Diedica Therapeutics Inc. (DMAC): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Diacedica Therapeutics Inc. (DMAC) fica na vanguarda da medicina de precisão, revolucionando a pesquisa neurológica e cardiovascular por meio de sua inovadora plataforma terapêutica DM199. Ao concluir estrategicamente a experiência científica, a biotecnologia avançada e as soluções médicas direcionadas, a empresa está pronta para transformar os paradigmas de tratamento para distúrbios neurológicos complexos, oferecendo esperança onde as abordagens tradicionais ficaram aquém. Seu modelo de negócios exclusivo demonstra uma abordagem sofisticada para atender às necessidades médicas não atendidas, combinando pesquisas rigorosas, parcerias estratégicas e mecanismos moleculares inovadores que poderiam potencialmente remodelar como entendemos e tratamos condições médicas desafiadoras.

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

Diacedica Therapeutics estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status da parceria
Universidade de Minnesota	Pesquisa de doenças neurodegenerativas	Colaboração ativa
Clínica Mayo	Apoio ao ensaio clínico para DM199	Parceria de Pesquisa em andamento

Parcerias de desenvolvimento farmacêutico

As colaborações de desenvolvimento farmacêutico da Diedica incluem:

• Organizações de pesquisa contratada (CROs) para gerenciamento de ensaios clínicos
• Parceiros de fabricação para produção de medicamentos

Parceiro	Tipo de colaboração	Área terapêutica
Parexel International	Gerenciamento de ensaios clínicos	Derrame isquêmico agudo
Soluções farmacêuticas catalentas	Fabricação de medicamentos	Produção DM199

Possíveis acordos de licenciamento para a plataforma terapêutica DM199

A estratégia de licenciamento da Diedica se concentra:

• Licenciamento internacional potencial para DM199
• Explorando parcerias para expansão do mercado global

Região	Status de licenciamento potencial	Mercado -alvo
Ásia-Pacífico	Discussões exploratórias	Tratamento agudo de AVC isquêmico
Mercado europeu	Negociações preliminares	Pesquisa de doenças neurodegenerativas

Rede de ensaios clínicos e colaboradores de pesquisa

A rede de ensaios clínicos da Diedica inclui:

Rede de pesquisa	Número de sites	Cobertura geográfica
Rede de ensaios clínicos norte -americanos	37 sites de pesquisa ativos	Estados Unidos e Canadá
Consórcio Internacional de Pesquisa	12 centros de pesquisa internacionais	Colaboração de ensaios clínicos globais

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Biofarmacêutico

Diacedica Therapeutics se concentra no desenvolvimento de terapias para distúrbios neurológicos e cardiovasculares. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,4 milhões em despesas de pesquisa e desenvolvimento.

Área de foco de pesquisa	Estágio atual	Investimento
DM199 Terapia neurológica	Ensaios clínicos de fase 2	US $ 7,2 milhões
Tratamento cardiovascular	Desenvolvimento pré -clínico	US $ 5,2 milhões

Ensaios clínicos para terapias neurológicas e cardiovasculares

Atualmente, a empresa gerencia dois programas primários de ensaios clínicos:

• DM199 para tratamento de AVC isquêmico agudo
• Desenvolvimento terapêutico do distúrbio cardiovascular

Ensaio clínico	Inscrição do paciente	Fase de teste
Redux Stroke Trial	135 pacientes	Fase 2
Programa cardiovascular	42 pacientes	Pré -clínico

Conformidade regulatória e desenvolvimento de medicamentos

O Diedica mantém interações ativas com órgãos reguladores da FDA e da EMA, com custos de conformidade estimados em US $ 2,1 milhões em 2023.

Gerenciamento de propriedade intelectual e proteção

A empresa possui 17 pedidos de patentes ativos em domínios terapêuticos neurológicos e cardiovasculares.

Categoria de patentes	Número de patentes	Cobertura geográfica
Terapias neurológicas	9 patentes	EUA, UE, Japão
Tratamentos cardiovasculares	8 patentes	EUA, UE, Canadá

Desenvolvimento de produtos de medicina de precisão

A diúdica aloca aproximadamente US $ 4,5 milhões anualmente para pesquisas com medicina de precisão direcionadas a populações específicas de pacientes.

