Inmune Bio, Inc. (INMB): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da biotecnologia, a Inmune Bio, Inc. (INMB) surge como uma força pioneira, navegando estrategicamente no complexo terreno da imunoterapia e tratamentos direcionados para distúrbios neurológicos e câncer. Ao alavancar suas plataformas inovadoras de tecnologia e infraestrutura de pesquisa robusta, a empresa está pronta para potencialmente revolucionar a medicina de precisão por meio de abordagens inovadoras que abordam algumas das condições médicas mais desafiadoras. Investidores e profissionais médicos estão assistindo de perto o modelo estratégico de negócios da Inmune, que promete potencial transformador para atender às necessidades terapêuticas não atendidas através da neuroinflamação e da pesquisa oncológica.

Inmune Bio, Inc. (INMB) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

A Inmune Bio estabeleceu parcerias com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Detalhes da colaboração
Centro de Câncer Anderson da Universidade do Texas	Pesquisa de imunoterapia ao câncer	Colaboração de ensaios clínicos para XPro1595
Universidade de Stanford	Estudos de neuroinflamação	Suporte de pesquisa para a plataforma DN-TNF

Parcerias de desenvolvimento farmacêutico

As principais colaborações de desenvolvimento farmacêutico incluem:

• Colaboração com inúmeras genética para identificação de biomarcadores
• Parceria estratégica com a Novartis para pesquisa de imunoterapia

Organizações de pesquisa contratada (CROs) para ensaios clínicos

Inmune Bio trabalha com os seguintes CROs:

Nome do CRO	Fase de ensaios clínicos	Áreas de pesquisa
Icon plc	Ensaios de Fase 2/3	Doença de Alzheimer e imunoterapia contra o câncer
Medpace	Ensaios de Fase 1/2	Desenvolvimento clínico da plataforma DN-TNF

Potenciais acordos de licenciamento farmacêutico

Parcerias de licenciamento potenciais atuais:

• Discussões exploratórias com o Merck para o licenciamento XPRO1595
• Colaboração potencial com as plataformas de imunoterapia AstraZeneca para plataformas de imunoterapia

Colaborações da rede de pesquisa de biotecnologia

As parcerias de rede de biotecnologia incluem:

Rede/organização	Tipo de colaboração	Foco na pesquisa
Instituto Nacional de Envelhecimento	Pesquisa concede colaboração	Pesquisa de neuroinflamação
Michael J. Fox Foundation	Suporte de pesquisa	Pesquisa em doenças neurológicas

Inmune Bio, Inc. (INMB) - Modelo de negócios: Atividades -chave

Pesquisa clínica e pré -clínica para tratamentos de imunoterapia

O Inmune Bio concentra -se na pesquisa avançada de imunoterapia com áreas de foco específicas:

• Desenvolvimento terapêutico de neuroinflamação
• Pesquisa de imunoterapia ao câncer
• Estratégias de intervenção molecular direcionadas

Categoria de pesquisa	Programas ativos	Estágio atual
Neuroinflamação	XPro1595	Ensaios clínicos de fase 2
Imunoterapia contra o câncer	DNL343	Desenvolvimento pré -clínico

Desenvolvimento de medicamentos com foco em neuroinflamação e câncer

Parâmetros específicos de desenvolvimento de medicamentos incluem:

• Plataforma DN-TNF proprietária
• Intervenções de transtorno neurológico direcionado
• Abordagens de imunomodulação de precisão

Realização de ensaios clínicos para terapias XPRO1595 e DNL343

Terapia	Indicação	Fase de teste	População de pacientes
XPro1595	Doença de Alzheimer	Fase 2	Comprometimento cognitivo leve
DNL343	Câncer avançado	Pré -clínico	Tumores sólidos

Pesquisa molecular e celular em distúrbios neurológicos

As áreas de foco de pesquisa incluem:

• Mecanismos de neuroinflamação
• Vias de sinalização TNF
• Estratégias de intervenção em neurodegeneração

Processos de conformidade regulatória e aprovação de medicamentos

Agência regulatória	Status da interação	Foco de conformidade
FDA	Engajamento ativo	Aplicações IND
Ema	Discussões preliminares	Protocolos de ensaios clínicos

Inmune Bio, Inc. (INMB) - Modelo de negócios: Recursos -chave

Plataformas de tecnologia de imunoterapia proprietárias

As plataformas de tecnologia primárias da Inmune Bio incluem:

• Plataforma XToll para modulação imune inata
• Tecnologia de terapia celular DNT

Propriedade intelectual e portfólio de patentes

Categoria de patentes	Número de patentes	Faixa de validade
Tecnologias de imunoterapia	8	2030-2041
Métodos de tratamento do câncer	5	2032-2039

Equipe de pesquisa científica e experiência

Pessoal de Pesquisa Total: 37

• Pesquisadores de doutorado: 22
• Pesquisadores de MD: 6
• Fellows de pós-doutorado: 9

