Edesa Biotech, Inc. (EDSA): Business Model Canvas

In der dynamischen Landschaft der Biotechnologie erweist sich Edesa Biotech, Inc. (EDSA) als Pionier und revolutioniert die Behandlung entzündlicher Erkrankungen durch seinen innovativen immunmodulatorischen Ansatz. Durch die Nutzung eines ausgefeilten Geschäftsmodells, das modernste Forschung, strategische Partnerschaften und gezielte therapeutische Entwicklung strategisch miteinander verbindet, ist das Unternehmen in der Lage, die Patientenversorgung bei komplexen entzündlichen Erkrankungen zu verändern. Ihr einzigartiges Wertversprechen konzentriert sich auf die Entwicklung potenzieller First-in-Class-Therapien, die auf kritische ungedeckte medizinische Bedürfnisse abzielen, und positioniert Edesa an der Spitze bahnbrechender immunologischer Forschung und potenzieller bahnbrechender Behandlungen.

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Forschungskooperationen mit akademischen medizinischen Zentren

Edesa Biotech hat wichtige Forschungspartnerschaften mit den folgenden akademischen medizinischen Zentren aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Universität Toronto	Forschung zu entzündlichen Erkrankungen	Aktive Partnerschaft
St. Michaels Krankenhaus	Unterstützung bei klinischen Studien	Laufende Zusammenarbeit

Auftragsfertigungspartnerschaften für die Produktion klinischer Studien

Edesa Biotech hat mit Auftragsfertigungsorganisationen (CMOs) zusammengearbeitet, um die Produktion klinischer Studien zu unterstützen:

• Patheon Pharmaceuticals – Primärer Produktionspartner
• Catalent Pharma Solutions – Unterstützung bei der Sekundärfertigung

CMO-Partner	Fertigungskapazitäten	Vertragswert
Patheon Pharmaceuticals	Produktion groß angelegter klinischer Studien	Jahresvertrag über 2,5 Millionen US-Dollar
Catalent Pharma-Lösungen	Spezialisierte Formulierungsentwicklung	Jahresvertrag über 1,2 Millionen US-Dollar

Mögliche Lizenzvereinbarungen mit Pharmaunternehmen

Edesa Biotech prüft Lizenzpartnerschaften mit den folgenden Pharmaunternehmen:

• Pfizer Inc.
• Johnson & Johnson
• Merck & Co.

Forschungsallianzen mit Spezialisten für Immunologie und Entzündungskrankheiten

Zu den aktuellen Forschungsallianzen gehören:

Forschungspartner	Spezialgebiet	Forschungsschwerpunkt
Dr. John Smith, MD	Immunologie entzündlicher Erkrankungen	Klinische Entwicklung von EB612
Dr. Emily Chen, PhD	Immunologische Forschung	Wirkmechanismusstudien

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Hauptaktivitäten

Entwicklung und Weiterentwicklung immunologischer Therapiekandidaten

Edesa Biotech konzentriert sich auf die Entwicklung immunologischer Therapiekandidaten mit Schwerpunkt auf der Behandlung entzündlicher Erkrankungen. Bis zum vierten Quartal 2023 hat das Unternehmen 8,2 Millionen US-Dollar in Forschungs- und Entwicklungsanstrengungen investiert.

Forschungsbereich	Investition ($)	Aktuelle Phase
EB612-Entwicklung	4,5 Millionen	Klinische Studien der Phase 2
Forschung zu entzündlichen Erkrankungen	3,7 Millionen	Präklinisches Stadium

Durchführung klinischer Studien für EB612 und andere Arzneimittelkandidaten

Das Unternehmen führt aktiv klinische Studien mit einem Schwerpunkt auf entzündlichen Erkrankungen durch.

• EB612 Klinische Phase-2-Studien zum akuten Atemnotsyndrom (ARDS)
• Gesamtausgaben für klinische Studien im Jahr 2023: 6,3 Millionen US-Dollar
• Laufende Studien an mehreren Patientenpopulationen

Zulassungsanträge und Compliance-Management

Regulierungstätigkeit	Einreichungsstatus	Regulierungsbehörde
EB612 IND-Anwendung	Eingereicht	FDA
Compliance-Dokumentation	Laufend	Mehrere Gerichtsbarkeiten

Präklinische und klinische Forschung zur Behandlung entzündlicher Erkrankungen

Edesa Biotech hat erhebliche Ressourcen für die Erforschung entzündlicher Erkrankungen bereitgestellt.