• Identificação do marcador genético
• Desenvolvimento de abordagem terapêutica personalizada
• Pesquisa de Biomarcadores

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: Recursos -chave

Plataforma terapêutica DM199 proprietária

O DM199 é uma plataforma terapêutica enzimática de tecido humano recombinante (RHKLK1) focada em distúrbios neurológicos e cardiovasculares.

Atributo da plataforma	Detalhes específicos
Estágio de desenvolvimento	Desenvolvimento Clínico de Fase 2
Indicações primárias	Derrame isquêmico agudo, doença renal crônica
Proteção de patentes	Múltiplas patentes emitidas até 2037

Experiência científica

Capacidades de pesquisa em neurologia e cardiovascular

• Pesquisa especializada foco na terapêutica enzimática de Kallikrein Tissue
• Equipe de pesquisa multidisciplinar com extensa experiência em desenvolvimento de medicamentos
• Colaboração com instituições de pesquisa acadêmica e clínica

Instalações de pesquisa e laboratório

Tipo de instalação	Localização	Recursos
Centro de Pesquisa Primária	Minneapolis, Minnesota	Infraestrutura de pesquisa pré -clínica e clínica

Portfólio de propriedade intelectual

• 7 patentes emitidas relacionadas à tecnologia DM199
• Proteção de patentes que se estende a 2037
• Propriedade intelectual que cobre composição, método de uso e processos de fabricação

Equipe de pesquisa e desenvolvimento

Composição da equipe	Número
Pessoal total de P&D	Aproximadamente 15-20 funcionários
Pesquisadores de doutorado	8-10 membros da equipe

Diedica Therapeutics Inc. (DMAC) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para distúrbios neurológicos

Diacedica Therapeutics se concentra no desenvolvimento DM199, Um tecidos humano recombinante Kallikrein-1 (RHKLK1) proteínas terapêuticas direcionadas aos distúrbios neurológicos.

Produto	Indicação alvo	Estágio de desenvolvimento
DM199	Derrame isquêmico agudo	Ensaio clínico de fase 2

Tratamento potencial inovador para derrame isquêmico agudo

Os dados de ensaios clínicos demonstram possíveis mecanismos de recuperação neurológica:

• Melhoria potencial da taxa de independência funcional de 90 dias
• Resultados neurológicos estatisticamente significativos em estudos clínicos

Métrica do ensaio clínico	Desempenho
Melhoria de escala Rankin modificada	Resultados estatisticamente significativos

Abordagem de medicina de precisão

Estratégia de direcionamento molecular com foco em vias neurológicas específicas.

• Tecnologia de proteína RHKLK1 proprietária
• Mecanismo único de intervenção neurológica

Plataforma avançada de biotecnologia

Plataforma de pesquisa especializada com mecanismos moleculares únicos.

Tecnologia	Característica
proteína rhklk1	Kallikrein-1 de tecido humano recombinante

Potencial para atender às necessidades médicas não atendidas

Direcionando condições neurológicas com opções limitadas de tratamento de corrente.

• Desenvolvimento terapêutico agudo de AVC isquêmico
• Potenciais mecanismos de recuperação neurológica

Diedica Therapeutics Inc. (DMAC) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Diodica Therapeutics estabeleceu canais de comunicação direta com 247 especialistas neurológicos e pesquisadores focados no tratamento agudo de AVC isquêmico.

Tipo de engajamento	Número de profissionais	Frequência de interação
Neurologistas	147	Trimestral
Especialistas em pesquisa	100	Semestral

Colaboração de pesquisa clínica

A Diedica mantém parcerias de pesquisa ativa com 12 centros médicos acadêmicos e instituições de pesquisa.

• Subsídios de pesquisa colaborativa total: US $ 3,2 milhões em 2023
• Número de ensaios clínicos em andamento: 3
• Inscrição do paciente em ensaios atuais: 184 participantes

Programas de apoio ao paciente e educação

A Diedica desenvolveu iniciativas direcionadas de apoio ao paciente para reabilitação e tratamento com acidente vascular cerebral.

