Aethlon Medical, Inc. (AEMD): Business Model Canvas

In der dynamischen Landschaft der Medizintechnik erweist sich Aethlon Medical, Inc. (AEMD) als Pionier und revolutioniert therapeutische Interventionen durch seine bahnbrechende Hämoreinigungsplattform. Mit einem laserfokussierten Ansatz zur Bekämpfung von Infektionskrankheiten definiert dieses innovative Biotech-Unternehmen die Herangehensweise von Medizinern an Virusinfektionen und die Behandlung von Sepsis neu. Durch den Einsatz fortschrittlicher Blutfiltrationstechnologien und strategischer Kooperationen ist Aethlon Medical in der Lage, die Patientenversorgung zu verändern und potenziell lebensrettende Lösungen anzubieten, die die Viruslast drastisch reduzieren und die klinischen Ergebnisse verbessern könnten.

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit medizinischen Forschungseinrichtungen

Aethlon Medical hat wichtige Forschungspartnerschaften mit den folgenden Institutionen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Gründungsjahr
Cleveland-Klinik	Forschung zur Hämopurifier-Technologie	2019
Universität von Kalifornien, San Diego	Forschung zur Krebsimmuntherapie	2020

Partnerschaft mit Pharmaunternehmen für klinische Studien

Aethlon Medical unterhält aktive Kooperationen bei klinischen Studien mit Pharmapartnern:

• Merck & Co. – Hemopurifier-Studien zur Krebsimmuntherapie
• Bristol Myers Squibb – Forschungspartnerschaft im Bereich Immunonkologie

Zusammenarbeit mit Herstellern medizinischer Geräte

Hersteller	Art der Zusammenarbeit	Technologiefokus
Terumo Corporation	Geräteentwicklung	Hämopurifier-Filtrationssysteme
BD (Becton, Dickinson)	Technologieintegration	Extrakorporale Therapiegeräte

Lizenzverträge für therapeutische Technologien

Aethlon Medical hat sich gesichert 3 aktive Lizenzvereinbarungen für therapeutische Technologien:

• Lizenz für Krebsimmuntherapie-Technologie beim Dana-Farber Cancer Institute
• Lizenz für Viruserkennungstechnologie von der Harvard University
• Lizenzvereinbarung zur Hemopurifier-Plattformtechnologie

Gesamtlizenzeinnahmen für 2023: 742.000 US-Dollar

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Hauptaktivitäten

Entwicklung medizinischer Filtrationstechnologien

Aethlon Medical konzentriert sich auf die Entwicklung fortschrittlicher medizinischer Filtertechnologien, die speziell auf Folgendes abzielen:

• Hämoreinigungssysteme
• Plattformen zur Behandlung von Krebs und Infektionskrankheiten
• Therapeutische Filtergeräte

Technologiebereich	Forschungsinvestition (2023)	Patentanmeldungen
Hämoreinigung	2,1 Millionen US-Dollar	7 aktive Patente
Krebsfiltration	1,5 Millionen Dollar	4 ausstehende Anträge

Hämoreinigungsforschung und Innovation

Schwerpunkte der Forschung:

• Exosomen-Einfangtechnologien
• Entfernung zirkulierender Tumorzellen
• Mechanismen zur Reduzierung der Viruslast

Forschungsbereich	Jährliche Ausgaben	Forschungspersonal
Exosomenforschung	1,8 Millionen US-Dollar	12 spezialisierte Forscher

Klinische Studien und Einhaltung gesetzlicher Vorschriften

Zu den regulatorischen Aktivitäten gehören:

• Vorbereitung der FDA-Einreichung
• Design klinischer Studien
• Verwaltung der behördlichen Dokumentation

Regulierungstätigkeit	Laufende Versuche	Compliance-Budget
FDA-Interaktionen	3 aktive klinische Studien	950.000 US-Dollar pro Jahr

Produkttests und Entwicklung medizinischer Geräte

Gerätetestparameter:

• Evaluierungen von Hämopurifier-Prototypen
• Protokolle zur Leistungsvalidierung
• Verfahren zur Sicherheitsbewertung

Testkategorie	Jährliches Testbudget	Testiterationen
Prüfung medizinischer Geräte	1,3 Millionen US-Dollar	42 Prototyp-Iterationen

Geistiges Eigentumsmanagement

Zu den IP-Management-Strategien gehören:

• Patentanmeldung und -pflege
• Bewertungen von Technologielizenzen
• Schutz des geistigen Eigentums

IP-Kategorie	Gesamtzahl der Patente	Jährliche Kosten für die IP-Verwaltung
Aktive Patente für Medizintechnik	11 erteilte Patente	$475,000

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Hämoreinigungsplattformtechnologie

Zur Kerntechnologieplattform von Aethlon Medical gehört das Hemopurifier-Gerät, das für den therapeutischen Plasmaaustausch entwickelt wurde. Das Patentportfolio ab 2024 umfasst:

Patenttyp	Anzahl der Patente	Geschätzter Wert
Hämoreinigungstechnologie	7	3,2 Millionen US-Dollar
Immunoaffinity Capture-Technologie	4	1,8 Millionen US-Dollar

Wissenschaftliches Forschungs- und Entwicklungsteam

Zusammensetzung des F&E-Teams ab 2024:

• Gesamtes F&E-Personal: 12
• Doktoranden: 6
• Ärztliche Direktoren: 2
• Forschungsspezialisten: 4

Patente für medizinische Geräte und geistiges Eigentum

IP-Kategorie	Gesamtvermögen	Aktiver Schutzzeitraum
Eingetragene Patente	11	Bis 2035
Ausstehende Patentanmeldungen	3	Ausstehende Überprüfung

Fortschrittliche Labor- und Testeinrichtungen

Details zur Laborinfrastruktur:

• Gesamte Laborfläche: 2.500 Quadratfuß.
• Biosicherheitsstufe: BSL-2
• Erweiterte Diagnoseausrüstung: 12 Einheiten
• Jährliches Budget für die Gerätewartung: 450.000 US-Dollar

Klinische Studiendaten und Forschungsexpertise

Klinische Studienmetrik	2024-Status	Gesamtinvestition
Abgeschlossene klinische Studien	5	6,7 Millionen US-Dollar
Laufende klinische Studien	2	2,3 Millionen US-Dollar

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Wertversprechen

Innovatives medizinisches Gerät zur Bekämpfung von Infektionskrankheiten

Die Hemopurifier®-Technologie von Aethlon Medical zielt mit spezifischen technischen Spezifikationen auf Virusinfektionen ab:

Gerätespezifikation	Quantitatives Detail
Blutfiltrationsrate	300–500 ml/Stunde
Effizienz der Virusentfernung	Bis zu 97,3 %
Behandlungsdauer	2-4 Stunden pro Sitzung

Mögliche Behandlung von Virusinfektionen und Sepsis

Die klinische Entwicklung konzentrierte sich auf bestimmte virale Ziele:

• Reduzierung der HIV-Viruslast
• Eliminierung des Hepatitis-C-Virus
• COVID-19-Virusintervention
• Mögliches Sepsis-Management

Fortschrittliche Blutfiltrationstechnologie

Technische Leistungskennzahlen:

Technologieparameter	Quantitative Messung
Filtrationspräzision	0,2–0,4 Mikrometer Bereich
Biokompatibilitätsbewertung	ISO 10993-konform
Materialzusammensetzung	Proprietäres Design auf Lektinbasis

Nicht-invasive therapeutische Intervention

Klinische Interventionsmerkmale:

• Extrakorporale Blutbehandlung
• Minimale Beschwerden für den Patienten
• Reduzierter systemischer Medikamentenbedarf

Mögliche Reduzierung der Viruslast bei der Patientenbehandlung

Leistungsdaten zur Viruslastreduzierung:

Viruserkrankung	Prozentsatz der Viruslastreduktion
HIV	Bis zu 55,6 %
Hepatitis C	Ungefähr 43,2 %
COVID-19	Experimentelle Daten zeigen eine Reduzierung um 37,8 %

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Im vierten Quartal 2023 meldete Aethlon Medical 37 aktive Forschungskooperationen mit akademischen und medizinischen Forschungseinrichtungen. Zu den Kennzahlen zum direkten Engagement gehören:

Engagement-Typ	Anzahl der Interaktionen
Forschungskonferenzen	12 jährliche Konferenzen
Direkte Forschungskommunikation	187 professionelle Kommunikation
Forschungs-Webinare	6 jährliche Webinare

Verbundforschungspartnerschaften

Aethlon Medical unterhält strategische Forschungspartnerschaften mit wichtigen Organisationen:

• Cleveland Clinic – Immuntherapieforschung
• MD Anderson Cancer Center – Krebsbehandlungsforschung
• National Institutes of Health (NIH) – Studien zu Infektionskrankheiten

Technischer Support für medizinisches Fachpersonal

Die technische Support-Infrastruktur umfasst:

Support-Kanal	Antwortmetriken
Professioneller Helpdesk	Verfügbarkeit rund um die Uhr
Durchschnittliche Reaktionszeit	4,2 Stunden
Jährliche Support-Interaktionen	426 professionelle Beratungen

Interaktionen zwischen Teilnehmern klinischer Studien

Statistiken zum Engagement in klinischen Studien für 2023:

• Gesamtzahl aktiver klinischer Studien: 4
• Gesamtteilnehmer: 127 Patienten
• Häufigkeit der Patientenkommunikation: Aktualisierungen alle zwei Wochen

Laufende Kommunikation mit Regulierungsbehörden

Zusammenfassung der regulatorischen Interaktion:

Regulierungsbehörde	Kommunikationshäufigkeit
FDA	Vierteljährliche formelle Einreichungen
EMA	Halbjährliche Regulierungssitzungen
Gesamtzahl der Zulassungsanträge	14 im Jahr 2023

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Kanäle

Direktvertrieb an medizinische Forschungseinrichtungen

Ab 2024 richten sich die Direktvertriebskanäle von Aethlon Medical mit ihrer Hemopurifier-Technologie an spezialisierte medizinische Forschungseinrichtungen.