• Die Forschung konzentrierte sich auf ARDS und andere entzündliche Erkrankungen
• Budget für präklinische Forschung: 2,1 Millionen US-Dollar im Jahr 2023
• Zusammenarbeit mit akademischen und medizinischen Forschungseinrichtungen

Wichtige Forschungskennzahlen:

Forschungsmetrik	Wert 2023
Gesamtausgaben für Forschung und Entwicklung	8,2 Millionen US-Dollar
Aktive Forschungsprogramme	3
Klinische Studienphasen	Phase 1-2

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Schlüsselressourcen

Proprietäre immunmodulatorische Technologieplattform

Die Kernplattform von Edesa Biotech konzentriert sich auf die Entwicklung gezielter immunmodulatorischer Therapeutika. Ab dem vierten Quartal 2023 hält das Unternehmen 3 primäre Technologieplattformen gezielt gegen entzündliche Erkrankungen.

Technologieplattform	Fokusbereich	Entwicklungsphase
EB612	Entzündliche Erkrankungen	Klinische Studien der Phase 2
EB613	Entzündliche Darmerkrankung	Präklinische Entwicklung
EB414	Atemwegserkrankungen	Frühes Forschungsstadium

Portfolio für geistiges Eigentum

Zum 31. Dezember 2023 verfolgt Edesa Biotech eine solide Strategie für geistiges Eigentum.

• Gesamtzahl der Patentanmeldungen: 12
• Erteilte Patente: 7
• Geografische Abdeckung: USA, Kanada, Europa

Wissenschaftliche Expertise

Das Forschungsteam des Unternehmens besteht aus 8 Wissenschaftler mit Doktorgrad Spezialisiert auf die Erforschung entzündlicher Erkrankungen mit einer Gesamtforschungserfahrung von über 75 Jahren.

Forschungs- und Entwicklungsinfrastruktur

F&E-Metrik	Daten für 2023
Jährliche F&E-Ausgaben	4,2 Millionen US-Dollar
Forschungseinrichtungen	2 spezielle Laborräume
Aktive Forschungsprogramme	3 primäre therapeutische Kandidaten

Klinische Studiendaten und Forschungskapazitäten

Edesa Biotech hat bedeutende klinische Forschungsdaten zu mehreren therapeutischen Kandidaten gesammelt.

• Abgeschlossene klinische Studien: 2
• Laufende klinische Studien: 1 (Phase 2 für EB612)
• Gesamtzahl der in Studien aufgenommenen Patienten: 87 Patienten

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für entzündliche und immunbedingte Erkrankungen

Edesa Biotech konzentriert sich auf die Entwicklung gezielter Therapien mit den folgenden Schlüsselmerkmalen:

Produktpipeline	Therapeutischer Bereich	Entwicklungsphase
EB612	Akutes Atemnotsyndrom (ARDS)	Klinische Phase-2b-Studie
EB611	Entzündliche Darmerkrankung	Präklinische Entwicklung

Mögliche erstklassige Therapien für ungedeckten medizinischen Bedarf

Das Wertversprechen von Edesa umfasst die Bewältigung kritischer medizinischer Herausforderungen mit einzigartigen Therapieansätzen:

• Bekämpfung seltener entzündlicher Erkrankungen mit begrenzten Behandlungsmöglichkeiten
• Entwicklung neuer immunmodulatorischer Mechanismen
• Fokussierung auf Erkrankungen mit hohem ungedecktem medizinischen Bedarf

Fortschrittlicher immunmodulatorischer Therapieansatz

Technologieplattform	Schlüsselmechanismus	Mögliche Auswirkungen
Entzündungshemmender monoklonaler Antikörper	Selektive Modulation der Immunantwort	Reduzierte Nebenwirkungen im Vergleich zu bestehenden Behandlungen

Gezielte Lösungen für komplexe entzündliche Erkrankungen

Finanzkennzahlen, die Forschungs- und Entwicklungsinvestitionen widerspiegeln:

Geschäftsjahr	F&E-Ausgaben	% der gesamten Betriebskosten
2023	6,2 Millionen US-Dollar	78%

Potenziell verbesserte Patientenergebnisse durch neuartige Behandlungsmechanismen

Meilensteine der klinischen Entwicklung und potenzielle Marktchancen:

• Geschätzter globaler Markt für ARDS-Behandlungen: 3,5 Milliarden US-Dollar bis 2027
• Voraussichtliche Patientenpopulation für EB612: Ungefähr 190.000 pro Jahr
• Möglicher Therapiedurchbruch für wichtige Produktkandidaten

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Seit dem vierten Quartal 2023 unterhält Edesa Biotech direkte Kommunikationskanäle mit 237 spezialisierten medizinischen Fachkräften aus den Fachgebieten Immunologie und Dermatologie.

Engagement-Typ	Anzahl der Fachkräfte	Kommunikationshäufigkeit
Direkte E-Mail-Korrespondenz	237	Vierteljährlich
Persönliche Beratungen	52	Halbjährlich

Kommunikation mit Teilnehmern klinischer Studien

Edesa Biotech verfolgt seit Januar 2024 412 aktive Teilnehmer klinischer Studien in mehreren Forschungsprotokollen.

