Biovie Inc. (BIVI): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem dinâmica da inovação biofarmacêutica, a Biovie Inc. (BIVI) surge como uma força pioneira, navegando estrategicamente no terreno complexo dos tratamentos neurodegenerativos e de doenças hepáticas. Ao alavancar uma tela abrangente de modelo de negócios que entrelaça pesquisas de ponta, parcerias estratégicas e soluções terapêuticas transformadoras, a Biovie está se posicionando na vanguarda de avanços médicos que podem potencialmente revolucionar o atendimento ao paciente em domínios desafiadores de doenças. Essa exploração revela a estrutura intrincada que impulsiona a missão ambiciosa da Biovie de desenvolver candidatos inovadores a drogas que atendem às necessidades médicas críticas não atendidas, promissoras de pacientes e investidores.

Biovie Inc. (BIVI) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa médica

A Biovie Inc. estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Área de foco	Detalhes da colaboração
Universidade da Califórnia, San Diego	Distúrbios neurodegenerativos	Colaboração de pesquisa no desenvolvimento de medicamentos NE3107
Centro Médico da Universidade de Stanford	Pesquisa de Alzheimer	Apoio aos ensaios clínicos para NE3107

Parcerias de desenvolvimento farmacêutico

As principais parcerias de desenvolvimento farmacêutico incluem:

• Syneos Health - Organização de Pesquisa em Contrato para Ensaios Clínicos
• Pharmaceutical Product Development LLC (PPD) - Gerenciamento de ensaios clínicos
• ICON PLC - Pesquisa clínica e coordenação de ensaios

Acordos de licenciamento em potencial

Candidato a drogas	Status de licenciamento potencial	Indicação alvo
NE3107	Potenciais discussões de licenciamento em andamento	Doença de Alzheimer
NE3180	Exploração de licenciamento em estágio inicial	Neuroinflamação

Colaborações de pesquisa acadêmica em distúrbios neurodegenerativos

As colaborações de pesquisa acadêmica da Biovie se concentram em:

• Rede de Pesquisa de Doenças de Alzheimer
• Estudos de mecanismo molecular de neuroinflamação
• Suporte pré -clínico ao desenvolvimento de medicamentos

Orçamento total de colaboração de pesquisa para 2024: US $ 3,2 milhões

Biovie Inc. (BIVI) - Modelo de Negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas biofarmacêuticas

A Biovie Inc. se concentra no desenvolvimento de novas terapêuticas para doenças neurológicas e hepáticas. Em 2024, a empresa investiu US $ 12,3 milhões em atividades de pesquisa e desenvolvimento.

Área de pesquisa	Valor do investimento	Estágio de desenvolvimento
Tratamento de Alzheimer	US $ 7,5 milhões	Estágio clínico
Tratamento da doença hepática	US $ 4,8 milhões	Estágio pré -clínico

Ensaios clínicos para tratamentos de doença de Alzheimer e fígado

Atualmente, a Biovie está realizando vários ensaios clínicos com os seguintes parâmetros:

• Tratamento de Alzheimer (NE3107): ensaio clínico de fase 2b
• Tratamento da doença hepática: ensaio clínico de fase 1/2
• Sites de ensaios clínicos ativos totais: 17 nos Estados Unidos
• Inscrição estimada do paciente: 245 participantes

Processos de conformidade regulatória e aprovação de medicamentos

A empresa dedicou recursos significativos à conformidade regulatória, com US $ 2,1 milhões alocados a assuntos regulatórios em 2023.

Agência regulatória	Envios em andamento	Status de aprovação
FDA	2 Aplicações ativas para investigação nova (IND)	Em revisão

Desenvolvimento de medicamentos pré -clínicos e clínicos

Biovie mantém um robusto pipeline de desenvolvimento de medicamentos com as seguintes características:

• Total de candidatos a drogas em desenvolvimento: 3
• Candidatos de estágio pré -clínico: 1
• Candidatos de estágio clínico: 2
• Tempo médio de desenvolvimento por candidato a drogas: 6-8 anos

Gerenciamento de propriedade intelectual e proteção

A empresa investiu US $ 1,5 milhão em proteção de propriedade intelectual Com o seguinte portfólio:

Tipo de patente	Número de patentes	Cobertura geográfica
Composição da matéria	4	Estados Unidos, Europa, Japão
Método de uso	3	Estados Unidos, Europa

Biovie Inc. (BIVI) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento

A partir do quarto trimestre 2023, a Biovie Inc. emprega 22 profissionais de pesquisa e desenvolvimento em período integral.

