INmune Bio, Inc. (INMB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la biotecnología, Inmune Bio, Inc. (INMB) emerge como una fuerza pionera, navegando estratégicamente el complejo terreno de la inmunoterapia y los tratamientos dirigidos para los trastornos neurológicos y el cáncer. Al aprovechar sus innovadoras plataformas de tecnología e infraestructura de investigación sólida, la compañía está preparada para revolucionar potencialmente la medicina de precisión a través de enfoques innovadores que abordan algunas de las afecciones médicas más desafiantes. Los inversores y los profesionales médicos están observando de cerca el modelo de negocio estratégico de Inmune, lo que promete un potencial transformador para abordar las necesidades terapéuticas no satisfechas en la neuroinflamación y la investigación oncológica.

Inmune Bio, Inc. (INMB) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

Inmune Bio ha establecido asociaciones con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Detalles de colaboración
Centro de cáncer de Anderson de la Universidad de Texas	Investigación de inmunoterapia con cáncer	Colaboración de ensayos clínicos para XPRO1595
Universidad de Stanford	Estudios de neuroinflamación	Soporte de investigación para la plataforma DN-TNF

Asociaciones de desarrollo farmacéutico

Las colaboraciones clave de desarrollo farmacéutico incluyen:

• Colaboración con Myriad Genetics para la identificación de biomarcadores
• Asociación estratégica con Novartis para la investigación de inmunoterapia

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Inmune Bio trabaja con los siguientes CRO:

Nombre de Cro	Fase de ensayo clínico	Áreas de investigación
Ícono plc	PRUEBAS DE FASE 2/3	La enfermedad de Alzheimer y la inmunoterapia contra el cáncer
Medpacio	PRUEBAS FASE 1/2	Desarrollo clínico de la plataforma DN-TNF

Acuerdos potenciales de licencia farmacéutica

Asociaciones de licencias potenciales actuales:

• Discusiones exploratorias con Merck para la licencia XPRO1595
• Colaboración potencial con AstraZeneca para plataformas de inmunoterapia

Colaboraciones de la red de investigación de biotecnología

Las asociaciones de redes de biotecnología incluyen:

Red/organización	Tipo de colaboración	Enfoque de investigación
Instituto Nacional del Envejecimiento	Colaboración de la subvención de investigación	Investigación de neuroinflamación
Fundación Michael J. Fox	Soporte de investigación	Investigación de enfermedades neurológicas

Inmune Bio, Inc. (INMB) - Modelo de negocio: actividades clave

Investigación preclínica y clínica para tratamientos de inmunoterapia

Inmune Bio se centra en la investigación avanzada de inmunoterapia con áreas de enfoque específicas:

• Desarrollo terapéutico de neuroinflamación
• Investigación de inmunoterapia con cáncer
• Estrategias de intervención molecular dirigidas

Categoría de investigación	Programas activos	Etapa actual
Neuroinflamación	XPRO1595	Ensayos clínicos de fase 2
Inmunoterapia con cáncer	DNL343	Desarrollo preclínico

Desarrollo de fármacos centrados en la neuroinflamación y el cáncer

Los parámetros específicos de desarrollo de fármacos incluyen:

• Plataforma DN-TNF patentada
• Intervenciones de trastorno neurológico dirigido
• Enfoques de inmunomodulación de precisión

Realización de ensayos clínicos para terapias XPRO1595 y DNL343

Terapia	Indicación	Fase de prueba	Población de pacientes
XPRO1595	Enfermedad de Alzheimer	Fase 2	Deterioro cognitivo leve
DNL343	Cánceres avanzados	Preclínico	Tumores sólidos

Investigación molecular y celular en trastornos neurológicos

Las áreas de enfoque de investigación incluyen:

• Mecanismos de neuroinflamación
• Vías de señalización TNF
• Estrategias de intervención de neurodegeneración

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Agencia reguladora	Estado de interacción	Enfoque de cumplimiento
FDA	Compromiso activo	Aplicaciones de IN
EMA	Discusiones preliminares	Protocolos de ensayos clínicos

Inmune Bio, Inc. (INMB) - Modelo de negocio: recursos clave

Plataformas de tecnología de inmunoterapia patentadas

Las plataformas de tecnología primaria de Inmune Bio incluyen:

• Plataforma Xtoll para modulación inmune innata
• Tecnología de terapia con células DNT

