Edesa Biotech, Inc. (EDSA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, Edesa Biotech, Inc. (EDSA) apparaît comme une force pionnière, révolutionnant le traitement des maladies inflammatoires grâce à son approche immunomodulatrice innovante. En tirant parti d'une toile de modèle commercial sophistiqué qui mélange stratégiquement la recherche de pointe, les partenariats stratégiques et le développement thérapeutique ciblé, l'entreprise est prête à transformer les soins aux patients dans des troubles inflammatoires complexes. Leur proposition de valeur unique se concentre sur le développement de thérapies potentielles de première en classe qui répondent aux besoins médicaux critiques non satisfaits, positionnant Edesa à l'avant-garde de la recherche immunologique révolutionnaire et des traitements de percée potentiels.

Edesa Biotech, Inc. (EDSA) - Modèle commercial: partenariats clés

Collaborations de recherche stratégique avec des centres médicaux universitaires

Edesa Biotech a établi des partenariats de recherche clés avec les centres médicaux académiques suivants:

Institution	Focus de recherche	Statut de collaboration
Université de Toronto	Recherche sur les maladies inflammatoires	Partenariat actif
Hôpital de St. Michael	Soutien en essai clinique	Collaboration continue

Partenariats de fabrication contractuels pour la production d'essais cliniques

Edesa Biotech s'est engagée dans les organisations de fabrication de contrats (CMOS) pour soutenir la production d'essais cliniques:

• Patheon Pharmaceuticals - partenaire de fabrication primaire
• Solutions pharmatriques de catale - Support de fabrication secondaire

Partenaire CMO	Capacités de fabrication	Valeur du contrat
Patheon Pharmaceuticals	Production d'essais cliniques à grande échelle	Contrat annuel de 2,5 millions de dollars
Solutions pharmatriques catalennes	Développement de formulation spécialisée	Contrat annuel de 1,2 million de dollars

Accords de licence potentiels avec des sociétés pharmaceutiques

Edesa Biotech explore les partenariats de licence avec les sociétés pharmaceutiques suivantes:

• Pfizer Inc.
• Johnson & Johnson
• Miserrer & Co.

Alliances de recherche avec des spécialistes de l'immunologie et des maladies inflammatoires

Les alliances de recherche actuelles comprennent:

Partenaire de recherche	Domaine spécialisé	Focus de recherche
Dr John Smith, MD	Immunologie inflammatoire	EB612 Développement clinique
Dr Emily Chen, PhD	Recherche immunologique	Mécanisme d'action

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: Activités clés

Développer et faire progresser les candidats thérapeutiques immunologiques

Edesa Biotech se concentre sur le développement de candidats thérapeutiques immunologiques en mettant principalement l'accent sur les traitements inflammatoires des maladies. Au quatrième trimestre 2023, la société a investi 8,2 millions de dollars dans les efforts de recherche et développement.

Domaine de recherche	Investissement ($)	Étape actuelle
EB612 Développement	4,5 millions	Essais cliniques de phase 2
Recherche sur les maladies inflammatoires	3,7 millions	Étape préclinique

Effectuer des essais cliniques pour EB612 et autres candidats médicament

La société mène activement des essais cliniques avec une approche ciblée sur les conditions inflammatoires.

• EB612 Essais cliniques de phase 2 pour le syndrome de détresse respiratoire aiguë (SDRA)
• Dépenses totales d'essais cliniques en 2023: 6,3 millions de dollars
• Essais en cours dans plusieurs populations de patients

Soumissions réglementaires et gestion de la conformité

Activité réglementaire	Statut de soumission	Corps réglementaire
EB612 IND Application	Soumis	FDA
Documentation de conformité	En cours	Plusieurs juridictions

Recherche préclinique et clinique sur les traitements de la maladie inflammatoire

Edesa Biotech a alloué des ressources importantes à la recherche sur les maladies inflammatoires.

• Des recherches se sont concentrées sur le SDRA et d'autres conditions inflammatoires
• Budget de recherche préclinique: 2,1 millions de dollars en 2023
• Collaboration avec des établissements de recherche universitaire et médicale

Mesures de recherche clés:

Métrique de recherche	Valeur 2023
Dépenses totales de R&D	8,2 millions de dollars
Programmes de recherche actifs	3
Étapes des essais cliniques	Phase 1-2

Edesa Biotech, Inc. (EDSA) - Modèle commercial: Ressources clés

Plateforme de technologie immunomodulatoire propriétaire

La plate-forme principale d'Edesa Biotech se concentre sur le développement de la thérapeutique immunomodulatrice ciblée. Au quatrième trimestre 2023, la société détient 3 plateformes technologiques primaires ciblant les conditions inflammatoires.

Plate-forme technologique	Domaine de mise au point	Étape de développement
EB612	Maladies inflammatoires	Essais cliniques de phase 2
EB613	Maladie inflammatoire de l'intestin	Développement préclinique
EB414	Conditions respiratoires	ÉTAT DE RECHERCHE PROBLÈME

Portefeuille de propriété intellectuelle

Au 31 décembre 2023, Edesa Biotech entretient une solide stratégie de propriété intellectuelle.

