Inmune Bio, Inc. (INMB): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage en évolution rapide de la biotechnologie, Inmune Bio, Inc. (INMB) émerge comme une force pionnière, naviguant stratégiquement sur le terrain complexe de l'immunothérapie et des traitements ciblés pour les troubles neurologiques et le cancer. En tirant parti de ses plates-formes technologiques innovantes et de ses infrastructures de recherche robustes, la société est sur le point de révolutionner potentiellement la médecine de précision grâce à des approches révolutionnaires qui abordent certaines des conditions médicales les plus difficiles. Les investisseurs et les professionnels de la santé regardent de près le modèle commercial stratégique d'Inmune, qui promet un potentiel transformateur pour répondre aux besoins thérapeutiques non satisfaits à travers la neuroinflammation et la recherche oncologique.

Inmune Bio, Inc. (INMB) - Modèle commercial: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

Inmune Bio a établi des partenariats avec les établissements universitaires suivants:

Institution	Focus de recherche	Détails de collaboration
Université du Texas MD Anderson Cancer Center	Recherche d'immunothérapie contre le cancer	Collaboration d'essais cliniques pour xpro1595
Université de Stanford	Études de neuroinflammation	Support de recherche pour la plate-forme DN-TNF

Partenariats de développement pharmaceutique

Les principales collaborations de développement pharmaceutique comprennent:

• Collaboration avec une myriade de génétique pour l'identification des biomarqueurs
• Partenariat stratégique avec Novartis pour la recherche sur l'immunothérapie

Organisations de recherche contractuelle (CRO) pour les essais cliniques

Inmune Bio fonctionne avec les CRO suivants:

Nom de CRO	Phase d'essai clinique	Domaines de recherche
Icône plc	Essais de phase 2/3	Maladie d'Alzheimer et immunothérapie contre le cancer
Medpace	Essais de phase 1/2	Platform DN-TNF Développement clinique

Accords potentiels de licence pharmaceutique

Partenariats actuels de licence potentielle:

• Discussions exploratoires avec Merck pour les licences XPRO1595
• Collaboration potentielle avec AstraZeneca pour les plateformes d'immunothérapie

Biotechnology Research Network Collaborations

Les partenariats du réseau de biotechnologie comprennent:

Réseau / organisation	Type de collaboration	Focus de recherche
Institut national du vieillissement	Collaboration de subvention de recherche	Recherche de neuroinflammation
Fondation Michael J. Fox	Soutien à la recherche	Recherche de maladies neurologiques

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: Activités clés

Recherche préclinique et clinique pour les traitements d'immunothérapie

Inmune Bio se concentre sur la recherche avancée par immunothérapie avec des domaines d'intervention spécifiques:

• Développement thérapeutique de neuroinflammation
• Recherche d'immunothérapie contre le cancer
• Stratégies d'intervention moléculaire ciblées

Catégorie de recherche	Programmes actifs	Étape actuelle
Neuroinflammation	Xpro1595	Essais cliniques de phase 2
Immunothérapie contre le cancer	DNL343	Développement préclinique

Développement de médicaments axé sur la neuroinflammation et le cancer

Les paramètres spécifiques de développement de médicaments comprennent:

• Plate-forme DN-TNF propriétaire
• Interventions de troubles neurologiques ciblés
• Approches d'immunomodulation de précision

Effectuer des essais cliniques pour les thérapies XPRO1595 et DNL343

Thérapie	Indication	Phase de procès	Population de patients
Xpro1595	Maladie d'Alzheimer	Phase 2	Troubles cognitifs légers
DNL343	Cancers avancés	Préclinique	Tumeurs solides

Recherche moléculaire et cellulaire sur les troubles neurologiques

Les domaines d'intérêt de la recherche comprennent:

• Mécanismes de neuroinflammation
• Voies de signalisation TNF
• Stratégies d'intervention de neurodégénérescence

Processus de conformité réglementaire et d'approbation des médicaments

Agence de réglementation	Statut d'interaction	Focus de la conformité
FDA	Engagement actif	Applications IND
Ema	Discussions préliminaires	Protocoles d'essais cliniques

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: Ressources clés

Plateformes de technologie d'immunothérapie propriétaire

Les plates-formes technologiques principales d'Inmune Bio comprennent:

• Plateforme XToll pour la modulation immunitaire innée
• Technologie de thérapie cellulaire DNT

Propriété intellectuelle et portefeuille de brevets

Catégorie de brevet	Nombre de brevets	Plage d'expiration
Technologies d'immunothérapie	8	2030-2041
Méthodes de traitement du cancer	5	2032-2039

Équipe de recherche scientifique et expertise

Personnel de recherche total: 37

• Rechercheurs de doctorat: 22
• Chercheurs MD: 6
• Fellows post-doctoraux: 9

Installations avancées de laboratoire et de recherche

Type d'installation	Total en pieds carrés	Emplacement
Laboratoire de recherche	12 500 pieds carrés	San Diego, Californie