Propiedad intelectual y cartera de patentes

Categoría de patente	Número de patentes	Rango de vencimiento
Tecnologías de inmunoterapia	8	2030-2041
Métodos de tratamiento del cáncer	5	2032-2039

Equipo de investigación científica y experiencia

Personal de investigación total: 37

• Investigadores de doctorado: 22
• Investigadores de MD: 6
• Compañeros postdoctorales: 9

Instalaciones avanzadas de laboratorio e investigación

Tipo de instalación	Hoques cuadrados totales	Ubicación
Laboratorio de investigación	12,500 pies cuadrados	San Diego, California

Datos de ensayos clínicos e información de investigación

Fase de ensayo clínico	Pruebas activas	Inscripción total del paciente
Fase 1/2	3	87
Fase 2	2	45

Inmune Bio, Inc. (INMB) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de inmunoterapia dirigidas

Inmune Bio se centra en el desarrollo de plataformas de inmunoterapia específicas con enfoques tecnológicos específicos:

Plataforma tecnológica	Enfoque específico	Etapa de desarrollo actual
XPRO1595	Tratamiento de neuroinflamación	Ensayos clínicos de fase 2
Receptor de activación de DNAX	Inmunoterapia con cáncer	Investigación preclínica

Tratamientos potenciales para enfermedades neurodegenerativas

Intervenciones terapéuticas dirigidas para condiciones neurológicas específicas:

• Manejo de la enfermedad de Alzheimer
• Reducción de la neuroinflamación de la enfermedad de Parkinson
• Modulación de inflamación neurológica

Enfoque de medicina de precisión para la neuroinflamación

Estrategias de orientación de precisión con métricas cuantificables:

Biomarcador	Medición de precisión	Relevancia clínica
Niveles de citocinas inflamatorias	Evaluación cuantitativa	Predicción de respuesta al tratamiento
Marcadores de neuroinflamación	Perfil molecular	Diseño de intervención personalizada

Posible avance en los mecanismos de tratamiento del cáncer

Desarrollo innovador de inmunoterapia del cáncer:

• Plataforma DN-TNF dirigida al microambiente tumoral
• Estrategias de modulación de punto de control inmune
• Enfoques de inmunoterapia con cáncer personalizado

Intervenciones terapéuticas personalizadas para enfermedades complejas

Desarrollo terapéutico especializado centrado en:

Categoría de enfermedades	Enfoque terapéutico	Estado de investigación actual
Trastornos neurodegenerativos	Reducción de neuroinflamación dirigida	Ensayos clínicos de fase 2
Condiciones oncológicas	Plataformas de inmunoterapia	Desarrollo preclínico

Inmune Bio, Inc. (INMB) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

Inmune Bio mantiene la participación directa a través de interacciones específicas con instituciones de investigación clave y centros médicos. A partir del cuarto trimestre de 2023, la compañía informó 37 colaboraciones de investigación activa en oncología y dominios de enfermedad neurodegenerativa.

Tipo de colaboración	Número de asociaciones activas	Enfoque de investigación
Instituciones académicas	22	Investigación oncológica
Centros de investigación médica	15	Enfermedades neurodegenerativas

Comunicación transparente del progreso del ensayo clínico

Inmune BIO proporciona actualizaciones completas sobre los desarrollos de ensayos clínicos a través de múltiples canales de comunicación.

• Llamadas de conferencia trimestralmente de inversores
• Comunicados de prensa detallados en hitos de ensayos clínicos
• Presentaciones anuales de inversores
• SEC presentando actualizaciones

Enfoque colaborativo con profesionales de la salud

La compañía involucra a los profesionales de la salud a través de estrategias de comunicación científica específicas. En 2023, Inmune BIO participó en 14 principales conferencias médicas, presentando 8 resúmenes científicos.

Tipo de conferencia	Número de conferencias	Presentaciones científicas
Conferencias oncológicas	7	4
Conferencias de neurociencia	7	4

Investigación y desarrollo centrados en el paciente

Inmune bio prioriza enfoques de investigación centrados en el paciente, con $ 24.3 millones asignado a iniciativas de I + D centradas en el paciente en 2023.

Conferencia científica y presentaciones de simposio

La compañía mantiene una presencia activa en foros científicos, con 18 presentaciones científicas en plataformas internacionales en 2023.