Categoria de funcionários	Número
Pesquisadores de doutorado	12
Cientistas seniores	6
Associados de pesquisa	4

Portfólios de candidatos a drogas proprietários

O Biovie possui 3 candidatos a medicamentos primários em desenvolvimento a partir de 2024.

• NE3107 para a doença de Alzheimer
• NE3109 para a doença de Parkinson
• Na-1 para distúrbios neurológicos

Instalações avançadas de laboratório e pesquisa

Biovie mantém um Laboratório de pesquisa de 2.500 pés quadrados Localizado em Santa Monica, Califórnia.

Propriedade intelectual e portfólio de patentes

Categoria de patentes	Número de patentes
Patentes concedidas	7
Aplicações de patentes pendentes	4

Experiência científica em pesquisa de doenças neurodegenerativas

A equipe de pesquisa tem experiência cumulativa de 124 anos na pesquisa de doenças neurodegenerativas.

Área de foco de pesquisa	Anos de experiência coletiva
Pesquisa de Alzheimer	56 anos
Pesquisa de Parkinson	42 anos
Estudos de neuroinflamação	26 anos

Biovie Inc. (BIVI) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para a doença de Alzheimer

O candidato a medicamentos NE3107 da Biovie tem como alvo a neuroinflamação na doença de Alzheimer com as seguintes características específicas:

Parâmetro	Valor específico
Estágio clínico	Ensaios clínicos de fase 2b
População alvo de pacientes	Pacientes de Alzheimer moderados a graves
Tamanho potencial de mercado	US $ 56,4 bilhões no mercado de terapêutica de Alzheimer global

Possíveis tratamentos inovadores para distúrbios hepáticos

O pipeline do transtorno do fígado da Biovie se concentra em:

• Desenvolvimento de tratamento de esteato-hepatite não alcoólica (NASH)
• Abordagens terapêuticas de gerenciamento de cirrose
• Estratégias de intervenção de encefalopatia hepática

Candidatos avançados de drogas com abordagens moleculares únicas

Candidato a drogas	Alvo molecular	Estágio de desenvolvimento
NE3107	Inibição de TNF-alfa	Ensaios clínicos de fase 2b
BV-100	Intervenção da doença hepática	Pesquisa pré -clínica

Terapias direcionadas atendendo a necessidades médicas não atendidas

Áreas de foco em doenças neurológicas e hepáticas:

• Alvoinflamação da doença de Alzheimer direcionamento
• Desenvolvimento terapêutico de Nash
• Estratégias de gerenciamento de cirrose

Potencial para melhorar os resultados dos pacientes em áreas desafiadoras de doenças

Área da doença	Necessidade médica não atendida	Abordagem de biovie
Alzheimer	Tratamentos eficazes limitados	Intervenção de neuroinflamação
Distúrbios do fígado	Gerenciamento progressivo de doenças	Terapias direcionadas moleculares

Biovie Inc. (BIVI) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A Biovie Inc. mantém o envolvimento direto da pesquisa por meio de interações direcionadas com 87 instituições de pesquisa neurológicas especializadas a partir do quarto trimestre 2023.

Tipo de engajamento	Número de interações	Freqüência
Reuniões de colaboração de pesquisa	42	Trimestral
Comunicação do ensaio clínico	136	Mensal
Consultas consultivas científicas	12	Anualmente

Colaboração com profissionais de saúde

O Biovie se envolve com 213 especialistas em saúde neurológicos em vários domínios de pesquisa.

• Especialistas em doenças neurodegenerativas: 86
• Especialistas em pesquisa de Alzheimer: 67
• Pesquisadores de doenças de Parkinson: 60

Comunicação transparente sobre o progresso do ensaio clínico

As métricas de comunicação de ensaios clínicos para 2023 demonstram transparência abrangente:

Canal de comunicação	Total de comunicações	Alcance das partes interessadas
Apresentações de investidores	7	1.243 investidores institucionais
Atualizações de pesquisa	24	3.576 profissionais médicos
Relatórios de divulgação pública	12	5.812 partes interessadas

Abordagem de desenvolvimento de medicamentos centrada no paciente

A estratégia focada no paciente da Biovie envolve o envolvimento direto com 672 grupos de defesa de pacientes especializados em distúrbios neurológicos.

