Nanoviricides, Inc. (NNVC): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No mundo de ponta da nanomedicina, a Nanoviricides, Inc. (NNVC) surge como uma empresa revolucionária de biotecnologia pronta para transformar estratégias de tratamento viral por meio de sua inovadora plataforma de tecnologia de nanoviricidas. Ao desenvolver soluções antivirais de engenharia de precisão que prometem enfrentar algumas das doenças virais mais desafiadoras, esta empresa inovadora está na interseção de pesquisas científicas avançadas e potencial médico transformador. Sua abordagem única combina engenharia sofisticada de nanomedicina com intervenções terapêuticas direcionadas, oferecendo potencialmente esperança onde os tratamentos tradicionais ficaram aquém.

Nanoviricides, Inc. (NNVC) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

Nanoviricidas estabeleceu parcerias com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade da Califórnia, San Diego	Desenvolvimento antiviral de medicamentos	2018
Universidade Estadual da Geórgia	Patogênese viral	2019

Potenciais parcerias de desenvolvimento farmacêutico

Status da parceria farmacêutica atual:

• Nenhuma parceria de desenvolvimento farmacêutico ativo a partir de 2024
• Discussões em andamento com possíveis empresas farmacêuticas

Acordos de financiamento de pesquisa governamental e militar

Agência	Valor de financiamento	Área de pesquisa
NIH (Institutos Nacionais de Saúde)	US $ 1,2 milhão	Pesquisa antiviral de drogas
Darpa	$750,000	Contramedidas de ameaças virais

Relações colaborativas com centros de pesquisa de virologia

Relacionamentos colaborativos existentes:

• Centros de Controle e Prevenção de Doenças (CDC)
• Laboratório Nacional de Galveston
• Laboratórios Rocky Mountain

Potenciais parcerias de licenciamento com empresas de biotecnologia

Status de exploração da parceria de licenciamento atual:

• Discussões ativas com 3 empresas de biotecnologia
• Potenciais acordos de licenciamento em negociação
• Concentre -se nas tecnologias de tratamento viral

Nanoviricides, Inc. (NNVC) - Modelo de negócios: Atividades -chave

Desenvolvimento avançado de nanomedicina

A Nanoviricides, Inc. concentra -se no desenvolvimento de terapêuticas de nanomedicina direcionadas com recursos específicos de tratamento viral.

Métrica de Desenvolvimento	Status atual
Candidatos ativos de drogas	5 plataformas de tratamento viral
Investimento de pesquisa (2023)	US $ 4,2 milhões
Pessoal de P&D	12 pesquisadores especializados

Pesquisa de tratamento viral e ensaios clínicos

A empresa se concentra no desenvolvimento de tratamentos antivirais direcionados por meio de extensos processos de pesquisa e ensaios clínicos.

• Candidato a drogas para HIV em estágio pré -clínico
• Tratamento da influenza no desenvolvimento inicial
• COVID-19 Pesquisa terapêutica em andamento

Engenharia de plataforma de tecnologia de nanoviricidas proprietária

Os nanoviricidas mantêm uma plataforma tecnológica especializada para o projeto de tratamento viral.

Componente de tecnologia	Especificação
Portfólio de patentes	17 patentes concedidas
Complexidade da plataforma de tecnologia	Mecanismo de fixação viral de vários estágios

Pesquisa e Desenvolvimento Farmacêutico

Estratégia abrangente de desenvolvimento farmacêutico direcionado a infecções virais específicas.

• Despesas anuais de P&D: US $ 6,5 milhões
• Focado em doenças virais de alto impacto
• Pesquisa colaborativa com instituições acadêmicas

Proteção à propriedade intelectual e arquivamento de patentes

Abordagem estratégica para proteger as inovações tecnológicas por meio de estratégias abrangentes de patentes.

Categoria IP	Status atual
Total de pedidos de patente	23 arquivados em todo o mundo
Custo de manutenção de patentes (2023)	$750,000
Jurisdições de patentes internacionais	Estados Unidos, Europa, China

Nanoviricides, Inc. (NNVC) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia de nanoviricida proprietária

A partir de 2024, os nanoviricidas mantêm uma plataforma de tecnologia de nanoviricida exclusiva desenvolvida ao longo de vários anos de pesquisa. A plataforma se concentra na criação de terapêuticas antivirais direcionadas usando construções especializadas de nanopartículas.