• Presentaciones científicas totales: 18
• Conferencias internacionales a las que asistió: 12
• Publicaciones revisadas por pares: 6

Inmune Bio, Inc. (INMB) - Modelo de negocio: canales

Publicaciones científicas directas

Inmune Bio, Inc. ha publicado 12 publicaciones científicas revisadas por pares en 2023, centrándose en las plataformas XToll y DN-TNF.

Lugar de publicación	Número de publicaciones	Factor de impacto
Revista de neuroinflamación	4	6.2
Investigación de Alzheimer & Terapia	3	5.8
Otras revistas especializadas	5	Variado

Presentaciones de conferencia médica

Inmune Bio participó en 7 conferencias médicas principales en 2023.

• Conferencia internacional de la Asociación de Alzheimer
• Reunión Anual de la Asociación Americana de Cirujanos Neurológicos
• Ensayos clínicos en la conferencia de enfermedades de Alzheimer
• Conferencia Internacional de Inmunología

Comunicaciones de relaciones con los inversores

Inmune Bio realizó 24 eventos de comunicaciones de inversores en 2023.

Tipo de comunicación	Frecuencia
Llamadas de ganancias trimestrales	4
Conferencias de inversores	6
Reuniones de inversores individuales	14

Interacciones de la agencia reguladora

Inmune Bio participó en 9 interacciones formales con agencias reguladoras en 2023.

• Reuniones de pre-India de la FDA: 3
• Procedimientos de asesoramiento científico de EMA: 2
• Revisiones de protocolo de ensayo clínico: 4

Plataformas de comunicación científica digital

Inmune Bio mantiene canales activos de comunicación digital.

Plataforma	Seguidores/suscriptores	Frecuencia postal
LinkedIn	8,500	Semanalmente
Gorjeo	5,200	Quincenal
Sitio web de la empresa	45,000 visitantes mensuales	Actualizaciones mensuales

Inmune Bio, Inc. (INMB) - Modelo de negocio: segmentos de clientes

Investigadores de enfermedades neurológicas

Tamaño del mercado objetivo: aproximadamente 15,000 investigadores activos de enfermedades neurológicas a nivel mundial

Enfoque de investigación	Interés potencial	Presupuesto de investigación anual
Neuroinflamación	Alto	$ 2.3 millones promedio por institución
Investigación de Alzheimer	Muy alto	$ 4.1 millones promedio por institución

Especialistas en tratamiento de oncología

Mercado total direccionable: 22,500 especialistas en oncología en todo el mundo

• Enfoque de investigación de inmunoterapia contra el cáncer
• Interés en nuevos enfoques de modulación inflamatoria
• Participación potencial del ensayo clínico

Compañías farmacéuticas

Potencios Partidos farmacéuticos: 37 principales compañías farmacéuticas con divisiones de neurociencia/oncología

Tipo de empresa	Interés potencial de colaboración	Presupuesto anual de I + D
Farmacéutico grande	Alto	Promedio de $ 1.2 mil millones
Farmacéutico de tamaño mediano	Medio	Promedio de $ 350 millones

Instituciones de investigación académica

Número de posibles socios institucionales: 289 a nivel mundial

• Centros de investigación de neurociencia: 124
• Centros de investigación de oncología: 165
• Financiación promedio de la investigación anual: $ 5.7 millones por institución

Pacientes con afecciones neuroinflamatorias

Población potencial total de la población de pacientes

Condición	Pacientes estimados	Potencial de mercado
Enfermedad de Alzheimer	6.2 millones (EE. UU.)	$ 12.4 mil millones de mercado potencial
Enfermedad de Parkinson	1.0 millones (EE. UU.)	Mercado potencial de $ 2.8 mil millones

Inmune Bio, Inc. (INMB) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal finalizado el 31 de diciembre de 2022, Inmune Bio reportó gastos de I + D de $ 24.1 millones.

Año	Gastos de I + D	Aumento porcentual
2020	$ 15.7 millones	N / A
2021	$ 19.3 millones	22.9%
2022	$ 24.1 millones	24.9%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para Inmune BIO en 2022 totalizaron aproximadamente $ 12.5 millones.

• Ensayos clínicos XTZ-2010: $ 5.2 millones
• Programa DN-TNF: $ 4.3 millones
• Investigación clínica de apoyo: $ 3.0 millones

Mantenimiento de la propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual para Inmune BIO fueron de $ 1.2 millones en 2022.