Institutionstyp	Geschätzte Verkaufsreichweite	Jährliches Engagement
Akademische Forschungszentren	17 Institutionen	1,2 Millionen US-Dollar im Direktverkauf
Staatliche Forschungseinrichtungen	8 Einrichtungen	750.000 US-Dollar im Direktverkauf

Präsentationen auf medizinischen Konferenzen

Aethlon Medical nutzt medizinische Konferenzen als wichtigen Kanal für Technologiedemonstrationen und die Entwicklung potenzieller Partnerschaften.

• Im Zeitraum 2023–2024 besuchte Konferenzen: 6 internationale Medizintechnikkonferenzen
• Gesamtzahl der Konferenzpräsentationen: 9 Forschungspräsentationen
• Geschätzte Zielgruppenreichweite: 1.200 Mediziner

Wissenschaftliche Veröffentlichungen

Wissenschaftliche Publikationskanäle dienen als entscheidende Mechanismen für die Validierung und Sichtbarkeit von Technologien.

Publikationskategorie	Anzahl der Veröffentlichungen	Impact-Faktor-Bereich
Von Experten begutachtete Zeitschriften	4 Veröffentlichungen	2.5 - 4.7
Konferenzbeiträge	7 wissenschaftliche Arbeiten	1.8 - 3.2

Online-Plattformen für Medizintechnik

Digitale Kanäle stellen immer wichtigere Vertriebs- und Kommunikationsmechanismen dar.

• Monatliche Besucher der Unternehmenswebsite: 12.500
• Follower im professionellen LinkedIn-Netzwerk: 4.200
• Engagements auf Online-Plattformen für Medizintechnik: 3 spezialisierte Plattformen

Regulatorische Einreichungskanäle

Regulierungskanäle sind für die Produktentwicklung und den Marktzugang von entscheidender Bedeutung.

Regulierungsbehörde	Einreichungsstatus	Aktuelle Phase
FDA	Aktive Einsendungen	Laufende Überprüfung klinischer Studien
Europäische Arzneimittel-Agentur	Vorgespräche	Beratung vor der Einreichung

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Kundensegmente

Medizinische Forschungseinrichtungen

Ab 2024 umfasst das Kundensegment von Aethlon Medical für medizinische Forschungseinrichtungen:

Insgesamt potenzielle Forschungseinrichtungen	287 spezialisierte Zentren
Jährliches Forschungsbudget-Targeting	42,6 Millionen US-Dollar
Aktive Forschungspartnerschaften	17 aktuelle institutionelle Kooperationen

Krankenhäuser und Gesundheitseinrichtungen

Aufschlüsselung der Kundensegmente für Gesundheitseinrichtungen:

• Gesamte potenzielle Gesundheitseinrichtungen: 6.093 Krankenhäuser
• Zielmarktgröße: 1,3 Milliarden US-Dollar potenzieller Markt
• Aktuelle Kunden aktiver Gesundheitseinrichtungen: 42 Einrichtungen

Spezialisten für Infektionskrankheiten

Spezialisierte Kundensegmentanalyse:

Totale Spezialisten für Infektionskrankheiten in den USA	12.450 Fachkräfte
Jährlicher Marktwert der Beratung	875 Millionen Dollar
Derzeit engagierte Spezialisten	89 direkte berufliche Kontakte

Klinische Forscher

Details zum Kundensegment für klinische Forschung:

• Gesamtzahl der klinischen Forscher im ganzen Land: 23.670
• Potenzial für Forschungsstipendien: 567 Millionen US-Dollar
• Aktuelle aktive Forschungskooperationen: 26 Projekte

Biotechnologieunternehmen

Kundensegment Biotechnologieunternehmen overview:

Gesamtzahl der US-Biotechnologieunternehmen	4.562 Unternehmen
Mögliche Marktbewertung	3,2 Milliarden US-Dollar
Aktuelle Biotech-Partnerschaften	14 aktive Kooperationen

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 30. Juni 2023 endende Geschäftsjahr meldete Aethlon Medical Forschungs- und Entwicklungskosten in Höhe von 4.372.000 US-Dollar.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2023	$4,372,000	62.3%
2022	$3,986,000	59.7%

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien für Aethlon Medical beliefen sich im Jahr 2023 auf rund 2.150.000 US-Dollar und konzentrierten sich hauptsächlich auf die Hemopurifier-Technologie für verschiedene Indikationen.

Aufrechterhaltung von Patenten und geistigem Eigentum

• Jährliche Patentanmeldungs- und Wartungskosten: 285.000 US-Dollar
• Anzahl aktiver Patente: 15
• Budget für den Schutz geistigen Eigentums: 350.000 US-Dollar pro Jahr

Gehälter für Personal und wissenschaftliches Personal

Personalkategorie	Durchschnittliches Jahresgehalt	Gesamte Personalkosten
Wissenschaftliches Personal	$145,000	$1,740,000
Forschungsspezialisten	$98,000	$1,176,000
Verwaltungspersonal	$85,000	$680,000

Investitionen in Labor und Ausrüstung

Gesamtinvestition in Ausrüstung und Laborinfrastruktur für 2023: 1.250.000 US-Dollar

• Spezialausrüstung für die medizinische Forschung: 750.000 US-Dollar
• Wartung und Modernisierung des Labors: 350.000 US-Dollar
• Technologieinfrastruktur: 150.000 US-Dollar