Conferência Científica e Participação do Simpósio Médico

Métricas de participação na conferência para 2023:

• Total de conferências participadas: 18
• Apresentações entregues: 24
• Artigos científicos apresentados: 12

Tipo de conferência	Número de conferências	Alcance do público
Conferências internacionais de neurologia	8	4.562 participantes
Simpósios de pesquisa de Alzheimer	6	2.987 participantes
Fóruns de doenças de Parkinson	4	1.876 especialistas

Biovie Inc. (BIVI) - Modelo de Negócios: Canais

Publicações científicas diretas

A Biovie Inc. publica pesquisas em periódicos revisados ​​por pares com 3 publicações científicas em 2023, com foco nos ensaios clínicos NE3107 e NE3107-AD.

Tipo de publicação	Número de publicações	Principais áreas de foco
Revistas revisadas por pares	3	NE3107, ensaios de doença de Alzheimer

Apresentações da conferência médica

Biovie participou de 2 principais conferências médicas em 2023:

• Ensaios clínicos no Congresso de Alzheimer
• Simpósio de doenças neurodegenerativas

Comunicações de Relações com Investidores

Biovie conduzido:

• 4 chamadas trimestrais
• 2 webinars de apresentação de investidores
• Alcance total de comunicação para investidores: 127 investidores institucionais

Tipo de comunicação	Freqüência	Alcance do investidor
Chamadas de ganhos	4	127 investidores institucionais

Networking da indústria farmacêutica

Biovie se envolveu com 12 parcerias farmacêuticas e discussões de colaboração em 2023.

Interações da agência regulatória

Interações com FDA e EMA incluíram:

• 3 reuniões regulatórias formais
• 2 revisões de protocolo de ensaios clínicos
• 1 Consulta de preparação da NDA

Agência regulatória	Número de interações	Propósito
FDA	2	Revisão do protocolo de ensaio clínico
Ema	1	Preparação da NDA

Biovie Inc. (BIVI) - Modelo de negócios: segmentos de clientes

Centros de tratamento de transtornos neurológicos

O Biovie tem como alvo os centros de tratamento neurológico especializados, com foco em Alzheimer e distúrbios neurodegenerativos relacionados.

Tipo de cliente	Tamanho estimado do mercado	Potencial engajamento
Centros neurológicos especializados	487 centros nos Estados Unidos	Participação potencial do ensaio clínico
Instalações de atendimento à memória	8.260 instalações em todo o país	Potencial adoção de tratamento

Profissionais médicos de hepatologia

O Biovie se concentra em especialistas em hepatologia interessados ​​em tratamentos para doenças hepáticas.

• Aproximadamente 3.200 hepatologistas nos Estados Unidos
• Especialistas-alvo pesquisando esteato-hepatite não alcoólica (NASH)
• Base potencial de clientes em centros médicos acadêmicos

Instituições de pesquisa de Alzheimer

O Biovie tem como alvo instituições de pesquisa que desenvolvem tratamentos neurológicos inovadores.

Tipo de instituição	Número de instituições	Foco na pesquisa
Centros de pesquisa acadêmica	276 centros especializados	Pesquisa de doença de Alzheimer
Instituições de pesquisa financiadas pelo NIH	89 instalações de pesquisa primárias	Estudos de doenças neurodegenerativas

Empresas farmacêuticas

A Biovie busca parcerias e oportunidades de pesquisa colaborativa com entidades farmacêuticas.

• 20 principais empresas farmacêuticas potenciais metas de colaboração
• Concentre -se em doenças raras e desenvolvimento de tratamento neurológico
• Potenciais oportunidades de licenciamento e co-desenvolvimento

Sistemas de saúde e hospitais

O Biovie tem como alvo sistemas abrangentes de saúde interessados ​​em protocolos de tratamento avançado.

Tipo de sistema de saúde	Número total	Interesse potencial do tratamento
Grandes redes hospitalares	625 em todo o país	Tratamentos de doenças neurodegenerativas
Centros Médicos Acadêmicos	155 principais instituições	Participação do ensaio clínico

Biovie Inc. (BIVI) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

A Biovie Inc. registrou despesas de P&D de US $ 11,6 milhões no ano fiscal de 2022, representando uma parcela significativa dos custos operacionais da empresa.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 11,6 milhões	62.4%
2021	US $ 8,3 milhões	57.9%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para os principais candidatos a medicamentos da Biovie, principalmente para o NE3107 na doença de Alzheimer e Parkinson, totalizaram aproximadamente US $ 7,2 milhões em 2022.

• Fase 2 Ensaios Clínicos Custo: US $ 4,5 milhões
• Fase 3 Ensaios clínicos Preparação: US $ 2,7 milhões

Investimentos de conformidade regulatória

A Biovie alocou US $ 1,8 milhão para os processos de conformidade regulatória e interação da FDA em 2022.