Categoría de IP	Costo
Presentación de patentes	$650,000
Renovación de patente	$350,000
Apoyo legal	$200,000

Inversiones de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2022 fueron de $ 3.8 millones.

Adquisición de personal y talento científico

Los gastos totales de personal para 2022 fueron de $ 16.4 millones.

Categoría de empleado	Número de empleados	Compensación total
Investigar científicos	38	$ 7.2 millones
Desarrollo clínico	22	$ 4.6 millones
Personal administrativo	15	$ 4.6 millones

INMUNE BIO, Inc. (INMB) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Inmune Bio aún no ha informado ningún ingreso activo de licencia de medicamentos. El enfoque principal de la compañía sigue siendo el desarrollo de posibles tecnologías terapéuticas.

Subvenciones de investigación y financiación

Año	Fuente de subvenciones	Cantidad
2022	Institutos Nacionales de Salud (NIH)	$ 1.2 millones
2023	Ministerio de defensa	$750,000

Asociaciones de investigación colaborativa

• Asociación con MD Anderson Cancer Center
• Acuerdo de investigación colaborativa con la Universidad de Pensilvania

Venta de productos terapéuticos potenciales

La tubería actual del producto incluye:

• XPRO1595 para la enfermedad de Alzheimer
• Plataforma DN-TNF para inmunoterapia contra el cáncer

Monetización de la propiedad intelectual

A partir de 2023, Inmune Bio sostiene 8 patentes emitidas y 12 solicitudes de patentes pendientes en dominios de neuroinflamación e inmuno-oncología.

Categoría de patente	Número de patentes
Neuroinflamación	5
Inmuno-oncología	3

INmune Bio, Inc. (INMB) - Canvas Business Model: Value Propositions

The Value Propositions for INMune Bio, Inc. center on its three distinct product platforms, each addressing significant unmet needs through novel mechanisms targeting innate immune dysfunction.

XPro1595: Selective neutralization of soluble TNF to slow neurodegeneration in inflammation-driven Alzheimer's.

The Phase 2 MINDFuL trial data, presented on December 1, 2025, provided evidence supporting this approach in a specific patient group. The trial involved 208 patients with MCI and early Alzheimer's disease (AD), with the analysis focusing on the pre-defined ADi population of 100 amyloid-positive early Alzheimer's patients with high inflammatory burden.

• XPro1595 demonstrated consistent positive trends across cognitive endpoints in the ADi population, with an EMACC (Early Mild Alzheimer's Cognitive Composite) effect size of 0.27.
• Neuropsychiatric symptoms showed improvement on the NPI (Neuropsychiatric Inventory) with an effect size of -0.23.
• New neuroimaging data using PerpPD+ showed a trend towards slowed neurodegeneration progression in the dose-compliant subgroup.
• The Company anticipates requesting an End of Phase 2 meeting with the FDA in Q1, 2026.

CORDStrom: Allogeneic cell therapy for systemic treatment of rare diseases like Recessive Dystrophic Epidermolysis Bullosa (RDEB).

CORDStrom, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform, completed a blinded randomized trial in pediatric RDEB patients. The company is targeting regulatory submission timelines based on this data.

• The FDA has granted CORDStrom both Rare Pediatric Disease Designation and Orphan Drug Designation for RDEB.
• The company intends to file a Marketing Authorization Application (MAA) in the U.K. in mid-2026, followed shortly by a Biologics License Application (BLA) with the FDA.
• The estimated patient population potentially benefiting from CORDStrom in RDEB is approximately 4,500 children.
• As of the Q3 2025 earnings report on October 30, 2025, INmune Bio, Inc. had completed the first two commercial pilot-scale manufacturing runs of CORDStrom.

INKmune: NK-priming immunotherapy to eliminate minimal residual disease in cancer.

INKmune is designed to convert resting Natural Killer (NK) cells into tumor-killing memory-like NK cells (mlNK cells). The platform is currently in a trial for metastatic castration-resistant prostate cancer (mCRPC).

• In treated patients, INKmune primed tumor-killing NK cells have persisted for more than 100 days.
• Final data analysis for the INKmune CARE-PC trial is expected in Q4 2026.
• The Phase I portion of the trial met its primary safety endpoint.

Differentiated mechanism of action from anti-amyloid Alzheimer's therapies (no ARIA risk).

The mechanism of XPro1595, which selectively neutralizes soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors, provides a key differentiator from anti-amyloid agents. This is best illustrated by comparing the safety profile against the risk associated with other Alzheimer's treatments.