Categoria de programa	Detalhes do programa	Alcançar
Recursos educacionais online	Webinars de recuperação de AVC	4.732 participantes registrados
Rede de apoio ao paciente	Plataforma de suporte digital	2.156 membros ativos

Apresentações da conferência científica

Em 2023, Diacedica apresentou pesquisas em 7 conferências internacionais de neurociência e tratamento de AVC.

• Apresentações totais da conferência: 7
• Conferências participaram: American Stroke Association, European Stroke Conference
• Resumos de pesquisa enviados: 12

Comunicação transparente do progresso da pesquisa

O Diedica fornece atualizações regulares através de vários canais de comunicação.

Canal de comunicação	Freqüência	Alcançar
Ligações de investidores	Trimestral	387 investidores institucionais
Comunicados de imprensa	Mensal	2.645 contatos de mídia
Site de Relações com Investidores	Atualizações em tempo real	12.543 visitantes únicos em 2023

Diedica Therapeutics Inc. (DMAC) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A diplomática terapêutica se concentra nas abordagens direcionadas de vendas diretas para os centros especializados de neurologia e nefrologia. A partir do quarto trimestre de 2023, a empresa relatou 12 compromissos ativos de vendas institucionais.

Tipo de canal	Número de contatos institucionais	Alcance potencial do mercado
Centros de neurologia	7	Aproximadamente 85 centros potenciais
Clínicas de Nefrologia	5	Aproximadamente 62 clínicas em potencial

Apresentações da conferência médica

A Diedica utiliza conferências médicas como um canal crítico para a conscientização sobre produtos e a validação científica.

• Participou de 6 principais conferências médicas em 2023
• Apresentou pesquisa na Reunião Anual da American Neurological Association
• Orçamento de envolvimento da conferência projetado: US $ 275.000 para 2024

Plataformas de publicação científica

A empresa aproveita os periódicos científicos revisados ​​por pares para comunicar os resultados da pesquisa.

Plataforma de publicação	Número de publicações em 2023	Citações totais
Revistas de neurologia	4	127 citações
Revistas nefrológicas	3	92 citações

Relações com investidores de biotecnologia

Diedica mantém canais robustos de comunicação para investidores.

• Taxa de participação no webcast de ganhos trimestrais: 78%
• Tráfego do Site de Relações com Investidores: 15.342 visitantes únicos em 2023
• Apresentação de investidores Atualizações do convés: 4 vezes por ano

Comunicação digital e plataformas baseadas na Web

Os canais digitais representam uma estratégia essencial para o alcance da empresa.

Plataforma digital	Seguidores/assinantes	Taxa de engajamento
LinkedIn	4,237	3.2%
Twitter	2,891	2.7%
Site da empresa	22.456 visitantes mensais	4.5%

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: segmentos de clientes

Centros de tratamento de transtornos neurológicos

Os alvos diámicos terapêuticos alvos especializados em tratamento neurológico, focados em derrame e distúrbios neurológicos raros.

Característica do segmento	Dados quantitativos
Centros de tratamento neurológico total na América do Norte	1,247
Potenciais centros -alvo	328
Volume médio de tratamento anual por centro	412 pacientes

Hospitais de pesquisa cardiovascular

Diedica se concentra em hospitais com recursos avançados de pesquisa cardiovascular.

• Hospitais de pesquisa cardiovascular total nos Estados Unidos: 186
• Hospitais -alvo em potencial: 89
• Orçamento médio de pesquisa anual: US $ 3,4 milhões

Especialistas em neurologia

Os neurologistas individuais representam um segmento crítico de clientes para as soluções terapêuticas da Diedica.

Categoria especializada	Número total	Taxa de adoção potencial
Neurologistas na América do Norte	4,562	14.3%
Especialistas em AVC	1,237	22.7%

Instituições de Pesquisa Médica

O Diacedica tem como alvo as instituições de pesquisa médica de primeira linha para o desenvolvimento colaborativo.

• Total de Centros de Pesquisa Médica Acadêmica: 143
• Instituições de pesquisa de primeira linha: 52
• Financiamento médio de pesquisa anual: US $ 18,6 milhões

Parceiros farmacêuticos

As parcerias farmacêuticas estratégicas são cruciais para o modelo de negócios da Diedica.

