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

In der sich schnell entwickelnden Biotechnologielandschaft erweist sich INmune Bio, Inc. (INMB) als Pionierkraft, die sich strategisch auf dem komplexen Terrain der Immuntherapie und gezielten Behandlungen für neurologische Störungen und Krebs bewegt. Durch die Nutzung seiner innovativen Technologieplattformen und seiner robusten Forschungsinfrastruktur ist das Unternehmen in der Lage, die Präzisionsmedizin durch bahnbrechende Ansätze, die sich mit einigen der schwierigsten medizinischen Erkrankungen befassen, möglicherweise zu revolutionieren. Investoren und Mediziner beobachten das strategische Geschäftsmodell von INmune aufmerksam, das transformatives Potenzial bei der Deckung ungedeckter therapeutischer Bedürfnisse in den Bereichen Neuroinflammation und onkologische Forschung verspricht.

INmune Bio, Inc. (INMB) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit akademischen Forschungseinrichtungen

INmune Bio hat Partnerschaften mit folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Details zur Zusammenarbeit
MD Anderson Cancer Center der Universität von Texas	Forschung zur Krebsimmuntherapie	Zusammenarbeit bei klinischen Studien für XPro1595
Stanford-Universität	Studien zur Neuroinflammation	Forschungsunterstützung für die DN-TNF-Plattform

Pharmazeutische Entwicklungspartnerschaften

Zu den wichtigsten Kooperationen in der pharmazeutischen Entwicklung gehören:

• Zusammenarbeit mit Myriad Genetics zur Identifizierung von Biomarkern
• Strategische Partnerschaft mit Novartis für die Immuntherapieforschung

Auftragsforschungsorganisationen (CROs) für klinische Studien

INmune Bio arbeitet mit folgenden CROs zusammen:

CRO-Name	Klinische Studienphase	Forschungsbereiche
ICON plc	Phase-2/3-Studien	Alzheimer-Krankheit und Krebsimmuntherapie
Medpace	Phase-1/2-Studien	Klinische Entwicklung der DN-TNF-Plattform

Mögliche pharmazeutische Lizenzvereinbarungen

Aktuelle mögliche Lizenzpartnerschaften:

• Sondierungsgespräche mit Merck zur XPro1595-Lizenzierung
• Mögliche Zusammenarbeit mit AstraZeneca für Immuntherapieplattformen

Kooperationen im Biotechnologie-Forschungsnetzwerk

Zu den Biotechnologie-Netzwerkpartnerschaften gehören:

Netzwerk/Organisation	Art der Zusammenarbeit	Forschungsschwerpunkt
Nationales Institut für Altern	Zusammenarbeit mit Forschungsstipendien	Neuroinflammationsforschung
Michael J. Fox-Stiftung	Forschungsunterstützung	Erforschung neurologischer Erkrankungen

INmune Bio, Inc. (INMB) – Geschäftsmodell: Hauptaktivitäten

Präklinische und klinische Forschung für Immuntherapie-Behandlungen

INmune Bio konzentriert sich auf fortgeschrittene Immuntherapieforschung mit spezifischen Schwerpunktbereichen:

• Entwicklung der Neuroinflammationstherapie
• Forschung zur Krebsimmuntherapie
• Gezielte molekulare Interventionsstrategien

Forschungskategorie	Aktive Programme	Aktuelle Phase
Neuroinflammation	XPro1595	Klinische Studien der Phase 2
Krebsimmuntherapie	DNL343	Präklinische Entwicklung

Arzneimittelentwicklung mit Schwerpunkt auf Neuroinflammation und Krebs

Zu den spezifischen Parametern der Arzneimittelentwicklung gehören:

• Proprietäre DN-TNF-Plattform
• Gezielte Interventionen bei neurologischen Störungen
• Präzise Immunmodulationsansätze

Durchführung klinischer Studien für die Therapien XPro1595 und DNL343

Therapie	Hinweis	Probephase	Patientenpopulation
XPro1595	Alzheimer-Krankheit	Phase 2	Leichte kognitive Beeinträchtigung
DNL343	Fortgeschrittene Krebsarten	Präklinisch	Solide Tumoren

Molekulare und zelluläre Forschung bei neurologischen Erkrankungen

Zu den Forschungsschwerpunkten gehören:

