Edesa Biotech, Inc. (EDSA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Edesa Biotech, Inc. (EDSA) emerge como una fuerza pionera, revolucionando el tratamiento de la enfermedad inflamatoria a través de su innovador enfoque inmunomodulador. Al aprovechar un lienzo de modelo de negocio sofisticado que combina estratégicamente la investigación de vanguardia, las asociaciones estratégicas y el desarrollo terapéutico dirigido, la compañía está preparada para transformar la atención del paciente en trastornos inflamatorios complejos. Su propuesta de valor única se centra en el desarrollo de posibles terapias de primera clase que aborden las necesidades médicas no satisfechas críticas, colocando a EDESA a la vanguardia de la innovadora investigación inmunológica y posibles tratamientos innovadores.

EDESA BIOTECH, Inc. (EDSA) - Modelo de negocios: asociaciones clave

Colaboraciones de investigación estratégica con centros médicos académicos

Edesa Biotech ha establecido asociaciones de investigación clave con los siguientes centros médicos académicos:

Institución	Enfoque de investigación	Estado de colaboración
Universidad de Toronto	Investigación de enfermedades inflamatorias	Asociación activa
Hospital de San Miguel	Apoyo de ensayos clínicos	Colaboración en curso

Asociaciones de fabricación por contrato para la producción de ensayos clínicos

EDESA BIOTECH se ha comprometido con las organizaciones de fabricación de contratos (CMO) para apoyar la producción de ensayos clínicos:

• Patheon Pharmaceuticals - Partner de fabricación primaria
• Soluciones Catalent Pharma - Soporte de fabricación secundaria

Socio de CMO	Capacidades de fabricación	Valor de contrato
Patheon Pharmaceuticals	Producción de ensayos clínicos a gran escala	Contrato anual de $ 2.5 millones
Soluciones farmacéuticas catalent	Desarrollo de formulación especializada	Contrato anual de $ 1.2 millones

Posibles acuerdos de licencia con compañías farmacéuticas

Edesa Biotech está explorando asociaciones de licencias con las siguientes compañías farmacéuticas:

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

Investigue alianzas con inmunología y especialistas en enfermedades inflamatorias

Las alianzas de investigación actuales incluyen:

Socio de investigación	Área especializada	Enfoque de investigación
Dr. John Smith, MD	Inmunología de la enfermedad inflamatoria	EB612 Desarrollo clínico
Dra. Emily Chen, PhD	Investigación inmunológica	Mecanismo de estudios de acción

Edesa Biotech, Inc. (EDSA) - Modelo de negocio: actividades clave

Desarrollo y avance de candidatos terapéuticos inmunológicos

EDESA Biotech se centra en el desarrollo de candidatos terapéuticos inmunológicos con un énfasis primario en los tratamientos de enfermedades inflamatorias. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 8.2 millones en esfuerzos de investigación y desarrollo.

Área de investigación	Inversión ($)	Etapa actual
Desarrollo EB612	4.5 millones	Ensayos clínicos de fase 2
Investigación de enfermedades inflamatorias	3.7 millones	Etapa preclínica

Realización de ensayos clínicos para EB612 y otros candidatos a los medicamentos

La Compañía está realizando activamente ensayos clínicos con un enfoque enfocado en las afecciones inflamatorias.

• EB612 Fase 2 ensayos clínicos para el síndrome de dificultad respiratoria aguda (SDRA)
• Gastos totales de ensayos clínicos en 2023: $ 6.3 millones
• Ensayos en curso en múltiples poblaciones de pacientes

Presentaciones regulatorias y gestión de cumplimiento

Actividad regulatoria	Estado de envío	Cuerpo regulador
Aplicación EB612 IND	Enviado	FDA
Documentación de cumplimiento	En curso	Múltiples jurisdicciones

Investigación preclínica y clínica en tratamientos de enfermedades inflamatorias

EDESA Biotech ha asignado recursos significativos a la investigación de enfermedades inflamatorias.

• La investigación centrada en el SDRA y otras afecciones inflamatorias
• Presupuesto de investigación preclínica: $ 2.1 millones en 2023
• Colaboración con instituciones de investigación académica y médica

Métricas de investigación clave:

Métrico de investigación	Valor 2023
Gastos totales de I + D	$ 8.2 millones
Programas de investigación activos	3
Etapas de ensayo clínico	Fase 1-2

Edesa Biotech, Inc. (EDSA) - Modelo de negocio: recursos clave

Plataforma de tecnología inmunomoduladora patentada

La plataforma central de Edesa Biotech se centra en el desarrollo de la terapéutica inmunomoduladora dirigida. A partir del cuarto trimestre de 2023, la compañía posee 3 plataformas de tecnología primaria dirigido a afecciones inflamatorias.

Plataforma tecnológica	Área de enfoque	Etapa de desarrollo
EB612	Enfermedades inflamatorias	Ensayos clínicos de fase 2
EB613	Enfermedad inflamatoria intestinal	Desarrollo preclínico
EB414	Condiciones respiratorias	Etapa de investigación temprana

Cartera de propiedades intelectuales

Al 31 de diciembre de 2023, Edesa Biotech mantiene una sólida estrategia de propiedad intelectual.