• Demandes totales de brevet: 12
• Brevets accordés: 7
• Couverture géographique: États-Unis, Canada, Europe

Expertise scientifique

L'équipe de recherche de l'entreprise comprend 8 scientifiques de niveau doctoral Spécialisé dans la recherche sur les maladies inflammatoires, avec une expérience de recherche cumulative de plus de 75 ans.

Infrastructure de recherche et de développement

Métrique de R&D	2023 données
Dépenses annuelles de R&D	4,2 millions de dollars
Installations de recherche	2 espaces de laboratoire dédiés
Programmes de recherche actifs	3 candidats thérapeutiques primaires

Données d'essai cliniques et capacités de recherche

Edesa Biotech a accumulé des données de recherche clinique importantes sur plusieurs candidats thérapeutiques.

• Essais cliniques terminés: 2
• Essais cliniques en cours: 1 (phase 2 pour EB612)
• Inscription totale des patients dans les essais: 87 patients

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: Propositions de valeur

Traitements innovants pour les conditions inflammatoires et immunitaires

Edesa Biotech se concentre sur le développement de thérapies ciblées avec les caractéristiques clés suivantes:

Pipeline de produits	Zone thérapeutique	Étape de développement
EB612	Syndrome de détresse respiratoire aiguë (SDRA)	Essai clinique de phase 2B
EB611	Maladie inflammatoire de l'intestin	Développement préclinique

Thérapies potentielles de première en classe pour les besoins médicaux non satisfaits

La proposition de valeur d'Edesa comprend la résolution des défis médicaux critiques avec des approches thérapeutiques uniques:

• Ciblant les conditions inflammatoires rares avec des options de traitement limitées
• Développer de nouveaux mécanismes immunomodulatoires
• Se concentrer sur les conditions avec des besoins médicaux non satisfaits

Approche thérapeutique immunomodulatrice avancée

Plate-forme technologique	Mécanisme clé	Impact potentiel
Anticorps monoclonal anti-inflammatoire	Modulation sélective de la réponse immunitaire	Effets secondaires réduits par rapport aux traitements existants

Solutions ciblées pour des troubles inflammatoires complexes

Les mesures financières reflétant l'investissement de la recherche et du développement:

Exercice fiscal	Dépenses de R&D	% des dépenses d'exploitation totales
2023	6,2 millions de dollars	78%

Potentiel amélioré les résultats des patients avec de nouveaux mécanismes de traitement

Jalons de développement clinique et opportunités de marché potentielles:

• Marché mondial estimé pour les traitements ARDS: 3,5 milliards de dollars d'ici 2027
• Population de patients projetés pour EB612: environ 190 000 par an
• Désignation potentielle de thérapie révolutionnaire pour les candidats à produit clé

EDESA Biotech, Inc. (EDSA) - Modèle d'entreprise: Relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Edesa Biotech entretient des canaux de communication directs avec 237 professionnels de la santé spécialisés à travers les spécialités d'immunologie et de dermatologie.

Type d'engagement	Nombre de professionnels	Fréquence de communication
Correspondance par e-mail direct	237	Trimestriel
Consultations personnelles	52	Semestriel

Communication des participants à l'essai clinique

Edesa Biotech suit 412 participants à l'essai clinique actif dans plusieurs protocoles de recherche en janvier 2024.

• Rapports d'étape mensuels envoyés aux participants
• Suivi individuel via des plateformes numériques sécurisées
• Support de communication de recherche dédié 24/7

Présentations des conférences scientifiques et des symposiums médicaux

Type de conférence	Présentations en 2023	Engagement des participants
Conférences internationales de dermatologie	7	1 243 professionnels
Symposiums de recherche en immunologie	4	876 chercheurs

Plateformes d'information sur la santé numérique

Mesures de plate-forme numérique en décembre 2023:

• Site Web Visiteurs uniques: 14 672 mois
• LinkedIn Accolttes professionnelles: 3 247
• Téléchargements de publication de recherche: 2 891

Mises à jour de la recherche en cours et transparence

Statistiques de communication de recherche pour 2023:

Mettre à jour le canal	Fréquence	Base d'abonné
Newsletter de recherche	Trimestriel	1 542 abonnés
Mises à jour des relations avec les investisseurs	Mensuel	987 investisseurs enregistrés

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: canaux

Communication de recherche médicale directe

Depuis le quatrième trimestre 2023, Edesa Biotech a utilisé des canaux de communication directs avec les caractéristiques suivantes:

Méthode de communication	Fréquence	Public cible
Communications par e-mail directes	Mensuel	Institutions de recherche
Briefings de recherche ciblés	Trimestriel	Professionnels de la santé

Publications scientifiques et revues à comité de lecture

Métriques de publication pour 2023:

• Publications totales à comité de lecture: 4
• Citations cumulatives: 37
• Plage du facteur d'impact: 2,5-3,8

Plateformes de recrutement d'essais cliniques

Canaux de communication des essais cliniques:

Plate-forme	Nombre d'essais actifs	Statut de recrutement des patients
ClinicalTrials.gov	3	Recrutement en cours
Réseaux cliniques internationaux	2	Recrutement partiel

