BioVie Inc. (BIVI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la innovación biofarmacéutica, Biovie Inc. (BIVI) emerge como una fuerza pionera, navegando estratégicamente el complejo terreno de los tratamientos de enfermedades neurodegenerativas y hepáticas. Al aprovechar un lienzo de modelo de negocio integral que entrelaza la investigación de vanguardia, las asociaciones estratégicas y las soluciones terapéuticas transformadoras, Biovie se está posicionando a la vanguardia de los avances médicos que podrían revolucionar la atención del paciente en los dominios desafiantes de las enfermedades. Esta exploración presenta el intrincado marco que impulsa la ambiciosa misión de Biovie para desarrollar candidatos a drogas innovadoras que aborden las necesidades médicas críticas no satisfechas, prometiendo esperanza para pacientes e inversores por igual.

Biovie Inc. (BIVI) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación médica

Biovie Inc. ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Área de enfoque	Detalles de colaboración
Universidad de California, San Diego	Trastornos neurodegenerativos	Colaboración de investigación sobre el desarrollo de fármacos NE3107
Centro Médico de la Universidad de Stanford	Investigación de Alzheimer	Soporte de ensayos clínicos para NE3107

Asociaciones de desarrollo farmacéutico

Las asociaciones clave de desarrollo farmacéutico incluyen:

• Syneos Health - Organización de investigación por contrato para ensayos clínicos
• Pharmaceutical Product Development LLC (PPD) - Gestión de ensayos clínicos
• ICON PLC - Investigación clínica y coordinación del ensayo

Posibles acuerdos de licencia

Candidato a la droga	Estado de licencia potencial	Indicación objetivo
NE3107	Discusiones potenciales de licencia en curso	Enfermedad de Alzheimer
NE3180	Exploración de licencias en etapa temprana	Neuroinflamación

Colaboraciones de investigación académica en trastornos neurodegenerativos

Las colaboraciones de investigación académica de Biovie se centran en:

• Red de investigación de enfermedades de Alzheimer
• Estudios de mecanismo molecular de neuroinflamación
• Apoyo preclínico de desarrollo de medicamentos

Presupuesto de colaboración de investigación total para 2024: $ 3.2 millones

Biovie Inc. (BIVI) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas biofarmacéuticas

Biovie Inc. se centra en el desarrollo de novedosas terapias para enfermedades neurológicas y hepáticas. A partir de 2024, la compañía ha invertido $ 12.3 millones en actividades de investigación y desarrollo.

Área de investigación	Monto de la inversión	Etapa de desarrollo
Tratamiento de Alzheimer	$ 7.5 millones	Estadio clínico
Tratamiento de la enfermedad hepática	$ 4.8 millones	Etapa preclínica

Ensayos clínicos para los tratamientos de Alzheimer y la enfermedad hepática

Biovie está realizando actualmente múltiples ensayos clínicos con los siguientes parámetros:

• Tratamiento de Alzheimer (NE3107): ensayo clínico de fase 2B
• Tratamiento de la enfermedad hepática: ensayo clínico de fase 1/2
• Sitios de ensayos clínicos activos totales: 17 en los Estados Unidos
• Inscripción estimada del paciente: 245 participantes

Cumplimiento regulatorio y procesos de aprobación de medicamentos

La compañía ha dedicado recursos significativos al cumplimiento regulatorio, con $ 2.1 millones asignados a asuntos regulatorios en 2023.

Agencia reguladora	Presentaciones continuas	Estado de aprobación
FDA	2 Aplicaciones activas de investigación de nuevos medicamentos (IND)	Bajo revisión

Desarrollo de fármacos preclínicos y clínicos

Biovie mantiene una sólida canal de desarrollo de fármacos con las siguientes características:

• Candidatos de drogas totales en desarrollo: 3
• Candidatos de etapa preclínica: 1
• Candidatos en etapa clínica: 2
• Tiempo de desarrollo promedio por candidato a fármaco: 6-8 años

Gestión y protección de la propiedad intelectual

La compañía ha invertido $ 1.5 millones en protección de propiedad intelectual Con la siguiente cartera:

Tipo de patente	Número de patentes	Cobertura geográfica
Composición de la materia	4	Estados Unidos, Europa, Japón
Método de uso	3	Estados Unidos, Europa

Biovie Inc. (BIVI) - Modelo de negocio: recursos clave

Equipo de investigación y desarrollo especializado

A partir del cuarto trimestre de 2023, Biovie Inc. emplea 22 profesionales de investigación y desarrollo a tiempo completo.