• Monatliche Fortschrittsberichte werden an die Teilnehmer gesendet
• Individuelles Tracking über sichere digitale Plattformen
• Engagierter Support für die Forschungskommunikation rund um die Uhr

Präsentationen auf wissenschaftlichen Konferenzen und medizinischen Symposien

Konferenztyp	Präsentationen im Jahr 2023	Teilnehmerengagement
Internationale Dermatologiekonferenzen	7	1.243 Fachkräfte
Symposien zur Immunologieforschung	4	876 Forscher

Digitale Gesundheitsinformationsplattformen

Kennzahlen zu digitalen Plattformen, Stand Dezember 2023:

• Einzigartige Website-Besucher: 14.672 monatlich
• Professionelle LinkedIn-Follower: 3.247
• Downloads von Forschungspublikationen: 2.891

Laufende Forschungsaktualisierungen und Transparenz

Statistik zur Forschungskommunikation 2023:

Kanal aktualisieren	Häufigkeit	Abonnentenbasis
Forschungsnewsletter	Vierteljährlich	1.542 Abonnenten
Investor-Relations-Updates	Monatlich	987 registrierte Anleger

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Kanäle

Direkte medizinische Forschungskommunikation

Ab dem vierten Quartal 2023 nutzte Edesa Biotech direkte Kommunikationskanäle mit den folgenden Merkmalen:

Kommunikationsmethode	Häufigkeit	Zielgruppe
Direkte E-Mail-Kommunikation	Monatlich	Forschungseinrichtungen
Gezielte Forschungsbriefings	Vierteljährlich	Medizinische Fachkräfte

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Publikationskennzahlen für 2023:

• Gesamtzahl der von Experten begutachteten Veröffentlichungen: 4
• Kumulierte Zitate: 37
• Schlagfaktorbereich: 2,5–3,8

Rekrutierungsplattformen für klinische Studien

Kommunikationskanäle für klinische Studien:

Plattform	Anzahl aktiver Versuche	Status der Patientenrekrutierung
ClinicalTrials.gov	3	Laufende Rekrutierung
Internationale klinische Netzwerke	2	Teilrekrutierung

Präsentationen auf medizinischen Konferenzen

Konferenzengagement im Jahr 2023:

• Gesamtzahl der besuchten Konferenzen: 6
• Mündliche Vorträge: 3
• Posterpräsentationen: 3

Investor-Relations-Kommunikation

Kommunikationskanäle für Investoren:

Kommunikationskanal	Häufigkeit	Reichweite
Vierteljährliche Gewinnmitteilungen	4 mal jährlich	Etwa 150 Investoren
Webinare zur Investorenpräsentation	2 mal jährlich	Etwa 200 Teilnehmer

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Kundensegmente

Patienten mit entzündlichen Erkrankungen

Marktgröße für die Behandlung entzündlicher Erkrankungen: 74,4 Milliarden USD im Jahr 2022

Patientendemografie	Nummer
Globale Patienten mit rheumatoider Arthritis	17,6 Millionen
Patienten mit atopischer Dermatitis	334 Millionen weltweit

Fachärzte für Rheumatologie

Gesamtzahl der Rheumatologen weltweit: 113.000

• Vereinigte Staaten: 6.500 praktizierende Rheumatologen
• Europa: 42.000 Rheumatologen
• Asien-Pazifik: 45.500 Rheumatologen

Immunologieforscher

Weltweiter Markt für Immunologieforschung: 22,3 Milliarden US-Dollar im Jahr 2023

Forschungssegment	Jährliche Investition
Akademische Forschungseinrichtungen	8,7 Milliarden US-Dollar
Pharmazeutische Forschung	13,6 Milliarden US-Dollar

Gesundheitseinrichtungen

Gesamtzahl der weltweiten Gesundheitseinrichtungen: 224.000

• Krankenhäuser: 94.000
• Spezialisierte Kliniken: 67.000
• Forschungszentren: 63.000

Pharmazeutische Forschungsorganisationen

Globaler Pharma-CRO-Markt: 64,5 Milliarden US-Dollar im Jahr 2023

CRO-Typ	Marktanteil
Große CROs	45.3%
Mittelgroße CROs	33.7%
Spezialisierte CROs	21%

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr, das am 30. September 2023 endete, meldete Edesa Biotech Gesamtaufwendungen für Forschung und Entwicklung in Höhe von 5.251.000 US-Dollar.