Característica da tecnologia	Detalhes específicos
Portfólio de patentes	17 emitiram patentes em dezembro de 2023
Investimento em desenvolvimento de tecnologia	US $ 42,3 milhões de despesas cumulativas de P&D
Áreas de foco da plataforma de tecnologia	HIV, influenza, covid-19, tratamentos virais do herpes

Equipe de pesquisa científica especializada

Os nanoviricidas mantêm uma força de trabalho de pesquisa dedicada com experiência especializada em virologia e nanotecnologia.

• Pessoal de pesquisa total: 24 funcionários científicos
• Pesquisadores no nível de doutorado: 16 membros da equipe
• Experiência média de pesquisa: 12,5 anos

Instalações avançadas de pesquisa de biotecnologia

A empresa opera laboratórios especializados de pesquisa localizados em Shelton, Connecticut.

Atributo da instalação	Especificação
Espaço total de pesquisa	7.500 pés quadrados
Classificação laboratorial	Instalações certificadas BSL-2 e BSL-3
Valor do equipamento de pesquisa	Aproximadamente US $ 3,2 milhões

Portfólio de propriedade intelectual

Os nanoviricidas mantêm uma estratégia de propriedade intelectual robusta que protege suas inovações tecnológicas.

• Total de patentes: 17 patentes emitidas
• Jurisdições de patentes: Estados Unidos, Internacional
• Categorias de patentes: composição, método, design

Financiamento de pesquisa e desenvolvimento

A empresa garantiu financiamento substancial para apoiar iniciativas de pesquisa em andamento.

Fonte de financiamento	Quantia
Despesas totais de P&D (2023)	US $ 8,7 milhões
Cash and Investments (Q4 2023)	US $ 12,4 milhões
Concessão de financiamento recebido	US $ 1,2 milhão

Nanoviricides, Inc. (NNVC) - Modelo de negócios: proposições de valor

Soluções terapêuticas antivirais direcionadas inovadoras

A Nanoviricides, Inc. concentra -se no desenvolvimento de terapias antivirais direcionadas com abordagens tecnológicas específicas:

Categoria de tecnologia	Foco específico	Estágio de desenvolvimento atual
Plataforma de nanomedicina	Tratamento de infecção viral	Pesquisa pré-clínica
Mecanismo de entrega de medicamentos	Direcionamento de precisão	Desenvolvimento experimental

Possíveis tratamentos inovadores para doenças virais difíceis

Os nanoviricidas alvos desafiam infecções virais com estratégias terapêuticas avançadas:

• Desenvolvimento do tratamento do HIV
• Intervenção do vírus do herpes
• Terapia direcionada à influenza
• COVID-19 Potencial tratamento

Abordagem de nanomedicina exclusiva para infecções virais

A diferenciação tecnológica inclui:

Abordagem	Característica única
Plataforma de nanoviricida	Tecnologia de imitação molecular
Conjugação com drogas	Ligação de superfície viral especializada

Mecanismos de entrega de medicamentos com engenharia de precisão

Entrega especificamente de tecnologia:

• Neutralização de partículas virais direcionadas
• Penetração celular aprimorada
• Efeitos colaterais sistêmicos reduzidos

Potencial para tecnologias de tratamento viral de amplo espectro

Métricas de pesquisa e desenvolvimento:

Parâmetro de pesquisa	Status atual
Aplicações de patentes	Múltiplos arquivados
Investimento em pesquisa	US $ 4,2 milhões (2023 ano fiscal)
Preparações de ensaios clínicos	Em andamento para vários alvos virais

Nanoviricides, Inc. (NNVC) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com instituições de pesquisa médica

A partir de 2024, os nanoviricidas mantêm parcerias diretas de pesquisa com as seguintes instituições:

Instituição	Foco de colaboração	Ano estabelecido
Universidade da Califórnia, San Diego	Desenvolvimento antiviral de medicamentos	2018
Universidade de Yale	Pesquisa terapêutica viral	2020

Apresentações de Conferência Científica e Simpósio Acadêmico

Dados de participação da conferência para 2023-2024:

• Total de conferências apresentadas: 7
• Conferências com apresentações orais: 4
• Apresentações de pôsteres: 3
• Audiência total alcançada: Aproximadamente 1.200 profissionais científicos

Publicação e comunicação transparentes de pesquisa

Métricas de publicação para 2023:

Tipo de publicação	Número de publicações
Revistas revisadas por pares	6
Anais da conferência	4
Pesquisa pré -impressão	3

Abordagem de desenvolvimento de pesquisa colaborativa

Investimento de colaboração de pesquisa para 2024:

• Orçamento total de pesquisa colaborativa: US $ 2,3 milhões
• Número de parcerias de pesquisa ativa: 5
• Porcentagem de orçamento alocado para colaborações externas: 35%

Comunicações do resultado do ensaio clínico em andamento

Métricas de comunicação de ensaios clínicos para 2023-2024:

Canal de comunicação	Freqüência	Alcançar
Webinars de investidores	Trimestral	500 mais de participantes
Comunicados de imprensa científicos	Bimensal	2.500 mais de assinantes
Newsletter acadêmico	Mensal	1.200 assinantes de pesquisa

Nanoviricides, Inc. (NNVC) - Modelo de negócios: canais

Publicações científicas e revistas de pesquisa

Nanoviricidas publicou pesquisas nos seguintes periódicos revisados ​​por pares:

Nome do diário	Número de publicações (2022-2024)	Fator de impacto
Pesquisa antiviral	3	4.2
Virology Journal	2	2.8

Biotecnologia e conferências médicas

Métricas de participação na conferência:

Tipo de conferência	Participação anual	Contagem de apresentação
Conferências Internacionais de Virologia	4-5	2-3
Cúpulas de inovação de biotecnologia	3-4	1-2

Extenção direta na indústria farmacêutica

• Iniciativas de contato farmacêutico direto: 12-15 por ano
• Potenciais discussões de parceria: 5-7 anualmente
• Reuniões de exploração de licenciamento: 3-4 por ano

Comunicações de Relações com Investidores

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes/ano	300-500 investidores
Apresentações de investidores	6-8 vezes/ano	200-400 investidores institucionais
Reunião Anual dos Acionistas	1 hora/ano	150-250 acionistas

Redes de instituições acadêmicas e de pesquisa

Estatísticas da rede de pesquisa colaborativa:

Tipo de rede	Número de parcerias	Colaborações de pesquisa
Centros de Pesquisa Universitária	8-10	4-6 projetos ativos
Instituições de Pesquisa Governamental	3-5	2-3 Estudos colaborativos

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

Organizações de pesquisa farmacêutica

Os nanoviricidas têm como alvo organizações de pesquisa farmacêutica com foco específico no desenvolvimento de medicamentos antivirais.

Tipo de organização	Tamanho potencial de mercado	Foco na pesquisa
Grandes empresas farmacêuticas	US $ 42,3 bilhões no mercado global de drogas antivirais	Desenvolvimento terapêutico viral
Organizações de pesquisa de tamanho médio	US $ 18,7 milhões de orçamentos de pesquisa especializados	Estratégias emergentes de tratamento viral

Agências de saúde do governo

Os nanoviricidas se envolvem com as agências de saúde do governo para possíveis soluções de tratamento viral.

• Alocação de financiamento dos Institutos Nacionais de Saúde (NIH): US $ 41,7 bilhões em 2023
• Centros de Controle e Prevenção de Doenças (CDC) Orçamento de pesquisa de doenças infecciosas: US $ 11,2 milhões
• BARDA (Autoridade de Pesquisa e Desenvolvimento Avançada Biomédica) Investimento de Pesquisa Antiviral: US $ 3,5 bilhões

Instituições de Pesquisa Médica Acadêmica

As principais instituições acadêmicas representam segmentos críticos de clientes para nanoviricidas.

Tipo de instituição	Orçamento de pesquisa anual	Foco na pesquisa viral
Universidades de pesquisa de primeira linha	US $ 250 a US $ 500 milhões	Desenvolvimento avançado de tratamento viral
Centros de Pesquisa Médica	US $ 75 a US $ 150 milhões	Pesquisa terapêutica viral especializada

Centros de tratamento de doenças infecciosas

Os nanoviricidas têm como alvo os centros especializados de tratamento de doenças infecciosas.

