NanoViricides, Inc. (NNVC): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de vanguardia de la nanomedicina, Nanoviricides, Inc. (NNVC) emerge como una compañía revolucionaria de biotecnología preparada para transformar las estrategias de tratamiento viral a través de su innovadora plataforma de tecnología de nanoviricidas. Al desarrollar soluciones antivirales diseñadas con precisión que prometen abordar algunas de las enfermedades virales más desafiantes, esta empresa innovadora se encuentra en la intersección de la investigación científica avanzada y el potencial médico transformador. Su enfoque único combina ingeniería sofisticada de nanomedicina con intervenciones terapéuticas específicas, ofreciendo potencialmente esperanza donde los tratamientos tradicionales se han quedado corto.

Nanoviricides, Inc. (NNVC) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

Nanoviricides ha establecido asociaciones con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de colaboración
Universidad de California, San Diego	Desarrollo de fármacos antivirales	2018
Universidad Estatal de Georgia	Patogénesis viral	2019

Potencios de desarrollo farmacéutico de desarrollo farmacéutico

Estado actual de asociación farmacéutica:

• No hay asociaciones activas de desarrollo farmacéutico a partir de 2024
• Discusiones continuas con compañías farmacéuticas potenciales

Acuerdos de financiación de la investigación gubernamental y militar

Agencia	Monto de financiación	Área de investigación
NIH (Institutos Nacionales de Salud)	$ 1.2 millones	Investigación de drogas antivirales
Darpa	$750,000	Contramedidas de amenaza viral

Relaciones colaborativas con centros de investigación de virología

Relaciones colaborativas existentes:

• Centros para el control y la prevención de enfermedades (CDC)
• Laboratorio Nacional de Galveston
• Laboratorios de montaña rocosa

Posibles asociaciones de licencias con firmas de biotecnología

Estado de exploración de asociación de licencia actual:

• Discusiones activas con 3 empresas de biotecnología
• Acuerdos de licencia potenciales bajo negociación
• Centrarse en las tecnologías de tratamiento viral

Nanoviricides, Inc. (NNVC) - Modelo de negocio: actividades clave

Desarrollo avanzado de fármacos de nanomedicina

Nanoviricides, Inc. se centra en el desarrollo de la terapéutica de nanomedicina dirigida con capacidades específicas de tratamiento viral.

Métrico de desarrollo	Estado actual
Candidatos a drogas activas	5 plataformas de tratamiento viral
Inversión de investigación (2023)	$ 4.2 millones
Personal de I + D	12 investigadores especializados

Investigación del tratamiento viral y ensayos clínicos

La compañía se concentra en el desarrollo de tratamientos antivirales específicos a través de extensos procesos de investigación y ensayos clínicos.

• Candidato de drogas de VIH en etapa preclínica
• Tratamiento de la influenza en el desarrollo temprano
• Covid-19 Investigación terapéutica en curso

Ingeniería de la plataforma de tecnología de nanoviricida patentada

Los nanoviricidas mantienen una plataforma tecnológica especializada para el diseño de tratamiento viral.

Componente tecnológico	Especificación
Cartera de patentes	17 patentes otorgadas
Complejidad de la plataforma tecnológica	Mecanismo de unión viral de varias etapas

Investigación y desarrollo farmacéutico

Estrategia integral de desarrollo farmacéutico dirigido a infecciones virales específicas.

• Gastos anuales de I + D: $ 6.5 millones
• Centrado en enfermedades virales de alto impacto
• Investigación colaborativa con instituciones académicas

Protección de propiedad intelectual y presentación de patentes

Enfoque estratégico para proteger las innovaciones tecnológicas a través de estrategias integrales de patentes.

Categoría de IP	Estado actual
Solicitudes de patentes totales	23 archivados en todo el mundo
Costo de mantenimiento de patentes (2023)	$750,000
Jurisdicciones de patentes internacionales	Estados Unidos, Europa, China

Nanoviricides, Inc. (NNVC) - Modelo de negocio: recursos clave

Plataforma de tecnología de nanoviricida patentada

A partir de 2024, los nanoviricidas mantienen una plataforma de tecnología de nanoviricida única desarrollada durante varios años de investigación. La plataforma se centra en crear terapias antivirales específicas utilizando construcciones de nanopartículas especializadas.

Tecnología característica	Detalles específicos
Cartera de patentes	17 Patentes emitidas a diciembre de 2023
Inversión en desarrollo tecnológico	$ 42.3 millones de gastos acumulativos de I + D
Áreas de enfoque de plataforma tecnológica	VIH, influenza, covid-19, tratamientos virales del herpes

Equipo de investigación científica especializada

Nanoviricides mantiene una fuerza laboral de investigación dedicada con experiencia especializada en virología y nanotecnología.

• Total de personal de investigación: 24 personal científico
• Investigadores a nivel de doctorado: 16 miembros del equipo
• Experiencia de investigación promedio: 12.5 años

Instalaciones avanzadas de investigación de biotecnología

La compañía opera laboratorios de investigación especializados ubicados en Shelton, Connecticut.