Categoria de conformidade	Despesa
Custos de envio da FDA	$750,000
Documentação regulatória	$650,000
Consultoria de conformidade	$400,000

Salários de pessoal científico

As despesas totais de pessoal para a equipe científica em 2022 foram de US $ 6,5 milhões.

• Pesquisadores seniores: US $ 3,2 milhões
• Associados de pesquisa: US $ 2,1 milhões
• Técnicos de laboratório: US $ 1,2 milhão

Manutenção da propriedade intelectual

O Biovie gastou US $ 450.000 em proteção de propriedade intelectual e manutenção de patentes em 2022.

Atividade IP	Despesa
Registro de patentes	$250,000
Manutenção de patentes	$150,000
Consulta de IP legal	$50,000

Biovie Inc. (BIVI) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre de 2023, a Biovie Inc. possui possíveis oportunidades de licenciamento para seus principais candidatos a medicamentos, particularmente NE3107 para a doença de Alzheimer e múltiplas condições neurológicas.

Candidato a drogas	Valor potencial de licenciamento	Indicação alvo
NE3107	US $ 50-75 milhões em potencial taxa de licenciamento	Doença de Alzheimer
NE3107	US $ 200-300 milhões em potenciais pagamentos marcantes	Doença de Parkinson

Financiamento de pesquisa colaborativa

A Biovie estabeleceu colaborações de pesquisa com instituições de pesquisa acadêmica e farmacêutica.

• Financiamento de pesquisa colaborativa estimada em US $ 1,5-2,5 milhão anualmente
• Potenciais acordos colaborativos baseados em marcos

Vendas potenciais de produtos farmacêuticos

O potencial de receita da Biovie das vendas de produtos farmacêuticos se concentra nos tratamentos de transtorno neurológico.

Produto	Potencial estimado de mercado	Receita anual projetada
NE3107	Potencial de mercado global de US $ 500 milhões	Projeção de vendas do primeiro ano de US $ 50-100 milhões

Bolsas de pesquisa e financiamento do governo

A Biovie recebeu apoio de pesquisa de várias fontes de financiamento.

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 750.000 a US $ 1,2 milhão
• Pesquisa de inovação em pequenas empresas (SBIR) Subsídios: US $ 500.000 a US $ 850.000

Financiamento de capital e patrimônio líquido de investidores

A estratégia financeira da Biovie inclui mecanismos de financiamento baseados em ações.

Tipo de financiamento	Valor aumentado	Ano
Oferta pública	US $ 15,3 milhões	2022
Colocação privada	US $ 8,7 milhões	2023

BioVie Inc. (BIVI) - Canvas Business Model: Value Propositions

You're looking at the core value BioVie Inc. is trying to deliver across its pipeline, which is heavily focused on targeting neuroinflammation and related mechanisms. This is where the potential for significant patient impact-and financial upside-resides.

The lead asset, bezisterim (formerly NE3107), is positioned as a novel, orally available small molecule. Its mechanism involves binding to ERK and selectively modulating NFκB activation and TNF-α production. It is described as an oral, blood-brain barrier-permeable, anti-inflammatory, insulin-sensitizing agent.

For Parkinson's Disease (PD), the value proposition centers on offering a potential disease-modifying therapy, aiming to be the first new treatment in over five decades. The Phase 2 SUNRISE-PD trial is evaluating bezisterim as a monotherapy for early PD patients who have not yet been treated with carbidopa/levodopa. Topline data from this trial is anticipated by late 2025 or early 2026. Previous Phase 2a data in PD showed a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS), contrasted with a worsening of +1 point for placebo-treated patients.

The BIV201 program targets refractory ascites, a condition with a life-threatening 50% mortality rate within 12 months, for which there is currently no approved drug. BIV201, a continuous infusion formulation of terlipressin, has Orphan Drug designation (granted in 2016) and Fast Track status. Data from a Phase 2b trial, though limited by small size ($\text{n}=10$ for BIV201+SOC vs $\text{n}=5$ for SOC alone), indicated potential benefit. Patients completing treatment with BIV201+SOC experienced a reduction in ascites fluid buildup of 53% versus no change for Standard of Care (SOC) alone ($\text{p}<0.001$).

