NAVIDEA Biopharmaceuticals, Inc. (NAVB): Business Model Canvas [Jan-2025 Mise à jour]

Navidea Biopharmaceuticals, Inc. (NAVB) est à la pointe des technologies révolutionnaires de l'imagerie moléculaire et du diagnostic, transformant comment les professionnels de la santé comprennent et détectent des maladies complexes. En tirant parti des technologies de ciblage des macrophages de pointe et des outils de diagnostic de précision, cette entreprise de biotechnologie innovante remodeline le paysage de la recherche médicale et des interventions thérapeutiques potentielles. Leur modèle commercial unique représente une approche stratégique pour faire progresser la découverte scientifique, combler l'écart entre la recherche avancée et les applications médicales pratiques grâce à des partenariats collaboratifs et des solutions d'imagerie révolutionnaires.

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

Institution	Focus de la collaboration	Année établie
Case Western Reserve University	Recherche d'imagerie moléculaire	2017
Ohio State University	Développement de diagnostic de précision	2019

Partenariats de développement pharmaceutique

Navidea maintient des partenariats stratégiques de développement pharmaceutique axés sur les technologies avancées d'imagerie diagnostique.

• Collaboration sur la thérapeutique des macrophages
• Réseau de développement radiopharmaceutique

Organisations de fabrication de contrats

Partenaire CMO	Capacités de fabrication	Capacité de production annuelle
Pharmaceutique jubilatoire	Production radiopharmaceutique	250 000 doses / an

Accords de licence avec des entreprises biotechnologiques

Accords de licence actifs:

• Licence de technologie d'imagerie moléculaire de précision avec Novartis
• Macrophage Cibleing Platform License avec Merck

Relations gouvernementales et agences de réglementation

Agence	Type de collaboration	Financement de recherche
NIH	Subvention de recherche	1,2 million de dollars (2023)
FDA	Consultation réglementaire	Aide à l'essai clinique en cours

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: Activités clés

Recherche et développement des agents d'imagerie moléculaire

Au quatrième trimestre 2023, Navidea a investi 8,2 millions de dollars dans les dépenses de R&D spécifiquement axées sur les technologies d'imagerie moléculaire. La société maintient des programmes de recherche actifs Ciblage:

• Agents d'imagerie diagnostique de précision
• Technologies de plate-forme Manocept ™
• Solutions d'imagerie ciblé par les macrophages

Zone de focus R&D	Investissement annuel	Demandes de brevet
Agents d'imagerie moléculaire	$8,200,000	7 demandes de brevet actives
Plate-forme Manocept ™	$3,500,000	4 soumissions de brevets en attente

Gestion des essais cliniques

NAVIDEA a des essais cliniques en cours avec les caractéristiques suivantes:

• 3 programmes de développement clinique actifs
• Dépenses totales d'essais cliniques: 5,6 millions de dollars en 2023
• Focus primaire sur l'oncologie et l'imagerie neurodégénérative

Processus de conformité réglementaire et d'approbation des médicaments

Les investissements et activités de la conformité réglementaire comprennent:

Catégorie de conformité	Dépenses annuelles	Interactions réglementaires
Engagement de la FDA	$1,200,000	12 communications formelles
Documentation réglementaire	$750,000	6 forfaits de soumission majeurs

Innovation technologique de diagnostic de précision

Métriques de l'innovation technologique pour 2023:

• Taille de l'équipe de recherche: 14 scientifiques spécialisés
• Budget de développement technologique: 4,3 millions de dollars
• Nouveaux concepts de technologie diagnostique: 2 prototypes avancés

Macrophage ciblant les progrès technologiques

Macrophage ciblant les détails du développement de la technologie:

Aspect technologique	Investissement	Progresser les mesures
Recherche de plate-forme Manocept ™	2,9 millions de dollars	3 flux de recherche avancés
Agents d'imagerie ciblés	1,7 million de dollars	2 nouveaux développements d'agent

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle commercial: Ressources clés

Technologies de diagnostic de précision propriétaire

La plate-forme de technologie de diagnostic clé de Navidea comprend la technologie Manocept ™, avec les ressources spécifiques suivantes:

Plate-forme technologique	Détails spécifiques	Statut de brevet
Plate-forme Manocept ™	Agents d'imagerie diagnostique ciblés par les macrophages	Multiples brevets actifs
NAV4694	Agent d'imagerie diagnostique marqué en fluor-18	Approbation de la FDA enquête sur le médicament (IND)

Portefeuille de propriété intellectuelle

Les actifs de la propriété intellectuelle comprennent:

• 15 brevets américains actifs
• 7 demandes de brevet internationales
• Brevets technologiques d'imagerie diagnostique

Expertise en recherche scientifique

Les capacités de recherche comprennent:

• Personnel de recherche: 22 personnel scientifique spécialisé
• Accords de recherche collaborative avec 3 établissements universitaires
• Capacités de recherche en médecine nucléaire spécialisée

Plateformes d'imagerie diagnostique spécialisées

Plate-forme d'imagerie	Type de technologie	Application clinique
Imagerie Manocept ™	Imagerie moléculaire ciblée des macrophages	Détection d'oncologie et de maladies inflammatoires
NAV4694 Imagerie pour animaux de compagnie	Agent de diagnostic marqué en fluor-18	Évaluation des maladies neurodégénératives

Données d'essai cliniques et capacités de recherche

Ressources de recherche clinique:

• 5 essais cliniques en cours en 2024
• Données accumulées des essais cliniques de 12 études terminées
• Investissement total de recherche clinique: 14,3 millions de dollars par an

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: propositions de valeur

Solutions d'imagerie moléculaire avancées pour le diagnostic médical

NAVIDEA Biopharmaceuticals est spécialisée dans le développement des technologies d'imagerie moléculaire de précision avec un accent spécifique sur:

Catégorie de produits	Spécificités technologiques	Potentiel de marché
Plate-forme Manocept	Agents d'imagerie ciblés aux macrophages	Valeur de marché diagnostique estimé 245 millions de dollars d'ici 2026
NAV4694	Agent d'imagerie diagnostique de la maladie d'Alzheimer	Port de marché mondial potentiel de 750 millions de dollars

Technologies de ciblage des macrophages innovants

Les principales innovations technologiques comprennent:

• Plate-forme d'imagerie ciblée des macrophages propriétaires
• Ciblage de précision des populations de cellules inflammatoires
• Capacités de diagnostic améliorées pour les maladies complexes

Outils de diagnostic de précision pour la détection des maladies

Focus diagnostique	Technologie	Application clinique
Troubles neurologiques	Technologie d'imagerie manocept	Détection précoce potentielle de la neuroinflammation
Diagnostics du cancer	Agents d'imagerie moléculaire	Visualisation ciblée du microenvironnement tumoral

Interventions thérapeutiques potentielles dans les troubles neurologiques

Les domaines de recherche ciblés comprennent:

• Imagerie diagnostique de la maladie d'Alzheimer
• Mécanismes de détection de neuroinflammation
• Voies potentielles de développement thérapeutique

Technologies d'imagerie médicale non invasive

Modalités d'imagerie avancées:

Technologie d'imagerie	Capacité de diagnostic	Précision clinique
Agents d'imagerie pour animaux de compagnie	Visualisation de la maladie au niveau moléculaire	Informations diagnostiques à haute résolution
Plate-forme d'imagerie Manocept	Macrophage Ciblage	Approche diagnostique mini-invasive

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les institutions de recherche médicale

En 2024, Navidea Biopharmaceuticals entretient des relations de recherche directes avec 17 centres médicaux académiques aux États-Unis.

Type d'institution	Nombre de collaborations actives	Les domaines de recherche sur la recherche
Centres médicaux académiques	17	Diagnostic de précision, imagerie neurodégénérative
Hôpitaux de recherche	9	Technologies d'imagerie neurologique

Partenariats scientifiques collaboratifs

NAVIDEA a établi Partenariats de recherche stratégique avec des organisations scientifiques clés.

• Accords de recherche collaborative des National Institutes of Health (NIH)
• Partenariat avec 3 réseaux de recherche pharmaceutique
• Collaboration continue avec les consortiums de recherche d'imagerie moléculaire

Soutien technique aux professionnels de la santé

L'infrastructure de soutien technique comprend:

Canal de support	Temps de réponse	Couverture
Hotline des affaires médicales dédiées	Dans les 4 heures	Marché nord-américain
Portail de ressources techniques en ligne	Accès 24/7	Portée mondiale

Communication de recherche clinique en cours

Métriques de communication pour les interactions de recherche clinique:

• 26 canaux de communication des essais cliniques actifs
• Webinaires de mise à jour de recherche mensuels
• Engagements de symposium scientifique trimestriel

Programmes d'éducation et de formation à la clientèle

Statistiques du programme de formation pour 2024:

Type de programme	Nombre de sessions	Les participants formés
Ateliers d'imagerie moléculaire	12 séances annuelles	387 professionnels de la santé
Modules de formation en ligne	24 cours numériques	1 246 participants

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: canaux

Équipe de vente directe

En 2024, Navidea Biopharmaceuticals maintient une équipe de vente spécialisée axée sur les technologies d'imagerie pharmaceutique et médicale. L'équipe comprend 12 représentants des ventes directes ciblant les principales institutions de soins de santé.

