announcing the extension of the plan designed to protect Net Operating Losses (NOLs) on March 31, 2025.
• Issuing a press release on October 8, 2025, regarding the Chapter 11 filing.

The company previously held shareholder meetings, such as the special meeting on July 8, 2024.

Formal legal communication with creditors and stakeholders during Chapter 11

The relationship with creditors and stakeholders became formalized under the U.S. Bankruptcy Code following the voluntary petition for relief under Chapter 11, Subchapter V, filed on October 1, 2025, in the U.S. Bankruptcy Court for the District of Delaware.

This process is managed through a designated agent, Epiq Corporate Restructuring, LLC, which serves as the claims and noticing agent. The company intends to use the process to ensure fair treatment of creditors.

Critical dates defining this relationship include:

• Filing Date: October 1, 2025.
• 341 Meeting of Creditors: Scheduled for November 14, 2025, at 10:00 AM ET.
• General Bar Date for proofs of claim: December 1, 2025, 11:59 p.m. (ET).

The case is assigned to Judge J Kate Stickles.

Scientific engagement with researchers through grant-funded studies

Navidea Biopharmaceuticals, Inc. engages with the scientific community, often through grant funding, to advance its pipeline products based on the Manocept platform. The company has historically pursued funding from entities like the National Institutes of Health (NIH) to support development efforts.

Past and ongoing grant engagement provides a measure of scientific relationship activity:

Additionally, a past Third Frontier Grant supporting Lymphoseek NDA & Commercialization required $1,000,000 in matching funds.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Channels

You're looking at the channels Navidea Biopharmaceuticals, Inc. (NAVB) uses to reach its customers and partners as of late 2025. Honestly, the landscape shifted significantly this year, especially with the Chapter 11 filing on October 1, 2025.

Commercial partners (e.g., Cardinal Health) for product distribution to nuclear pharmacies

Specific, current distribution figures with partners like Cardinal Health are not publicly detailed in the latest available filings as of late 2025. The company's strategy has centered on commercialization efforts for its Manocept platform products, such as Tc99m tilmanocept, which requires distribution to nuclear pharmacies.

Global licensing agreements for international market access (China, India, Europe)

Navidea Biopharmaceuticals, Inc.'s stated strategy involves advancing the pipeline through global partnering. However, specific financial metrics or the number of active licensing agreements for China, India, or Europe are not reported for 2025 in the readily accessible data, likely superseded by the restructuring efforts.

• Strategy Focus: Advancing pipeline through global partnering.
• Last Known Financial Context: Contingent liability for CRG judgment settled in late 2023 was $2,711,806.

Direct investor relations via company website and SEC filings

Investor relations channels remain active for communication, particularly regarding the restructuring. The company's stock, trading on OTC under NAVB as of October 2025, had a closing price of $0.00 on October 1, 2025. The company maintains its direct communication via its website and required SEC filings, though the latest detailed financial report available is the Q3 2023 10-Q. The company is focused on preserving tax assets, which are significant.

The Board extended the authority for a reverse stock split up to a 1-for-50,000 ratio until July 8, 2027, partly to reduce costs associated with public reporting thresholds.

Clinical trial sites and academic institutions for pipeline development

Development channels via clinical sites have been impacted by recent trial outcomes. Navidea Biopharmaceuticals, Inc. announced disappointing results from the exploratory analysis of its pivotal NAV3-33 clinical trial (RA Trial) in July 2024, leading to the suspension of all activities related to that trial. This directly affects the use of clinical trial sites for that specific indication.

• RA Trial Status (NAV3-33): Suspended activities as of July 2024.
• Prior Enrollment (NAV3-35): Arm 1 enrolled 120 healthy volunteers.
• Pipeline Focus Shift: Pivoting to focus on exploring all opportunities related to therapeutic assets.

The use of academic institutions for research collaborations is part of the broader strategy to advance the pipeline, but specific 2025 site counts or partnership financials aren't disclosed.

Finance: review cash burn rate under Chapter 11 structure by end of Q1 2026.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Customer Segments

Nuclear medicine physicians and surgeons are a core segment, utilizing Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping procedures in solid tumor cancers. The FDA approval for Lymphoseek covers use in patients with:

• Breast cancer.
• Melanoma.
• Squamous cell carcinoma of the oral cavity.

Patients represent the end-users for the diagnostic agent. The current primary indications are for staging cancer spread. Navidea Biopharmaceuticals, Inc. is also developing products based on its Manocept platform for autoimmune conditions, specifically mentioning a Third-Party Asset Valuation of Tc99m Tilmanocept for indications in Rheumatoid Arthritis.

Global pharmaceutical and biotech companies form a segment targeted for licensing and partnering. Historically, the North American rights to Lymphoseek were sold to Cardinal Health for $83 million at closing, with an additional $227 million earmarked based on certain milestones through 2026.

Creditors and shareholders are distinct customer segments whose interests are managed following the voluntary petition for relief under Chapter 11, Subchapter V filed on October 1, 2025. The process intends to preserve value for these parties while pursuing orderly restructuring.

