Navidea Biopharmaceuticals

What Navidea Biopharmaceuticals does

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a clinical-stage biopharmaceutical company headquartered in Dublin, Ohio, founded in 1983 (originally as Neoprobe Corporation). The company develops precision immunodiagnostic agents and immunotherapeutics for patients with cancer, autoimmune, and inflammatory diseases. Its work is anchored by the proprietary Manocept™ platform, an immuno-targeted technology designed to identify the sites and pathways of undetected disease. The lead clinical asset built on this platform is Tc99m Tilmanocept, a technetium-99m-labeled imaging agent that advanced into Phase IIb and Phase III trials for rheumatoid arthritis, with a third-party asset valuation covering U.S. and EU indications completed in April 2022. Earlier commercial lineage includes Lymphoseek, whose FDA approval was discussed in a March 2013 conference call.

Navidea operated as a pre-commercial enterprise throughout its recent history, generating no significant product revenue and instead funding operations through capital-raises: a $2.5 million secured bridge loan from largest shareholder John K. Scott, Jr. in April 2022, an additional $1.0 million tranche from the same investor in July 2022, and an April 2023 plan to monetize an $8 million Cardinal Health milestone payment alongside a new $2.75 million equity line of credit for up to $10.75 million in total capital. Prior debt-financed rounds included $60 million from CRG (May 2015), $30 million from Oxford Finance LLC (March 2014), and $30 million from Crede Capital Group (September 2013). The company's go-to-market motion centered on enterprise sales to healthcare providers and nuclear medicine facilities, with investor outreach via SEC filings, quarterly earnings calls, conference presentations (BIO, ACR, SNMMI, RSNA, SITC), and an investor relations portal.

The company filed for bankruptcy on October 8, 2025, per its own press release, ending its status as a going concern. Its go-to-market focus prior to bankruptcy was on partnership-driven commercialization through licensing arrangements (e.g., the Cardinal Health milestone payment) rather than direct product distribution. Target customer segments were healthcare providers and nuclear medicine facilities that would administer Tc99m-labeled Manocept imaging agents, with end-patient populations in rheumatoid arthritis, oncology, and other autoimmune and inflammatory indications.

Name

Navidea Biopharmaceuticals

Legal name

Navidea Biopharmaceuticals, Inc.

Website

https://navidea.com

Company type

Public

Founded year

1983

Operating status

Closed

Headcount range

11–50 employees

Short description

Navidea Biopharmaceuticals (NYSE American: NAVB) is a clinical-stage biopharmaceutical company developing precision immunodiagnostic agents and immunotherapeutics based on its proprietary Manocept platform, targeting cancer, autoimmune, and inflammatory diseases. The company filed for bankruptcy on October 8, 2025.

Ownership category

akta.pro rank

Product category

Radiopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

akta.pro secondary industries

Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)

Keywords

• Precision immunodiagnostics
• Radiopharmaceutical imaging agents
• Immunotherapeutic development
• Cancer diagnostics therapeutics
• Autoimmune disease therapeutics

Headquarters

HQ city

Columbus

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others

Revenue model

1. Milestone Payment Sale (One-Time): Navidea announced intent to sell its Cardinal Milestone Payment of $8 million to generate non-dilutive capital for clinical trial funding. Represents a one-time liquidity event tied to a prior licensing/milestone arrangement.
2. Equity Line of Credit Financing: Navidea secured a new $2.75 million equity line of credit in 2023 to fund Phase IIb and Phase III trials and expand operations, supplementing the milestone payment sale for up to $10.75 million of total capital. Represents capital-raise financing activity rather than product revenue.
3. Bridge Loan Financing: Navidea secured bridge loans (up to $2.5 million in April 2022 from John K. Scott, Jr.; additional $1 million in July 2022) to support Phase 3 and R&D efforts, indicating the company was pre-commercial and reliant on dilutive and debt financing rather than product sales.
4. Pre-Commercial / Pre-Revenue Operations: As a clinical-stage biopharmaceutical company with assets in Phase IIb and Phase III trials, Navidea had no significant product commercialization revenue; the company's website references its Manocept pipeline rather than marketed products. Operations were funded via financing and asset/royalty monetization rather than product sales.

Go-to-market motion2 records

Marketing channels7 records

Core offering

Navidea develops precision immunodiagnostic agents and immunotherapeutics based on its proprietary Manocept™ platform, designed to identify sites and pathways of undetected disease in cancer, autoimmune conditions, and other inflammatory diseases. The company's lead asset, Tc99m Tilmanocept (a technetium-99m-labeled radiopharmaceutical imaging agent), was advancing through Phase IIb and Phase III clinical trials, with a third-party asset valuation completed for rheumatoid arthritis indications covering U.S. and EU markets. The company was pre-commercial and funded clinical development through licensing milestone payments, bridge loans, and equity financings.