Product/Feature	Metric/Value	Context/Population
XPro1595 Safety (ARIA Risk)	0 reported cases of ARIA	Phase 2 MINDFuL Trial participants
XPro1595 High-Risk Population	Approximately 70%	Trial participants considered high risk for ARIA
XPro1595 Efficacy Signal (Cognition)	Effect Size 0.27	ADi population (n=100) on EMACC
INKmune NK Cell Persistence	More than 100 days	In treated patients
Q3 2025 Cash Position	Approximately $27.7 million	As of September 30, 2025
Q3 2025 Net Loss	Approximately $6.5 million	Q3 2025 vs. $12.1 million in Q3 2024

The company's financial runway, based on the Q3 2025 results, is believed to be sufficient to fund operations into Q4 2026.

INmune Bio, Inc. (INMB) - Canvas Business Model: Customer Relationships

You're looking at how INmune Bio, Inc. manages its critical relationships with the various groups that drive its clinical and financial success as of late 2025. It's a mix of very close scientific collaboration and broad financial communication.

High-touch engagement with clinical investigators and trial participants

The relationship with those running and participating in the trials is intensely personal, given the focus on neuroinflammation in Alzheimer's disease. The Phase 2 MINDFuL trial, for example, enrolled a total of 208 participants, split between 92 individuals diagnosed with mild cognitive impairment (MCI) and 116 with mild Alzheimer's disease.

Engagement is focused on specific patient profiles. The analysis highlighted benefits in a predefined subgroup of 100 patients identified as amyloid-positive early Alzheimer's patients with high inflammatory burden (the ADi population). Still, the trial saw common adverse events, with injection site reactions (ISR) occurring in 80% of the XPro™ group, leading to 10 discontinuations out of 14 total dropouts in that arm.

The trial utilized the Early and Mild Alzheimer's Cognitive Composite (EMACC) measure, which showed a reliability correlation of 0.93 when measured during screening versus the first study visit.

Direct communication with regulatory bodies (FDA, MHRA) for BLA/MAA alignment

The path to market requires direct, documented alignment with the FDA. INmune Bio, Inc. is on track to request an End of Phase 2 meeting with the FDA, which is anticipated to occur in Q1, 2026. This is a crucial step following the Phase 2 data releases.

For the CORDStrom™ platform, the company is targeting an MAA submission mid-2026, which will be followed shortly by an anticipated BLA filing with the FDA. This demonstrates a structured, multi-jurisdictional regulatory strategy.

Investor relations via earnings calls and conference presentations (e.g., CTAD)

Investor communication is frequent, balancing clinical updates with financial performance. The Q3 2025 results conference call was scheduled for October 30, 2025, at 4:30pm ET, covering the quarter ended September 30, 2025.

Financially, the Q2 2025 results showed a net loss attributable to common stockholders of approximately $24.5 million for the quarter ended June 30, 2025, compared to approximately $9.7 million for the comparable period in 2024. The Q2 2025 EPS was -$1.05, missing the forecast of -$0.40, and revenue was reported at $0 against a forecast of $3,000. As of September 30, 2025, cash and cash equivalents stood at approximately $27.7 million.

Market engagement around data is also key. Following the presentation of new Phase 2 neuroimaging data at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD) on December 1-4, 2025, the stock closed at $1.86 on December 1, 2025, reflecting a market capitalization of $46M at that time.

Here's a quick look at some key metrics related to these touchpoints:

Metric Category	Specific Data Point	Value/Amount
Clinical Trial Enrollment (MINDFuL)	Total Participants	208
Clinical Trial Subgroup Size (ADi)	High-Inflammation Patients	100
Regulatory Milestone (FDA)	Anticipated End of Phase 2 Meeting	Q1, 2026
Financial Performance (Q2 2025)	Reported EPS	-$1.05
Financial Position (Q3 2025)	Cash & Equivalents (Sep 30, 2025)	$27.7 million
Market Data (Dec 1, 2025)	Market Cap	$46M

Scientific peer-review process through journal submissions (e.g., npj Dementia)

The scientific community is engaged through formal peer review. INmune Bio, Inc. announced the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial to npj Dementia, a Nature Portfolio journal, on September 29, 2025.

The data within that submission showed that in the predefined ADi population, XPro™ demonstrated slowed cognitive decline on EMACC with an effect size of 0.27, and reduced neuropsychiatric symptoms on the NPI with an effect size of -0.23.