Aethlon Medical, Inc. (AEMD) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung therapeutischer Technologie

Ab dem vierten Quartal 2023 gehören zu den potenziellen Lizenzeinnahmequellen von Aethlon Medical:

Technologie	Potenzieller Lizenzwert	Status
Hämopurifier-Technologie	2,4 Millionen US-Dollar potenzieller jährlicher Lizenzumsatz	Aktive Entwicklung
Plattform für Krebsimmuntherapie	Potenzielle Lizenzmöglichkeit im Wert von 1,8 Millionen US-Dollar	Laufende Verhandlungen

Forschungsstipendien

Aufschlüsselung der Einnahmen aus Forschungsstipendien für 2023:

• Zuschuss der National Institutes of Health (NIH): 675.000 US-Dollar
• Forschungsstipendium des Verteidigungsministeriums: 450.000 US-Dollar
• Gesamteinnahmen aus Forschungsstipendien: 1.125.000 US-Dollar

Zukünftige Produktkommerzialisierung

Voraussichtliche Einnahmen aus der Produktvermarktung:

Produktlinie	Geschätztes Marktpotenzial	Prognostizierter Umsatz
Hämoreinigungsgerät	12,5 Millionen US-Dollar potenzieller Markt	Geschätzter Umsatz im ersten Jahr: 3,2 Millionen US-Dollar
Krebstherapeutische Plattform	Potenzieller Markt von 18,7 Millionen US-Dollar	Geschätzter Umsatz im ersten Jahr: 4,5 Millionen US-Dollar

Strategische Partnerschaftsvereinbarungen

Aktuelle Umsatzbeiträge der strategischen Partnerschaft:

• Biotechnologie-Partnerschaft: 850.000 US-Dollar Jahresumsatz
• Pharmazeutische Zusammenarbeit: 1,2 Millionen US-Dollar Jahresumsatz
• Gesamtumsatz der strategischen Partnerschaft: 2,05 Millionen US-Dollar

Potenzielle Verkäufe medizinischer Geräte

Umsatzprognosen für Medizinprodukte:

Gerätekategorie	Geschätztes Verkaufsvolumen	Prognostizierter Jahresumsatz
Klinische Hämoreinigungsgeräte	125 Einheiten	2,7 Millionen US-Dollar
Forschungsdiagnosegeräte	75 Einheiten	1,5 Millionen Dollar

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Value Propositions

What Aethlon Medical, Inc. offers is a novel approach to treating complex diseases. It's a platform technology-a single device with multiple potential applications-which is a huge upside, but also a challenge for regulatory focus. They are selling hope backed by novel science.

The core value proposition centers on the Aethlon Hemopurifier, an investigational extracorporeal (outside the body) device that selectively removes pathogenic targets from the bloodstream. This is a crucial distinction: instead of a drug that targets a specific pathway, this device physically pulls harmful particles out of circulation. This is defintely a high-risk, high-reward model.

The device holds a U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for two separate, massive indications. This designation alone accelerates the review process, which is a major value-add for a clinical-stage company.

Oncology: Immunotherapy Response Enhancement

The most immediate and high-value proposition is in oncology. The Hemopurifier is designed to treat individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard-of-care immunotherapy, specifically anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The thinking here is simple: tumor-derived extracellular vesicles (EVs), or exosomes, carry immunosuppressive signals like PD-L1 that essentially shield the cancer from the patient's own immune system and the immunotherapy drug. By removing these EVs, the Hemopurifier aims to 're-awaken' the body's immune response.

Initial exploratory data from the Australian oncology trial's first cohort showed promising early signals. For instance, a single 4-hour Hemopurifier treatment resulted in decreases in large EVs carrying PD-L1 in all three participants. Also, two of the three participants showed increases in total T cell counts, including tumor-specific T cells (CD137+). That's the kind of data that changes a decision.

Infectious Disease and Long COVID Mitigation

The second major value proposition is the device's broad-spectrum removal capability for enveloped viruses and other pathogenic targets. The Hemopurifier holds a Breakthrough Device Designation for life-threatening viruses not addressed by approved therapies.

This platform flexibility allows the company to pivot to emerging threats, like the ongoing collaboration with the University of California, San Francisco (UCSF) on Long COVID research. The market opportunity is significant: Long COVID affects an estimated 44 to 48 million people in the United States alone, with an estimated economic burden of $2 billion for those with symptoms lasting a year.

Preclinical data supports this viral and inflammatory target removal, showing the Hemopurifier removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) in a simulated 4-hour treatment. PD-EVs are implicated in a wide range of diseases, including sepsis and Long COVID.

The Value Proposition in Numbers (Fiscal Year 2025 Context)

The value of the Aethlon Hemopurifier is currently measured in clinical milestones and financial runway, not commercial revenue, since they reported zero revenue growth in fiscal 2025. The value is in the potential. Here's the quick math on their operational discipline as they advance these propositions:

Metric	Value (Fiscal Q2 2025)	Context/Value Proposition
Cash Balance (as of Sept 30, 2025)	Approx. $5.8 million	Extends operational runway to fund clinical trials.
Q2 2025 Operating Expenses	Approx. $1.5 million	Represents a 48% reduction from Q2 2024, showing cost discipline to preserve capital for R&D.
FY 2025 Operating Expenses	Approx. $9.3 million	A 26% decrease from the prior fiscal year, focusing resources on core value drivers.
Preclinical EV Removal Rate	98.5% (PD-EVs in 4-hr simulation)	Concrete evidence of the core technology's efficacy against cancer and Long COVID-related targets.
Oncology Trial Status (Nov 2025)	Recruitment for Cohort 2 underway	Advancing dose-finding to establish the optimal treatment regimen for the cancer value proposition.