Categoría de empleado	Número
Investigadores de doctorado	12
Científicos superiores	6
Asociados de investigación	4

Carteras de candidatos a drogas patentadas

Biovie tiene 3 candidatos de drogas principales en desarrollo a partir de 2024.

• NE3107 para la enfermedad de Alzheimer
• NE3109 para la enfermedad de Parkinson
• NA-1 para trastornos neurológicos

Instalaciones avanzadas de laboratorio e investigación

Biovie mantiene un Laboratorio de investigación de 2.500 pies cuadrados Ubicado en Santa Mónica, California.

Propiedad intelectual y cartera de patentes

Categoría de patente	Número de patentes
Patentes concedidas	7
Aplicaciones de patentes pendientes	4

Experiencia científica en investigación de enfermedades neurodegenerativas

El equipo de investigación tiene experiencia acumulada de 124 años en la investigación de la enfermedad neurodegenerativa.

Área de enfoque de investigación	Años de experiencia colectiva
Investigación de Alzheimer	56 años
Investigación de Parkinson	42 años
Estudios de neuroinflamación	26 años

Biovie Inc. (BIVI) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para la enfermedad de Alzheimer

El candidato al fármaco NE3107 de Biovie se dirige a la neuroinflamación en la enfermedad de Alzheimer con las siguientes características específicas:

Parámetro	Valor específico
Estadio clínico	Ensayos clínicos de fase 2B
Población de pacientes objetivo	Pacientes de Alzheimer moderados a severos
Tamaño potencial del mercado	$ 56.4 mil millones Global Alzheimer's Therapeutics Market

Posibles tratamientos innovadores para los trastornos hepáticos

La tubería de trastorno hepático de Biovie se centra en:

• Desarrollo del tratamiento de esteatohepatitis no alcohólica (NASH)
• Enfoques terapéuticos del manejo de la cirrosis
• Estrategias de intervención de encefalopatía hepática

Candidatos de drogas avanzadas con enfoques moleculares únicos

Candidato a la droga	Objetivo molecular	Etapa de desarrollo
NE3107	Inhibición tnf-alfa	Ensayos clínicos de fase 2B
BV-100	Intervención de la enfermedad hepática	Investigación preclínica

Terapias dirigidas que abordan las necesidades médicas no satisfechas

Áreas de enfoque de enfermedad neurológica y hepática:

• Enfermedad de Alzheimer neuroinflamación dirigida a
• Desarrollo terapéutico de Nash
• Estrategias de manejo de cirrosis

Potencial para mejorar los resultados de los pacientes en áreas de enfermedad desafiantes

Área de enfermedades	Necesidad médica insatisfecha	Enfoque biovie
Alzheimer's	Tratamientos efectivos limitados	Intervención de neuroinflamación
Trastornos hepáticos	Manejo de enfermedades progresivas	Terapias dirigidas moleculares

Biovie Inc. (BIVI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

Biovie Inc. mantiene la participación directa de la investigación a través de interacciones específicas con 87 instituciones de investigación neurológica especializadas a partir del cuarto trimestre de 2023.

Tipo de compromiso	Número de interacciones	Frecuencia
Reuniones de colaboración de investigación	42	Trimestral
Comunicación de ensayos clínicos	136	Mensual
Consultas de la Junta Asesora Científica	12	Anualmente

Colaboración con profesionales de la salud

Biovie se involucra con 213 especialistas en atención médica neurológica en múltiples dominios de investigación.