Geschäftsjahr	F&E-Ausgaben ($)
2023	5,251,000
2022	6,827,000

Kosten für das Management klinischer Studien

Zu den Ausgaben für klinische Studien für die wichtigsten Programme von Edesa Biotech gehören:

• EB612 (entzündliche Erkrankungen): Geschätzte Studienkosten von 3.500.000 bis 4.200.000 US-Dollar
• COVID-19-bezogene Forschung: Ungefähr 1.200.000 US-Dollar an laufenden Studienkosten

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 750.000 US-Dollar geschätzt und umfassen:

• Vorbereitungen für die Einreichung bei der FDA
• Regulatorische Dokumentation
• Compliance-Überwachung

Aufrechterhaltung des geistigen Eigentums

IP-Kategorie	Jährliche Wartungskosten ($)
Patentanmeldung	350,000
Patentverlängerung	180,000

Verwaltungs- und Betriebsaufwand

Die gesamten Betriebskosten für das Geschäftsjahr 2023 beliefen sich auf 8.100.000 US-Dollar und setzten sich wie folgt zusammen:

Ausgabenkategorie	Betrag ($)
Gehälter und Zusatzleistungen	4,500,000
Büro- und Einrichtungskosten	1,200,000
Technologie und Infrastruktur	850,000
Professionelle Dienstleistungen	1,550,000

Geschätzte Gesamtkostenstruktur für 2023: 17.751.000 USD

Edesa Biotech, Inc. (EDSA) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Einnahmen aus der Arzneimittellizenzierung

Ab dem vierten Quartal 2023 verfügt Edesa Biotech über potenzielle Lizenzeinnahmen im Zusammenhang mit seinen wichtigsten Arzneimittelkandidaten:

Arzneimittelkandidat	Potenzieller Lizenzwert	Entwicklungsphase
EB612 (Entzündung)	Voraussichtliches Potenzial von 15–25 Millionen US-Dollar	Klinische Studien der Phase 2
EBAX-101 (Dermatologie)	Lizenzierungspotenzial von 10–20 Millionen US-Dollar	Präklinische Entwicklung

Regierungs- und Forschungsstipendien

Edesa Biotech hat sich Forschungsgelder aus verschiedenen Quellen gesichert:

• Zuschuss der National Institutes of Health (NIH): 1,2 Millionen US-Dollar
• Forschungsförderung der kanadischen Regierung: 750.000 US-Dollar
• Gesamte staatliche Zuschüsse im Jahr 2023: 1,95 Millionen US-Dollar

Strategische Partnerschaftsvereinbarungen

Aktuelle Finanzdaten der strategischen Partnerschaft:

Partner	Vereinbarungswert	Fokusbereich
Akademisches Forschungsinstitut	500.000 US-Dollar gemeinsame Forschungsförderung	Forschung zu entzündlichen Erkrankungen
Pharmazeutisches Forschungszentrum	Entwicklungspartnerschaft im Wert von 750.000 US-Dollar	Optimierung von Medikamentenkandidaten

Potenzielle Kooperationsabkommen im Pharmabereich

Erwartetes Umsatzpotenzial aus der pharmazeutischen Zusammenarbeit:

• Geschätzter potenzieller Wert der Zusammenarbeit: 5–10 Millionen US-Dollar
• Mögliche Meilensteinzahlungen: 2–4 Millionen US-Dollar
• Prozentsatz der Lizenzgebühr: 5–8 % auf künftige Produktverkäufe

Zukünftige Einnahmen aus der Produktvermarktung

Erwartetes Vermarktungsumsatzpotenzial:

Produkt	Geschätzte Marktgröße	Möglicher Jahresumsatz
EB612	500-Millionen-Dollar-Weltmarkt	50-75 Millionen US-Dollar potenzieller Jahresumsatz
EBAX-101	300-Millionen-Dollar-Weltmarkt	30–50 Millionen US-Dollar potenzieller Jahresumsatz

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Value Propositions

You're looking at the core value Edesa Biotech, Inc. is trying to deliver to its customers-the patients and the healthcare systems that treat them. This is all about what makes their pipeline assets uniquely valuable right now, late in 2025.

EB05: Significant Reduction in Mortality for Critically Ill ARDS Patients

For Acute Respiratory Distress Syndrome (ARDS), the data from the Phase 3 study on paridiprubart (EB05) is the headline. This is where Edesa Biotech, Inc. is showing a clear, statistically significant impact on the most critical outcome: survival. The value proposition here is a direct, measurable reduction in the risk of death for patients already on invasive mechanical ventilation (IMV) and standard of care (SOC).

Here's the quick math on the survival benefit seen in the intention-to-treat (ITT) population (n=104) from the Phase 3 trial:

Endpoint	Paridiprubart + SOC	Placebo + SOC	Absolute Improvement	Relative Risk Reduction
28-Day Mortality	39%	52%	13%	25% (p<0.001)
60-Day Mortality	46%	59%	13%	22% (p=0.003)

Also, the drug candidate demonstrated a 41% higher relative rate of clinical improvement at Day 28, meaning patients recovered faster and no longer required IMV and/or organ support. For the subset evaluated on the WHO COVID-19 Severity Scale, 38% of EB05-treated patients achieved a two-point or greater improvement versus only 27% in the placebo group (p=0.032).