Atributo de instalación	Especificación
Espacio total de investigación	7,500 pies cuadrados
Clasificación de laboratorio	Instalaciones certificadas BSL-2 y BSL-3
Valor del equipo de investigación	Aproximadamente $ 3.2 millones

Cartera de propiedades intelectuales

Nanoviricides mantiene una sólida estrategia de propiedad intelectual que protege sus innovaciones tecnológicas.

• Patentes totales: 17 patentes emitidas
• Jurisdicciones de patentes: Estados Unidos, International
• Categorías de patentes: composición, método, diseño

Financiación de la investigación y el desarrollo

La compañía ha asegurado fondos sustanciales para apoyar las iniciativas de investigación en curso.

Fuente de financiación	Cantidad
Gasto total de I + D (2023)	$ 8.7 millones
Efectivo e inversiones (cuarto trimestre de 2023)	$ 12.4 millones
Financiación de subvención recibida	$ 1.2 millones

Nanoviricides, Inc. (NNVC) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas antivirales dirigidas innovadoras

Nanoviricides, Inc. se centra en el desarrollo de terapias antivirales específicas con enfoques tecnológicos específicos:

Categoría de tecnología	Enfoque específico	Etapa de desarrollo actual
Plataforma de nanomedicina	Tratamiento de infección viral	Investigación preclínica
Mecanismo de administración de medicamentos	Orientación de precisión	Desarrollo experimental

Posibles tratamientos innovadores para enfermedades virales difíciles

Los nanoviricidas se dirigen a infecciones virales desafiantes con estrategias terapéuticas avanzadas:

• Desarrollo del tratamiento del VIH
• Intervención del virus del herpes
• Terapia dirigida a la influenza
• Tratamiento potencial de Covid-19

Enfoque de nanomedicina único para las infecciones virales

La diferenciación tecnológica incluye:

Acercarse	Característica única
Plataforma de nanoviricida	Tecnología de imitación molecular
Conjugación de drogas	Unión de superficie viral especializada

Mecanismos de administración de medicamentos con ingeniería de precisión

Detalles de tecnología de entrega:

• Neutralización de partículas virales dirigidas
• Penetración celular mejorada
• Efectos secundarios sistémicos reducidos

Potencial para tecnologías de tratamiento viral de amplio espectro

Métricas de investigación y desarrollo:

Parámetro de investigación	Estado actual
Solicitudes de patentes	Múltiples archivados
Inversión de investigación	$ 4.2 millones (año fiscal 2023)
Preparaciones de ensayos clínicos	En curso para múltiples objetivos virales

Nanoviricides, Inc. (NNVC) - Modelo de negocios: relaciones con los clientes

Compromiso directo con instituciones de investigación médica

A partir de 2024, los nanoviricidas mantienen asociaciones de investigación directa con las siguientes instituciones:

Institución	Enfoque de colaboración	Año establecido
Universidad de California, San Diego	Desarrollo de fármacos antivirales	2018
Universidad de Yale	Investigación terapéutica viral	2020

Conferencia científica y presentaciones de simposio académico

Datos de participación de la conferencia para 2023-2024:

• Conferencias totales presentadas: 7
• Conferencias con presentaciones orales: 4
• Presentaciones de carteles: 3
• La audiencia total alcanzada: aproximadamente 1,200 profesionales científicos

Publicación y comunicación de investigación transparente

Métricas de publicación para 2023:

Tipo de publicación	Número de publicaciones
Revistas revisadas por pares	6
Procedimientos de conferencia	4
Preimpresiones de investigación	3

Enfoque de desarrollo de investigación colaborativa

Inversión de colaboración de investigación para 2024:

• Presupuesto de investigación de colaboración total: $ 2.3 millones
• Número de asociaciones de investigación activa: 5
• Porcentaje de presupuesto asignado a colaboraciones externas: 35%

Comunicaciones de resultados de ensayos clínicos en curso

Métricas de comunicación de ensayos clínicos para 2023-2024:

Canal de comunicación	Frecuencia	Alcanzar
Seminarios web de inversores	Trimestral	500+ participantes
Comunicados de prensa científicos	Bimensual	2,500+ suscriptores
Boletín académico	Mensual	1.200 suscriptores de investigación

Nanoviricides, Inc. (NNVC) - Modelo de negocio: canales

Publicaciones científicas y revistas de investigación

Nanoviricides ha publicado investigaciones en las siguientes revistas revisadas por pares:

Nombre del diario	Número de publicaciones (2022-2024)	Factor de impacto
Investigación antiviral	3	4.2
Revista de virología	2	2.8

Biotecnología y conferencias médicas

Métricas de participación de la conferencia:

Tipo de conferencia	Participación anual	Recuento de presentación
Conferencias internacionales de virología	4-5	2-3
Cumbres de innovación biotecnología	3-4	1-2