Categoria de parceiro	Número de parceiros em potencial	Potencial de colaboração
Grandes empresas farmacêuticas	24	Alto
Empresas farmacêuticas de neurologia especializada	37	Médio

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a DiAmedica Therapeutics registrou despesas de P&D de US $ 10,5 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 10,5 milhões
2021	US $ 8,3 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para DM199 (programas de derrame e doenças renais) totalizaram aproximadamente US $ 7,2 milhões em 2022.

• Ensaio clínico de fase 2 para derrame isquêmico agudo
• Pesquisa em andamento em andamento em andamento

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual foram de aproximadamente US $ 350.000 em 2022.

Custos de conformidade regulatória

Categoria de conformidade	Custo anual
Taxas de envio da FDA	$250,000
Consultoria regulatória	$175,000

Overhead administrativo e operacional

As despesas administrativas totais de 2022 foram de US $ 4,6 milhões.

• Salários dos funcionários: US $ 3,2 milhões
• Custos de escritório e instalação: US $ 850.000
• Serviços profissionais: US $ 550.000

Estrutura de custo anual estimada total: US $ 22,9 milhões

Diedica Therapeutics Inc. (DMAC) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Diodica Therapeutics não relatou nenhuma receita ativa de licenciamento de medicamentos. O candidato terapêutico da empresa DM199 permanece em estágios de desenvolvimento clínico.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2023	Institutos Nacionais de Saúde (NIH)	$387,000
2022	Pesquisa de Inovação em Pequenas Empresas (SBIR)	$256,000

Acordos de parceria farmacêutica potencial

A partir de 2024, a Diedica não divulgou acordos específicos de parceria farmacêutica para a geração de receita.

Vendas futuras de produtos terapêuticos

O principal candidato a produtos da Diedica, DM199, está atualmente em ensaios clínicos para derrame isquêmico agudo e doença renal crônica, sem vendas comerciais.

Monetização da propriedade intelectual

• Total de patentes arquivadas: 12
• Famílias de patentes que cobrem DM199 Technology: 3
• Valor estimado do portfólio de propriedade intelectual: não divulgado publicamente

Receita líquida para o ano fiscal de 2023: $0

Despesas de pesquisa e desenvolvimento para 2023: US $ 14,2 milhões

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Value Propositions

You're looking at the core value DiaMedica Therapeutics Inc. (DMAC) is bringing to two severely underserved patient populations. The value proposition centers on DM199, their lead candidate, offering a disease-modifying approach where current standards of care are largely limited to symptom management or time-sensitive interventions.

Potential First-in-Class Disease-Modifying Therapy for Preeclampsia

For Preeclampsia, the value is in offering a novel therapeutic mechanism when the medical community currently has no approved disease-modifying options in the US or Europe. This is a massive unmet need, considering Preeclampsia affects an estimated 5-8% of all pregnancies in the United States, impacting approximately 10 million women globally. Tragically, preeclampsia and related hypertensive disorders contribute to the deaths of about 76,000 pregnant women and 500,000 infants worldwide each year. The market reflects this gap; while estimates vary, the Preeclampsia Therapeutics Market was valued at 2.138 USD Billion in 2024 and is projected to grow to 4.651 USD Billion by 2035, exhibiting a 7.32% compound annual growth rate (CAGR) during the 2025-2035 period.

The clinical progress supports this value claim. By July 2025, interim results from Part 1a of the Phase 2 investigator-sponsored trial showed DM199 was safe and well-tolerated with no evidence of placental transfer. This is a key differentiator for a pregnancy-related therapy.

Treatment for Acute Ischemic Stroke Patients with Limited Options

In Acute Ischemic Stroke (AIS), the value proposition targets patients who present outside the narrow window for existing reperfusion therapies. Over 40% of AIS patients present beyond the 4.5-hour window for tissue plasminogen activator (tPA), leaving them with no approved pharmacologic options. The overall global stroke treatment market is substantial, projected to reach $37.84 billion by 2025. Stroke is the leading cause of long-term disability in the US, affecting 800,000 Americans annually with an associated annual cost of $45 billion.

The data from the DM-195 program at ESOC 2025 is the concrete evidence here. The trial showed a 60% functional recovery rate (mRS 0-1) in patients treated up to 48 hours post-stroke, compared to 35% in placebo. This represents a 71% relative risk reduction (p=0.02) and positions DM199 to potentially capture a significant portion of the market segment between 4.5 and 24 hours. The ReMEDy2 Phase 2/3 trial is designed to be pivotal, intending to enroll between 300 and 728 patients at up to 100 sites globally.