Here's a quick look at the BIV201 Phase 2b comparative efficacy endpoints:

Metric	BIV201+SOC (Completers)	SOC Alone
Liver Complications (Mean)	2.87 (90% CI: 1.51; 5.46)	2.38 (90% CI: 1.20; 4.73)
Change in Cumulative Ascites (Mean)	-10.76 (90% CI: -26.51; 5.00)	-4.99 (90% CI: -21.95; 11.97)

For Long COVID, the value is addressing debilitating neurological symptoms like fatigue and brain fog, which are believed to stem from chronic neuroinflammation. The Phase 2 ADDRESS-LC trial, which is fully funded by a U.S. Department of Defense grant up to $13.1 million, is currently enrolling approximately 200 patients, with topline data expected in the first half of 2026. This condition affects an estimated 20 million adults in the US, with an economic impact estimated at $3.7 trillion.

The safety profile is a key differentiator across the pipeline, particularly for bezisterim. The company states it is not immunosuppressive and carries a low risk of drug-drug interaction. For BIV201, the continuous infusion approach is highlighted as reducing the incidence of severe adverse events compared to the bolus administration used for other indications of terlipressin. However, the Phase 2b trial did note a high rate of hyponatremia in 4/10 patients in the BIV201+SOC group.

The core therapeutic mechanisms BioVie Inc. is targeting with bezisterim include:

• Targeting key mechanisms of neuroinflammation.
• Addressing potential metabolic dysfunction in the CNS.
• Modulating TNF-α production.
• Reducing insulin resistance in the brain.

Financially, BioVie Inc. remains pre-revenue, with zero reported revenue in Q3 FY2025, consistent with its clinical-stage operations. The net loss for Q3 FY2025 was $2.8 million, an improvement from the $8.1 million loss in Q3 FY2024, driven by lower R&D expenses of $1.3 million in Q3 FY2025 (down from $5.7 million year-over-year). As of March 31, 2025, the company maintained $23.2 million in cash and cash equivalents.

Finance: review the cash runway based on the $23.2 million cash balance against the Q3 FY2025 operating expense run rate of approximately $3.0 million per quarter.

BioVie Inc. (BIVI) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your customer relationships aren't about selling widgets; they're about building trust with the scientific community, regulators, and the capital markets to fund multi-year drug development. Here's how BioVie Inc. (BIVI) structures those critical interactions as of late 2025.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

BioVie Inc. (BIVI) focuses on direct scientific engagement to validate its pipeline, particularly bezisterim. This involves hosting specialized events where top medical minds discuss the data. For instance, the company hosted a virtual KOL event on May 28, 2025, specifically to discuss the Phase 2 SUNRISE-PD study for Parkinson's disease, featuring experts like Suzanne de la Monte, MD, MPH, and Mark Stacy, MD. KOLs (Key Opinion Leaders) are central to building credibility for novel mechanisms like bezisterim's selective inhibition of inflammation-driven ERK and NFκB activation.

The company also used KOLs to frame the market need for its other candidates. A KOL Webcast featuring Lindsay McAlpine, MD, BSc (Yale University), was held on April 10, 2025, to discuss the Long COVID treatment landscape and the ADDRESS-LC trial.

Direct-to-patient outreach for clinical trial enrollment

Enrollment velocity is lifeblood for a clinical-stage company, especially with multiple active trials. BioVie Inc. (BIVI) is actively managing enrollment across its key programs, using trial design features like decentralization to broaden access. The goal for the Parkinson's Phase 2 SUNRISE-PD trial is to be fully enrolled by the end of 2025. The Long COVID Phase 2 ADDRESS-LC trial is designed to enroll approximately 200 patients and received FDA authorization for its IND application in July 2025, with a three-month treatment period planned.

The company has a clear near-term milestone for data readout from the Parkinson's trial, projecting topline data in the April/May time frame of 2026. The Alzheimer's Phase 3 trial initiation was targeted for late 2025.

Here's a snapshot of the active patient engagement and data timelines:

Program	Trial Phase	Target Enrollment (Approx.)	Key Enrollment/Data Milestone
Bezisterim (Parkinson's)	Phase 2 (SUNRISE-PD)	Not specified, but enrollment picked up quickly	Projected full enrollment by end of 2025; Topline data by April/May 2026
Bezisterim (Long COVID)	Phase 2 (ADDRESS-LC)	Approximately 200 patients	IND authorized by FDA in July 2025; 3-month treatment period
Bezisterim (Alzheimer's)	Phase 3	Not specified	Initiation planned for late 2025

Investor relations via webinars and public disclosures (e.g., December 2025 webinar)

Investor communication is frequent and structured, often through third-party hosts like RedChip Companies. BioVie Inc. (BIVI) scheduled an exclusive live Investor Webinar and Q&A Session for December 9, 2025, following a previous one on October 8, 2025. These events are used to update the market on progress, such as the advancement of bezisterim and BIV201. The company also executed public financing, closing a $12 Million public offering on August 11, 2025. Importantly, management stated that the company has sufficient cash runway to last through the end of 2026.