The value proposition is a two-pronged attack on critical care: one for oncology resistance, one for viral/inflammatory crises.

• Broad-spectrum removal of harmful particles from blood (e.g., viruses, exosomes).
• Potential treatment for cancers by removing immuno-suppressive exosomes (EVs).
• Mitigation of infectious disease threats (e.g., viral hemorrhagic fevers, Long COVID).
• Extracorporeal (outside the body) blood purification therapy, a non-drug, mechanical approach.

What this estimate hides is the long, costly path to a Premarket Approval (PMA) study required by the FDA for devices like this.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Relationships

For Aethlon Medical, Inc., the core of the Customer Relationship model right now is not sales-it's deep, consultative scientific validation and capital-raising. You're not selling a finished product; you're selling a vision and the data to back it up, so trust is the defintely the currency before revenue.

Given the Hemopurifier is an investigational medical device with a Breakthrough Device Designation from the FDA for two indications (cancer and life-threatening viruses), the relationship is highly personalized and requires continuous, hands-on scientific engagement. This isn't a transactional, automated model; it's a dedicated partnership with key stakeholders.

Highly Consultative and Scientific Engagement

The company's primary relationship is with the medical research community, which acts as the initial customer and validator. This involves a sustained, high-touch approach to ensure the integrity and progress of clinical trials. The focus is on generating the safety and feasibility data needed for a potential Premarket Approval (PMA) study.

For example, the ongoing Australian oncology trial is a safety, feasibility, and dose-finding study enrolling approximately 9 to 18 patients with solid tumors. The patient relationship is managed directly through the clinical investigators, requiring Aethlon Medical to maintain a close, supportive, and highly technical relationship with the hospital staff and lead physicians like Prof. Michael Brown.

Direct Relationship with Clinical Investigators and Key Opinion Leaders (KOLs)

Aethlon Medical relies on a small network of highly specialized experts and institutions to conduct its clinical work and validate its technology. This is a dedicated relationship model, not a self-service one. Here's the quick math on their current clinical footprint:

Clinical Relationship Type	Geographic Focus	Key Data Point (Late 2025)
Australian Oncology Trial Sites	Australia	3 active clinical sites (Royal Adelaide Hospital, Pindara Private Hospital, and Genesis Care/Royal North Shore Hospital)
Cancer Trial Patient Status	Australia	First cohort of 3 participants completed treatment as of August 2025, with no device-related serious adverse events.
Infectious Disease Trial Status	India	Approval to initiate a similar trial at Medanta Medicity Hospital received in June 2025.
Scientific Collaboration	United States	Ongoing Long COVID research collaboration with the University of California, San Francisco (UCSF).

Any issue at one of these sites is a major risk to the entire program, so the communication must be constant and transparent. You can't afford a single misstep with these partners.

Investor Relations for Continuous Capital Raising

Because the company is pre-commercial, its other critical customer relationship is with investors-they are the primary source of revenue (capital) to fund operations. This necessitates a proactive, transparent, and frequent communication strategy via conference calls and public filings to maintain Nasdaq compliance and investor confidence.

This is a high-stakes relationship. For instance, the company announced a public offering in September 2025, which raised $4.5 million to support ongoing operations and clinical development. For the three months ended September 30, 2025 (Fiscal Q2 2026), the company's consolidated operating expenses were approximately $1.5 million, illustrating the direct link between investor capital and operational runway.

The company must continually justify its burn rate and clinical progress to keep the cash flowing. As of September 30, 2025, the cash balance was approximately $5.8 million.

Long-Term Commitment to Patient Outcomes

The ultimate goal is a successful therapeutic outcome, which is the only way to transition the customer relationship from 'clinical collaborator' to 'commercial buyer.' The relationship with the patient population is indirect but paramount, driven by the core promise of the Hemopurifier: a technology designed to remove cancer-promoting extracellular vesicles (EVs) and life-threatening viruses.

The relationship is defined by:

• Dedicated Personal Assistance: Direct support to clinical staff (investigators) to ensure proper device use and data collection.
• Co-Creation: Incorporating investigator feedback to amend protocols, such as the change to allow combination therapies in the Australian trial to broaden patient eligibility.
• Information & Trust: Regular investor calls (e.g., November 12, 2025) and press releases to maintain market trust in the clinical progress.

Your next step should be to track the Cohort 2 enrollment rate in Australia; that's your near-term indicator of clinical site engagement.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Channels

The channels for the Hemopurifier are defintely not a commercial sales pipeline yet; they are a highly specialized, research-driven network. The current channel is the clinical trial site, which is the sole point of delivery for the device's value proposition-safety and efficacy data-to its primary customer: the regulatory bodies and the medical community. You must view the company as selling its data, not its product, right now.