The company also presented new Phase 2 neuroimaging analyses from the MINDFuL trial at CTAD between December 1-4, 2025.

The engagement with scientific peers involves specific reporting metrics:

• Manuscript submitted to npj Dementia on September 29, 2025.
• XPro™ effect size on EMACC in ADi population: 0.27.
• XPro™ effect size on NPI in ADi population: -0.23.
• XPro™ effect size on pTau217 in ADi population: -0.18.
• Data presented at CTAD from December 1-4, 2025.

Finance: draft 13-week cash view by Friday.

INmune Bio, Inc. (INMB) - Canvas Business Model: Channels

You're looking at how INmune Bio, Inc. gets its science and data out to the world-from the clinic to the conference hall and eventually to regulators and investors. This is all about the distribution and communication pathways for a clinical-stage biotech, which is quite different from a product company.

Global network of clinical trial sites for patient enrollment

The primary channel for generating clinical evidence is through its network of trial sites. For the XPro™ program targeting Alzheimer's disease, the Phase 2 MINDFuL trial (also referred to as AD02) was a global effort. This trial successfully completed enrollment, securing a total of 208 patients, which actually exceeded the initial target enrollment of 201 patients. Randomization for all participants was finalized on November 11, 2024. This established network of sites is the essential conduit for testing the therapy in the target population.

Here's a quick look at the scale of the key clinical trial activities that define this channel:

Program/Trial	Indication Focus	Enrollment Status (as of late 2025)	Key Milestone Date
MINDFuL (AD02) Phase 2	Early Alzheimer's Disease (AD) with Neuroinflammation	208 patients enrolled	Enrollment completed September 27, 2024
CORDStrom™ Trial	Recessive Dystrophic Epidermolysis Bullosa (RDEB)	Completed blinded randomized trial	Completed prior to late 2025 updates
INKmune® Phase II	Metastatic Castration-Resistant Prostate Cancer	Ongoing trial in veterans via VA Health Care System	Phase II high dose cohort opened

Scientific and medical conferences for data dissemination (e.g., CTAD)

Getting data in front of peers and key opinion leaders happens at specialized medical meetings. INmune Bio, Inc. was actively using these forums in late 2025 to disseminate findings from its trials. For instance, the company announced two presentations at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), held in San Diego, CA, from December 1-4, 2025. This is a critical channel for validating the science behind XPro1595.

Furthermore, data on XPro™ was presented previously at the Alzheimer's Association International Conference (AAIC) on July 29th. The company also participated in a Dermatologic Rare Disease Panel at the Maxim Growth Summit 2025.

These presentations are the primary way the company communicates clinical progress outside of formal press releases:

• Data presented at CTAD 2025 included XPro1595 results from the Phase 2 MINDFuL Trial.
• New neuroimaging data from the MINDFuL trial was presented on December 1, 2025.
• The company presented at the Maxim Growth Summit 2025, focusing on CORDStrom™.

Regulatory submission pathways (BLA/MAA) for market access

The ultimate channel to market access is the regulatory filing itself. For the CORDStrom™ platform in RDEB, INmune Bio, Inc. has clear targets for these major submissions. Honestly, hitting these dates is what drives the next phase of valuation.

The planned regulatory milestones are:

• File a Marketing Authorization Application (MAA) in the UK for CORDStrom™ in RDEB.
• File a Biologic License Application (BLA) with the FDA for CORDStrom™ in RDEB.
• The target filing window for both the MAA and BLA is set for mid-2026.

The company also reported having a Type C meeting with the FDA, which supported the intent to submit the BLA/MAA.

Corporate website and press releases for investor and public updates

For investors and the general public, the corporate website (www.inmunebio.com) and official press releases via services like GlobeNewswire are the direct channels for official communication. You can track the cadence of these updates, which is crucial for understanding near-term risk awareness.

For example, the company provided a major update via its Q3 2025 results conference call on Thursday, October 30, 2025, at 4:30 PM Eastern Time. This call included updates from CEO David Moss and CSO Dr. Mark Lowdell.