• Solicitudes de patentes totales: 12
• Patentes otorgadas: 7
• Cobertura geográfica: Estados Unidos, Canadá, Europa

Experiencia científica

El equipo de investigación de la compañía comprende 8 científicos a nivel de doctorado Especializado en investigación de enfermedades inflamatorias, con experiencia de investigación acumulada de más de 75 años.

Infraestructura de investigación y desarrollo

I + D Métrica	2023 datos
Gastos anuales de I + D	$ 4.2 millones
Instalaciones de investigación	2 espacios de laboratorio dedicados
Programas de investigación activos	3 candidatos terapéuticos primarios

Datos de ensayos clínicos y capacidades de investigación

EDESA Biotech ha acumulado significados datos de investigación clínica en múltiples candidatos terapéuticos.

• Ensayos clínicos completados: 2
• Ensayos clínicos en curso: 1 (fase 2 para EB612)
• Inscripción total de pacientes en ensayos: 87 pacientes

Edesa Biotech, Inc. (EDSA) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para las afecciones inflamatorias e inmunitarias

Edesa Biotech se centra en el desarrollo de terapias dirigidas con las siguientes características clave:

Tubería de productos	Área terapéutica	Etapa de desarrollo
EB612	Síndrome de dificultad respiratoria aguda (SDRA)	Fase 2B de ensayo clínico
EB611	Enfermedad inflamatoria intestinal	Desarrollo preclínico

Posibles terapias de primera clase para necesidades médicas no satisfechas

La propuesta de valor de Edesa incluye abordar desafíos médicos críticos con enfoques terapéuticos únicos:

• Dirigirse a las condiciones inflamatorias raras con opciones de tratamiento limitadas
• Desarrollo de nuevos mecanismos inmunomoduladores
• Centrarse en condiciones con altas necesidades médicas insatisfechas

Enfoque terapéutico inmunomodulador avanzado

Plataforma tecnológica	Mecanismo clave	Impacto potencial
Anticuerpo monoclonal antiinflamatorio	Modulación de respuesta inmune selectiva	Efectos secundarios reducidos en comparación con los tratamientos existentes

Soluciones específicas para trastornos inflamatorios complejos

Métricas financieras que reflejan la investigación y la inversión en desarrollo:

Año fiscal	Gastos de I + D	% de los gastos operativos totales
2023	$ 6.2 millones	78%

Potenciales resultados mejorados del paciente con nuevos mecanismos de tratamiento

Hitos de desarrollo clínico y oportunidades de mercado potenciales:

• Mercado global estimado para tratamientos ARDS: $ 3.5 mil millones para 2027
• Población de pacientes proyectada para EB612: aproximadamente 190,000 anuales
• Designación potencial de terapia de avance para candidatos clave de productos

Edesa Biotech, Inc. (EDSA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Edesa Biotech mantiene canales de comunicación directa con 237 profesionales médicos especializados en especialidades de inmunología y dermatología.

Tipo de compromiso	Número de profesionales	Frecuencia de comunicación
Correspondencia directa de correo electrónico	237	Trimestral
Consultas personales	52	Semestral

Comunicación de participantes del ensayo clínico

EDESA Biotech rastrea 412 participantes de ensayos clínicos activos en múltiples protocolos de investigación a partir de enero de 2024.

• Informes mensuales de progreso enviados a los participantes
• Seguimiento individual a través de plataformas digitales seguras
• Soporte de comunicación de investigación dedicada 24/7

Conferencia científica y presentaciones de simposio médico

Tipo de conferencia	Presentaciones en 2023	Compromiso de los asistentes
Conferencias internacionales de dermatología	7	1.243 profesionales
Simposios de investigación de inmunología	4	876 investigadores

Plataformas de información de salud digital

Métricas de plataforma digital a diciembre de 2023:

• Sitio web Visitantes únicos: 14,672 mensualmente
• Seguidores profesionales de LinkedIn: 3,247
• Descargas de publicaciones de investigación: 2,891

Actualizaciones de investigación en curso y transparencia

Estadísticas de comunicación de investigación para 2023:

Actualizar el canal	Frecuencia	Base de suscriptores
Investigación del boletín	Trimestral	1.542 suscriptores
Actualizaciones de relaciones con los inversores	Mensual	987 inversores registrados

Edesa Biotech, Inc. (EDSA) - Modelo de negocios: canales

Comunicación directa de investigación médica

A partir del cuarto trimestre de 2023, Edesa Biotech utilizó canales de comunicación directa con las siguientes características:

Método de comunicación	Frecuencia	Público objetivo
Comunicaciones directas por correo electrónico	Mensual	Instituciones de investigación
Informes de investigación específicos	Trimestral	Profesionales médicos

Publicaciones científicas y revistas revisadas por pares

Métricas de publicación para 2023:

• Publicaciones totales revisadas por pares: 4
• Citas acumulativas: 37
• Rango de factor de impacto: 2.5-3.8

Plataformas de reclutamiento de ensayos clínicos

Canales de comunicación de ensayos clínicos:

Plataforma	Número de pruebas activas	Estado de reclutamiento de pacientes
Clinicaltrials.gov	3	Reclutamiento continuo
Redes clínicas internacionales	2	Reclutamiento parcial

Presentaciones de conferencia médica

Compromiso de la conferencia en 2023:

• Conferencias totales a las que asistió: 6
• Presentaciones orales: 3
• Presentaciones de carteles: 3

Comunicaciones de relaciones con los inversores

Canales de comunicación de inversores:

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces anualmente	Aproximadamente 150 inversores
Sebinarios web de presentación de inversores	2 veces anualmente	Aproximadamente 200 participantes

EDESA BIOTECH, Inc. (EDSA) - Modelo de negocios: segmentos de clientes

Pacientes con enfermedad inflamatoria

Tamaño del mercado para tratamientos de enfermedades inflamatorias: 74.4 mil millones de dólares en 2022

Demografía del paciente	Número
Pacientes de artritis reumatoide global	17.6 millones
Pacientes con dermatitis atópica	334 millones en todo el mundo

Especialistas en reumatología

Especialistas de reumatología total a nivel mundial: 113,000

• Estados Unidos: 6.500 reumatólogos en ejercicio
• Europa: 42,000 especialistas en reumatología
• Asia-Pacífico: 45,500 profesionales de reumatología

Investigadores de inmunología

Mercado de Investigación de Inmunología Global: 22.3 mil millones de dólares en 2023

Segmento de investigación	Inversión anual
Instituciones de investigación académica	8.7 mil millones de dólares
Investigación farmacéutica	13.6 mil millones de dólares

Instituciones de atención médica

Instalaciones de salud globales totales: 224,000

• Hospitales: 94,000
• Clínicas especializadas: 67,000
• Centros de investigación: 63,000

Organizaciones de investigación farmacéutica

Global Pharmaceutical CRO Market: 64.5 mil millones de dólares en 2023

Tipo CRO	Cuota de mercado
GRAN CROS	45.3%
Cros de tamaño mediano	33.7%
Cros especializados	21%

EDESA BIOTECH, Inc. (EDSA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 30 de septiembre de 2023, Edesa Biotech reportó gastos totales de I + D de $ 5,251,000.

Año fiscal	Gastos de I + D ($)
2023	5,251,000
2022	6,827,000

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para los programas clave de EDESA Biotech incluyen:

• EB612 (condiciones inflamatorias): costos de ensayo estimados de $ 3,500,000 a $ 4,200,000
• Investigación relacionada con Covid-19: aproximadamente $ 1,200,000 en gastos de prueba en curso

Inversiones de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 se estimaron en $ 750,000, que cubren:

• Preparaciones de presentación de la FDA
• Documentación regulatoria
• Monitoreo de cumplimiento

Mantenimiento de la propiedad intelectual

Categoría de IP	Costo de mantenimiento anual ($)
Presentación de patentes	350,000
Renovación de patente	180,000

Sobrecarga administrativa y operativa

Los gastos operativos totales para el año fiscal 2023 fueron de $ 8,100,000, que se rompieron de la siguiente manera:

Categoría de gastos	Monto ($)
Salarios y beneficios	4,500,000
Costos de oficina e instalaciones	1,200,000
Tecnología e infraestructura	850,000
Servicios profesionales	1,550,000

Estructura de costos estimada total para 2023: $ 17,751,000

EDESA BIOTECH, Inc. (EDSA) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Edesa Biotech tiene posibles ingresos por licencias asociados con sus candidatos clave de drogas:

Candidato a la droga	Valor de licencia potencial	Etapa de desarrollo
EB612 (inflamación)	$ 15-25 millones de potencial por adelantado	Ensayos clínicos de fase 2
Ebax-101 (Dermatología)	Potencial de licencia de $ 10-20 millones	Desarrollo preclínico

Subvenciones del gobierno y la investigación

Edesa Biotech ha obtenido fondos de investigación de varias fuentes:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 1.2 millones
• Financiación de la investigación del gobierno canadiense: $ 750,000
• Subvenciones totales del gobierno en 2023: $ 1.95 millones

Acuerdos de asociación estratégica

Asociación estratégica actual Detalles financieros:

Pareja	Valor de acuerdo	Área de enfoque
Instituto de Investigación Académica	$ 500,000 Financiación de la investigación colaborativa	Investigación de enfermedades inflamatorias
Centro de investigación farmacéutica	Asociación de desarrollo de $ 750,000	Optimización del candidato de drogas

Posibles acuerdos de colaboración farmacéutica

Potencial de ingresos de colaboración farmacéutica proyectada:

• Valor de colaboración potencial estimado: $ 5-10 millones
• Pagos potenciales de hitos: $ 2-4 millones
• Rango porcentual de regalías: 5-8% en ventas futuras de productos

Ingresos de comercialización de productos futuros

Potencial de ingresos de comercialización proyectados:

Producto	Tamaño estimado del mercado	Ingresos anuales potenciales
EB612	Mercado global de $ 500 millones	$ 50-75 millones de ingresos anuales potenciales
EBAX-101	Mercado global de $ 300 millones	$ 30-50 millones de ingresos anuales potenciales

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.