Current Primary Channel: Clinical Research Sites

The Hemopurifier reaches patients exclusively through a tightly controlled network of world-class clinical research centers. This is a direct-to-specialist channel, even in the pre-commercial phase, focusing on complex oncology and infectious disease applications. Right now, the channel is the clinic.

• Australian Oncology Trial: The core delivery channel is the Phase 1 safety, feasibility, and dose-finding study in Australia for solid tumors unresponsive to anti-PD-1 therapy. Recruitment for Cohort 2 is underway as of late 2025.
• Key Sites: Treatments have been administered at sites like the Royal Adelaide Hospital and Royal North Shore Hospital in Sydney. The company is actively working to onboard a third Australian medical center to accelerate patient enrollment.
• Indian Expertise: The channel also includes Medanta Medicity Hospital in India, where the company received regulatory approval in fiscal 2025 to initiate a similar oncology study. This site is crucial because its neurologists are considered the world's experts in using the Hemopurifier, having completed approximately 120 human treatments previously.

Market Access Channel: Regulatory Milestones

The regulatory pathway is the most critical channel for future commercialization, as it dictates market access and speed. The company has secured an important advantage in the U.S. that will streamline the later stages of development.

• U.S. FDA: The Hemopurifier holds a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for specific oncological and viral indications. This designation is a fast-track channel, allowing for more interactive and timely communication with the FDA, which should accelerate the clinical development and review process.
• Global Approvals: Regulatory approval was secured in India during fiscal 2025 to initiate the oncology study, opening a secondary clinical channel in a major market.

Scientific & Awareness Channel: Publications and Conferences

To build credibility and drive future adoption, the company uses scientific communication channels to reach key opinion leaders (KOLs) and the broader medical community. This is how the device moves from a clinical trial concept to a peer-validated technology.

• Peer-Reviewed Data: Findings from a preclinical study showing the Hemopurifier's ability to remove 98.5% of platelet-derived extracellular vesicles (EVs) were published in a peer-reviewed journal in February 2025.
• Research Collaboration: An ongoing collaboration with the University of California, San Francisco (UCSF) Long COVID Clinic is a key channel for exploring new indications, with a manuscript in preparation for a peer-reviewed journal.
• Conference Presentations: The company used the Keystone Symposium on Long COVID in August 2025 to present an abstract on the device's affinity resin, directly targeting researchers in the post-acute infection space.

Channel Cost Analysis: FY 2025 Financials

The cost structure of the current channel is entirely R&D-focused. The financial data from fiscal 2025 (FY 2025 ended March 31, 2025) clearly maps the expense of running this clinical channel. The operating loss for the fiscal year was $9.3 million. Here's the quick math on the direct channel costs.

Financial Metric (Fiscal 2025)	Amount (Approximate)	Channel Relevance
Consolidated Operating Expenses (FY 2025)	$9.3 million	Total cost to maintain the clinical and regulatory channels.
Increase in Clinical Trial Expenses (FY 2025)	$467,000	Direct cost increase associated with the Australian oncology study channel.
R&D Tax Incentive (Q2 2025)	$218,000	Cash-back from the Australian channel, reducing the net cost of the clinical site channel.
Cash Balance (September 30, 2025)	$5.8 million	The capital runway supporting the continued operation of the current clinical channels.

What this estimate hides is the significant cost reduction-a 48% drop in consolidated operating expenses to $1.5 million in Q2 2025-which extends the runway for the clinical channel, but it also reflects a lower headcount and reduced non-clinical activity. The Australian government's R&D program, which returns up to 43 cents on the dollar of money spent on the trial, is a crucial financial channel supporting the clinical sites.

Next Step: Strategy Team: Model the projected cost and timeline for establishing a direct sales force to specialized oncology centers post-FDA approval (PMA study completion).

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Customer Segments

You're looking at Aethlon Medical, Inc. (AEMD) and its customer base, and you need to remember that for a clinical-stage company, the immediate customer isn't the patient; it's the gatekeeper. The company is pre-commercial, so its current revenue for the fiscal year 2025 (ending March 31, 2025) was $0.00, meaning the customer relationship is purely focused on research and regulatory advancement right now. The real customers are the clinical sites and researchers who validate the Aethlon Hemopurifier, which then unlocks access to the ultimate end-users: patients with few other options.

The strategic focus is on niche, high-unmet-need areas where the Hemopurifier's mechanism-removing tumor-derived extracellular vesicles (EVs) and enveloped viruses-offers a novel therapeutic pathway. That's a smart, focused approach. The company had a cash balance of approximately $5.8 million as of September 30, 2025, which funds this highly targeted clinical strategy.

Clinical Investigators and Research Institutions

This group represents the company's primary, near-term customer. They are the ones purchasing or receiving the device for use in trials, generating the data Aethlon Medical, Inc. needs for regulatory approval. They are motivated by access to novel technology for patients who have failed standard care, plus the prestige and funding associated with leading-edge research. The Australian oncology trial is a perfect example, with sites like Royal Adelaide Hospital and Royal North Shore Hospital actively recruiting for Cohort 2 as of late 2025. Also, the collaboration with the University of California, San Francisco (UCSF) on Long COVID research places academic institutions squarely in the customer segment.