Instalações avançadas de laboratório e pesquisa

Tipo de instalação	Mágua quadrada total	Localização
Laboratório de Pesquisa	12.500 pés quadrados	San Diego, Califórnia

Dados de ensaios clínicos e insights de pesquisa

Fase de ensaios clínicos	Ensaios ativos	Inscrição total do paciente
Fase 1/2	3	87
Fase 2	2	45

Inmune Bio, Inc. (INMB) - Modelo de negócios: proposições de valor

Soluções inovadoras de imunoterapia direcionadas

O Inmune Bio concentra -se no desenvolvimento de plataformas de imunoterapia direcionadas com abordagens tecnológicas específicas:

Plataforma de tecnologia	Foco específico	Estágio de desenvolvimento atual
XPro1595	Tratamento de neuroinflamação	Ensaios clínicos de fase 2
Receptor de ativação do DNAX	Imunoterapia contra o câncer	Pesquisa pré -clínica

Tratamentos potenciais para doenças neurodegenerativas

Intervenções terapêuticas direcionadas para condições neurológicas específicas:

• Gerenciamento de doenças de Alzheimer
• Redução de neuroinflamação da doença de Parkinson
• Modulação de inflamação neurológica

Abordagem de medicina de precisão para neuroinflamação

Estratégias de segmentação de precisão com métricas quantificáveis:

Biomarcador	Medição de precisão	Relevância clínica
Níveis inflamatórios de citocinas	Avaliação quantitativa	Previsão da resposta ao tratamento
Marcadores de neuroinflamação	Perfil molecular	Design de intervenção personalizada

Potencial avanço nos mecanismos de tratamento do câncer

Desenvolvimento inovador de imunoterapia ao câncer:

• Plataforma dn-tnf direcionando microambiente tumoral
• Estratégias de modulação do ponto de verificação imune
• Abordagens personalizadas de imunoterapia ao câncer

Intervenções terapêuticas personalizadas para doenças complexas

Desenvolvimento terapêutico especializado com foco em:

Categoria de doença	Abordagem terapêutica	Status de pesquisa atual
Distúrbios neurodegenerativos	Redução de neuroinflamação direcionada	Ensaios clínicos de fase 2
Condições oncológicas	Plataformas de imunoterapia	Desenvolvimento pré -clínico

Inmune Bio, Inc. (INMB) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A Inmune Bio mantém o envolvimento direto por meio de interações direcionadas com instituições de pesquisa e centros médicos importantes. A partir do quarto trimestre de 2023, a empresa relatou 37 colaborações de pesquisa ativa em domínios de doenças oncológicas e neurodegenerativas.

Tipo de colaboração	Número de parcerias ativas	Foco na pesquisa
Instituições acadêmicas	22	Pesquisa de oncologia
Centros de Pesquisa Médica	15	Doenças neurodegenerativas

Comunicação transparente do progresso do ensaio clínico

A InMune Bio fornece atualizações abrangentes sobre desenvolvimentos de ensaios clínicos por meio de vários canais de comunicação.

• Chamadas trimestrais de conferência de investidores
• Com comunicados de imprensa detalhados em marcos de ensaios clínicos
• Apresentações anuais de investidores
• Atualizações de arquivamento da SEC

Abordagem colaborativa com profissionais de saúde

A empresa envolve os profissionais de saúde por meio de estratégias de comunicação científica direcionadas. Em 2023, a Inmune Bio participou de 14 principais conferências médicas, apresentando 8 resumos científicos.

Tipo de conferência	Número de conferências	Apresentações científicas
Conferências de oncologia	7	4
Conferências de neurociência	7	4

Pesquisa e desenvolvimento focados no paciente

Inmune Bio prioriza abordagens de pesquisa centradas no paciente, com US $ 24,3 milhões Alocados para iniciativas de P&D focadas no paciente em 2023.

Apresentações de conferência científica e simpósio

A empresa mantém uma presença ativa em fóruns científicos, com 18 apresentações científicas em plataformas internacionais em 2023.

• Apresentações científicas totais: 18
• Conferências Internacionais Participadas: 12
• Publicações revisadas por pares: 6

Inmune Bio, Inc. (INMB) - Modelo de Negócios: Canais

Publicações científicas diretas

A Inmune Bio, Inc. publicou 12 publicações científicas revisadas por pares em 2023, concentrando-se nas plataformas XToll e DN-TNF.

Local de publicação	Número de publicações	Fator de impacto
Jornal de Neuroinflamação	4	6.2
Pesquisa de Alzheimer & Terapia	3	5.8
Outros periódicos especializados	5	Variado

Apresentações da conferência médica

A Inmune Bio participou de 7 principais conferências médicas em 2023.

• Conferência Internacional da Associação de Alzheimer
• Associação Americana de Cirurgiões Neurológicos Reunião Anual
• Ensaios clínicos na Conferência de Doença de Alzheimer
• Conferência Internacional de Imunologia

Comunicações de Relações com Investidores

A Inmune Bio conduziu 24 eventos de comunicação de investidores em 2023.