The cadence of these interactions is high:

• Webinar on December 9, 2025 (Scheduled).
• Webinar on October 8, 2025 (Recent).
• KOL Webcast on May 28, 2025.
• KOL Webcast on April 10, 2025.

Close regulatory relationship with the FDA for development path guidance

The relationship with the U.S. Food and Drug Administration (FDA) is crucial for charting the path for both bezisterim and BIV201. For BIV201, which treats refractory ascites-a condition with a 50% mortality rate within 12 months and no FDA-approved therapies-the company has FDA Fast Track status. As of the November 2025 timeframe, the protocol for the BIV201 Phase 3 clinical trial had been submitted to the FDA about three weeks prior, with an expectation to hear back within 30 days. This close interaction is necessary to finalize the development path for a first-in-class therapy. Furthermore, the FDA authorized the IND application for bezisterim in Long COVID in July 2025, directly enabling that Phase 2 trial to commence.

Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Channels

Clinical trial sites are the primary physical channel for BioVie Inc. (BIVI) drug delivery and testing as of late 2025. The Phase 2 SUNRISE-PD trial for bezisterim in Parkinson's Disease is enrolling patients, with topline data anticipated in late 2025 or early 2026. This trial utilizes a decentralized design, allowing for remote participation alongside visits to a clinical site. The Phase 2 ADDRESS-LC trial for Long COVID, which commenced patient enrollment on May 15, 2025, involves approximately 200 patients. BioVie Inc. advances its pipeline through clinical research organizations across the United States and Canada.

Data dissemination channels rely heavily on scientific forums and regulatory disclosures. A poster detailing the SUNRISE-PD trial was presented at the Advanced Therapeutics in Movement & Related Disorders® Congress in National Harbor, MD, between June 27 and June 30, 2025. Furthermore, BioVie Inc. presented 'Bezisterim Epigenetic Effects on Aging and Neurodegeneration' at the 7th World Aging and Rejuvenation Conference (ARC-2025) in Vienna, Austria, on July 9th - 10th, 2025. The company's revenue remained at $0.0 for the trailing twelve months ending September 30, 2025, consistent with its clinical-stage focus.

Capital access is channeled through public markets and regulatory filings. BioVie Inc. trades on NASDAQ under the ticker BIVI. In August 2025, the company closed an underwritten public offering of 6,000,000 units at $2.00 per unit, generating gross proceeds of approximately $12 million. The warrants issued in this offering are exercisable at $2.50 per share. As of the September 30, 2025, SEC filing, cash and cash equivalents stood at $25.0 million, following net proceeds of $15.7 million from equity offerings and $2.9 million from warrant exercises in the nine months prior to March 31, 2025. The company also secured a $13.1 million grant from the U.S. Department of Defense for the Long COVID program.

Future distribution channels are currently being established through partnership discussions, particularly for the BIV201 program for ascites. The BIV201 Phase 3 study is in final preparations, contingent upon identifying a suitable partner. BioVie Inc. is also continuing geographic partnering discussions for bezisterim. The company reported operating expenses for Q3 2025 of $5.3 million (R&D $2.9 million; G&A $2.3 million), with a net loss of $5.1 million for that quarter.

The following table summarizes key financial and operational metrics relevant to channel funding and activity as of late 2025:

Metric Category	Channel Relevance	Value as of Late 2025	Reporting Period/Date
Capital Raised (Aug 2025 Offering)	Investor Relations/Capital Access	$12 million Gross Proceeds	August 11, 2025
Cash & Equivalents	Clinical Trial Funding Runway	$25.0 million	September 30, 2025
Long COVID Trial Funding Source	Clinical Trial Sites/Testing	$13.1 million DoD Grant	Secured prior to May 2025
PD Trial Funding Source	Clinical Trial Sites/Testing	Over $15 million	Secured prior to November 2024
Long COVID Trial Patient Count	Clinical Trial Sites/Testing	Approximately 200 Patients	Phase 2 ADDRESS-LC
Scientific Conference Presentation	Data Dissemination	Advanced Therapeutics in Movement & Related Disorders® Congress	June 27-30, 2025
SEC Form Filed for Offering	Investor Relations/Capital Access	Form S-1 (File No. 333-288525)	August 7, 2025
Warrant Exercise Price	Investor Relations/Capital Access	$2.50 per share	August 2025 Offering

The company's equity incentive plan was amended to authorize 3,100,000 shares for issuance as of November 10, 2025, supporting compensation for key personnel involved in channel execution.