Données des essais cliniques et idées de recherche

Phase d'essai clinique	Essais actifs	Inscription totale
Phase 1/2	3	87
Phase 2	2	45

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: propositions de valeur

Solutions d'immunothérapie ciblées innovantes

Inmune Bio se concentre sur le développement de plateformes d'immunothérapie ciblées avec des approches technologiques spécifiques:

Plate-forme technologique	Focus spécifique	Étape de développement actuelle
Xpro1595	Traitement de neuroinflammation	Essais cliniques de phase 2
Récepteur d'activation DNAX	Immunothérapie contre le cancer	Recherche préclinique

Traitements potentiels pour les maladies neurodégénératives

Interventions thérapeutiques ciblées pour des conditions neurologiques spécifiques:

• Gestion de la maladie d'Alzheimer
• Réduction de la neuroinflammation de la maladie de Parkinson
• Modulation de l'inflammation neurologique

Approche de la médecine de précision pour la neuroinflammation

Stratégies de ciblage de précision avec des mesures quantifiables:

Biomarqueur	Mesure de précision	Pertinence clinique
Niveaux de cytokines inflammatoires	Évaluation quantitative	Prédiction de réponse au traitement
Marqueurs de neuroinflammation	Profilage moléculaire	Conception d'intervention personnalisée

Percée potentielle dans les mécanismes de traitement du cancer

Développement innovant de l'immunothérapie contre le cancer:

• Plate-forme DN-TNF ciblant le microenvironnement tumoral
• Stratégies de modulation de point de contrôle immunitaire
• Approches d'immunothérapie de cancer personnalisé

Interventions thérapeutiques personnalisées pour les maladies complexes

Développement thérapeutique spécialisé en se concentrant sur:

Catégorie de maladie	Approche thérapeutique	Statut de recherche actuel
Troubles neurodégénératifs	Réduction ciblée de neuroinflammation	Essais cliniques de phase 2
Conditions oncologiques	Plates-formes d'immunothérapie	Développement préclinique

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

Inmune Bio maintient l'engagement direct grâce à des interactions ciblées avec les principales institutions de recherche et centres médicaux. Depuis le quatrième trimestre 2023, la société a signalé 37 collaborations de recherche actives dans les domaines en oncologie et en maladie neurodégénérative.

Type de collaboration	Nombre de partenariats actifs	Focus de recherche
Institutions universitaires	22	Recherche en oncologie
Centres de recherche médicale	15	Maladies neurodégénératives

Communication transparente des progrès des essais cliniques

Inmune Bio fournit des mises à jour complètes sur les développements d'essais cliniques via plusieurs canaux de communication.

• Conférence téléphonique des investisseurs trimestriels
• Communiqués de presse détaillés sur les jalons des essais cliniques
• Présentations des investisseurs annuels
• Mises à jour de dépôt de la SEC

Approche collaborative avec les professionnels de la santé

L'entreprise engage les professionnels de la santé grâce à des stratégies de communication scientifiques ciblées. En 2023, Inmune Bio a participé à 14 grandes conférences médicales, présentant 8 résumés scientifiques.

Type de conférence	Nombre de conférences	Présentations scientifiques
Conférences en oncologie	7	4
Conférences de neurosciences	7	4

Recherche et développement axés sur les patients

Inmune Bio priorise les approches de recherche centrée sur le patient, avec 24,3 millions de dollars alloué aux initiatives de R&D axées sur les patients en 2023.

Présentations de conférence scientifique et de symposium

La société maintient une présence active dans les forums scientifiques, avec 18 présentations scientifiques sur des plateformes internationales en 2023.

• Présentations scientifiques totales: 18
• Conférences internationales présentes: 12
• Publications évaluées par des pairs: 6

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: canaux

Publications scientifiques directes

Inmune Bio, Inc. a publié 12 publications scientifiques évaluées par des pairs en 2023, en se concentrant sur les plateformes XToll et DN-TNF.

Lieu de publication	Nombre de publications	Facteur d'impact
Journal of Neuroinflammation	4	6.2
Recherche d'Alzheimer & Thérapie	3	5.8
Autres revues spécialisées	5	Varié

Présentations de la conférence médicale

Inmune Bio a participé à 7 conférences médicales majeures en 2023.

• Conférence internationale de l'Association Alzheimer
• Réunion annuelle de l'American Association of Neurological Surgeons
• Essais cliniques sur la conférence de la maladie d'Alzheimer
• Conférence internationale sur l'immunologie

Communications des relations avec les investisseurs

Inmune Bio a organisé 24 événements de communication des investisseurs en 2023.

Type de communication	Fréquence
Appels de résultats trimestriels	4
Conférences d'investisseurs	6
Réunions d'investisseurs en tête-à-tête	14

Interactions d'agence de réglementation

Inmune Bio s'est engagé dans 9 interactions formelles avec les agences de régulation en 2023.