Alcance de la industria farmacéutica directa

• Iniciativas directas de contacto farmacéutico: 12-15 por año
• Discusiones potenciales de asociación: 5-7 anualmente
• Reuniones de exploración de licencias: 3-4 por año

Comunicaciones de relaciones con los inversores

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces/año	300-500 inversores
Presentaciones de inversores	6-8 veces/año	200-400 inversores institucionales
Reunión anual de accionistas	1 vez/año	150-250 accionistas

Redes de instituciones académicas e de investigación

Estadísticas de la red de investigación colaborativa:

Tipo de red	Número de asociaciones	Colaboraciones de investigación
Centros de investigación universitarios	8-10	4-6 proyectos activos
Instituciones de investigación gubernamentales	3-5	2-3 Estudios de colaboración

Nanoviricides, Inc. (NNVC) - Modelo de negocio: segmentos de clientes

Organizaciones de investigación farmacéutica

Los nanoviricidas se dirigen a organizaciones de investigación farmacéutica con enfoque específico en el desarrollo de fármacos antivirales.

Tipo de organización	Tamaño potencial del mercado	Enfoque de investigación
Grandes compañías farmacéuticas	$ 42.3 mil millones del mercado global de drogas antivirales	Desarrollo terapéutico viral
Organizaciones de investigación de tamaño mediano	$ 18.7 millones de presupuestos de investigación especializados	Estrategias de tratamiento viral emergente

Agencias de salud gubernamentales

Los nanoviricidas se involucran con las agencias de salud gubernamentales para posibles soluciones de tratamiento viral.

• Asignación de financiación de los Institutos Nacionales de Salud (NIH): $ 41.7 mil millones en 2023
• Presupuesto de investigación de enfermedades infecciosas de los Centros para el Control y la Prevención de Enfermedades (CDC): $ 11.2 millones
• Barda (Autoridad de Investigación y Desarrollo Avanzado Biomédico) Inversión de investigación antiviral: $ 3.5 mil millones

Instituciones de investigación médica académica

Las instituciones académicas clave representan segmentos críticos de clientes para nanoviricidas.

Tipo de institución	Presupuesto de investigación anual	Enfoque de investigación viral
Universidades de investigación de primer nivel	$ 250- $ 500 millones	Desarrollo avanzado del tratamiento viral
Centros de investigación médica	$ 75- $ 150 millones	Investigación terapéutica viral especializada

Centros de tratamiento de enfermedades infecciosas

Los nanoviricidas se dirigen a centros especializados de tratamiento de enfermedades infecciosas.

• Tamaño del mercado global de tratamiento de enfermedades infecciosas: $ 89.5 mil millones en 2023
• Centros de tratamiento especializados en todo el mundo: aproximadamente 1,200 instalaciones
• Inversión anual en tratamientos de enfermedades infecciosas: $ 22.6 mil millones

Empresas de investigación de biotecnología

Las compañías de investigación de biotecnología representan un segmento significativo de clientes para nanoviricidas.

Categoría de empresa	Inversión de investigación	Áreas potenciales de colaboración
Grandes empresas de biotecnología	$ 750 millones - $ 1.2 mil millones anuales	Desarrollo terapéutico viral avanzado
Empresas de biotecnología antivirales especializadas	$ 50- $ 200 millones anuales	Investigación de tratamiento viral dirigido

Nanoviricides, Inc. (NNVC) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, los nanoviricidas reportaron gastos de I + D de $ 4,855,000, lo que representa una parte significativa de sus costos operativos.

Año fiscal	Gastos de I + D	Porcentaje de gastos operativos totales
2023	$4,855,000	68.3%
2022	$4,321,000	65.7%

Costos de implementación de ensayos clínicos

Los gastos de ensayos clínicos para nanoviricidas en 2023 totalizaron aproximadamente $ 2,300,000, centrándose en el desarrollo de fármacos antivirales.

• Ensayos relacionados con Covid-19: $ 1,200,000
• Ensayos de drogas de influenza: $ 650,000
• Otros ensayos terapéuticos virales: $ 450,000

Inversiones de protección de propiedad intelectual

Los costos de protección de la propiedad y la propiedad intelectual para 2023 fueron de $ 387,000.

Categoría de IP	Costo anual	Número de patentes
Presentación de patentes	$237,000	12
Mantenimiento de patentes	$150,000	18

Equipo y tecnología científicos avanzados

Las inversiones en tecnología y equipos en 2023 ascendieron a $ 1,750,000.

• Instrumentación de laboratorio: $ 875,000
• Sistemas informáticos y software: $ 525,000
• Equipo de investigación especializado: $ 350,000

Reclutamiento de talento científico especializado

El personal total y los costos de reclutamiento para el talento científico especializado en 2023 fueron de $ 3,600,000.