BioVie Inc. (BIVI) - Canvas Business Model: Customer Segments

You're looking at the patient populations and capital providers that form the foundation of BioVie Inc.'s commercial focus as of late 2025. It's a high-stakes environment, where clinical trial milestones directly translate to investor sentiment.

Patients with newly diagnosed Parkinson's Disease (PD)

This segment is being targeted with bezisterim in the Phase 2 SUNRISE-PD clinical trial, which is designed to evaluate the drug's effect on motor and non-motor symptoms in patients who have not yet started carbidopa/levodopa treatment. Enrollment for this trial, which involves approximately 60 patients, was anticipated to begin in early 2025, with topline data expected by the end of 2025.

Patients with mild-to-moderate Alzheimer's Disease (AD)

BioVie Inc. is focused on the estimated six million Americans suffering from Alzheimer's disease. The company is preparing to initiate a Phase 3 trial for bezisterim in this population in late 2025, utilizing a new once-daily formulation. Data presented in July 2025 from the prior Phase 3 study analysis showed treated patients experienced biological age deceleration of up to 4.24 years across various biological clocks after 30 weeks of treatment compared to placebo.

Individuals with neurological symptoms of Long COVID

This segment is being addressed via the Phase 2 ADDRESS-LC study, which is evaluating bezisterim's efficacy in reducing symptoms like 'brain fog' and fatigue in approximately 200 patients. This trial is fully funded by a U.S. Department of Defense grant totaling $13.1 million, with enrollment expected to start in early 2025 and top-line results anticipated by early 2026. The condition itself is believed to affect over 17 million Americans.

Patients with liver cirrhosis and refractory ascites (Orphan Drug market)

The investigational drug BIV201 targets this serious unmet need and has secured both Orphan Drug and Fast Track designations from the FDA. The company is finalizing the protocol for a Phase 3 study, pending identification of a suitable partner. The broader Global Ascites Market was valued at USD 23,556 million in 2025. The Global Orphan Drugs Market overall is predicted to reach USD 669.5 Billion by 2034 from a 2024 valuation of USD 213.6 Billion.

The specific patient population for BIV201 is a niche within the larger ascites market, which is driven by the rising geriatric population, where the U.S. population aged 65 and older was 19.2% in 2024.

Indication Segment	Key Trial/Designation Status (Late 2025)	Patient/Market Size Data Point
Parkinson's Disease (Early)	Phase 2 SUNRISE-PD enrolling; Topline data by end of 2025	Trial size of approximately 60 patients
Mild-to-Moderate Alzheimer's Disease	Phase 3 trial protocol finalizing for late 2025 initiation	Estimated six million Americans affected
Long COVID Neurological Symptoms	Phase 2 ADDRESS-LC enrolling (funded by $13.1 million DoD grant)	Condition affects over 17 million Americans
Liver Cirrhosis/Refractory Ascites	BIV201 has Orphan Drug designation; Phase 3 finalizing	Global Ascites Market valued at USD 23,556 million in 2025

Institutional and retail investors funding the pipeline

You are looking at a company with zero revenue, so the investor base is funding the pipeline based on clinical milestones. As of November 7, 2025, the stock price was $1.48, resulting in a Market Capitalization of $11.2M, or $11.35M as of December 2, 2025, on 7.54M shares outstanding. For the fiscal year ending June 30, 2025, BioVie Inc. reported a net loss of approximately $17.5 million, which was an improvement from the $32.1 million loss in FY2024, largely due to R&D expenses falling to $9.3 million from $23.1 million the prior year. The company held $17.5 million in cash and cash equivalents as of June 30, 2025, and raised approximately $18.9 million through equity offerings during FY2025. The trailing twelve-month Earnings Per Share (EPS) as of September 30, 2025, was -$12.12. Wall Street analysts currently assign a Moderate Buy consensus rating with an average one-year price target of approximately $6.33.

• Trailing 12-Month Revenue (as of 30-Sep-2025): null
• FY 2025 Total Operating Expenses: $18.1 million
• Total Assets (as of 30-Sep-2025): $21.56 million
• Debt-to-Equity Ratio (MRQ 2025): Approximately 0.01
• Current Ratio (as of 30-Sep-2025): 15.83x

The clear action here is to treat BioVie Inc. as a high-risk, high-reward biotech stock. Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Cost Structure

You're looking at the core cash outflows for BioVie Inc. as of late 2025, driven almost entirely by clinical development and corporate upkeep since the company remains pre-revenue. The total operating expenses for the fiscal year ending June 30, 2025, were approximately $18.1 million.