The value being preserved for these stakeholders is partially represented by the Company's tax assets, as detailed below:

The management of creditor and shareholder interests is further underscored by the stock's trading status post-filing. The stock price on October 1, 2025, was reported at $0.00010.

Key parties involved in managing creditor/shareholder claims include:

• Epiq Corporate Restructuring, LLC, serving as the claims and noticing agent for the Chapter 11 case.
• Creditors and shareholders obtaining information via the Epiq website: https://dm.epiq11.com/Navidea.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Navidea Biopharmaceuticals, Inc. (NAVB) right after a major event-the Chapter 11 filing on October 1, 2025. This changes the cost profile significantly, shifting focus to restructuring expenses while trying to manage ongoing operational costs.

The most immediate and significant cost driver post-petition is the legal and professional fees associated with the Chapter 11, Subchapter V process in the U.S. Bankruptcy Court for the District of Delaware. You know that retaining counsel for the Sub V Trustee, like Bielli & Klauder, LLC, means significant hourly billing for time and expenses related to the restructuring itself. While the exact 2025 legal spend is developing, the context is set by the filing itself, which aims to restructure financial obligations.

Research and development (R&D) expenses for the Manocept platform pipeline represent a core, ongoing cost. Even under Chapter 11, preserving the value of the pipeline-which includes Tc99m tilmanocept-is key. Before the filing, the value tied to future R&D utilization was substantial, as evidenced by the tax assets:

Here's a quick look at the R&D-related tax assets as of the end of 2024, which the bankruptcy aims to protect:

General and administrative (G&A) costs are under intense scrutiny during this period. The company's pre-restructuring financial position gives you a baseline for the liabilities that G&A must now support or reduce. The filing indicated the following balance sheet figures:

• Total Assets: $1.2 million
• Total Liabilities: $12.9 million

The goal within the restructuring is definitely to slash overhead, especially costs tied to public reporting, which become less critical when operations are limited and focused on reorganization. You'll see G&A costs being aggressively managed to preserve cash for secured and priority claims.

Costs for maintaining and defending intellectual property (IP) are crucial because the Manocept platform is the core asset. Navidea Biopharmaceuticals, Inc. holds a portfolio of U.S. and international patents. These costs are non-negotiable for preserving the platform's value, which is the primary asset being protected through the Chapter 11 process. The IP maintenance costs are baked into the ongoing operational budget that the Sub V Trustee must now approve.

The key cost buckets you need to track moving forward are:

• Professional fees for bankruptcy administration and counsel.
• Essential R&D spending to keep the Manocept pipeline viable.
• Severely constrained G&A, targeting public reporting expenses for reduction.
• Ongoing IP maintenance fees for the patent portfolio.

Finance: draft 13-week cash view by Friday, incorporating Epiq's initial fee estimates.

Navidea Biopharmaceuticals, Inc. (NAVB) - Canvas Business Model: Revenue Streams

You're looking at the core ways Navidea Biopharmaceuticals, Inc. (NAVB) brings in cash, which is critical for funding that pipeline development. Honestly, for a company at this stage, the revenue streams are heavily weighted toward past successes and non-dilutive funding sources.

The biggest potential bucket of cash flow relates to the earlier divestiture of North American rights for Lymphoseek to Cardinal Health. This isn't a steady stream, but a series of potential payouts tied to performance milestones that stretch out through 2026.

Here's the quick math on that contingent consideration:

What this estimate hides is that achieving these milestones is never a sure thing; it depends entirely on Cardinal Health's commercial success with the product in North America. Still, it's a significant contingent asset on the books.

Next up, you have the international licensing deals, which are designed to generate ongoing revenue. These agreements are structured to provide royalties on product sales outside of North America. For instance, the deal with Sayre Therapeutics for India includes eligibility for double-digit royalties associated with the sale of Tc 99m tilmanocept in that territory. These royalty streams, along with any other unit sales revenue from international partners like Norgine (which was mentioned in earlier milestone achievements), provide a more predictable, albeit likely smaller, revenue component compared to the upfront milestone cash.

The company also relies on non-dilutive funding through grants to support its Research and Development (R&D) efforts. This is a classic biotech funding mechanism to keep the lights on while advancing the pipeline without immediately selling equity. You can see this clearly in the funding secured for the Manocept platform:

• NIH SBIR grant for Rheumatoid Arthritis (RA) targeting macrophages, with a Budget Part 2 of $1,500,000.
• Other NIH grants, such as those for Kaposi Sarcoma (KS) imaging, also carried potential funding segments up to $1,500,000.

These grants are crucial for de-risking specific pipeline assets. They are revenue, but they are earmarked for specific research expenditures.

To give you a snapshot of recent operational performance, the latest reported quarterly figure available suggests the scale of these combined streams. Navidea Biopharmaceuticals' Q1 2025 total revenue was reported as $580,000, primarily sourced from those licensing activities and grant receipts. This number reflects the current reality of the business-it's lean and dependent on these specific, non-product-sales-driven inflows.

Finance: draft 13-week cash view by Friday.