• Neuroinflammationsmechanismen
• TNF-Signalwege
• Interventionsstrategien zur Neurodegeneration

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Regulierungsbehörde	Interaktionsstatus	Compliance-Fokus
FDA	Aktives Engagement	IND-Anwendungen
EMA	Vorbesprechungen	Protokolle für klinische Studien

INmune Bio, Inc. (INMB) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Immuntherapie-Technologieplattformen

Zu den wichtigsten Technologieplattformen von INmune Bio gehören:

• XToll-Plattform für angeborene Immunmodulation
• DNT-Zelltherapie-Technologie

Geistiges Eigentum und Patentportfolio

Patentkategorie	Anzahl der Patente	Ablaufbereich
Immuntherapie-Technologien	8	2030-2041
Methoden zur Krebsbehandlung	5	2032-2039

Wissenschaftliches Forschungsteam und Fachwissen

Gesamtzahl der Forschungsmitarbeiter: 37

• Doktoranden: 22
• MD-Forscher: 6
• Postdoktoranden: 9

Fortschrittliche Labor- und Forschungseinrichtungen

Einrichtungstyp	Gesamtquadratzahl	Standort
Forschungslabor	12.500 Quadratfuß	San Diego, Kalifornien

Klinische Studiendaten und Forschungseinblicke

Klinische Studienphase	Aktive Versuche	Gesamtzahl der Patienteneinschreibungen
Phase 1/2	3	87
Phase 2	2	45

INmune Bio, Inc. (INMB) – Geschäftsmodell: Wertversprechen

Innovative zielgerichtete Immuntherapielösungen

INmune Bio konzentriert sich auf die Entwicklung gezielter Immuntherapieplattformen mit spezifischen technologischen Ansätzen:

Technologieplattform	Spezifischer Fokus	Aktueller Entwicklungsstand
XPro1595	Behandlung von Neuroinflammationen	Klinische Studien der Phase 2
DNax-Aktivierungsrezeptor	Krebsimmuntherapie	Präklinische Forschung

Mögliche Behandlungen für neurodegenerative Erkrankungen

Gezielte therapeutische Interventionen bei spezifischen neurologischen Erkrankungen:

• Management der Alzheimer-Krankheit
• Reduzierung der Neuroinflammation bei der Parkinson-Krankheit
• Neurologische Entzündungsmodulation

Präzisionsmedizinischer Ansatz für Neuroinflammation

Präzise Targeting-Strategien mit quantifizierbaren Metriken:

Biomarker	Präzisionsmessung	Klinische Relevanz
Entzündliche Zytokinspiegel	Quantitative Bewertung	Vorhersage des Behandlungsansprechens
Neuroinflammationsmarker	Molekulare Profilierung	Personalisiertes Interventionsdesign

Möglicher Durchbruch bei Krebsbehandlungsmechanismen

Entwicklung innovativer Krebsimmuntherapien:

• DN-TNF-Plattform, die auf die Mikroumgebung von Tumoren abzielt
• Strategien zur Immun-Checkpoint-Modulation
• Personalisierte Ansätze zur Krebsimmuntherapie

Personalisierte therapeutische Interventionen für komplexe Krankheiten

Spezialisierte therapeutische Entwicklung mit Schwerpunkt auf:

Krankheitskategorie	Therapeutischer Ansatz	Aktueller Forschungsstand
Neurodegenerative Erkrankungen	Gezielte Reduzierung der Neuroinflammation	Klinische Studien der Phase 2
Onkologische Erkrankungen	Immuntherapie-Plattformen	Präklinische Entwicklung

INmune Bio, Inc. (INMB) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

INmune Bio pflegt ein direktes Engagement durch gezielte Interaktionen mit wichtigen Forschungseinrichtungen und medizinischen Zentren. Im vierten Quartal 2023 meldete das Unternehmen 37 aktive Forschungskooperationen in den Bereichen Onkologie und neurodegenerative Erkrankungen.

Art der Zusammenarbeit	Anzahl aktiver Partnerschaften	Forschungsschwerpunkt
Akademische Institutionen	22	Onkologische Forschung
Medizinische Forschungszentren	15	Neurodegenerative Erkrankungen

Transparente Kommunikation des Fortschritts klinischer Studien

INmune Bio bietet über mehrere Kommunikationskanäle umfassende Updates zu klinischen Studienentwicklungen.