Key financial and operational data points released through these channels as of the Q3 2025 update include:

Metric	Value (as of September 30, 2025)	Context
Cash and Equivalents	$27.7 million	Sufficient to fund operations into Q4 2026
Common Shares Outstanding	Approximately 26.6 million	As of October 30, 2025
R&D Expenses (Q3 2025)	Approximately $4.9 million	Compared to $10.1 million in Q3 2024
Net Loss (Q3 2025)	$6.5 million	Compared to $12.1 million in Q3 2024

The Head of Investor Relations, Daniel Carlson, is the direct contact point for professional inquiries. Finance: draft 13-week cash view by Friday.

INmune Bio, Inc. (INMB) - Canvas Business Model: Customer Segments

You're looking at the specific groups INmune Bio, Inc. (INMB) is targeting with its pipeline assets as of late 2025. This isn't a broad market play; it's precision medicine focused on inflammation drivers in distinct, high-need patient populations.

Patients with early Alzheimer's Disease and high inflammatory burden (ADi population)

This segment is targeted by the XPro1595 (DN-TNF) platform. The Phase 2 MINDFuL trial specifically focused on an enriched population within early Alzheimer's Disease (AD) patients.

• The predefined ADi population for analysis consisted of amyloid-positive early Alzheimer's patients with high inflammatory burden, totaling n=100 patients.
• The overall Phase 2 MINDFuL trial enrolled 208 patients with MCI and early Alzheimer's.
• In the ADi cohort, XPro demonstrated an effect size of 0.27 on EMACC (cognition) and -0.23 on NPI (neuropsychiatric symptoms).
• Imaging data from this trial is anticipated for release in Q4 2025.

To put this in context, the broader US population aged 65 and older living with Alzheimer's dementia was estimated at 7.2 million in 2024.

Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

The CORDStrom platform is aimed squarely at RDEB patients. The strategy here is regulatory submission based on trial data.

• INmune Bio, Inc. has completed the first two commercial pilot-scale manufacturing runs for CORDStrom in preparation for filings.
• The company is on target to file a Marketing Authorization Application (MAA) submission in the U.K. in mid-2026.
• A Biologics License Application (BLA) with the FDA is anticipated shortly after the MAA filing.

Patients with metastatic castration-resistant prostate cancer (mCRPC)

The INKmune platform is being tested in an open-label Phase I/II trial for mCRPC patients in the US during 2025.

Here's a snapshot of the financial context surrounding these clinical efforts as of the Q3 2025 report:

Financial Metric	Value as of September 30, 2025
Cash and Cash Equivalents	$27.7 million
Net Loss (Q3 2025)	$6.5 million
R&D Expense (Q3 2025)	$4.9 million
Common Shares Outstanding	Approximately 26.6 million (as of October 30, 2025)

The company stated its current cash position is sufficient to fund operations into Q4 2026. The INKmune CARE-PC trial closed to recruitment due to high patient disease burden, with final data analysis expected in Q4 2026.

Future large pharmaceutical companies for licensing or acquisition post-Phase 2/3 data

This represents the ultimate exit or partnership customer segment. The value proposition for these entities hinges on de-risked clinical data, particularly for XPro1595 and CORDStrom.

• The market capitalization for INmune Bio, Inc. stood at $51 million on October 30, 2025.
• Positive data from the XPro1595 Phase 2 trial, especially for the ADi subgroup, is the key catalyst for attracting this segment.
• Successful MAA filing for CORDStrom in mid-2026 would significantly enhance attractiveness to potential acquirers in the cell therapy space.

You'll want to watch the final data release from the INKmune CARE-PC trial, expected in Q4 2025, as this will provide the final data point for that platform before a potential partnership discussion.

INmune Bio, Inc. (INMB) - Canvas Business Model: Cost Structure

The Cost Structure for INmune Bio, Inc. (INMB) is heavily weighted toward the necessary expenditures to advance its clinical pipeline, reflecting its status as a clinical-stage biotechnology company. You see these costs primarily broken down into Research and Development and General and Administrative categories in their public filings.

Here's the quick math on the major components from the third quarter of 2025:

Cost Component	Q3 2025 Amount (USD)	Comparison to Q3 2024 (USD)
Research and Development (R&D) Expenses	$4.9 million	Decreased from $10.1 million
General and Administrative (G&A) Expenses	$2.5 million	Increased from $2.2 million
Total Operating Expenses (Approximate Sum)	$7.43 million	Decreased from $12.29 million

High Research and Development (R&D) expenses, approximately $4.9 million for Q3 2025, represent the core investment in advancing the CORDStrom™, XPro™, and INKmune® platforms. This figure was significantly lower than the $10.1 million spent on R&D in the same period last year, showing tighter spend while advancing programs.