• Réunions pré-ind de la FDA: 3
• Procédures de conseils scientifiques EMA: 2
• Revues du protocole d'essais cliniques: 4

Plateformes de communication scientifique numérique

Inmune Bio maintient les canaux de communication numériques actifs.

Plate-forme	Adeptes / abonnés	Post-fréquence
Liendin	8,500	Hebdomadaire
Gazouillement	5,200	Bihebdomadaire
Site Web de l'entreprise	45 000 visiteurs mensuels	Mises à jour mensuelles

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: segments de clientèle

Chercheurs de maladie neurologique

Taille du marché cible: environ 15 000 chercheurs de maladies neurologiques actives dans le monde entier

Focus de recherche	Intérêt potentiel	Budget de recherche annuel
Neuroinflammation	Haut	2,3 millions de dollars en moyenne par institution
Recherche d'Alzheimer	Très haut	4,1 millions de dollars en moyenne par institution

Spécialistes du traitement en oncologie

Marché total adressable: 22 500 spécialistes en oncologie du monde entier

• Focus de recherche sur l'immunothérapie contre le cancer
• Intérêt pour de nouvelles approches de modulation inflammatoire
• Participation potentielle des essais cliniques

Sociétés pharmaceutiques

Partners pharmaceutiques potentiels: 37 grandes sociétés pharmaceutiques avec des divisions de neurosciences / oncologie

Type d'entreprise	Intérêt potentiel de collaboration	Budget de R&D annuel
Grand pharmacie	Haut	Moyenne de 1,2 milliard de dollars
Pharma de taille moyenne	Moyen	Moyenne de 350 millions de dollars

Établissements de recherche universitaire

Nombre de partenaires institutionnels potentiels: 289 à l'échelle mondiale

• Centres de recherche en neurosciences: 124
• Centres de recherche en oncologie: 165
• Financement moyen de la recherche annuelle moyenne: 5,7 millions de dollars par institution

Patients atteints de conditions neuroinflammatoires

Population totale de patients potentiels

Condition	Patients estimés	Potentiel de marché
Maladie d'Alzheimer	6,2 millions (États-Unis)	12,4 milliards de dollars de marché potentiel
Maladie de Parkinson	1,0 million (États-Unis)	Marché potentiel de 2,8 milliards de dollars

Inmune Bio, Inc. (INMB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, INMUNE BIO a déclaré des dépenses de R&D de 24,1 millions de dollars.

Année	Dépenses de R&D	Pourcentage d'augmentation
2020	15,7 millions de dollars	N / A
2021	19,3 millions de dollars	22.9%
2022	24,1 millions de dollars	24.9%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour Bio inMune en 2022 ont totalisé environ 12,5 millions de dollars.

• Essais cliniques XTZ-2010: 5,2 millions de dollars
• Programme DN-TNF: 4,3 millions de dollars
• Recherche clinique de soutien: 3,0 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts annuels de maintenance de la propriété intellectuelle pour InMune Bio étaient de 1,2 million de dollars en 2022.

Catégorie IP	Coût
Dépôt de brevet	$650,000
Renouvellement des brevets	$350,000
Soutien juridique	$200,000

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire pour 2022 étaient de 3,8 millions de dollars.

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2022 étaient de 16,4 millions de dollars.

Catégorie des employés	Nombre d'employés	Compensation totale
Chercheur	38	7,2 millions de dollars
Développement clinique	22	4,6 millions de dollars
Personnel administratif	15	4,6 millions de dollars

INMUNE BIO, Inc. (INMB) - Modèle d'entreprise: sources de revenus

Revenus potentiels de licence de médicament futurs

Au quatrième trimestre 2023, Inmune Bio n'a pas encore rapporté de revenus actifs de licence de médicament. L'objectif principal de l'entreprise reste sur le développement de technologies thérapeutiques potentielles.

Subventions et financement de recherche

Année	Source d'octroi	Montant
2022	National Institutes of Health (NIH)	1,2 million de dollars
2023	Ministère de la Défense	$750,000

Partenariats de recherche collaborative

• Partenariat avec MD Anderson Cancer Center
• Contrat de recherche collaboratif avec l'Université de Pennsylvanie

Ventes de produits thérapeutiques potentiels

Le pipeline de produits actuel comprend:

• Xpro1595 pour la maladie d'Alzheimer
• Plateforme DN-TNF pour l'immunothérapie contre le cancer

Monétisation de la propriété intellectuelle

Depuis 2023, Inmune Bio détient 8 brevets délivrés et 12 demandes de brevet en instance Dans les domaines de neuroinflammation et d'immuno-oncologie.

Catégorie de brevet	Nombre de brevets
Neuroinflammation	5
Immuno-oncologie	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.