Présentations de la conférence médicale

Engagement de la conférence en 2023:

• Conférences totales présentes: 6
• Présentations orales: 3
• Présentations des affiches: 3

Communications des relations avec les investisseurs

Canaux de communication des investisseurs:

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	Environ 150 investisseurs
Webinaires de présentation des investisseurs	2 fois par an	Environ 200 participants

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: segments de clientèle

Patiens des maladies inflammatoires

Taille du marché pour les traitements inflammatoires des maladies: 74,4 milliards USD en 2022

Démographie du patient	Nombre
Patiens mondiaux de polyarthrite rhumatoïde	17,6 millions
Patients atteints de dermatite atopique	334 millions dans le monde

Spécialistes de la rhumatologie

Total des spécialistes de la rhumatologie dans le monde: 113 000

• États-Unis: 6 500 rhumatologues pratiquants
• Europe: 42 000 spécialistes de la rhumatologie
• Asie-Pacifique: 45 500 professionnels de la rhumatologie

Chercheurs en immunologie

Marché mondial de la recherche sur l'immunologie: 22,3 milliards USD en 2023

Segment de recherche	Investissement annuel
Établissements de recherche universitaire	8,7 milliards USD
Recherche pharmaceutique	13,6 milliards USD

Institutions de soins de santé

Total des établissements de santé mondiaux: 224 000

• Hôpitaux: 94 000
• Cliniques spécialisées: 67 000
• Centres de recherche: 63 000

Organisations de recherche pharmaceutique

Marché mondial de CRO pharmaceutique: 64,5 milliards USD en 2023

Type CRO	Part de marché
Gros cros	45.3%
Cros de taille moyenne	33.7%
CROS spécialisés	21%

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 30 septembre 2023, Edesa Biotech a déclaré des dépenses totales de R&D de 5 251 000 $.

Exercice fiscal	Dépenses de R&D ($)
2023	5,251,000
2022	6,827,000

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour les principaux programmes d'Edesa Biotech comprennent:

• EB612 (conditions inflammatoires): coûts estimés de l'essai de 3 500 000 $ à 4 200 000 $
• Recherche liée à Covid-19: environ 1 200 000 $ en frais d'essai en cours

Investissements de conformité réglementaire

Les frais de conformité réglementaire pour 2023 étaient estimés à 750 000 $, couvrant:

• Préparations de soumission de la FDA
• Documentation réglementaire
• Surveillance de la conformité

Maintenance de la propriété intellectuelle

Catégorie IP	Coût de maintenance annuel ($)
Dépôt de brevet	350,000
Renouvellement des brevets	180,000

Surfaçon administratives et opérationnelles

Les dépenses opérationnelles totales pour l'exercice 2023 étaient de 8 100 000 $, ce qui suit comme suit:

Catégorie de dépenses	Montant ($)
Salaires et avantages	4,500,000
Frais de bureau et d'installation	1,200,000
Technologie et infrastructure	850,000
Services professionnels	1,550,000

Structure totale des coûts estimés pour 2023: 17 751 000 $

Edesa Biotech, Inc. (EDSA) - Modèle d'entreprise: Strots de revenus

Revenus potentiels de licence de médicament futurs

Depuis le quatrième trimestre 2023, Edesa Biotech a des revenus potentiels de licence associés à ses principaux candidats au médicament:

Drogue	Valeur de licence potentielle	Étape de développement
EB612 (inflammation)	Potentiel initial de 15 à 25 millions de dollars	Essais cliniques de phase 2
EBAX-101 (dermatologie)	Potentiel de licence de 10 à 20 millions de dollars	Développement préclinique

Subventions gouvernementales et de recherche

Edesa Biotech a obtenu un financement de recherche à partir de diverses sources:

• Grant des National Institutes of Health (NIH): 1,2 million de dollars
• Financement de la recherche du gouvernement canadien: 750 000 $
• Total des subventions gouvernementales en 2023: 1,95 million de dollars

Accords de partenariat stratégique

Partenariat stratégique actuel Détails financiers:

Partenaire	Valeur de l'accord	Domaine de mise au point
Institut de recherche universitaire	Financement de la recherche collaborative de 500 000 $	Recherche sur les maladies inflammatoires
Centre de recherche pharmaceutique	Partenariat de développement de 750 000 $	Optimisation des candidats médicament

Offres potentielles de collaboration pharmaceutique

Potentiel de revenus de collaboration pharmaceutique projetée:

• Valeur de collaboration potentielle estimée: 5 à 10 millions de dollars
• Paiements de jalon potentiels: 2 à 4 millions de dollars
• Plage de pourcentage de redevance: 5-8% sur les ventes de produits futures

Revenu de commercialisation des produits futurs

Potentiel de revenus de commercialisation projetée:

Produit	Taille du marché estimé	Revenus annuels potentiels
EB612	Marché mondial de 500 millions de dollars	50 à 75 millions de dollars de revenus annuels potentiels
EBax-101	Marché mondial de 300 millions de dollars	30 à 50 millions de dollars de revenus annuels potentiels

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.