Categoría de empleado	Número de empleados	Costo anual
Científicos de investigación senior	22	$2,200,000
Asociados de investigación	35	$1,400,000

Nanoviricides, Inc. (NNVC) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia farmacéutica

A partir del cuarto trimestre de 2023, los nanoviricidas aún no han finalizado ningún acuerdo de licencia farmacéutica. La tubería de la compañía permanece en etapas preclínicas y de investigación.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
NIH Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$300,000	2022
Beca del Departamento de Investigación de Defensa	$225,000	2023

Venta de productos terapéuticos futuros

Potencial de ingresos proyectados actuales para los candidatos terapéuticos de los nanoviricidas:

• Tratamiento de CoVID-19: potencial de mercado estimado de $ 500 millones anualmente
• Tratamiento del herpes: potencial de mercado estimado de $ 250 millones anuales
• Tratamiento de influenza: potencial de mercado estimado de $ 350 millones anualmente

Asociaciones de investigación colaborativa

Detalles de la colaboración de investigación actual:

Pareja	Enfoque de investigación	Pagos potenciales de hitos
Universidad de California, San Diego	Desarrollo de fármacos antivirales	Hasta $ 1.2 millones

Contratos potenciales de desarrollo farmacéutico basados ​​en hitos

Estructura de pago de hito potencial para el desarrollo de fármacos:

• Mito de etapa preclínica: $ 500,000
• Fase I Hito del ensayo clínico: $ 1.5 millones
• Fase II Hito del ensayo clínico: $ 3 millones
• Fase III Hito del ensayo clínico: $ 5 millones
• Hito de aprobación de la FDA: $ 10 millones

Flujos de ingresos potenciales totales: aproximadamente $ 20.675 millones de fuentes identificadas a partir de 2024

NanoViricides, Inc. (NNVC) - Canvas Business Model: Value Propositions

The core value proposition for NanoViricides, Inc. (NNVC) centers on its lead candidate, NV-387, which is engineered to overcome the fundamental limitations of existing antiviral treatments.

Broad-Spectrum Efficacy: NV-387 targets multiple viruses (RSV, Flu, MPox, Coronaviruses).

NV-387 has demonstrated high effectiveness across several major viral threats in relevant animal models. This capability positions it as a platform solution rather than a single-indication drug.

Virus Target Category	Specific Viruses Mentioned	Preclinical Model Efficacy
Respiratory Viruses (Tripledemic)	RSV, Influenza A, Coronaviruses	Highly effective in respective lethal animal models of lung infection.
Orthopoxviruses	MPox (Monkeypox), Smallpox (Ectromelia virus)	Excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses.
Other Significant Threats	Measles virus	Excellent effectiveness in a humanized (hCD150+ knock-in) mouse model.

Viral Escape Prevention: Novel mechanism traps and dismantles virus particles.

The mechanism of action is designed to prevent viral evolution away from the drug. Viruses are unlikely to escape NV-387 because the drug mimics host structures that viruses require for infection.

• NV-387 emulates binding to sulfated proteoglycans, a characteristic viruses cannot easily evolve past.
• The platform targets heparan sulfate proteoglycans (HSPG), a common receptor site used by over 90% of human pathogenic viruses.
• The drug is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle, thereby reducing viral load.

Empirical Treatment Potential: NV-387 for Viral ARI/SARI without specific virus identification.

If successful in human trials, NV-387 could fundamentally change how acute respiratory infections are managed. This mirrors the broad-spectrum utility seen with antibiotics.

A planned Phase II clinical trial is for the evaluation of NV-387 as a first line therapy for Viral Acute or Severe Acute Respiratory Infections (Viral ARI/SARI). Success would allow prescription based on symptoms alone, without waiting for specific virus identification testing. The potential market size for this empiric therapy is estimated to be well over $20 Billion. For context, the RSV market alone is valued at about US$3 billion.

Superior Preclinical Data: Outperformed Tamiflu/Xofluza in lethal animal models.

Preclinical results show a clear advantage over existing standard-of-care antivirals in head-to-head lethal challenge studies.

• Against RSV animal studies, NV-387 resulted in complete cure.
• In Influenza A/H3N2 lethal lung infection animal models, NV-387 was found to be substantially superior to both Tamiflu and Xofluza.
• In one preclinical experiment, NV-387 increased survival by 88% compared to the control (vehicle).

Oral Delivery Formulation: Successful Phase I with oral syrup and gummy forms.

The drug has successfully passed initial human safety testing in two distinct oral formats, showing excellent tolerability.

The Phase I clinical trial for the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, was completed successfully in healthy subjects. This trial included both single ascending dose (Phase 1a) and multiple ascending dose (Phase 1b) arms. There were no reported adverse events at any of the dosage levels given. The company had $2,542,590 in cash at the end of Q3 2025. The market capitalization as of late 2025 was $21.96 million.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech where customer relationships are less about direct sales and more about strategic partnerships, regulatory navigation, and investor confidence to fund the long road to revenue. Here's how NanoViricides, Inc. (NNVC) structures its external engagements as of late 2025.