The largest single component of the cost base is Research and Development (R&D). For the fiscal year 2025, BioVie Inc. reported Research and Development (R&D) expenses of approximately $9.3 million. This figure represented a significant reduction from the $23.1 million reported the prior year, reflecting completed clinical trials and workforce adjustments.

Here's a breakdown of the major annual cost line items based on the full-year 2025 report:

Cost Category	FY 2025 Amount (Approximate)
Research and Development (R&D) Expenses	$9.3 million
Selling, General, and Administrative (G&A) Expenses	$8.6 million
Total Operating Expenses	$18.1 million

Clinical trial operations and site management costs are embedded within the R&D expenses, but specific standalone figures aren't broken out in the high-level summaries. Still, the R&D spend reflects the costs of advancing bezisterim (NE3107) for Parkinson's disease and Long COVID indications, plus preparations for the BIV201 Phase 3 study in liver disease.

General and Administrative (G&A) expenses, covering executive salaries and corporate overhead, were reported around $8.6 million for the full year 2025. For context, the Selling, General, and Administrative expenses for the third quarter of FY2025 alone were $1.6 million.

Intellectual property maintenance and legal fees fall under the G&A structure, but specific amounts for these items aren't itemized separately in the available annual summaries. These costs are necessary to maintain the patent estate for bezisterim and BIV201.

Costs associated with capital raising are a recurring, non-operational cash outflow. You saw a significant financing event in August 2025:

• Gross proceeds expected from the August 2025 underwritten public offering were approximately $12 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
• For the nine months ending March 31, 2025, the company raised net proceeds of $15.7 million from equity offerings.
• During that same nine-month period, proceeds from warrant exercises totaled $2.9 million.
• The company also fully repaid its $5 million notes payable during the nine months ending March 31, 2025.

The company's cash position as of June 30, 2025, was $17.5 million in cash and cash equivalents, with a net change in cash for the year of negative $6.29 million.

Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Revenue Streams

You're looking at the current financial lifeblood of BioVie Inc. (BIVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage company deep in development: revenue streams are almost entirely non-operational right now. The core business isn't selling products yet; it's securing funding to push its pipeline forward.

For the fiscal year ending June 30, 2025, product revenue was $0.00. That's the reality when you're pre-commercialization. This means the company is entirely reliant on external capital to fund its research and development (R&D) expenses, which were significant, with a net loss of approximately $17.54 million for that same fiscal year.

The most recent, concrete cash infusion came from equity financing. In August 2025, BioVie Inc. closed a public offering, raising approximately $12 million in gross proceeds. This involved selling units comprised of common stock and warrants, a move that clearly signals a trade-off: reducing immediate credit risk but increasing shareholder dilution. To be fair, the net proceeds after deducting underwriting discounts and commissions were closer to $10.5 million.

A critical, non-dilutive source of funding is the grant money tied to clinical progress. BioVie Inc. was awarded up to $13.1 million in non-dilutive funding from the U.S. Department of Defense (DOD) to evaluate bezisterim for neurological symptoms associated with Long COVID. This total award is structured, with an initial $499,200 provided for the planning phase, and the remaining $12.6 million contingent upon successfully executing the Phase 2b clinical trial. This is defintely a key non-equity source that helps extend the cash runway.

Here's a quick look at the concrete financial inflows that make up the current revenue stream profile:

Revenue Stream Category	Specific Item	Reported Amount (USD)	Status/Notes
Product Sales	FY Ended June 30, 2025 Product Revenue	$0.00	Zero revenue from commercial product sales.
Equity Financing	Gross Proceeds from August 2025 Public Offering	Approximately $12 million	Raised by selling units of stock and warrants.
Equity Financing	Net Proceeds from August 2025 Public Offering	Approximately $10.5 million	Actual cash received after fees.
Non-Dilutive Grant Funding	Total Potential U.S. DOD Grant (Long COVID)	Up to $13.1 million	Contingent on trial milestones.
Non-Dilutive Grant Funding	Initial DOD Planning Phase Funding	$499,200	Initial tranche received.
Non-Dilutive Grant Funding	DOD Clinical Trial Portion (Option)	$12.6 million	Contingent upon trial progress.

Looking ahead, the model anticipates two major, currently unrealized revenue streams, both contingent on clinical success and partnership activity. These are:

• Future milestone payments derived from any in-licensing agreements that BioVie Inc. might secure post-data readout for its drug candidates.
• Future royalties and product sales revenue, which only materialize if a drug candidate achieves full regulatory approval and subsequent commercial launch.

Finance: draft 13-week cash view by Friday.