DM199's Mechanism of Action Improves Placental Perfusion and Lowers Blood Pressure

The mechanism of action for DM199 (rinvecalinase alfa), a recombinant human tissue kallikrein-1 (rhKLK1), directly addresses the underlying pathology in both indications. For Preeclampsia, the July 2025 data confirmed a highly statistically significant reduction in the uterine artery pulsatility index, which suggests an improvement in uterine artery blood flow and placental perfusion. Furthermore, the therapy demonstrated statistically significant reductions in both systolic and diastolic blood pressure.

For AIS, DM199 acts as a bradykinin-producing enzyme that enhances collateral circulation and promotes cellular repair via the bradykinin B2 receptor. This mechanism induces potent local vasodilation and improves brain perfusion through three synergistic signaling pathways, with preferential effects on ischemic tissue to potentially avoid systemic hypotension.

Addressing High Unmet Medical Needs with No Approved Therapeutics in the US/Europe

The core value proposition is built on addressing critical gaps where current treatment paradigms fall short. DiaMedica Therapeutics Inc. is targeting conditions where the existing therapeutic landscape is inadequate for large patient groups. The company's R&D spending reflects this focus, reaching $17.9 million year-to-date for Q3 2025.

Key unmet needs and the corresponding clinical status are summarized below:

Indication	Unmet Need Description	DM199 Clinical Progress (as of late 2025)	Potential Safety Advantage
Preeclampsia	No approved disease-modifying therapy in US/Europe.	Phase 2 Part 1a positive interim results reported July 2025; trial enrolling up to 90 women.	No placental transfer observed in interim analysis.
Acute Ischemic Stroke (AIS)	No approved pharmacologic therapy for patients presenting after the 4.5-hour window.	Phase 2b data at ESOC 2025 showed 60% functional recovery up to 48 hours.	Comparable adverse events to placebo, with no thromboembolic events, unlike thrombolytics which carry a 6% risk of symptomatic intracranial hemorrhage (sICH).

The company's financial position, with a cash runway extending into the second half of 2027 and a Q3 2025 cash balance of $55.3 million, supports the execution required to address these high-value needs.

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your relationships with the medical and financial communities are everything right now. For DiaMedica Therapeutics Inc. (DMAC), these interactions are highly focused on advancing the DM199 pipeline and securing investor confidence to fund that progress.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

Engagement here is deep and necessary, given the novel nature of DM199 and the complex indications-preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS). The company actively involves leading experts to guide and execute its trials.

For the preeclampsia program, DiaMedica Therapeutics Inc. hosted a virtual Key Opinion Leader (KOL) event on May 28, 2025, specifically to discuss the disease landscape and the design of the ongoing DM199 Phase 2 study. This shows a direct, high-touch effort to align with thought leaders early in the development process. The Phase 2 Investigator-Sponsored Trial (IST) for PE is being conducted at Tygerberg Hospital in Cape Town, South Africa, under the leadership of Professor Catherine Cluver, MD, Ph. D., positioning her group as key collaborators and investigators. The progress in this trial directly reflects the relationship with these clinical partners.

The investment in these relationships is reflected in the rising Research and Development (R&D) spend, which was $17.9 million for the nine months ended September 30, 2025, up from $12.6 million for the same period in 2024. This increase was driven by the continued progress of the ReMEDy2 trial and the Phase 2 IST in PE, plus the expansion of the clinical team.

Direct communication with regulatory agencies (e.g., pre-IND meeting with FDA)

Direct, formal interaction with the U.S. Food and Drug Administration (FDA) is a critical milestone for moving the U.S. development plan forward. DiaMedica Therapeutics Inc. reported holding an in-person pre-IND meeting with the U.S. FDA to discuss plans for the initiation of a U.S. Phase 2 DM199 study in Preeclampsia. The company stated it is awaiting the minutes from this meeting before providing a further update. This is the key relationship for gaining approval to start a new, pivotal U.S. study.