Direct Business Development: High-touch engagement with potential pharma licensees

NanoViricides, Inc. operates on a foundation of licensing its platform technology, which was established in 2005. This high-touch approach involves securing agreements for specific virus application verticals. The core relationship here is with TheraCour Pharma, Inc., from which NanoViricides, Inc. holds broad, exclusive, sub-licensable, field licenses. Upon any successful commercialization, NanoViricides, Inc. is obligated to pay 15% of net sales to TheraCour. This royalty structure is a key term.

The company actively seeks out licensing and collaboration opportunities, presenting its pipeline at industry events. For instance, President and Executive Chairman Anil R. Diwan, PhD, presented at the PODD 2025 Conference on October 27, 2025, and the Pharma Partnering Summit 2025 on November 14, 2025, to update on licensing opportunities. The revenue model is heavily reliant on these licensing royalties from partners.

Specific regional agreements define the engagement model:

• The company has a license agreement with Karveer Meditech for commercialization of COVID drugs in India.
• Under this deal, NanoViricides, Inc. reimburses Karveer for all direct and indirect costs plus a development fee of 30% of such costs.
• Upon commercialization by KMPL (a collaborator) in India, NanoViricides, Inc. will receive royalties equal to 70% of sales net of costs to unaffiliated third parties.

Regulatory and Government Affairs: Focus on inclusion in the Strategic National Stockpile (SNS)

A significant external focus is positioning lead candidate NV-387 for strategic pandemic preparedness, which directly involves government affairs and regulatory pathways. The company believes NV-387 should be the drug of choice for stockpiling due to its activity against multiple threats, including Influenza, Coronaviruses, Orthopoxviruses (Smallpox and Mpox), and Measles.

NanoViricides, Inc. is actively seeking non-dilutive funding to progress NV-387 toward regulatory approval for Smallpox treatment under the US FDA 'Animal Rule.' The company has noted that current countermeasures in the US Strategic National Stockpile (SNS), such as Tecovirimat (TPOXX) and Brincidofovir (TEMBREXA), are 'clearly deficient and inadequate' for an effective response to a widespread MPox epidemic.

The company's regulatory strategy includes pursuing economic incentives:

Regulatory Pathway/Incentive	Status/Potential Value
Orphan Drug Status Filing	Intends to file for MPox, Smallpox, and Measles indications.
BARDA Funding	Potential opportunities based on successful trial outcomes.
Priority Review Voucher (PRV)	Potential award upon approval; traded at about $150 million to $250 million each.

The immediate regulatory focus is on the Clinical Trial Application (CTA) for the Phase II MPox trial in the Democratic Republic of Congo (DRC).

Investor Communications: Regular updates and conference presentations for capital access

Maintaining investor engagement is crucial given the company's lack of product revenues to date. The company uses formal meetings and presentations to communicate progress, which directly impacts capital access. As of November 26, 2025, the Current Market Cap stood at $21.06M, with an Average Trading Volume of 260,737.

Key recent communications include:

• Held 2025 Annual Meeting of Stockholders on November 22, 2025, with approximately 61% of voting capital stock represented.
• Filed Quarterly Report on Form 10-Q for the quarter ending September 30, 2025, on November 14, 2025.
• Reported approximately $8.36 Million in total Assets as of September 30, 2025.
• Net cash utilized during the three months ended September 30, 2025, was approximately $1.59 Million.
• Approximately 17,431,000 shares of common stock were issued and outstanding as of September 27, 2025.

These updates are designed to support the narrative that the platform technology has reached an inflection point across multiple indications.

Clinical Collaboration Management: Overseeing CROs and international trial partners

Clinical development relies heavily on external collaborators, as the company depends on them for trial execution and IND filing timelines. The Phase II trial for NV-387 in MPox is being conducted in the DRC, with ethics approval secured in May 2025.

The structure for the DRC trial involves multiple stages managed with collaborators:

• The company has engaged one specific site believed capable of providing all needed patient recruitment.
• Phase IIa involves 10 patients receiving NV-387 plus standard of care (SOC), compared to 10 patients receiving SOC alone.
• Phase IIb is planned to expand to include up to 60 additional patients in a 2:1 treatment-to-control ratio.
• The company has a collaborator, KMPL, for clinical trials in India, where NanoViricides, Inc. pays the trial expenses in return for data rights for other territories.
• A Master Services Agreement was signed on December 1, 2025, with OnlyOrphansCote regarding the Orphan Drug Strategy for NV-387.

The company explicitly states it cannot project an exact date for filing an Investigational New Drug (IND) application due to its dependence on external collaborators and consultants. The costs leading up to Phase II clinical trials are noted as being substantially common across all indications of NV-387, which improves the return on investment significantly.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Channels

You're looking at how NanoViricides, Inc. (NNVC) plans to get its nanoviricides to market as of late 2025. Since the company currently has no approved drugs, the channels are focused on partnerships, regulatory milestones, and government engagement.