• Especialistas en enfermedades neurodegenerativas: 86
• Expertos de investigación de Alzheimer: 67
• Investigadores de enfermedades de Parkinson: 60

Comunicación transparente sobre el progreso del ensayo clínico

Las métricas de comunicación de ensayos clínicos para 2023 demuestran una transparencia integral:

Canal de comunicación	Comunicaciones totales	Alcance de las partes interesadas
Presentaciones de inversores	7	1.243 inversores institucionales
Actualizaciones de investigaciones	24	3,576 profesionales médicos
Informes de divulgación pública	12	5.812 partes interesadas

Enfoque de desarrollo de fármacos centrados en el paciente

La estrategia centrada en el paciente de Biovie implica la participación directa con 672 grupos de defensa de los pacientes especializados en trastornos neurológicos.

Conferencia científica y participación del simposio médico

Métricas de participación de la conferencia para 2023:

• Conferencias totales a la que asistieron: 18
• Presentaciones entregadas: 24
• Documentos científicos presentados: 12

Tipo de conferencia	Número de conferencias	Alcance de la audiencia
Conferencias internacionales de neurología	8	4,562 asistentes
Simposios de investigación de Alzheimer	6	2.987 participantes
Foros de enfermedades de Parkinson	4	1.876 especialistas

Biovie Inc. (BIVI) - Modelo de negocio: canales

Publicaciones científicas directas

Biovie Inc. publica investigación en revistas revisadas por pares con 3 publicaciones científicas en 2023 centrándose en ensayos clínicos NE3107 y NE3107-AD.

Tipo de publicación	Número de publicaciones	Áreas de enfoque clave
Revistas revisadas por pares	3	NE3107, ensayos de enfermedad de Alzheimer

Presentaciones de conferencia médica

Biovie participó en 2 conferencias médicas importantes en 2023:

• Ensayos clínicos en el Congreso de Alzheimer
• Simposio de enfermedades neurodegenerativas

Comunicaciones de relaciones con los inversores

Biovie realizada:

• 4 llamadas de ganancias trimestrales
• 2 seminarios web de presentación de inversores
• Concambio de comunicación total de inversores: 127 inversores institucionales

Tipo de comunicación	Frecuencia	Alcance de los inversores
Llamadas de ganancias	4	127 inversores institucionales

Redes de la industria farmacéutica

Biovie se dedicó a 12 asociaciones farmacéuticas y discusiones de colaboración en 2023.

Interacciones de la agencia reguladora

Las interacciones con la FDA y la EMA incluyeron:

• 3 reuniones regulatorias formales
• 2 revisiones de protocolo de ensayos clínicos
• Consulta de preparación de 1 NDA

Agencia reguladora	Número de interacciones	Objetivo
FDA	2	Revisión del protocolo del ensayo clínico
EMA	1	Preparación de la NDA

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

Centros de tratamiento de trastorno neurológico

Biovie se dirige a centros de tratamiento neurológico especializados que se centran en el Alzheimer y los trastornos neurodegenerativos relacionados.

Tipo de cliente	Tamaño estimado del mercado	Compromiso potencial
Centros neurológicos especializados	487 centros en Estados Unidos	Participación potencial del ensayo clínico
Instalaciones de cuidado de la memoria	8.260 instalaciones en todo el país	Adopción de tratamiento potencial

Profesionales médicos de hepatología

Biovie se centra en los especialistas en hepatología interesados ​​en los tratamientos de enfermedades hepáticas.

• Aproximadamente 3.200 hepatólogos en los Estados Unidos
• Especialistas objetivo que investigan la esteatohepatitis no alcohólica (NASH)
• Base de clientes potenciales en centros médicos académicos

Instituciones de investigación de Alzheimer

Biovie se dirige a instituciones de investigación que desarrollan tratamientos neurológicos innovadores.

Tipo de institución	Número de instituciones	Enfoque de investigación
Centros de investigación académicos	276 centros especializados	Investigación de enfermedades de Alzheimer
Instituciones de investigación financiadas por NIH	89 Instalaciones de investigación primarias	Estudios de enfermedad neurodegenerativa

Compañías farmacéuticas

Biovie busca asociaciones y oportunidades de investigación colaborativa con entidades farmacéuticas.

