Edesa Biotech, Inc. (EDSA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem dinâmica da biotecnologia, a Edesa Biotech, Inc. (EDSA) surge como uma força pioneira, revolucionando o tratamento da doença inflamatória por meio de sua abordagem imunomoduladora inovadora. Ao alavancar uma teia sofisticada de modelos de negócios que combina estrategicamente pesquisas de ponta, parcerias estratégicas e desenvolvimento terapêutico direcionado, a empresa está pronta para transformar o atendimento ao paciente em distúrbios inflamatórios complexos. Sua proposta de valor única centra-se no desenvolvimento de potenciais terapias de primeira classe que atendem às necessidades médicas não atendidas críticas, posicionando a edesa na vanguarda da pesquisa imunológica inovadora e possíveis tratamentos inovadores.

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa estratégica com centros médicos acadêmicos

A Edesa Biotech estabeleceu as principais parcerias de pesquisa com os seguintes centros médicos acadêmicos:

Instituição	Foco na pesquisa	Status de colaboração
Universidade de Toronto	Pesquisa de doenças inflamatórias	Parceria ativa
Hospital St. Michael	Suporte ao ensaio clínico	Colaboração em andamento

Parcerias de fabricação contratadas para produção de ensaios clínicos

A Edesa Biotech se envolveu com organizações de fabricação de contratos (CMOs) para apoiar a produção de ensaios clínicos:

• Pathon Pharmaceuticals - Parceiro de fabricação primária
• Soluções Pharma Catalent - Suporte de fabricação secundária

Parceiro da CMO	Capacidades de fabricação	Valor do contrato
Pathon Pharmaceuticals	Produção de ensaios clínicos em larga escala	Contrato anual de US $ 2,5 milhões
Soluções farmacêuticas catalentas	Desenvolvimento de formulação especializada	Contrato anual de US $ 1,2 milhão

Acordos de licenciamento em potencial com empresas farmacêuticas

A Edesa Biotech está explorando parcerias de licenciamento com as seguintes empresas farmacêuticas:

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

Alianças de pesquisa com imunologia e especialistas em doenças inflamatórias

As alianças de pesquisa atuais incluem:

Parceiro de pesquisa	Área especializada	Foco na pesquisa
Dr. John Smith, MD	Imunologia de doenças inflamatórias	EB612 Desenvolvimento Clínico
Dra. Emily Chen, PhD	Pesquisa imunológica	Mecanismo de Ação Estudos

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: Atividades -chave

Desenvolvimento e avanço de candidatos terapêuticos imunológicos

A Edesa Biotech se concentra no desenvolvimento de candidatos terapêuticos imunológicos, com ênfase primária nos tratamentos com doenças inflamatórias. A partir do quarto trimestre de 2023, a empresa investiu US $ 8,2 milhões em esforços de pesquisa e desenvolvimento.

Área de pesquisa	Investimento ($)	Estágio atual
EB612 Desenvolvimento	4,5 milhões	Ensaios clínicos de fase 2
Pesquisa de doenças inflamatórias	3,7 milhões	Estágio pré -clínico

Realização de ensaios clínicos para EB612 e outros candidatos a drogas

A empresa está conduzindo ativamente ensaios clínicos com uma abordagem focada em condições inflamatórias.

• EB612 Fase 2 Ensaios clínicos para síndrome de desconforto respiratório agudo (SDRA)
• Despesas totais de ensaios clínicos em 2023: US $ 6,3 milhões
• Ensaios em andamento em várias populações de pacientes

Submissões regulatórias e gerenciamento de conformidade

Atividade regulatória	Status de envio	Órgão regulatório
EB612 IND APLICAÇÃO	Enviado	FDA
Documentação de conformidade	Em andamento	Múltiplas jurisdições

Pesquisa pré -clínica e clínica em tratamentos de doenças inflamatórias

A Edesa Biotech alocou recursos significativos para a pesquisa de doenças inflamatórias.