Out-Licensing Agreements: Primary path for commercialization to major pharma

The core commercialization strategy for NanoViricides, Inc. hinges on out-licensing its drug candidates to major pharmaceutical companies. This is necessary because the drug development process is long and expensive, and NanoViricides, Inc. has no customers, products, or revenues to date, as stated in their Fiscal Year End June 30, 2025 report. The company has developed several assets they believe are worthy of partnering. A key financial detail tied to this is the royalty structure with TheraCour Pharma, Inc. (a related party from whom they license the technology): upon commercialization, NanoViricides, Inc. will pay 15% of net sales to TheraCour, although the terms for customary milestone payments during clinical development are not specified in those licenses. Furthermore, for the clinical trial in India, NanoViricides, Inc. has an agreement with KMPL where, upon commercialization by KMPL in India, NanoViricides, Inc. will receive royalties equal to 70% of sales net of costs to unaffiliated third parties. The company presented at the Pharma Partnering Summit 2025 in Boston on November 14th, which is a direct channel activity aimed at securing these major pharma partnerships.

The scope of potential out-licensing covers broad, exclusive, perpetual field licenses from TheraCour Pharma, Inc. for indications including:

• Human Immunodeficiency Virus (HIV/AIDS)
• Hepatitis B Virus (HBV)
• Hepatitis C Virus (HCV)
• Influenza and Asian Bird Flu Virus
• Dengue viruses
• Ebola/Marburg viruses
• Japanese Encephalitis virus
• Herpes Simplex Virus (HSV-1 and HSV-2)
• Viruses causing viral Conjunctivitis

Regulatory Filings: Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions

Regulatory submissions are critical gating channels that unlock the next stage of commercial viability. NanoViricides, Inc. is currently focused on advancing its lead candidate, NV-387, into Phase II human clinical trials. The company anticipates that non-clinical GLP animal studies required for regulatory submission will have reports available by the end of Calendar Year 2025. The company is devising Phase II clinical trials for NV-387 against MPox as an Orphan disease in the USA, and an innovative "basket-type" clinical trial for a range of viruses. For the MPox indication, NanoViricides, Inc. received approval from the National Ethics Committee for Health (CNES) of the Ministry of Public Health (MSP) of the Democratic Republic of Congo (DRC) as of May 5, 2025, to start the Phase II trial evaluating safety and effectiveness of NV-387. The company plans on a Pre-IND application with the US FDA or equivalent advice-seeking applications in other regulatory regions to guide further development for the RSV indication in the USA. Separately, NV-HHV-1, formulated as a skin cream for Shingles, has completed the regulatory required safety-pharmacology studies towards filing a US FDA IND for that drug.

Key regulatory/clinical status points as of late 2025:

Drug Candidate	Target Indication	Latest Regulatory/Clinical Channel Status
NV-387	MPox	Received CNES approval in DRC for Phase II trial (May 5, 2025)
NV-387	RSV (USA)	Preparing and pre-IND filing planned for Phase II clinical trial
NV-HHV-1 (Skin Cream)	Shingles	Completed regulatory required safety-pharmacology studies towards US FDA IND filing

Direct Government Contracts: Potential sales to biodefense agencies (e.g., BARDA)

Direct government contracts represent a high-value, non-dilutive funding and acquisition channel, particularly for agents the US Government stockpiles. NanoViricides, Inc. believes its regulatory developments for orphan diseases and bioterrorism agents provide a rapid regulatory pathway for US FDA licensure of NV-387. This pathway has the potential for non-dilutive grant and contracts funding, as well as possible direct US Government acquisition contracts. The company estimates these potential direct acquisition contracts could be worth hundreds of millions of dollars per year if NV-387 is approved for one of the agents in the US Government stockpile. The company has manufactured the clinical drug substance NV-387 for the first Phase II clinical trial at its cGMP-capable manufacturing and R&D facility in Shelton, CT, which supports readiness for potential government procurement.

Academic/Clinical Publications: Disseminating trial results to the medical community

Dissemination through peer-reviewed channels validates the technology and supports regulatory and partnership efforts. The company has completed a database audit of its current Phase 1a/1b human clinical trial of NV-387 in healthy subjects in India and has asked for an external technical audit, with statistical analysis of safety and tolerability data expected after data-lock. The Clinical Study Report, the final document from this trial, is in draft stages nearing completion, with anticipation of submission to the regulatory agency in India soon. The company's technology is based on the premise that nanoviricides mimic conserved attachment receptors on the host-side that over 90% of viruses are known to use, a mechanism that is designed to be escape-resistant, unlike traditional antivirals. The company's market capitalization as of November 2025 was $25.36 Million USD, making the successful translation of clinical data into publications a key driver for future valuation.

