DiaMedica Therapeutics Inc. (DMAC): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

DiaMedica Therapeutics Inc. (DMAC) se encuentra a la vanguardia de la medicina de precisión, revolucionando la investigación neurológica y cardiovascular a través de su innovadora plataforma terapéutica DM199. Al unir estratégicamente la experiencia científica, la biotecnología avanzada y las soluciones médicas específicas, la compañía está preparada para transformar los paradigmas de tratamiento para trastornos neurológicos complejos, ofreciendo la esperanza de que los enfoques tradicionales se hayan quedado corto. Su modelo de negocio único demuestra un enfoque sofisticado para abordar las necesidades médicas no satisfechas, combinando investigaciones rigurosas, asociaciones estratégicas y mecanismos moleculares innovadores que podrían remodelar la forma en que entendemos y tratamos afecciones médicas desafiantes.

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

DiaMedica Therapeutics ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de asociación
Universidad de Minnesota	Investigación de enfermedades neurodegenerativas	Colaboración activa
Clínica de mayonesa	Soporte de ensayos clínicos para DM199	Asociación de investigación en curso

Asociaciones de desarrollo farmacéutico

Las colaboraciones de desarrollo farmacéutico de DiaMedica incluyen:

• Organizaciones de investigación por contrato (CRO) para gestión de ensayos clínicos
• Socios de fabricación para la producción de drogas

Pareja	Tipo de colaboración	Área terapéutica
Parexel International	Gestión de ensayos clínicos	Accidente cerebrovascular isquémico agudo
Soluciones farmacéuticas catalent	Fabricación de drogas	Producción DM199

Posibles acuerdos de licencia para la plataforma terapéutica DM199

La estrategia de licencia de DiaMedica se centra en:

• Licencias internacionales potenciales para DM199
• Explorando asociaciones para la expansión del mercado global

Región	Estado de licencia potencial	Mercado objetivo
Asia-Pacífico	Discusiones exploratorias	Tratamiento de accidente cerebrovascular isquémico agudo
Mercado europeo	Negociaciones preliminares	Investigación de enfermedades neurodegenerativas

Red de ensayos clínicos y colaboradores de investigación

La red de ensayos clínicos de DiaMedica incluye:

Red de investigaciones	Número de sitios	Cobertura geográfica
Red de ensayos clínicos de América del Norte	37 sitios de investigación activos	Estados Unidos y Canadá
Consorcio de Investigación Internacional	12 centros de investigación internacionales	Colaboración de ensayos clínicos globales

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: actividades clave

Investigación y desarrollo biofarmacéutico

DiaMedica Therapeutics se centra en desarrollar terapias para trastornos neurológicos y cardiovasculares. A partir del cuarto trimestre de 2023, la compañía invirtió $ 12.4 millones en gastos de investigación y desarrollo.

Área de enfoque de investigación	Etapa actual	Inversión
Terapia neurológica DM199	Ensayos clínicos de fase 2	$ 7.2 millones
Tratamiento cardiovascular	Desarrollo preclínico	$ 5.2 millones

Ensayos clínicos para terapias neurológicas y cardiovasculares

La compañía actualmente administra dos programas de ensayos clínicos primarios:

• DM199 para tratamiento de accidente cerebrovascular isquémico agudo
• Desarrollo terapéutico del trastorno cardiovascular

Ensayo clínico	Inscripción del paciente	Fase de prueba
Prueba de trazo de Redux	135 pacientes	Fase 2
Programa cardiovascular	42 pacientes	Preclínico

Cumplimiento regulatorio y desarrollo de fármacos

DiaMedica mantiene interacciones activas con los organismos reguladores de la FDA y EMA, con costos de cumplimiento estimados en $ 2.1 millones en 2023.

Gestión y protección de la propiedad intelectual

La compañía posee 17 aplicaciones de patentes activas en dominios terapéuticos neurológicos y cardiovasculares.

Categoría de patente	Número de patentes	Cobertura geográfica
Terapias neurológicas	9 patentes	EE. UU., EU, Japón
Tratamientos cardiovasculares	8 patentes	EE. UU., EU, Canadá

Desarrollo de productos de medicina de precisión

DiaMedica asigna aproximadamente $ 4.5 millones anuales a la investigación de medicina de precisión dirigida a poblaciones específicas de pacientes.

• Identificación del marcador genético
• Desarrollo de enfoque terapéutico personalizado
• Investigación de biomarcadores

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: recursos clave

Plataforma terapéutica DM199 patentada

DM199 es una plataforma terapéutica enzimática de tejido humano recombinante (RHKLK1) centrada en trastornos neurológicos y cardiovasculares.