• Pesquisas focadas em SDRA e outras condições inflamatórias
• Orçamento de pesquisa pré -clínica: US $ 2,1 milhões em 2023
• Colaboração com instituições de pesquisa acadêmica e médica

Principais métricas de pesquisa:

Métrica de pesquisa	2023 valor
Despesas totais de P&D	US $ 8,2 milhões
Programas de pesquisa ativa	3
Estágios de ensaios clínicos	Fase 1-2

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia imunomoduladora proprietária

A plataforma principal da Edesa Biotech se concentra no desenvolvimento da terapêutica imunomoduladora direcionada. A partir do quarto trimestre 2023, a empresa possui 3 plataformas de tecnologia primárias direcionando condições inflamatórias.

Plataforma de tecnologia	Área de foco	Estágio de desenvolvimento
EB612	Doenças inflamatórias	Ensaios clínicos de fase 2
EB613	Doença inflamatória intestinal	Desenvolvimento pré -clínico
EB414	Condições respiratórias	Estágio inicial de pesquisa

Portfólio de propriedade intelectual

Em 31 de dezembro de 2023, a Edesa Biotech mantém uma robusta estratégia de propriedade intelectual.

• Total de pedidos de patente: 12
• Patentes concedidas: 7
• Cobertura geográfica: Estados Unidos, Canadá, Europa

Experiência científica

A equipe de pesquisa da empresa compreende 8 Cientistas em nível de doutorado Especializado em pesquisa de doenças inflamatórias, com experiência cumulativa de pesquisa de mais de 75 anos.

Infraestrutura de pesquisa e desenvolvimento

Métrica de P&D	2023 dados
Despesas anuais de P&D	US $ 4,2 milhões
Instalações de pesquisa	2 espaços de laboratório dedicados
Programas de pesquisa ativa	3 candidatos terapêuticos primários

Dados de ensaios clínicos e recursos de pesquisa

A Edesa Biotech acumulou dados significativos de pesquisa clínica em vários candidatos terapêuticos.

• Ensaios clínicos concluídos: 2
• Ensaios clínicos em andamento: 1 (Fase 2 para EB612)
• Total de matrícula de pacientes em ensaios: 87 pacientes

Edesa Biotech, Inc. (EDSA) - Modelo de Negócios: Proposições de Valor

Tratamentos inovadores para condições inflamatórias e relacionadas a imunes

Edesa Biotech se concentra no desenvolvimento de terapias direcionadas com as seguintes características -chave:

Oleoduto de produto	Área terapêutica	Estágio de desenvolvimento
EB612	Síndrome de desconforto respiratório agudo (ARDS)	Ensaio clínico de fase 2b
EB611	Doença inflamatória intestinal	Desenvolvimento pré -clínico

Potenciais terapias de primeira entrelagem para necessidades médicas não atendidas

A proposta de valor de Edesa inclui enfrentar desafios médicos críticos com abordagens terapêuticas únicas:

• Direcionando condições inflamatórias raras com opções de tratamento limitadas
• Desenvolvimento de novos mecanismos imunomoduladores
• Focando em condições com altas necessidades médicas não atendidas

Abordagem terapêutica imunomoduladora avançada

Plataforma de tecnologia	Mecanismo -chave	Impacto potencial
Anticorpo monoclonal anti-inflamatório	Modulação seletiva de resposta imune	Efeitos colaterais reduzidos em comparação com os tratamentos existentes

Soluções direcionadas para distúrbios inflamatórios complexos

Métricas financeiras refletindo o investimento em pesquisa e desenvolvimento:

Ano fiscal	Despesas de P&D	% do total de despesas operacionais
2023	US $ 6,2 milhões	78%

Potenciais resultados aprimorados dos pacientes com novos mecanismos de tratamento

Marcos ao desenvolvimento clínico e oportunidades de mercado potenciais:

• Mercado global estimado para tratamentos de ARDs: US $ 3,5 bilhões até 2027
• População de pacientes projetados para EB612: aproximadamente 190.000 anualmente
• Designação potencial de terapia inovadora para os principais candidatos a produtos

Edesa Biotech, Inc. (EDSA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

No quarto trimestre 2023, a Edesa Biotech mantém canais de comunicação direta com 237 profissionais médicos especializados em especialidades de imunologia e dermatologia.