Tipo de comunicação	Freqüência
Chamadas de ganhos trimestrais	4
Conferências de investidores	6
Reuniões individuais de investidores	14

Interações da agência regulatória

Bio inmune se envolveu em 9 interações formais com as agências reguladoras em 2023.

• FDA pré-iluminação reuniões: 3
• Procedimentos de aconselhamento científico da EMA: 2
• Revisões de protocolo de ensaios clínicos: 4

Plataformas de comunicação científica digital

O InMune Bio mantém canais de comunicação digital ativos.

Plataforma	Seguidores/assinantes	Pós -frequência
LinkedIn	8,500	Semanalmente
Twitter	5,200	Quinzenal
Site da empresa	45.000 visitantes mensais	Atualizações mensais

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

Pesquisadores de doenças neurológicas

Tamanho do mercado -alvo: aproximadamente 15.000 pesquisadores de doenças neurológicas ativas globalmente

Foco na pesquisa	Interesse potencial	Orçamento de pesquisa anual
Neuroinflamação	Alto	Média de US $ 2,3 milhões por instituição
Pesquisa de Alzheimer	Muito alto	Média de US $ 4,1 milhões por instituição

Especialistas em tratamento de oncologia

Mercado endereçável total: 22.500 especialistas em oncologia em todo o mundo

• Foco na pesquisa de imunoterapia ao câncer
• Interesse em novas abordagens de modulação inflamatória
• Participação potencial do ensaio clínico

Empresas farmacêuticas

Parceiros farmacêuticos em potencial: 37 principais empresas farmacêuticas com divisões de neurociência/oncologia

Tipo de empresa	Potencial interesse de colaboração	Orçamento anual de P&D
Grande farmacêutica	Alto	Média de US $ 1,2 bilhão
Farmacêutico de tamanho médio	Médio	Média de US $ 350 milhões

Instituições de pesquisa acadêmica

Número de potenciais parceiros institucionais: 289 globalmente

• Centros de pesquisa em neurociência: 124
• Centros de Pesquisa Oncológica: 165
• Financiamento médio de pesquisa anual: US $ 5,7 milhões por instituição

Pacientes com condições neuroinflamatórias

População total de pacientes em potencial

Doença	Pacientes estimados	Potencial de mercado
Doença de Alzheimer	6,2 milhões (EUA)	US $ 12,4 bilhões de mercado potencial
Doença de Parkinson	1,0 milhão (EUA)	Mercado potencial de US $ 2,8 bilhões

Inmune Bio, Inc. (INMB) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Inmune Bio registrou despesas de P&D de US $ 24,1 milhões.

Ano	Despesas de P&D	Aumento percentual
2020	US $ 15,7 milhões	N / D
2021	US $ 19,3 milhões	22.9%
2022	US $ 24,1 milhões	24.9%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para Bio inmune em 2022 totalizaram aproximadamente US $ 12,5 milhões.

• Ensaios clínicos XTZ-201: US $ 5,2 milhões
• Programa DN-TNF: US $ 4,3 milhões
• Pesquisa clínica de apoio: US $ 3,0 milhões

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual da Inmune Bio foram de US $ 1,2 milhão em 2022.

Categoria IP	Custo
Registro de patentes	$650,000
Renovação de patentes	$350,000
Apoio legal	$200,000

Investimentos de conformidade regulatória

Os gastos com conformidade regulatória para 2022 foram de US $ 3,8 milhões.

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2022 foram de US $ 16,4 milhões.

Categoria de funcionários	Número de funcionários	Compensação total
Cientistas de pesquisa	38	US $ 7,2 milhões
Desenvolvimento Clínico	22	US $ 4,6 milhões
Equipe administrativo	15	US $ 4,6 milhões

Inmune Bio, Inc. (INMB) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

No quarto trimestre 2023, a Inmune Bio ainda não relatou nenhuma receita ativa de licenciamento de medicamentos. O foco principal da empresa permanece no desenvolvimento de potenciais tecnologias terapêuticas.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2022	Institutos Nacionais de Saúde (NIH)	US $ 1,2 milhão
2023	Departamento de Defesa	$750,000

Parcerias de pesquisa colaborativa

• Parceria com o MD Anderson Cancer Center
• Acordo de Pesquisa Colaborativa com a Universidade da Pensilvânia

Vendas potenciais de produtos terapêuticos

O pipeline de produtos atual inclui:

• XPro1595 para a doença de Alzheimer
• Plataforma DN-TNF para imunoterapia contra o câncer

Monetização da propriedade intelectual

A partir de 2023, Inmune Bio detém 8 patentes emitidas e 12 pedidos de patente pendente em domínios de neuroinflamação e imuno-oncologia.

Categoria de patentes	Número de patentes
Neuroinflamação	5
Imuno-oncologia	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.