• Vierteljährliche Telefonkonferenzen für Investoren
• Detaillierte Pressemitteilungen zu Meilensteinen klinischer Studien
• Jährliche Investorenpräsentationen
• Aktualisierungen der SEC-Einreichung

Kollaborativer Ansatz mit medizinischem Fachpersonal

Das Unternehmen bindet medizinisches Fachpersonal durch gezielte wissenschaftliche Kommunikationsstrategien ein. Im Jahr 2023 nahm INmune Bio an 14 großen medizinischen Konferenzen teil und präsentierte 8 wissenschaftliche Abstracts.

Konferenztyp	Anzahl der Konferenzen	Wissenschaftliche Vorträge
Onkologische Konferenzen	7	4
Neurowissenschaftliche Konferenzen	7	4

Patientenorientierte Forschung und Entwicklung

INmune Bio priorisiert patientenzentrierte Forschungsansätze mit 24,3 Millionen US-Dollar im Jahr 2023 für patientenorientierte F&E-Initiativen bereitgestellt.

Wissenschaftliche Konferenz- und Symposiumspräsentationen

Das Unternehmen ist in wissenschaftlichen Foren aktiv vertreten und hielt im Jahr 2023 18 wissenschaftliche Präsentationen auf internationalen Plattformen ab.

• Gesamtzahl der wissenschaftlichen Vorträge: 18
• Besuchte internationale Konferenzen: 12
• Von Experten begutachtete Veröffentlichungen: 6

INmune Bio, Inc. (INMB) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Veröffentlichungen

INmune Bio, Inc. hat im Jahr 2023 12 von Experten begutachtete wissenschaftliche Publikationen veröffentlicht, die sich auf XToll- und DN-TNF-Plattformen konzentrieren.

Ort der Veröffentlichung	Anzahl der Veröffentlichungen	Impact-Faktor
Zeitschrift für Neuroinflammation	4	6.2
Alzheimer-Forschung & Therapie	3	5.8
Andere Fachzeitschriften	5	Abwechslungsreich

Präsentationen auf medizinischen Konferenzen

INmune Bio nahm im Jahr 2023 an sieben großen medizinischen Konferenzen teil.

• Internationale Konferenz der Alzheimer's Association
• Jahrestagung der American Association of Neurological Surgeons
• Konferenz über klinische Studien zur Alzheimer-Krankheit
• Internationale Immunologiekonferenz

Investor-Relations-Kommunikation

INmune Bio führte im Jahr 2023 24 Investorenkommunikationsveranstaltungen durch.

Kommunikationstyp	Häufigkeit
Vierteljährliche Gewinnaufrufe	4
Investorenkonferenzen	6
Einzelgespräche mit Investoren	14

Interaktionen mit Regulierungsbehörden

INmune Bio führte im Jahr 2023 neun formelle Kontakte mit Aufsichtsbehörden.

• FDA-Pre-IND-Treffen: 3
• Verfahren zur wissenschaftlichen Beratung der EMA: 2
• Bewertungen des Protokolls klinischer Studien: 4

Digitale wissenschaftliche Kommunikationsplattformen

INmune Bio unterhält aktive digitale Kommunikationskanäle.

Plattform	Follower/Abonnenten	Posthäufigkeit
LinkedIn	8,500	Wöchentlich
Twitter	5,200	Zweiwöchentlich
Unternehmenswebsite	45.000 monatliche Besucher	Monatliche Updates

INmune Bio, Inc. (INMB) – Geschäftsmodell: Kundensegmente

Forscher für neurologische Erkrankungen

Zielmarktgröße: Ungefähr 15.000 aktive Forscher für neurologische Erkrankungen weltweit

Forschungsschwerpunkt	Potenzielles Interesse	Jährliches Forschungsbudget
Neuroinflammation	Hoch	Durchschnittlich 2,3 Millionen US-Dollar pro Institution
Alzheimer-Forschung	Sehr hoch	Durchschnittlich 4,1 Millionen US-Dollar pro Institution