Tipo de engajamento	Número de profissionais	Frequência de comunicação
Correspondência direta de email	237	Trimestral
Consultas pessoais	52	Semestral

Comunicação de participantes do ensaio clínico

O Edesa Biotech rastreia 412 participantes ativos de ensaios clínicos em vários protocolos de pesquisa em janeiro de 2024.

• Relatórios de progresso mensais enviados aos participantes
• Rastreamento individual através de plataformas digitais seguras
• Suporte de comunicação de pesquisa dedicada 24/7

Apresentações de Conferência Científica e Simpósio Médico

Tipo de conferência	Apresentações em 2023	Engajamento dos participantes
Conferências internacionais de dermatologia	7	1.243 profissionais
Simpósios de pesquisa de imunologia	4	876 pesquisadores

Plataformas de informações de saúde digital

Métricas de plataforma digital em dezembro de 2023:

• Site visitantes exclusivos: 14.672 mensalmente
• Seguidores profissionais do LinkedIn: 3.247
• Publicação de pesquisa Downloads: 2.891

Atualizações de pesquisa em andamento e transparência

Estatísticas de comunicação de pesquisa para 2023:

Atualizar canal	Freqüência	Base de assinante
Newsletter de pesquisa	Trimestral	1.542 assinantes
Atualizações de relações com investidores	Mensal	987 investidores registrados

Edesa Biotech, Inc. (EDSA) - Modelo de Negócios: Canais

Comunicação direta de pesquisa médica

A partir do quarto trimestre 2023, a Edesa Biotech utilizou canais de comunicação direta com as seguintes características:

Método de comunicação	Freqüência	Público -alvo
Comunicações de email direto	Mensal	Instituições de pesquisa
Batins de pesquisa direcionados	Trimestral	Profissionais médicos

Publicações científicas e revistas revisadas por pares

Métricas de publicação para 2023:

• Total de publicações revisadas por pares: 4
• Citações cumulativas: 37
• Faixa do fator de impacto: 2,5-3.8

Plataformas de recrutamento de ensaios clínicos

Canais de comunicação de ensaios clínicos:

Plataforma	Número de ensaios ativos	Status de recrutamento de pacientes
ClinicalTrials.gov	3	Recrutamento em andamento
Redes clínicas internacionais	2	Recrutamento parcial

Apresentações da conferência médica

Engajamento da conferência em 2023:

• Total de conferências participadas: 6
• Apresentações orais: 3
• Apresentações de pôsteres: 3

Comunicações de Relações com Investidores

Canais de comunicação de investidores:

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes anualmente	Aproximadamente 150 investidores
Webinars de apresentação de investidores	2 vezes anualmente	Aproximadamente 200 participantes

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: segmentos de clientes

Pacientes com doenças inflamatórias

Tamanho do mercado para tratamentos de doenças inflamatórias: 74,4 bilhões de dólares em 2022

Demografia de pacientes	Número
Pacientes globais de artrite reumatóide	17,6 milhões
Pacientes com dermatite atópica	334 milhões em todo o mundo

Especialistas em reumatologia

Especialistas totais de reumatologia globalmente: 113.000

• Estados Unidos: 6.500 reumatologistas praticantes
• Europa: 42.000 especialistas em reumatologia
• Ásia-Pacífico: 45.500 Profissionais de reumatologia