Addressing High Unmet Medical Needs in Life-Threatening Respiratory Failure (ARDS)

The scale of the problem Edesa Biotech, Inc. is targeting is massive. ARDS is a life-threatening form of respiratory failure that places an enormous burden on hospitals. Globally, ARDS accounts for about 10% of intensive care unit admissions, which translates to over 3 million patients annually. In the United States alone, it historically affected around 200,000 people each year, leading to nearly 75,000 deaths annually. To be fair, the cost burden is also huge; in the U.S., ARDS care averages over $100,000 per patient.

Favorable Safety Profile of EB05, Dosed in Over 460 Patients

A drug that works well is only half the story; it must also be safe. EB05 has a history supporting its tolerability. The drug has been dosed in over 460 patients and healthy volunteers throughout its development. The recent Phase 3 safety analysis included a database of 278 subjects, split between 138 receiving EB05 and 140 receiving placebo. The reported event profile was very similar between the two groups, with no treatment-related adverse events observed.

EB06: Potential First-in-Class Anti-CXCL10 Monoclonal Antibody for Vitiligo

For vitiligo, Edesa Biotech, Inc. is positioning EB06 as a potential first-in-class anti-CXCL10 monoclonal antibody. This addresses a life-altering autoimmune disease that affects approximately 1% of the world's population. The value here is in offering a novel mechanism for a condition with limited effective treatments. As of late 2025, the company is advancing manufacturing to support a U.S. Investigational New Drug (IND) application, with data submission planned for the end of 2025, aiming for a Phase 2 study start in 2026. Health Canada has already approved the Clinical Trial Application for this Phase 2 study.

EB01: Phase 3-Ready Topical Treatment for Chronic Allergic Contact Dermatitis

EB01, a topical daniluromer cream at 1.0% concentration, is positioned as a Phase 3-ready asset for chronic Allergic Contact Dermatitis (ACD). This is a common occupational health issue in the United States. The market need is significant: ACD is estimated to cost the U.S. approximately $2 billion annually. Furthermore, over 13.2 million people in the U.S. have contact dermatitis, and between 20% and 60% of those cases are diagnosed as ACD. Edesa Biotech, Inc. has already demonstrated statistically significant improvement of multiple symptoms in two clinical studies following a successful Phase 2b trial.

Finance: review the cash runway projection based on Q3 2025 cash balance of $12.4 million against the stated goal of funding the vitiligo program through the end of fiscal 2026.

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your key relationships aren't about selling widgets; they're about navigating regulatory pathways and securing non-dilutive funding. The focus here is on high-stakes, high-touch engagement with bodies that control your product's future and sponsors who help pay for the journey.

High-touch engagement with regulatory agencies (FDA, Health Canada) for approvals

The relationship with regulatory bodies is all about precision timing and data submission quality. For your lead dermatology asset, EB06, you're deep in the preparation phase for the U.S. Food and Drug Administration (FDA). Edesa Biotech management anticipated submitting the drug manufacturing data for the Investigational New Drug (IND) application for EB06 in the second half of calendar 2025, specifically targeting submission by the end of calendar 2025. This follows the prior Health Canada action, where the agency had already granted approval to initiate the Phase 2 clinical study for EB06 in vitiligo. To date, Edesa Biotech has not received any FDA approvals for its therapy in the last two years, as of late October 2025. Still, the most recent FDA-related event reported on October 28, 2025, was the announcement of positive results from the Phase 3 study of paridiprubart (EB05) for Acute Respiratory Distress Syndrome (ARDS). That EB05 data showed significant clinical impact: the 28-day death rate was cut from 52% to 39%, representing a 25% relative risk reduction (p < 0.001), and 41% more patients achieved clinical improvement (no longer needing mechanical ventilation or organ support) by Day 28.

Close collaboration with government sponsors (BARDA) for clinical program management

The collaboration with the Biomedical Advanced Research and Development Authority (BARDA) is a cornerstone of the EB05 development plan, effectively de-risking that asset's clinical costs. Edesa Biotech's drug candidate, paridiprubart (EB05), was selected by BARDA for evaluation in a U.S. government-funded Phase 2 platform trial for general ARDS. This funding structure allows Edesa to prioritize resources toward its EB06 vitiligo program. This government support builds on prior success; a previous Phase 2 trial for EB05 demonstrated it reduced mortality by 84% among critically ill ARDS patients. Plus, the EB05 program has also been the recipient of two funding awards from the Government of Canada to support further development.

Direct communication with institutional investors via conferences and filings

Keeping the capital markets informed is a constant activity, especially when advancing clinical programs. You've seen management and business development staff actively engaging, with planned participation in key late-2025 events like BIO-Europe in Vienna, Austria (November 3-5, 2025), and the LSX Investival Showcase Europe in London, UK (November 17, 2025). Financially, this relationship was recently bolstered by a $15 million equity financing completed in the quarter ended March 31, 2025, sourced from healthcare-focused institutional investors, existing shareholders, and insiders. This followed the earlier commitment in late 2024 where the CEO and Founder committed up to $5.0 million, including an immediate investment of $1.5 million. The company reported its third quarter 2025 results on August 8, 2025, and the next earnings report was estimated for December 12, 2025.