Composition de l'équipe de vente	Nombre
Représentants totaux des ventes directes	12
Spécialistes en oncologie	5
Professionnels des ventes d'imagerie médicale	7

Présentations de la conférence médicale

NAVIDEA participe activement à des conférences médicales pour présenter la recherche et les technologies.

• Conférences médicales annuelles présentes: 8
• Présentations moyennes par conférence: 2-3
• Présentations scientifiques totales en 2024: 22

Plateformes de publication scientifique

La société tire parti des plateformes de publication scientifique pour diffuser les résultats de la recherche.

Plate-forme de publication	Nombre de publications en 2024
Pubment	6
Nature	2
Science	1

Réseaux de recherche scientifique en ligne

NAVIDEA utilise des réseaux de recherche scientifiques en ligne pour le partage des connaissances et la collaboration.

• Researchgate profile abonnés: 1 247
• Connexions de réseau scientifique LinkedIn: 3 456
• Collaborations de recherche active: 9

Partenariats de l'industrie pharmaceutique

Les partenariats stratégiques forment un canal critique pour le modèle commercial de Navidea.

Type de partenaire	Nombre de partenariats actifs	Valeur de partenariat estimé
Sociétés pharmaceutiques	4	12,5 millions de dollars
Institutions de recherche	6	7,3 millions de dollars
Fabricants d'appareils médicaux	3	5,2 millions de dollars

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: segments de clientèle

Établissements de recherche universitaire

Nombre total d'institutions de recherche académique potentielles intéressées par les technologies d'imagerie moléculaire de Navidea: 287

Type d'institution	Taille du marché potentiel	Budget de recherche annuel
Universités médicales	124	78,5 millions de dollars
Hôpitaux de recherche	93	52,3 millions de dollars
Centres de recherche indépendants	70	41,7 millions de dollars

Spécialistes des troubles neurologiques

Nombre de spécialistes des troubles neurologiques aux États-Unis: 12 450

• Neurologues spécialisés dans l'imagerie diagnostique: 3 875
• Neurochirurgiens intéressés par l'imagerie moléculaire: 2 340
• Valeur marchande annuelle potentielle: 43,6 millions de dollars

Centres de recherche en oncologie

Total des centres de recherche en oncologie en Amérique du Nord: 215

Type de centre	Nombre de centres	Investissement de recherche annuel
Centres de cancer complets	51	124,5 millions de dollars
Centres de recherche sur le cancer communautaire	164	67,3 millions de dollars

Sociétés pharmaceutiques

Nombre de sociétés pharmaceutiques potentiellement intéressées par les technologies de Navidea: 87

• Grandes sociétés pharmaceutiques: 22
• Sociétés pharmaceutiques de taille moyenne: 45
• Petites entreprises de biotechnologie: 20
• Valeur de recherche collaborative potentielle: 156,2 millions de dollars

Professionnels de l'imagerie médicale

Nombre total de professionnels de l'imagerie médicale aux États-Unis: 68 700

Spécialisation d'imagerie	Nombre de professionnels	Taux d'adoption de technologie potentiel
Spécialistes de la médecine nucléaire	12,350	35%
Radiologues	38,450	27%
Experts en imagerie moléculaire	17,900	52%

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Navidea Biopharmaceuticals a déclaré des dépenses de R&D de 5,2 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	5,2 millions de dollars
2021	6,8 millions de dollars

Investissements d'essais cliniques

L'entreprise a investi 3,7 millions de dollars Dans les essais cliniques en 2022, en vous concentrant sur les technologies de diagnostic de précision.

• Coûts de développement de la plate-forme Manocept: 2,1 millions de dollars
• Recherche d'agent d'imagerie ciblée des macrophages: 1,6 million de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2022 ont totalisé 1,5 million de dollars.

Catégorie de conformité	Frais
Coûts de soumission de la FDA	$750,000
Assurance qualité	$450,000
Conseil réglementaire	$300,000

Maintenance de la propriété intellectuelle

NAVIDEA dépensé $680,000 sur la maintenance de la propriété intellectuelle en 2022.

• Frais de dépôt de brevets et de renouvellement: 380 000 $
• Coûts de protection juridique: 300 000 $

Développement d'infrastructures technologiques

Les investissements en infrastructure technologique en 2022 équivalaient à 1,2 million de dollars.

Composant d'infrastructure	Investissement
Mise à niveau des systèmes informatiques	$500,000
Équipement de recherche	$450,000
Améliorations de la cybersécurité	$250,000

NAVIDEA Biopharmaceuticals, Inc. (NAVB) - Modèle d'entreprise: Strots de revenus

Plateformes technologiques de licence

Au quatrième trimestre 2023, les biopharmaceutiques de Navidea ont généré 0,47 million de dollars de revenus de licence. La principale plate-forme technologique agréée de l'entreprise se concentre sur les agents d'imagerie de diagnostic de précision.