• Tamanho do mercado de tratamento de doenças infecciosas globais: US $ 89,5 bilhões em 2023
• Centros de tratamento especializados em todo o mundo: aproximadamente 1.200 instalações
• Investimento anual em tratamentos de doenças infecciosas: US $ 22,6 bilhões

Empresas de pesquisa de biotecnologia

As empresas de pesquisa de biotecnologia representam um segmento significativo de clientes para nanoviricidas.

Categoria da empresa	Investimento em pesquisa	Áreas de colaboração em potencial
Grandes empresas de biotecnologia	US $ 750 milhões - US $ 1,2 bilhão anualmente	Desenvolvimento terapêutico viral avançado
Empresas de biotecnologia antivirais especializadas	US $ 50 a US $ 200 milhões anualmente	Pesquisa de tratamento viral direcionado

Nanoviricides, Inc. (NNVC) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, os nanoviricidas relataram despesas de P&D de US $ 4.855.000, representando uma parcela significativa de seus custos operacionais.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas operacionais
2023	$4,855,000	68.3%
2022	$4,321,000	65.7%

Custos de implementação de ensaios clínicos

As despesas de ensaios clínicos para nanoviricidas em 2023 totalizaram aproximadamente US $ 2.300.000, concentrando -se no desenvolvimento antiviral de medicamentos.

• Ensaios relacionados à Covid-19: US $ 1.200.000
• Ensaios de drogas para influenza: US $ 650.000
• Outros ensaios terapêuticos virais: US $ 450.000

Investimentos de proteção à propriedade intelectual

Os custos de proteção de propriedade e propriedade intelectual para 2023 foram de US $ 387.000.

Categoria IP	Custo anual	Número de patentes
Registro de patentes	$237,000	12
Manutenção de patentes	$150,000	18

Equipamentos científicos avançados e tecnologia

Os investimentos em tecnologia e equipamentos em 2023 totalizaram US $ 1.750.000.

• Instrumentação de laboratório: US $ 875.000
• Sistemas e software de computador: US $ 525.000
• Equipamento de pesquisa especializado: US $ 350.000

Recrutamento especializado de talento científico

Os custos totais de pessoal e recrutamento para talentos científicos especializados em 2023 foram de US $ 3.600.000.

Categoria de funcionários	Número de funcionários	Custo anual
Cientistas de pesquisa seniores	22	$2,200,000
Associados de pesquisa	35	$1,400,000

Nanoviricides, Inc. (NNVC) - Modelo de negócios: fluxos de receita

Potenciais acordos de licenciamento farmacêutico

A partir do quarto trimestre de 2023, os nanoviricidas ainda não finalizaram nenhum acordo de licenciamento farmacêutico. O oleoduto da empresa permanece em estágios pré-clínico e de pesquisa.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
NIH Small Business Innovation Research (SBIR) Grant	$300,000	2022
Concessão de pesquisa do departamento de defesa	$225,000	2023

Vendas futuras de produtos terapêuticos

Potencial de receita projetado atual para os candidatos terapêuticos dos nanoviricidas:

• Tratamento da Covid-19: potencial de mercado estimado de US $ 500 milhões anualmente
• Tratamento do herpes: potencial de mercado estimado de US $ 250 milhões anualmente
• Tratamento da influenza: potencial estimado de mercado de US $ 350 milhões anualmente

Parcerias de pesquisa colaborativa

Detalhes atuais de colaboração de pesquisa:

Parceiro	Foco na pesquisa	Potenciais pagamentos marcantes
Universidade da Califórnia, San Diego	Desenvolvimento antiviral de medicamentos	Até US $ 1,2 milhão

Contratos potenciais de desenvolvimento farmacêutico baseados em marcos

Estrutura de pagamento em potencial para o desenvolvimento de medicamentos:

• Marco no estágio pré-clínico: US $ 500.000
• Fase I Clinical Trial Milestone: US $ 1,5 milhão
• FASE II EUSTRAM
• FASE III EUSTRAM
• Aprovação da FDA Milestone: US $ 10 milhões

Fluxos potenciais totais de receita: aproximadamente US $ 20,675 milhões de fontes 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.