Product overview

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) offers a single-platform-plus-product portfolio built around its proprietary Manocept™ immuno-targeted technology platform. The Manocept platform underpins the company's Tc99m Tilmanocept diagnostic imaging agent (related to the FDA-approved product Lymphoseek) and its pipeline of precision immunodiagnostic agents and immunotherapeutics being advanced through Phase IIb and Phase III clinical trials for cancer, autoimmune conditions, and other inflammatory diseases.

Differentiator

Problem solved

Functional benefit

Brands

• Manocept: Proprietary Manocept™ platform technology used by Navidea to develop next-generation targeted diagnostics and therapies for cancer, autoimmune conditions, and other inflammatory diseases.
• Tc99m Tilmanocept

Products and services

• Manocept™ Technology Platform Proprietary immuno-targeted technology platform used to develop next-generation targeted diagnostics and therapies for cancer, autoimmune conditions, and other inflammatory diseases. Designed to enable identification of sites and pathways of undetected disease to support better diagnostic accuracy, clinical decision-making, and targeted treatment.
• Tc99m Tilmanocept Technetium-99m-labeled tilmanocept imaging agent based on the Manocept platform, used as Navidea's lead radiopharmaceutical asset for Phase IIb and Phase III clinical trials. Subject of a third-party asset valuation for rheumatoid arthritis indications covering U.S. and EU markets.
• Precision Immunodiagnostic and Immunotherapeutic Medicines Pipeline Clinical-stage pipeline of precision immunodiagnostic agents and immunotherapeutics based on the Manocept platform, advancing through Phase IIb and Phase III trials for cancer, autoimmune conditions, and other inflammatory diseases.
• Lymphoseek (tilmanocept) FDA-approved diagnostic product (tilmanocept) discussed at the March 13, 2013 conference call. Represents Navidea's historical, FDA-approved diagnostic imaging agent related to the Manocept platform and Tc99m Tilmanocept program.

Quantifiable outcome

• Up to $10.75M capital raise intent in April 2023 ($8M Cardinal milestone payment sale + $2.75M equity line of credit) to fund Phase IIb and Phase III trials
• +1 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Continental Stock Transfer & Trust CompanyminorOthers · 1 January 2023Continental Stock Transfer & Trust Company serves as Navidea's transfer agent (1 State Street, 30th Floor, New York, NY 10004-1561; T: 212-509-4000; [email protected]). Handles shareholder recordkeeping and stock transfer services for NAVB-listed shares.

Scale indicators7 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Lantheus Holdings: Lantheus is a leading radiopharmaceutical company with a portfolio of diagnostic imaging agents. It is directly comparable to Navidea as a specialty radiopharmaceutical developer focused on Tc-99m and other labeled imaging agents for diagnostic applications.
• Telix Pharmaceuticals: Telix develops targeted radiopharmaceuticals for diagnostic and therapeutic use across oncology and inflammatory disease, overlapping directly with Navidea's Tc99m Tilmanocept imaging and immunotherapeutic pipeline.
• Curium: Curium is a global nuclear medicine company developing and manufacturing diagnostic radiopharmaceuticals, making it a direct peer to Navidea in the targeted imaging agent category.

Broad incumbents

• Bracco Imaging: Bracco is a large incumbent in diagnostic imaging agents and contrast media, with a broad portfolio that includes nuclear medicine products overlapping with Navidea's Tc99m-labeled imaging focus.
• GE HealthCare: GE HealthCare is a broad incumbent with a significant radiopharmaceutical and molecular imaging business. While much larger, it competes in the same diagnostic imaging category as Navidea's Manocept-based agents.
• Bayer (Radiology / Curium JV partner): Bayer operates a broad radiology business including contrast agents and partnered radiopharmaceuticals, making it a relevant broad incumbent peer to Navidea's diagnostic imaging agent strategy.
• Philips (Imaging): Philips is a major imaging and nuclear medicine equipment vendor whose installed base consumes radiopharmaceutical imaging agents like Tc99m Tilmanocept, positioning it as a broad incumbent adjacent to Navidea's end-market.
• Siemens Healthineers: Siemens Healthineers is a broad incumbent in molecular imaging equipment and nuclear medicine, providing complementary infrastructure to Navidea's diagnostic imaging agent strategy.

Others

• Cardinal Health: Cardinal Health is the source of the $8M milestone payment Navidea monetized in 2023 and historically distributed radiopharmaceutical products in the U.S. market, making it a financial and distribution ecosystem peer.

Emerging players

• Blue Earth Diagnostics: Blue Earth Diagnostics is a focused radiopharmaceutical company developing molecular imaging agents for cancer, overlapping with the oncology applications of Navidea's Manocept platform.

Market position

Strengths3 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights4 records

Customer concentration

• LinkedInlinkedin.com/company/navidea-bio
• Xx.com/navideabio
• Facebookfacebook.com/NavideaBio

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds8 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Navidea Biopharmaceuticals