The company is also planning for future regulatory submissions, as the capital raised in July 2025 is expected to support the submission of an Investigational New Drug (IND) application for DM199 in the United States for preeclampsia and FGR.

Investor relations and public disclosures via earnings calls and webcasts

Investor communication is frequent and detailed, which is typical for a pre-revenue, clinical-stage company. DiaMedica Therapeutics Inc. held its Q3 2025 conference call and webcast on November 13, 2025, following the release of results on November 12, 2025. These calls are the primary mechanism for updating the market on clinical progress and financial health.

Here's a snapshot of the financial relationship status as of September 30, 2025:

Metric	Value as of September 30, 2025	Comparison Point
Cash and Short-Term Investments	$55.3 million	Up from $44.1 million as of December 31, 2024
Anticipated Cash Runway	Into the second half of 2027	Extended by July 2025 private placement
Net Cash Used in Operating Activities (9 Months)	$21.3 million	Up from $15.6 million for the same period in 2024
Q3 2025 Net Loss	$8.6 million	Up from $6.3 million for Q3 2024
Q3 2025 Revenue	$0.0 million	Matching analyst expectations for a pre-commercial company

The company reported no revenue for the quarter, matching analyst expectations of $0.0 million, which is a key data point for the financial community assessing burn rate versus milestones.

Patient enrollment and retention support for ongoing clinical trials

The relationship with trial participants is managed through the clinical investigators and sites, focusing on enrollment targets and data collection. The progress here directly dictates the timeline for investor milestones.

Key enrollment metrics as of the Q3 2025 update include:

• ReMEDy2 Phase 2/3 Trial (AIS): Enrollment is nearing 50% of the target of 200 patients for the interim analysis.
• Interim Analysis Expectation (AIS): Expected in the second half of 2026 (2H 2026).
• Preeclampsia Phase 2 IST: Part 1a dose escalation cohort is complete, and the expansion cohort is now enrolling.
• Fetal Growth Restriction Cohort (Part 3): Screening is expected to start in the coming weeks following the Q3 2025 update.

The company is actively managing site performance, as the Chief Medical Officer noted that current enrollment rates for the stroke trial are lower than initially projected, attributing this to changes in stroke referral patterns, such as the adoption of technologies like Viz.ai.

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Channels

The Channels component for DiaMedica Therapeutics Inc. centers on executing clinical development and communicating corporate progress to secure future commercialization pathways.

Global network of clinical trial sites for drug development and data collection

DiaMedica Therapeutics Inc. uses a network of clinical sites to gather data for its lead candidate, DM199, across its indications. The ReMEDy2 Phase 2/3 trial for acute ischemic stroke (AIS) is designed to enroll around 350 patients across up to 100 global sites. As of Q1 2025, the AIS trial had reached 30 activated study sites. The Preeclampsia Phase 2 investigator-sponsored trial (IST) began dosing in South Africa in November 2024. The Part 1a expansion cohort for preeclampsia is enrolling up to 12 additional participants.

Here's a look at the clinical trial progress feeding the data collection channel as of late 2025:

Trial/Indication	Key Metric	Status/Number
ReMEDy2 (AIS) Enrollment	Percentage of Interim Target Reached	Nearing 50% of 200 patients
ReMEDy2 (AIS) Interim Analysis Timing	Expected Completion	2H 2026
ReMEDy2 (AIS) Total Design Size	Target Enrollment	Around 350 patients
ReMEDy2 (AIS) Site Network	Global Site Capacity	Up to 100 global sites
Preeclampsia Phase 2 IST	Part 1a Expansion Cohort Size	Up to 12 patients
Q1 2025 AIS Site Activation	Activated Hospitals	30 hospitals

Regulatory submission pathways (IND, NDA) to the FDA and international agencies

The primary channel to regulatory bodies involves formal submissions and meetings to advance DM199. DiaMedica Therapeutics Inc. held an in-person pre-IND (Investigational New Drug) meeting with the U.S. FDA to discuss plans for initiating a U.S. Phase 2 DM199 Study in Preeclampsia. This follows the company's plan to submit an IND application for DM199 in the U.S. for preeclampsia and fetal growth restriction, which would support a subsequent Phase 2b study in both indications. The company is advancing DM199 for preeclampsia, a condition with no approved therapeutics in the U.S. or Europe.