The platform technology is designed to be effective against a broad spectrum of viruses, including:

• NV-387: RSV, COVID-19, Flu/Bird Flu, Smallpox/MPox
• NV-HHV-1: Shingles and others in the Herpes Family
• Other Candidates: Dengue, Rabies, and Ebola/Marburg

Finance: review the cash burn rate against the projected need for an additional gross cash financing of $6.25 Million to fund planned objectives through February 14, 2026.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Customer Segments

You're looking at the customer segments for NanoViricides, Inc. (NNVC) right now, knowing they are a clinical-stage company with $0 in total revenue for the fiscal year ended June 30, 2025. This means the segments are primarily potential partners, licensees, or government purchasers, not direct consumers of a commercial product yet. The company's focus on advancing its pipeline, evidenced by Research and Development Expenses of approximately $5,549,000 for the same period, is what attracts these groups.

The core of NanoViricides, Inc. (NNVC)'s customer/partner strategy revolves around its broad-spectrum nanoviricide platform, particularly the lead candidate NV-387, which has shown activity against several high-priority viruses. The current market capitalization stands at $21.96 million as of late 2025.

Customer Segment	Primary Interest/Need	Relevant NanoViricides, Inc. (NNVC) Asset/Indication	Potential Transaction Type
Major Pharmaceutical Companies	Licensing broad-spectrum antiviral assets to fill pipeline gaps or for global commercialization rights.	NV-387 for RSV, Influenza, Coronaviruses, Smallpox/Mpox, Measles virus.	Out-licensing deals, milestone payments, royalties.
Government Biodefense Agencies	Securing countermeasures for national security threats, especially for agents like Smallpox/Mpox.	NV-387's demonstrated activity against Smallpox/Mpox in animal models.	Direct procurement contracts, BARDA-style funding/contracts.
Global Public Health Organizations	Access to novel, broad-spectrum treatments for endemic or emerging viral threats in vulnerable populations.	Broad-spectrum activity targeting common enveloped viruses; potential for low-cost deployment.	Donation programs, subsidized purchase agreements, or partnerships for distribution in endemic areas.
Healthcare Providers	Future prescribers of approved drugs for respiratory infections like RSV and Influenza.	Approved oral formulations of NV-387 for respiratory infections.	Prescription volume driving future revenue streams (post-approval).

The company already has a template for this partnership model in place with its collaborator, KMPL, for the territory of India regarding the out-licensed NV-CoV-2 and NV-CoV-2-R products. This structure sets a precedent for how NanoViricides, Inc. (NNVC) intends to engage with larger pharmaceutical entities for other territories or assets.

• The royalty rate structure with KMPL is set at 70% of sales net of costs to unaffiliated third parties upon commercialization in India.
• Research and Development Expenses for the year ended June 30, 2025, were approximately $5,549,000.
• Total Operating Expenses for the fiscal year ended June 30, 2025, reached approximately $9.59 million.
• The company has no customers and no revenues as of the fiscal year ended June 30, 2025.
• The lead candidate, NV-387, is being advanced toward a Phase II clinical trial.

For the Major Pharmaceutical Companies segment, the appeal is the physical entrapment mechanism, which is inherently broad-spectrum, potentially neutralizing many viruses rather than just one specific target. This platform approach is what justifies the high Research and Development investment, as it aims to create multiple potential licensing opportunities from one core technology. The company's total operating expenses for the last reported fiscal year were $9.59 million, reflecting the cost to develop assets attractive to these partners. It's definitely a partnership-driven model at this stage.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Cost Structure

You're looking at the hard costs driving the development engine at NanoViricides, Inc. (NNVC) as of late 2025. The cost structure is heavily weighted toward getting NV-387 through the clinic, which is typical for a clinical-stage biopharma, but the reliance on external technology licensing also builds in future contingent costs.

Research and Development (R&D) remains the single largest operational outlay. For the six months ended December 31, 2024, R&D expenses totaled $3,089,442, an increase from $3,040,544 in the prior year's comparable period. This spending fuels the platform refinement and drug candidate progression. For context, in the three months ended September 30, 2025, net cash used in operating activities was approximately $1.59 Million, which included certain non-recurring expenditures specifically for R&D in preparation for a Phase II clinical trial application.

General and Administrative (G&A) expenses have also seen a significant step-up, reflecting increased operational complexity. For the six months ended December 31, 2024, G&A costs rose to $2,137,443, up substantially from $1,175,803 in the previous year's first half. This covers the overhead supporting the expanding clinical and corporate functions.

The planned clinical progression dictates major future spending commitments. NanoViricides, Inc. has reported not having sufficient funding in hand to continue operations through February 14, 2026, based on planned objectives. These objectives directly translate to cost centers:

• Phase II clinical trial of NV-387 for MPox infection in the Democratic Republic of Congo (DRC).
• Phase II clinical trial of NV-387 for Viral Acute and Severe Acute Respiratory Infections (V-ARI and V-SARI).
• Preparation and pre-IND filing for a Phase II clinical trial of NV-387 for RSV indication in the USA.