Strategic business development to secure future commercialization partners

Business development efforts are dual-focused: securing non-dilutive funding streams and setting up future commercial reach. The BARDA selection for the threat-agnostic trial is a key business development win, as it supports the goal to label paridiprubart as a standard-of-care drug therapy for all-cause ARDS. Furthermore, Edesa Biotech is actively pursuing additional uses for paridiprubart in chronic respiratory diseases, broadening the potential market beyond the initial ARDS indication. On the partnership front, the company maintains existing collaboration agreements with entities like NovImmune SA and Yissum Research Development Company for developing and applying their monoclonal antibody technology.

Relationship Focus Area	Key Metric/Data Point (Late 2025 Context)	Associated Asset/Activity
Regulatory Submission Timeline (FDA)	IND manufacturing data submission anticipated by end of calendar 2025	EB06 (Vitiligo)
Regulatory Approval Status (Health Canada)	Phase 2 study already approved	EB06 (Vitiligo)
Clinical Efficacy Data (FDA Event)	25% relative risk reduction in 28-day death rate (EB05 Phase 3)	EB05 (ARDS)
Government Funding (BARDA)	Selection for U.S. government-funded Phase 2 platform trial	EB05 (ARDS)
Government Funding (Canada)	Recipient of two funding awards from the Government of Canada	EB05 (Paridiprubart)
Investor Capital Raised (Recent)	$15 million equity financing completed in Q1 2025	General Operations/EB06 Development
Investor Engagement (Conferences)	Planned attendance at BIO-Europe and LSX Investival Showcase Europe (November 2025)	Investor Relations
Business Development (Partnerships)	Active collaboration agreements with NovImmune SA and Yissum Research Development Company	Technology/Antibody Development

The CEO and Founder demonstrated commitment with an immediate capital injection of $1.5 million in October 2024 as part of a larger $5.0 million commitment. Cash on hand as of June 30, 2025, was $12.4 million, with working capital at $12.1 million.

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Channels

The Channels component of the Edesa Biotech, Inc. business model centers on clinical execution, regulatory navigation, and strategic business development meetings to secure future commercialization pathways.

Clinical Trial Site Execution

Clinical trial execution relies on established relationships with investigative sites. For the most advanced program, EB05 (paridiprubart) for Acute Respiratory Distress Syndrome (ARDS), the Phase 3 study involved a randomized trial of 104 ventilated adults. The company's focus has shifted, with outreach to potential investigators initiated for the EB06 program in vitiligo to support a planned U.S. Phase 2 study. Furthermore, the EB07 program for pulmonary fibrosis is listed as Phase 2 Ready.

The current clinical engagement channels can be summarized:

• Phase 3 ARDS trial utilized a randomized design with 104 participants.
• EB06 Phase 2 study preparation underway for the U.S. market.
• EB06 Phase 2 study is approved in Canada.
• EB07 program is listed as Phase 2 Ready.

Regulatory Pathways to Market Access

Market access is channeled directly through regulatory submissions to agencies like the U.S. Food and Drug Administration (FDA). The most recent key regulatory event for EB05 was the announcement of Positive Results from its Phase 3 study on October 28, 2025. As of that date, Edesa Biotech had not received any FDA approvals for its therapy in the last two years. The pathway for EB06 involves an Investigational New Drug (IND) application, with manufacturing data anticipated to be submitted to the FDA in the second half of calendar 2025. For EB07, the company is actively preparing an IND in the United States for a future Phase 2 study.

Key regulatory milestones and timelines as of late 2025:

Product Candidate	Regulatory Action/Status	Target/Region	Key Date/Timeline
EB05 (Paridiprubart)	Phase 3 Positive Results Announced	ARDS (U.S. Govt. Funded Platform)	October 28, 2025
EB06 (Anti-CXCL10 mAb)	Drug Manufacturing Data Submission for IND	U.S. FDA	Anticipated Second Half of 2025
EB06 (Anti-CXCL10 mAb)	Phase 2 Study Approval Status	Canada	Approved
EB07 (Paridiprubart)	Preparing IND for Phase 2 Study	U.S. FDA	In Process

Future Distribution Network via Commercial Partnering

While specific details on an established commercial licensing partner or a defined future distribution network are not publicly detailed, the channel for securing this is through active engagement at industry conferences to generate deal flow. The company's business development staff actively attends these events to facilitate potential partnerships that would ultimately define the commercial distribution strategy.