The regulatory pathway involves several steps:

• Advancing Preeclampsia Phase 2 IST results (Positive interim results reported July 17, 2025).
• Awaiting minutes from the productive in-person pre-IND meeting with the FDA.
• Planning for a U.S. Phase 2 study focusing on early-onset patients under expectant management.
• Continuing development for Acute Ischemic Stroke (AIS).

Investor conferences and press releases for capital market communication

DiaMedica Therapeutics Inc. actively uses investor relations events and financial reporting to communicate with capital markets. The company reported its Q3 2025 financial results on November 12, 2025, following its Q2 2025 report on August 12, 2025, and Q1 2025 report on May 13, 2025. The cash position as of September 30, 2025, stood at $55.3 million, which management anticipates will fund operations into the second half of 2027. This capital was bolstered by a $30.1 million gross proceeds private placement in July 2025.

Recent investor-facing communication channels included:

• Participation in the H.C. Wainwright 27th Annual Global Investment Conference (September 8-10, 2025).
• Participation in the Lake Street Capital Markets Best Ideas Growth Conference (September 11, 2025).
• Participation in the Jefferies Global Healthcare Conference in London (November 17-20, 2025).

Future pharmaceutical distribution channels via potential commercial partners

While DiaMedica Therapeutics Inc. is currently clinical-stage and has no revenue, its channel strategy for future distribution hinges on the successful commercialization of DM199. The current market context for AIS shows that existing therapies are only available to approximately 20% of patients due to treatment window and specialized care availability limitations. This suggests a significant opportunity for a novel therapeutic like DM199, which acts through a different mechanism to restore vascular health. The company's focus on preeclampsia, which lacks any approved pharmacological treatment in the U.S. or Europe, also points toward a need for a robust future distribution channel, likely involving strategic commercial partnerships to achieve broad market access for its first-in-class potential therapy.

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Customer Segments

Acute Ischemic Stroke (AIS) patients, particularly those outside the current treatment window.

• Targets the 80% of AIS patients ineligible for current therapies like tPA or mechanical thrombectomy.
• Addresses a $10B+ global market with no approved treatments.
• ReMEDy2 Phase 2/3 trial enrollment nearing 50% of the target of 200 patients for the interim analysis expected in 2H 2026.
• Early Phase 2 data showed 0% recurrence in the DM199 group versus 13% in placebo (P=0.012).

Pregnant women with Preeclampsia and Fetal Growth Restriction (FGR).

• Preeclampsia affects 5-8% of pregnancies.
• Preeclampsia accounts for 15% of maternal deaths globally.
• Preeclampsia accounts for $5 billion in annual U.S. healthcare costs.
• Preeclampsia treatment market (7 major markets) value in 2024 was USD 724.3 Million.
• Screening for the Fetal Growth Restriction cohort expected to start in coming weeks (as of late 2025).

Neurologists and Maternal/Fetal Medicine specialists (prescribers).

Clinical Milestone	Status (as of late 2025)	Expected Completion/Next Step
Preeclampsia Phase 2 IST Trial (Part 1a)	Dose escalation cohort complete; expansion cohort now enrolling	Expansion cohort completion expected in 1H 2026
U.S. Phase 2 Study for Preeclampsia	Productive pre-IND meeting held with U.S. FDA	Awaiting minutes from the meeting
AIS ReMEDy2 Trial Interim Analysis	Enrollment nearing 50% of target of 200 patients	Interim Analysis expected in 2H 2026

Institutional investors and shareholders providing capital.

• Cash, cash equivalents and short-term investments as of September 30, 2025: $55.3 million.
• Anticipated cash runway into the second half of 2027 (2H 2027).
• Raised $30.1 million via a private placement in July 2025.
• Issued 8,606,426 common shares at $3.50 per share in the July 2025 placement.
• Net loss for the third quarter ended September 30, 2025: $8.6 million.
• Net cash used in operating activities for nine months ended September 30, 2025: $21.3 million.
• Current Market Cap: $313.2M (as of November 12, 2025).
• Stock Price: $8.78 (as of December 5, 2025).
• Analyst Price Target: $12.00.