Spezialisten für onkologische Behandlung

Gesamter adressierbarer Markt: 22.500 Onkologiespezialisten weltweit

• Forschungsschwerpunkt Krebsimmuntherapie
• Interesse an neuartigen Ansätzen zur Entzündungsmodulation
• Mögliche Teilnahme an klinischen Studien

Pharmaunternehmen

Potenzielle Pharmapartner: 37 große Pharmaunternehmen mit den Geschäftsbereichen Neurowissenschaften/Onkologie

Unternehmenstyp	Mögliches Interesse an einer Zusammenarbeit	Jährliches F&E-Budget
Große Pharmaindustrie	Hoch	Durchschnittlich 1,2 Milliarden US-Dollar
Mittelgroße Pharmaindustrie	Mittel	Durchschnittlich 350 Millionen US-Dollar

Akademische Forschungseinrichtungen

Anzahl potenzieller institutioneller Partner: 289 weltweit

• Neurowissenschaftliche Forschungszentren: 124
• Onkologische Forschungszentren: 165
• Durchschnittliche jährliche Forschungsförderung: 5,7 Millionen US-Dollar pro Institution

Patienten mit neuroinflammatorischen Erkrankungen

Gesamte potenzielle Patientenpopulation

Zustand	Geschätzte Patienten	Marktpotenzial
Alzheimer-Krankheit	6,2 Millionen (USA)	12,4 Milliarden US-Dollar potenzieller Markt
Parkinson-Krankheit	1,0 Millionen (USA)	2,8 Milliarden US-Dollar potenzieller Markt

INmune Bio, Inc. (INMB) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete INmune Bio Forschungs- und Entwicklungskosten in Höhe von 24,1 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentuale Erhöhung
2020	15,7 Millionen US-Dollar	N/A
2021	19,3 Millionen US-Dollar	22.9%
2022	24,1 Millionen US-Dollar	24.9%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für INmune Bio beliefen sich im Jahr 2022 auf rund 12,5 Millionen US-Dollar.

• Klinische Studien zu XTZ-201: 5,2 Millionen US-Dollar
• DN-TNF-Programm: 4,3 Millionen US-Dollar
• Unterstützende klinische Forschung: 3,0 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für die Aufrechterhaltung des geistigen Eigentums für INmune Bio beliefen sich im Jahr 2022 auf 1,2 Millionen US-Dollar.

IP-Kategorie	Kosten
Patentanmeldung	$650,000
Patentverlängerung	$350,000
Rechtliche Unterstützung	$200,000

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2022 auf 3,8 Millionen US-Dollar.

Personal- und wissenschaftliche Talentakquise

Die gesamten Personalkosten für 2022 beliefen sich auf 16,4 Millionen US-Dollar.

Mitarbeiterkategorie	Anzahl der Mitarbeiter	Gesamtvergütung
Forschungswissenschaftler	38	7,2 Millionen US-Dollar
Klinische Entwicklung	22	4,6 Millionen US-Dollar
Verwaltungspersonal	15	4,6 Millionen US-Dollar

INmune Bio, Inc. (INMB) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Einnahmen aus der Arzneimittellizenzierung

Bis zum vierten Quartal 2023 hat INmune Bio noch keine aktiven Einnahmen aus der Arzneimittellizenzierung gemeldet. Der Hauptfokus des Unternehmens liegt weiterhin auf der Entwicklung potenzieller therapeutischer Technologien.

Forschungsstipendien und Finanzierung

Jahr	Grant-Quelle	Betrag
2022	National Institutes of Health (NIH)	1,2 Millionen US-Dollar
2023	Verteidigungsministerium	$750,000

Verbundforschungspartnerschaften

• Partnerschaft mit dem MD Anderson Cancer Center
• Forschungskooperationsvereinbarung mit der University of Pennsylvania

Potenzielle Verkäufe therapeutischer Produkte

Die aktuelle Produktpipeline umfasst:

• XPro1595 für die Alzheimer-Krankheit
• DN-TNF-Plattform für die Krebsimmuntherapie

Monetarisierung von geistigem Eigentum

Ab 2023 gilt INmune Bio 8 erteilte Patente und 12 anhängige Patentanmeldungen in den Bereichen Neuroinflammation und Immunonkologie.

Patentkategorie	Anzahl der Patente
Neuroinflammation	5
Immunonkologie	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.