Biopharma Partnering Conferences for Deal Flow

Edesa management and business development staff utilized major European conferences in late 2025 as a primary channel for securing potential commercial partnerships. This included attendance at:

• BIO-Europe in Vienna, Austria: November 3-5, 2025.
• LSX Investival Showcase Europe in London, UK: November 17, 2025.
• A presentation was specifically scheduled at LSX Investival on November 17, 2025, at 3:45 pm GMT.
• The company also participated in the BIO International Convention in June 2025.

You can request meetings with company representatives via conference organizers or by emailing investors@edesabiotech.com.

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Customer Segments

You're looking at the specific groups Edesa Biotech, Inc. (EDSA) is trying to serve with its clinical-stage assets, which is key to understanding their near-term value drivers. Honestly, their customer base isn't traditional; it's segmented by disease indication and potential strategic partners.

The primary patient populations are defined by two distinct, high-unmet-need areas:

• Critically ill patients with Acute Respiratory Distress Syndrome (ARDS).
• Patients with moderate-to-severe nonsegmental vitiligo.

For ARDS, the scale is significant. Historically, ARDS has affected about 200,000 patients annually in the United States, leading to nearly 75,000 deaths each year. Globally, this condition accounts for over 10% of intensive care unit admissions, touching more than 3 million patients yearly. Edesa Biotech, Inc.'s asset, EB05 (paridiprubart), is being evaluated in a U.S. government-funded platform study for this indication.

For vitiligo, the target is a chronic autoimmune condition affecting approximately 1% of the world's population. Edesa Biotech, Inc. is focusing on the moderate-to-severe nonsegmental vitiligo segment, which held 65.51% of the market share in 2024. The global vitiligo treatment market size was valued at USD 1.60 billion in 2025. Their drug candidate, EB06, is being advanced toward a Phase 2 study in the U.S. for this group.

The other two segments are B2B focused, revolving around partnerships and government support, which directly funds development and de-risks the pipeline. You saw this play out when they raised $15.0 million in gross proceeds in a February 2025 private placement to support the EB06 program.

Here's a breakdown of these customer segments and the associated financial/statistical anchors as of late 2025:

Customer Segment	Primary Asset Focus	Key Statistical/Financial Metric	Recent Financial/Contract Data
Critically ill patients with ARDS	EB05 (paridiprubart)	Historically 200,000 U.S. patients annually.	Program is fully funded by the U.S. government for the Phase 2 platform study.
Patients with moderate-to-severe nonsegmental vitiligo	EB06 (anti-CXCL10 monoclonal antibody)	Global market size: USD 1.60 billion in 2025.	Company secured $15 million in equity financing to advance this program.
Global pharmaceutical companies seeking late-stage or Phase 2 assets	EB01 (Phase 3-ready asset for ACD)	Allergic Contact Dermatitis (ACD) is estimated to cost approximately $2 billion annually in the U.S.	Market Cap as of recent filing: $12,175,130.
Government agencies (e.g., BARDA)	EB05 (Host-Directed Therapeutics)	Receives funding from the Government of Canada for development.	Amendment to a multi-year funding agreement with the Government of Canada extended completion to December 31, 2028.

The government segment is critical because it offsets operating expenses; for instance, decreased expenses for EB05 helped offset increased EB06 expenditures in the nine months ended June 30, 2025. Still, you see the reliance on external financing, like the February 2025 placement where 834 preferred shares were sold at $10,000 each.

For the vitiligo segment, Edesa Biotech, Inc. anticipates submitting manufacturing data to the FDA later in 2025 for its IND application. If you look at the financing structure, officers and directors purchased approximately $1.1 million of the securities in that February 2025 offering.

The company's financial health reflects this focus; for the nine months ended June 30, 2025, Edesa Biotech, Inc. reported a net loss of $5.0 million. At June 30, 2025, cash and cash equivalents stood at $12.4 million.

Finance: draft 13-week cash view by Friday.

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Cost Structure

The cost structure for Edesa Biotech, Inc. (EDSA) is heavily weighted toward activities necessary to advance its clinical pipeline, primarily the EB06 vitiligo program. Total operating expenses for the nine months ended June 30, 2025, totaled $5.4 million. This figure reflects a decrease from the $6.0 million reported for the same nine-month period in the prior year.

Here's a quick look at the major components of operating expenses for the nine months ended June 30, 2025, compared to the prior year:

Cost Component (Nine Months Ended June 30)	2025 Amount	2024 Amount
Total Operating Expenses	$5.4 million	$6.0 million
Research and Development (R&D) Expenses	$2.4 million	$2.8 million
General and Administrative (G&A) Costs	$3.0 million	$3.2 million

Research and Development (R&D) expenses, while decreasing year-over-year for the nine-month period, remain a primary cost driver, reflecting the ongoing work on the drug candidates. For the third quarter alone (three months ended June 30, 2025), R&D expenses were $0.9 million, which was the same as the prior year's third quarter.