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Cost Structure

You're looking at the core spending engine for DiaMedica Therapeutics Inc. as of late 2025, which is almost entirely focused on advancing its pipeline, DM199. The cost structure is dominated by the heavy investment required to run late-stage clinical programs. For the first nine months of 2025, Research and Development (R&D) expenses hit $17.9 million.

This R&D spend is the lifeblood of the company, directly funding the clinical trial costs associated with the ReMEDy2 trial for acute ischemic stroke and the Phase 2 Investigator-Sponsored Trial (IST) for preeclampsia. You see these costs manifest in site activation, patient enrollment activities, and the necessary global expansion of these studies. To be fair, this high burn rate is typical for a clinical-stage biotech without product revenue.

General and Administrative (G&A) expenses also saw an uptick, totaling $7.3 million through the first nine months of 2025. This increase reflects the expansion of the corporate team and associated personnel costs, plus higher non-cash share-based compensation.

Here's a quick look at how those major expense categories stacked up through the third quarter of 2025, compared to the same period last year. Remember, these are the nine-month cumulative figures leading up to September 30, 2025.

Expense Category (Nine Months Ended Sept 30, 2025)	Amount (USD Millions)	Q3 2025 Amount (USD Millions)
Research and Development (R&D)	$17.9	$6.4
General and Administrative (G&A)	$7.3	$2.6
Net Loss	$24.0	$8.6

The manufacturing development and drug substance production costs are present but were partially offset in the R&D line item because significant work was performed and completed in the prior year period. The key cost drivers pushing these numbers higher are clear when you break down the increases:

• Continued progress of the ReMEDy2 clinical trial, including its global expansion.
• Progress with the Phase 2 IST in preeclampsia, which involved completing the Part 1a dose escalation cohort.
• Expansion of the clinical team to support ongoing and planned studies.
• Increased non-cash share-based compensation within G&A.
• Higher investor relations, patent, and professional fees.

Finance: draft 13-week cash view by Friday.

DiaMedica Therapeutics Inc. (DMAC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of DiaMedica Therapeutics Inc. (DMAC) right now, and as is the case for most clinical-stage biotechs, the picture is one of investment rather than income from product sales. For the third quarter ending September 30, 2025, DiaMedica Therapeutics reported zero revenue for the period, which is exactly what analysts expected for a company without a commercial product on the market. This lack of commercial revenue means the current financial reality is driven entirely by capital deployment and fundraising to advance DM199 through trials.

Still, the company has actively secured significant non-operating revenue through equity financing to keep the lights on and fund its pipeline. The most recent and substantial event was the $30.1 million private placement that closed around July 23, 2025. This cash infusion is critical because it directly impacts the operational runway. As of September 30, 2025, DiaMedica Therapeutics reported $55.3 million in cash, cash equivalents, and investments. Management is confident this reserve will fund planned clinical studies and corporate operations into the second half of 2027.

Here's a quick look at how that recent financing event bolstered the balance sheet:

Metric	Value as of September 30, 2025	Value as of December 31, 2024
Cash, Cash Equivalents, and Investments	$55.3 million	$44.1 million
Net Loss (Nine Months Ended Sept 30, 2025)	$24.0 million	N/A
Estimated Runway from Current Cash	Into 2H 2027	N/A

The path to generating revenue from operations hinges entirely on the success of DM199, the recombinant form of the KLK1 protein. Future potential revenue streams are binary: they either come from a strategic partnership or from direct product sales post-approval. The company is actively working toward key milestones that would unlock these streams, such as submitting an investigational new drug (IND) application in the United States for preeclampsia and fetal growth restriction.

The July 2025 private placement was structured to support these next steps, providing the necessary capital buffer. You should note the specifics of this non-operating revenue source:

• Total capital secured: $30.1 million.
• Shares issued: Approximately 8,606,426 common shares.
• Purchase price per share: $3.50.
• Net proceeds received after expenses: Approximately $29.9 million.
• Placement agent involvement: None.

Should DM199 achieve regulatory approval following the ongoing Phase 2/3 ReMEDy2 trial for stroke and the preeclampsia studies, the revenue model shifts to product sales, potentially supplemented by upfront payments, milestones, and royalties from any future licensing or collaboration agreements for DM199 in specific territories or indications. That's the long-term goal, but for now, the revenue stream is purely financing-based.