Clinical trial operations and patient enrollment costs are embedded within the R&D spend. For instance, the INKmune CARE-PC trial closed to further recruitment, which would shift costs from active enrollment to follow-up and final data analysis, with release expected in Q4 2026. Also, costs related to the Phase 2 MINDFuL trial for XPro™ continue as the company awaits regulatory alignment on next steps following the end of Phase II meeting outcomes anticipated in Q1 2026.

Manufacturing and supply chain costs are a critical, evolving component, particularly with the CORDStrom™ platform. INmune Bio, Inc. announced the successful completion of the first two commercial pilot-scale manufacturing runs of CORDStrom™ at the CGT Catapult facility in preparation for regulatory filings. This partnership is designed to establish large-scale, commercial-ready manufacturing, aiming for high-quality, off-the-shelf, low-cost production, which is a key strategy to manage future Cost of Goods Sold (COGS).

General and Administrative (G&A) expenses were approximately $2.5 million for Q3 2025, a slight uptick from the $2.2 million reported in Q3 2024. These costs cover the necessary overhead to run a public company and support ongoing operations.

Intellectual property maintenance and legal fees are inherent to protecting the pipeline assets, though specific dollar amounts for these were not itemized separately in the Q3 2025 summary data. These costs support the patent-pending nature of the CORDStrom™ platform and the ongoing regulatory strategy, which includes filing a Marketing Authorization Application (MAA) in the U.K. for CORDStrom™ in mid-2026.

The overall cost profile is managed with an eye toward runway extension, as the company held approximately $27.7 million in cash and cash equivalents as of September 30, 2025, which management believes is sufficient to fund operations into Q4 2026.

• R&D spending reduction year-over-year: approximately 51% ($10.1 million down to $4.9 million).
• G&A expense increase year-over-year: approximately 13.6% ($2.2 million up to $2.5 million).
• Cash runway projection: sufficient into Q4 2026.
• Key manufacturing milestone: completion of two pilot-scale runs at CGT Catapult.
• Trial status impacting R&D: INKmune CARE-PC trial closed to recruitment.

Finance: draft 13-week cash view by Friday.

INmune Bio, Inc. (INMB) - Canvas Business Model: Revenue Streams

For INmune Bio, Inc. (INMB), as a clinical-stage inflammation and immunology company as of late 2025, the revenue streams are almost entirely non-operational, revolving around capital formation and future potential monetization events.

Currently $0 revenue from product sales is the reality for INmune Bio, Inc. (INMB) given its clinical development stage. The financial results reflect this, showing significant net losses, such as the net loss attributable to common stockholders for the quarter ended September 30, 2025, being approximately $6.5 million. This operational burn is covered by non-sales funding sources.

The primary source of cash inflow is capital raised through equity markets. You saw this clearly in the middle of the year.

Financing Event Type	Date Announced/Expected Close	Gross Proceeds Amount	Purpose
Registered Direct Offering (RDO)	June 27, 2025 (Closing ~June 30, 2025)	Approximately $19 million	Working capital and general corporate procedures.
Stock Sale (Subsequent to Q1)	After March 31, 2025	Approximately $2.1 million	Not explicitly detailed, but contributed to cash position.

As of September 30, 2025, the cash and cash equivalents position stood at approximately $27.7 million, which the company believed was sufficient to fund operations into Q4 2026 based on the current operating plan. This cash runway is directly dependent on these financing activities.

Future revenue potential is tied to successful clinical progression and subsequent commercialization or collaboration events. These are currently contingent and not realized income.

• Potential future milestone payments from strategic partnerships, which the company is actively aspiring to secure to expand the pipeline using non-dilutive funding.
• Potential future licensing fees or royalties upon regulatory approval for the CORDStrom™ platform (targeting an MAA submission mid-2026 in the U.K. followed by a BLA with the FDA) or the XPro™ platform.

Another non-dilutive source that supported early development is grant funding. Specifically, the CORDStrom™ platform was 'Initially developed at the INKmune® manufacturing facilities utilizing UK academic grant funding.' This shows a history of non-dilutive support for key platform assets.

You're looking at a company whose current financial lifeblood is equity raises, funding the path toward the potential, but uncertain, revenue streams of partnerships and product sales.

Finance: draft 13-week cash view by Friday.