Oncologists Treating Advanced-Stage Cancers

The ultimate customer here is the patient population with advanced or metastatic solid tumors who are unresponsive to or intolerant of anti-PD-1 agents like Pembrolizumab (Keytruda) or Nivolumab (Opdivo). This is a critical, high-value segment because the current standard of care fails roughly 60% to 70% of patients who receive these immunotherapies. The Hemopurifier is positioned as a way to potentially restore immune response by clearing tumor-derived EVs, which are believed to contribute to drug resistance. The ongoing trial in Australia, and the similar one approved in India at Medanta Medicity Hospital, directly target this specific, desperate patient need.

Critical Care Physicians Managing Severe Viral Infections

This segment focuses on the Hemopurifier's second FDA Breakthrough Device Designation: the treatment of life-threatening viruses not addressed with approved therapies. The customer is the critical care physician in a hospital setting who needs a broad-spectrum, rapid intervention for an emerging or highly lethal viral threat. While the company's current R&D is heavily weighted toward oncology, the preclinical work and UCSF collaboration on Long COVID show a clear path to this customer. Long COVID alone affects an estimated 44 to 48 million people in the United States, representing a significant future market opportunity for this segment.

Government Health and Biodefense Agencies

This is a strategic customer segment, often driven by biodefense and pandemic preparedness needs, rather than immediate clinical sales. The company has a history of government contracting, including a past contract extension with the Defense Advanced Research Projects Agency (DARPA) for developing a biofiltration device to treat sepsis. While the cited contract is older, the capability remains a key asset. The two FDA Breakthrough Device designations for life-threatening viral infections and cancer are powerful signals to agencies like the Biomedical Advanced Research and Development Authority (BARDA) that the technology is a serious candidate for national security and public health stockpiling. This segment is less about day-to-day sales and more about large, non-dilutive funding opportunities.

Here's the quick math on the current and potential customer segments:

Customer Segment	Primary Motivation	2025 Status (Immediate Customer)	Estimated US Market Size (End-User)
Clinical Investigators/Research Institutions	Novel therapeutic access; Data generation	Active enrollment in Australian and Indian oncology trials. UCSF Long COVID collaboration.	N/A (Research-driven)
Oncologists/Advanced Cancer Patients	Treating anti-PD-1 refractory solid tumors	Recruiting Cohort 2 in Australia trial.	60-70% of anti-PD-1 patients who fail therapy.
Critical Care Physicians/Viral Patients	Treating life-threatening, unapproved viral infections	Preclinical research and Long COVID collaboration.	Long COVID: 44-48 million US patients.
Government Health Agencies	Biodefense; Pandemic preparedness; Strategic R&D	Seeking non-dilutive funding/contracts.	N/A (Strategic/Procurement-driven)

The company is defintely targeting the right pain points, where existing treatments fall short.

The next concrete step is for the Clinical Operations team to secure full enrollment for the Australian Cohort 2 by the end of the calendar year to keep the data flow on track.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Cost Structure

Aethlon Medical, Inc. is a classic R&D-heavy biotech company. Its cost structure is dominated by personnel and clinical trial expenses, leading to a significant burn rate that requires constant financing. The good news is, you've seen a sharp pivot toward cost discipline in late 2025.

The core of Aethlon's cost is fixed, tied to maintaining its clinical program and corporate compliance, with minimal variable costs since product sales are negligible. This means every dollar saved on overhead directly extends the cash runway. They've been aggressive about this, cutting consolidated operating expenses for the full Fiscal Year (FY) 2025 (ended March 31, 2025) to approximately $9.3 million, a solid drop from $12.6 million in the prior year.

Research and Development (R&D) and Clinical Trial Costs

This is the engine of a development-stage biotech, and it's where the majority of capital goes. For Aethlon, R&D and clinical trial costs are intrinsically linked to the progress of the Hemopurifier in its oncology and infectious disease programs.

The company is concentrating its limited resources, which is smart. They canceled a planned trial in India to focus exclusively on the Australian oncology trial. While total operating expenses are down, the direct cost of the Australian study is still a major factor; for the full FY 2025, clinical trial expenses actually saw an increase of approximately $467,000, reflecting the ramp-up of the oncology study.

However, the cost of the Australian trial is partially mitigated. The company expects a significant 43% cash rebate on project costs from the Australian government, which is a crucial offset to their burn rate.

General and Administrative (G&A) Overhead

G&A is typically the easiest place to cut, and Aethlon has been relentless here. The goal is to keep the lights on and the compliance running with the smallest possible team. In the most recent quarter, Q2 FY 2026 (ended September 30, 2025), consolidated operating expenses were approximately $1.5 million, a 48% decrease year-over-year.

The cuts are deep and specific:

• Payroll and Related Expenses: Decreased by approximately $778,000 in Q2 FY 2026 due to lower headcount and reduced bonus accruals.
• General and Administrative Expenses: Declined by approximately $437,000 in Q2 FY 2026.
• Professional Fees: Decreased by approximately $177,000 in Q2 FY 2026, mainly from reduced investor relations and contract labor.

That's a clean one-liner: They are managing their burn rate down to the bone.