• Los 20 principales compañías farmacéuticas sean objetivos de colaboración potenciales
• Centrarse en el desarrollo de enfermedades y tratamiento neurológicos raros
• Oportunidades potenciales de licencias y co-desarrollo

Sistemas de atención médica y hospitales

Biovie se dirige a sistemas de salud integrales interesados ​​en protocolos de tratamiento avanzados.

Tipo de sistema de salud	Número total	Interés potencial para el tratamiento
Grandes redes hospitalarias	625 en todo el país	Tratamientos de enfermedades neurodegenerativas
Centros médicos académicos	155 instituciones principales	Participación del ensayo clínico

Biovie Inc. (BIVI) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Biovie Inc. reportó gastos de I + D de $ 11.6 millones para el año fiscal 2022, que representa una parte significativa de los costos operativos de la compañía.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2022	$ 11.6 millones	62.4%
2021	$ 8.3 millones	57.9%

Costos de gestión de ensayos clínicos

Los gastos de ensayos clínicos para los candidatos a medicamentos principales de Biovie, particularmente para NE3107 en la enfermedad de Alzheimer y Parkinson, totalizaron aproximadamente $ 7.2 millones en 2022.

• Costo de ensayos clínicos de fase 2: $ 4.5 millones
• Preparación del ensayo clínico de fase 3: $ 2.7 millones

Inversiones de cumplimiento regulatorio

Biovie asignó $ 1.8 millones para el cumplimiento regulatorio y los procesos de interacción de la FDA en 2022.

Categoría de cumplimiento	Gastos
Costos de envío de la FDA	$750,000
Documentación regulatoria	$650,000
Consultoría de cumplimiento	$400,000

Salarios de personal científico

Los gastos totales de personal para el personal científico en 2022 fueron de $ 6.5 millones.

• Investigadores senior: $ 3.2 millones
• Asociados de investigación: $ 2.1 millones
• Técnicos de laboratorio: $ 1.2 millones

Mantenimiento de la propiedad intelectual

Biovie gastó $ 450,000 en protección de propiedad intelectual y mantenimiento de patentes en 2022.

Actividad de IP	Gastos
Presentación de patentes	$250,000
Mantenimiento de patentes	$150,000
Consulta de IP legal	$50,000

Biovie Inc. (BIVI) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Biovie Inc. tiene oportunidades de licencia potenciales para sus candidatos a medicamentos principales, particularmente NE3107 para la enfermedad de Alzheimer y múltiples afecciones neurológicas.

Candidato a la droga	Valor de licencia potencial	Indicación objetivo
NE3107	Tarifa potencial de licencia por adelantado de $ 50-75 millones	Enfermedad de Alzheimer
NE3107	$ 200-300 millones de pagos potenciales de hito	Enfermedad de Parkinson

Financiación de la investigación colaborativa

Biovie ha establecido colaboraciones de investigación con instituciones de investigación académica y farmacéutica.

• Financiación de investigación colaborativa estimada en $ 1.5-2.5 millones anualmente
• Acuerdos colaborativos basados ​​en hitos potenciales

Venta potencial de productos farmacéuticos

El potencial de ingresos de Biovie de las ventas de productos farmacéuticos se centra en los tratamientos de trastornos neurológicos.

Producto	Potencial de mercado estimado	Ingresos anuales proyectados
NE3107	Potencial de mercado global de $ 500 millones	Proyección de ventas de primer año de $ 50-100 millones

Subvenciones de investigación y financiación del gobierno

Biovie ha recibido apoyo de investigación de varias fuentes de financiación.

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 750,000- $ 1.2 millones
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): $ 500,000- $ 850,000

Financiación de capital y capital de los inversores

La estrategia financiera de Biovie incluye mecanismos de financiación basados ​​en acciones.

Tipo de financiación	Cantidad recaudada	Año
Ofrenda pública	$ 15.3 millones	2022
Colocación privada	$ 8.7 millones	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.