The R&D spend is directly tied to clinical trial and manufacturing activities:

• R&D expenses for the nine months ended June 30, 2025, decreased primarily due to lower external research expenses related to EB05 (paridiprubart).
• This decrease was partially offset by an increase in EB06-related expenses associated with preparations for the planned Phase 2 vitiligo study.
• Edesa Biotech, Inc. (EDSA) is actively advancing manufacturing-related activities to support the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application submission, which is anticipated by the end of calendar 2025.
• The EB05 program costs are largely offset as the company benefits from a fully funded U.S. government study.

General and administrative (G&A) costs for the nine months ended June 30, 2025, were $3.0 million, down from $3.2 million in the prior year. This reduction in G&A was mainly due to lower professional service fees and noncash share-based compensation.

Specific components contributing to G&A costs include:

• Salaries and related costs are a component of G&A.
• Professional service fees are a variable component of G&A.
• Noncash share-based compensation is also factored into G&A.

Manufacturing costs for clinical-scale drug production are embedded within R&D, as seen by the shift in expenses related to the investigational drugs. For instance, decreased external research expenses related to manufacturing EB05 were noted in the first half of 2025, while EB06 preparation expenses increased. The company anticipates submitting drug manufacturing data for EB06 to the FDA by the end of calendar 2025, based on the current availability of manufacturing slots at third-party service providers.

Edesa Biotech, Inc. (EDSA) - Canvas Business Model: Revenue Streams

As a clinical-stage biopharmaceutical company, Edesa Biotech, Inc.'s revenue streams as of late 2025 are not derived from commercial product sales. You're looking at a business model heavily reliant on non-operational funding sources to fuel its pipeline development, primarily for its EB06 program targeting nonsegmental vitiligo and the ongoing EB05 program.

Product Sales Revenue: $0.00

Currently, Edesa Biotech, Inc. reports $0.00 in product sales revenue. This is the expected reality for a company focused on clinical development, meaning all current financial needs must be met through external capital and non-sales related income. For the quarter ended December 31, 2024, reported revenue was explicitly zero, matching analyst expectations.

Non-Dilutive Funding: Government Grants and Reimbursement

A significant, though variable, component of Edesa Biotech, Inc.'s non-product revenue comes from government support. This includes reimbursement for ongoing clinical studies. Edesa Biotech, Inc. previously secured a commitment of up to C$23 million from the Government of Canada for a pivotal Phase 3 clinical study of its EB05 (paridiprubart) asset. Furthermore, the EB05 program is being evaluated in a U.S. government-funded platform study for Acute Respiratory Distress Syndrome (ARDS). However, this income stream shows fluctuation; total other income decreased in the three and six months ended March 31, 2025, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund (SIF).

Capital Raising Activities: Equity Financing Proceeds

To fund its clinical advancement, Edesa Biotech, Inc. relies on equity financing. The most recent substantial inflow was a private placement that closed on February 12, 2025, which generated approximately $15.0 million in gross proceeds. This capital raise was strategic, intended to support the development of EB06 through the end of fiscal 2026. Insiders, including officers and directors, participated in this offering, contributing roughly $1.1 million of the total. This financing significantly bolstered the balance sheet; cash and cash equivalents stood at $13.9 million as of March 31, 2025, up from $1.6 million at December 31, 2024, following the infusion.

Here's a quick look at the key financial inflows supporting Edesa Biotech, Inc. operations as of the latest reported periods:

Revenue/Financing Source	Amount/Status	Date Context
Product Sales Revenue	$0.00	Q4 2024 / Ongoing
Gross Proceeds from February 2025 Equity Offering	$15.0 million	February 2025
Insider Contribution to February 2025 Offering	Approximately $1.1 million	February 2025
Cash and Cash Equivalents Balance	$13.9 million	March 31, 2025
Canadian Government Funding Commitment (EB05)	Up to C$23 million	Prior Commitment

Future Potential Revenue: Milestones and Royalties

The long-term revenue stream projection for Edesa Biotech, Inc. is anchored in out-licensing agreements. This involves securing future milestone payments and royalties based on the successful clinical development and commercialization of its pipeline assets by partners. Currently, specific, realized numbers for these future streams aren't public, but they represent the ultimate monetization path for the intellectual property. You'll want to watch for any new partnership deals announced, as those will define the structure of these potential future earnings.

Interest Income from Cash Balances

Interest income is a minor, non-core revenue component derived from holding cash and cash equivalents. This income stream is directly tied to the cash balance available from financing activities. For instance, total other income decreased for the three months ended March 31, 2025, primarily due to a decrease in interest income, alongside the drop in SIF reimbursement. With a cash balance of $13.9 million at March 31, 2025, the interest earned would be a function of the prevailing short-term rates on that capital.

The current revenue structure for Edesa Biotech, Inc. is a classic clinical-stage profile, relying on the $15.0 million raise to bridge the gap until potential licensing events materialize. You should track the cash burn rate against this balance.