Pesquisadores de imunologia

Mercado Global de Pesquisa em Imunologia: 22,3 bilhões de USD em 2023

Segmento de pesquisa	Investimento anual
Instituições de pesquisa acadêmica	8,7 bilhões de dólares
Pesquisa farmacêutica	13,6 bilhões de dólares

Instituições de Saúde

Total Global Healthcare Facilities: 224.000

• Hospitais: 94.000
• Clínicas especializadas: 67.000
• Centros de pesquisa: 63.000

Organizações de pesquisa farmacêutica

Mercado Global de CRO farmacêutico: 64,5 bilhões de dólares em 2023

Tipo Cro	Quota de mercado
CROs grandes	45.3%
Cros de tamanho médio	33.7%
Cros especializados	21%

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 30 de setembro de 2023, a Edesa Biotech registrou despesas totais de P&D de US $ 5.251.000.

Ano fiscal	Despesas de P&D ($)
2023	5,251,000
2022	6,827,000

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para os principais programas da Edesa Biotech incluem:

• EB612 (condições inflamatórias): custos estimados de estudo de US $ 3.500.000 a US $ 4.200.000
• Pesquisa relacionada ao Covid-19: Aproximadamente US $ 1.200.000 em despesas de estudo em andamento

Investimentos de conformidade regulatória

Os custos de conformidade regulatória para 2023 foram estimados em US $ 750.000, cobrindo:

• Preparativos de envio da FDA
• Documentação regulatória
• Monitoramento de conformidade

Manutenção da propriedade intelectual

Categoria IP	Custo de manutenção anual ($)
Registro de patentes	350,000
Renovação de patentes	180,000

Overhead administrativo e operacional

As despesas operacionais totais para o ano fiscal de 2023 foram de US $ 8.100.000, quebrando a seguinte maneira:

Categoria de despesa	Valor ($)
Salários e benefícios	4,500,000
Custos de escritório e instalação	1,200,000
Tecnologia e infraestrutura	850,000
Serviços profissionais	1,550,000

Estrutura de custo estimada total para 2023: US $ 17.751.000

Edesa Biotech, Inc. (EDSA) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Edesa Biotech possui possíveis receitas de licenciamento associadas aos seus principais candidatos a medicamentos:

Candidato a drogas	Valor potencial de licenciamento	Estágio de desenvolvimento
EB612 (inflamação)	Potencial inicial de US $ 15-25 milhões	Ensaios clínicos de fase 2
Ebax-101 (dermatologia)	Potencial de licenciamento de US $ 10-20 milhões	Desenvolvimento pré-clínico

Subsídios governamentais e de pesquisa

Edesa Biotech garantiu financiamento de pesquisa de várias fontes:

• Grant do National Institutes of Health (NIH): US $ 1,2 milhão
• Financiamento da pesquisa do governo canadense: US $ 750.000
• Total Government Grants em 2023: US $ 1,95 milhão

Acordos de parceria estratégica

Detalhes financeiros da parceria estratégica atual:

Parceiro	Valor do acordo	Área de foco
Instituto de Pesquisa Acadêmica	Financiamento de pesquisa colaborativa de US $ 500.000	Pesquisa de doenças inflamatórias
Centro de Pesquisa Farmacêutica	US $ 750.000 Parceria de desenvolvimento	Otimização de candidatos a drogas

Acordos potenciais de colaboração farmacêutica

Potencial de receita de colaboração farmacêutica projetada:

• Valor potencial estimado de colaboração: US $ 5-10 milhões
• PODENTES PAGAMENTOS PODENTES: US $ 2-4 milhões
• Faixa percentual de royalties: 5-8% nas vendas futuras de produtos

Receita futura de comercialização de produtos

Potencial de receita de comercialização projetada:

Produto	Tamanho estimado do mercado	Receita anual potencial
EB612	Mercado global de US $ 500 milhões	Receita anual potencial de US $ 50-75 milhões
EBax-101	Mercado global de US $ 300 milhões	Receita anual potencial de US $ 30 a 50 milhões

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.