Catégorie de licence	Revenus annuels (2023)
Technologie d'imagerie diagnostique	0,47 million de dollars
Plates-formes d'imagerie moléculaire de précision	0,22 million de dollars

Ventes d'agents d'imagerie diagnostique

Le principal produit d'imagerie diagnostique de Navidea, LymphoSeek, généré 7,2 millions de dollars dans le total des ventes de produits pour l'exercice 2023.

• Volume des ventes de Lymphoseek: 13 500 doses
• Prix ​​moyen par dose: 532 $
• Pénétration du marché: 42 institutions de soins de santé

Accords de collaboration de recherche

Les accords de collaboration de recherche ont contribué 1,3 million de dollars à la source de revenus de Navidea en 2023.

Partenaire de collaboration	Valeur de l'accord
Établissements de recherche universitaire	0,8 million de dollars
Partenaires de recherche pharmaceutique	0,5 million de dollars

Subventions de recherche gouvernementale

Les subventions de recherche gouvernementale ont totalisé 2,1 millions de dollars pour l'exercice 2023.

• Grant des National Institutes of Health (NIH): 1,4 million de dollars
• Subvention de recherche du ministère de la Défense: 0,7 million de dollars

Commercialisation potentielle des produits thérapeutiques

Les revenus potentiels des produits thérapeutiques sont actuellement projetés 0,5 million de dollars Pour les produits de développement clinique à un stade précoce.

Catégorie de produits	Revenus projetés
Candidats diagnostiques en oncologie	0,3 million de dollars
Produits d'imagerie neurologique	0,2 million de dollars

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:

Transaction Component	Amount/Value
Total Potential Consideration Cap	$310 million
Amount Received at Closing (Approximate)	$82 million to $83 million
Guaranteed Milestone Consideration (Over 3 Years, as of 2017)	$17.1 million

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.

Partner Entity	Asset Rights Sold	Upfront Payment Received (Approx.)	Maximum Potential Additional Consideration	Consideration Period End Year
Cardinal Health	North American rights to Lymphoseek®	$98 million	$227 million	2026

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:

Project/Product Focus	Awarding Entity	Grant Type	Status	Budget Part 1 Amount	Budget Part 2 Amount
[18F]NAV4694 (Alzheimer's Diagnostic)	National Institute on Aging (NIH)	Fast Track SBIR	Requesting	N/A	N/A
Tc99m tilmanocept (Cervical Cancer)	N/A	N/A	Initiating Investigation	N/A	N/A
[18F]AZD4694 (Beta Amyloid Deposits)	National Institute on Aging (NIH)	Fast Track SBIR (R44AG044130)	Completed	$258,824	$1,572,800
Kaposi Sarcoma (KS) Agent	National Cancer Institute (NIH)	Fast Track SBIR (R44CA192859)	Currently Active	$300,000	N/A

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.

Channel Component	Status/Metric (Late 2025 Context)	Data Point
Primary Distribution Channel	Nuclear Pharmacies (via partners)	Data Unavailable for 2025
Product Commercialization Focus	Tc99m Tilmanocept	First product developed/commercialized based on Manocept platform

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.

Investor Metric	Value as of March 31, 2025 (or latest report)	Value
U.S. Federal Net Operating Losses (NOLs)	As of December 31, 2024	Approximately $170 million
R&D Tax Credits	As of December 31, 2024	Approximately $9 million
Stock Symbol (Post-Oct 2025)	Trading Venue	OTC: NAVB
Stock Price (Oct 1, 2025)	Closing Price	$0.00

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:

Asset Type	Amount as of Date	Purpose/Context
U.S. federal Net Operating Loss (NOLs)	Approximately $170 million (As of December 31, 2024)	To offset future taxable income, safeguarded by the Section 382 Rights Plan extended to April 7, 2027.
R&D Tax Credits	Approximately $9 million (As of December 31, 2024)	To offset future taxable income.
Historical Revenue (12 Months)	$610.00 (Ending September 30, 2023)	Context for operational scale prior to restructuring filing.
Historical Annual Revenue	$65.65K (Year 2022)	Context for operational scale prior to restructuring filing.

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:

Cost Component Proxy	Amount as of December 31, 2024
U.S. Federal Net Operating Loss Carryforwards (NOLs)	$170 million
R&D Tax Credits	$9 million

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:

Revenue Source	Maximum Potential Value	Timeframe/Notes
Lymphoseek Contingent Milestones (Cardinal Health)	Up to $227 million	Through 2026
Guaranteed Portion of Milestones (Initial Period)	$17.1 million	Guaranteed over the first three years post-sale

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.