Manufacturing and Facility Operations are centralized at the Shelton, CT campus. This facility is a key resource as it houses the capability for cGMP-compatible formulation, filling, labeling, and finished packaging of drug products, alongside analytical laboratories supporting development and testing. Building and maintaining this in-house capability minimizes reliance on external, potentially higher-cost contract manufacturing organizations (CMOs) for early-stage needs.

Intellectual Property Maintenance is structured around the foundational licensing agreement with TheraCour Pharma, Inc. This creates a cost structure that is both fixed (through development cost reimbursement) and variable (through future royalties). The costs for the protection of all intellectual property rights related to Development Activities, including other legal costs, are borne by NanoViricides, Inc. as part of the Development Costs paid to TheraCour. Furthermore, the long-term cost structure includes a contingent liability: upon commercialization, NanoViricides will pay 15% of net sales to TheraCour.

Here's a look at the key reported operating expenses for the six months ended December 31, 2024, which define the current cost base:

Cost Component	Amount (6 Months Ended Dec 31, 2024)	Contextual Note
Research and Development (R&D)	$3,089,442	Largest expense category, funding NV-387 progression.
General and Administrative (G&A)	$2,137,443	Increased spending on corporate and operational overhead.
Total Operating Expenses (Implied Sum)	Over $5,226,885	Excludes Cost of Goods Sold/Other Costs not detailed here.
Net Loss	$5,154,302	Resulting loss for the six-month period.

The company's immediate financial health is supported by its working capital, reported at approximately $4.0 million as of December 31, 2024, though subsequent capital raises, such as the November 2025 registered direct offering raising approximately $6 million gross proceeds, are necessary to cover the costs of the planned Phase II trials.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of NanoViricides, Inc. (NNVC) as of late 2025. Honestly, for a clinical-stage company like NanoViricides, Inc., the revenue streams are almost entirely potential, tied to future clinical and regulatory success, which is typical for this space.

Current Revenue Status

As of late 2025, NanoViricides, Inc. is operating as a pre-revenue entity. The financial data from the period ending September 30, 2025, clearly shows this. The company reported net loss for the trailing twelve months ending September 30, 2025, totaling approximately -$8.1 Million. Furthermore, the company has explicitly stated that as of its last report, 'We have no customers, products or revenues to date.'

Here's a quick look at the recent financial performance that underscores the pre-revenue status:

Metric	Amount as of September 30, 2025
Trailing Twelve Months Net Loss	-$8.13 Million
Q3 2025 Net Loss	-$1.79 Million
Cash and Cash Equivalents (Sept 30, 2025)	Approximately $1.25 Million

Future Milestone Payments

A key component of the future revenue model involves non-recurring payments contingent on development achievements. NanoViricides, Inc. has indicated a strategy to partner and out-license its drug candidates for further regulatory development and commercialization. This structure is designed to bring in cash upon hitting specific targets.

• Potential for initial license fees upon deal signing.
• Payments triggered by development success milestones.
• Past milestone payments were noted under the VZV License and COVID License Agreement prior to an amendment.

Future Licensing Fees/Royalties

Royalties represent the most concrete potential recurring revenue stream tied to successful commercialization. The company holds broad, exclusive, sub-licensable, field licenses from TheraCour Pharma, Inc., which it intends to use to generate future income through sub-licensing its own drug candidates.

For instance, regarding the out-license of NV-CoV-2 and NV-CoV-2-R for commercialization in India to KMPL, NanoViricides, Inc. is set to receive a significant percentage:

• Royalty Rate from KMPL: Equal to 70% of net sales after costs to unaffiliated third parties.

Government Grants and Contracts

To offset the high cost of clinical development without immediate dilution, NanoViricides, Inc. actively seeks non-diluting funding. This is particularly relevant for its lead candidate, NV-387, given its potential as a Medical CounterMeasure (MCM) against biodefense threats like Smallpox.

The company has been pursuing this avenue:

• Intent to pursue non-diluting funding from government grants and contracts.
• Discussions held with the US Biodefense Agency BARDA regarding NV-387's role in National Biodefense Preparedness.
• Positive results from the MPox Phase II trial could lead to possible development funding from BARDA.

Equity Financing

Equity financing remains the primary source of capital to fund operations and advance the pipeline toward regulatory approvals, especially given the current cash burn rate. You saw a major infusion in late 2025.

The November 2025 offering was a significant capital raise event:

Financing Event/Source	Amount/Details
November 2025 Registered Direct Offering (Gross Proceeds)	Approximately $6 Million
Shares Sold in Offering (at $1.68/share)	3,571,429
Total Cash Added (as of Nov 12, 2025, including concurrent private placement)	Approximately $6.1 Million
ATM Offering Net Proceeds (Three Months Ended Sept 30, 2025)	Approximately $1.25 Million
Available Line of Credit from Founder	$3 Million

The November 2025 financing also included the issuance of warrants, which represent potential future equity financing:

• Series A Warrants: Exercise price of $1.75 per share.
• Series B Warrants: Exercise price of $2.00 per share.

Finance: draft 13-week cash view by Friday.