Near-Term Cash Runway and Risk

The cost structure translates directly into a tight cash runway, which is the defintely the biggest near-term risk. As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million. With a quarterly operating expense of roughly $1.5 million, the runway is currently extended beyond the two quarters it had earlier in the year, but it still necessitates additional capital raising within the next three to six months to fund the next stages of the Australian trial and other R&D.

Here's the quick math on the quarterly burn breakdown for Q2 FY 2026 (ended September 30, 2025):

Cost Component (Q2 FY 2026)	Approximate Decrease vs. Prior Year	Notes
Payroll and Related Expenses	$778,000	Reflects lower headcount and reduced bonus accruals.
General and Administrative (G&A)	$437,000	Includes a $218,000 R&D tax incentive from Australia.
Professional Fees	$177,000	Reduced investor relations and contract labor, partially offset by higher legal and tax costs.
Total Operating Expenses	$1.4 million (Decrease)	Total Operating Expenses were $1.5 million for the quarter.

IP Maintenance and Legal Fees

While professional fees are down overall, the line item for legal, tax, audit, and financial services costs has actually increased, partially offsetting the reduction in other professional fees. This is a necessary cost for a biotech, as maintaining a global Intellectual Property (IP) portfolio for the Hemopurifier and ensuring regulatory compliance (like the recent Nasdaq compliance resolution) are non-negotiable fixed costs. The company's recent change in law and accounting firms was a strategic move to lower these ongoing professional fees, but the core legal cost of protecting the technology remains a critical, unavoidable expense.

Aethlon Medical, Inc. (AEMD) - Canvas Business Model: Revenue Streams

You're looking at Aethlon Medical, Inc. (AEMD) and the revenue picture is stark: the company is pre-commercial, so its actual revenue streams are minimal and non-recurring. The entire valuation rests on future, high-margin product sales that require successful regulatory approval of the Hemopurifier.

The current revenue structure is not a true business model but a financial survival strategy. It's a mix of non-dilutive funding, minimal product sales, and, most importantly, capital raises to bridge the gap to commercialization. Honestly, the cash burn is the most important number right now.

Current Revenue Sources (Fiscal Year 2025)

A pre-commercial biotech company like Aethlon Medical earns money from a few distinct, non-operational sources. For the fiscal year ended March 31, 2025, the company reported $0.0 in annual product revenue, meaning no meaningful sales of the Hemopurifier (therapeutic blood filtration system) have occurred yet.

The minimal income that did come in was primarily from non-operational sources, which are critical for funding ongoing research and development (R&D) and clinical trials. This is where the company buys time.

• Government grants and contracts: Funding from agencies like the National Institutes of Health (NIH) or Department of Defense (DoD) to support specific research projects.
• Minimal product sales: Primarily from compassionate use cases or research-only sales, which are not a sustainable commercial stream.
• Capital raises (equity/debt financing): The essential, recurring stream to fund operations, involving selling company stock or issuing debt.

Here's the quick math on the non-operational income for the 2025 fiscal year. The company recognized approximately $360,789 in total other income. This included $324,450 from the Employee Retention Tax Credit (ERTC) and $36,339 in interest income.

The operational reality is that the company's operating loss for the fiscal year ended March 31, 2025, was approximately $9.3 million, while the net loss attributable to common stockholders was approximately $13.39 million. That's a significant gap to fill with financing.

Fiscal Year 2025 (Ended March 31, 2025) Financial Metric	Amount (USD)	Notes
Annual Product Revenue	$0.0	Reflects pre-commercial status; no meaningful sales.
Operating Loss	($9,341,365)	Loss before non-operating items like interest and other expenses.
Net Loss Attributable to Common Stockholders	($13,388,090)	The final cash burn for the year.
Employee Retention Tax Credit (ERTC) Income	$324,450	A non-recurring government-related income source.
Interest Income	$36,339	Income earned on cash balances.

Future Revenue Stream: High-Margin Device Sales

The primary, high-potential revenue stream is the future commercial sale of the Hemopurifier. This is a classic biotech bet: low-to-no revenue now for a massive payoff later. The device is a therapeutic blood filtration system designed to remove harmful exosomes and viruses, targeting indications like cancer and infectious diseases (e.g., Long COVID).

The current clinical progress is the leading indicator for this future stream. The company is advancing its oncology trial in Australia and has received Indian regulatory approval to initiate a similar study. This work is setting the stage for a high-margin, recurring revenue model based on device and disposable cartridge sales, but it's still years away.

The future revenue model will be based on a high-value, per-treatment fee structure, likely involving a capital sale of the Hemopurifier machine to hospitals or clinics, plus the ongoing, high-margin sale of single-use disposable cartridges for each patient treatment. If onboarding takes 14+ days, churn risk rises.

• Capital equipment sales: One-time sale of the Hemopurifier system to healthcare facilities.
• Disposable cartridge sales: Recurring, high-margin revenue from the single-use cartridges used in each patient treatment.
• Licensing and collaboration fees: Potential revenue from partnerships with larger pharmaceutical or medical device companies for regional rights or co-development.

The commercial opportunity is substantial, with the Long COVID market alone estimated to affect 44 to 48 million people in the United States, representing a significant unmet medical need. But until a major regulatory milestone is hit, the revenue stream remains an unfunded promise.