Atributo de plataforma	Detalles específicos
Etapa de desarrollo	Desarrollo clínico de fase 2
Indicaciones primarias	Accidente cerebrovascular isquémico agudo, enfermedad renal crónica
Protección de patentes	Múltiples patentes emitidas hasta 2037

Experiencia científica

Neurología y capacidades de investigación cardiovascular

• Investigación especializada Enfoque en la enzima enzimática de los tejidos Kallikrein
• Equipo de investigación multidisciplinario con amplia experiencia en desarrollo de fármacos
• Colaboración con instituciones de investigación académica y clínica

Investigación e instalaciones de laboratorio

Tipo de instalación	Ubicación	Capacidades
Centro de investigación primario	Minneapolis, Minnesota	Infraestructura de investigación preclínica y clínica

Cartera de propiedades intelectuales

• 7 patentes emitidas relacionadas con la tecnología DM199
• Protección de patentes que se extiende a 2037
• Propiedad intelectual que cubre la composición, el método de uso y los procesos de fabricación

Equipo de investigación y desarrollo

Composición del equipo	Número
Personal total de I + D	Aproximadamente 15-20 empleados
Investigadores de doctorado	8-10 miembros del equipo

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para trastornos neurológicos

DiaMedica Therapeutics se centra en el desarrollo DM199, un tejido humano recombinante de tejido humano 1 (Rhklk1) proteína terapéutica dirigida a trastornos neurológicos.

Producto	Indicación objetivo	Etapa de desarrollo
DM199	Accidente cerebrovascular isquémico agudo	Ensayo clínico de fase 2

Potencial tratamiento innovador para accidente cerebrovascular isquémico agudo

Los datos del ensayo clínico demuestran posibles mecanismos de recuperación neurológica:

• Mejora de la tasa de independencia funcional de 90 días
• Resultados neurológicos estadísticamente significativos en estudios clínicos

Métrico de ensayo clínico	Actuación
Mejora de la escala Rankin modificada	Resultados estadísticamente significativos

Enfoque de medicina de precisión

Estrategia de orientación molecular centrada en vías neurológicas específicas.

• Tecnología de proteínas RHKLK1 patentada
• Mecanismo único de intervención neurológica

Plataforma de biotecnología avanzada

Plataforma de investigación especializada con mecanismos moleculares únicos.

Tecnología	Característica
proteína rhklk1	Tejido humano recombinante Kallikrein-1

Potencial para abordar las necesidades médicas no satisfechas

Dirigido a condiciones neurológicas con opciones de tratamiento actuales limitadas.

• Desarrollo terapéutico de accidente cerebrovascular isquémico agudo
• Mecanismos potenciales de recuperación neurológica

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, DiaMedica Therapeutics ha establecido canales de comunicación directa con 247 especialistas neurológicos e investigadores centrados en el tratamiento de accidente cerebrovascular isquémico agudo.

Tipo de compromiso	Número de profesionales	Frecuencia de interacción
Neurólogos	147	Trimestral
Especialistas en investigación	100	Semestral

Colaboración de investigación clínica

DiaMedica mantiene asociaciones de investigación activa con 12 centros médicos académicos e instituciones de investigación.

• Subvenciones de investigación de colaboración total: $ 3.2 millones en 2023
• Número de ensayos clínicos en curso: 3
• Inscripción de pacientes en ensayos actuales: 184 participantes

Programas de apoyo y educación del paciente

DiaMedica ha desarrollado iniciativas específicas de apoyo al paciente para la rehabilitación y el tratamiento del accidente cerebrovascular.

Categoría de programa	Detalles del programa	Alcanzar
Recursos educativos en línea	Seminarios web de recuperación de accidente cerebrovascular	4.732 participantes registrados
Red de apoyo para pacientes	Plataforma de soporte digital	2,156 miembros activos

Presentaciones de conferencias científicas

En 2023, DiaMedica presentó investigaciones en 7 conferencias internacionales de tratamiento de neurociencia y accidente cerebrovascular.

• Presentaciones de conferencia totales: 7
• Conferencias asistidas: American Stroke Association, Conferencia de accidente cerebrovascular europeo
• Resúmenes de investigación presentados: 12

Comunicación transparente del progreso de la investigación

DiaMedica proporciona actualizaciones regulares a través de múltiples canales de comunicación.

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de inversionista	Trimestral	387 inversores institucionales
Comunicados de prensa	Mensual	2.645 contactos mediáticos
Sitio web de relaciones con los inversores	Actualizaciones en tiempo real	12,543 visitantes únicos en 2023

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

DiaMedica Therapeutics se centra en enfoques de ventas directas dirigidos para los centros de especialidad de neurología y nefrología. A partir del cuarto trimestre de 2023, la compañía reportó 12 compromisos de ventas institucionales activas.

Tipo de canal	Número de contactos institucionales	Alcance del mercado potencial
Centros de neurología	7	Aproximadamente 85 centros potenciales
Clínicas de nefrología	5	Aproximadamente 62 clínicas potenciales

Presentaciones de conferencia médica

DiaMedica utiliza conferencias médicas como un canal crítico para la conciencia del producto y la validación científica.

• Participó en 6 conferencias médicas importantes en 2023
• Investigación presentada en la Reunión Anual de la Asociación Americana de Neurológica
• Presupuesto de participación de la conferencia proyectada: $ 275,000 para 2024

Plataformas de publicación científica

La compañía aprovecha revistas científicas revisadas por pares para comunicar los resultados de la investigación.

Plataforma de publicación	Número de publicaciones en 2023	Citas totales
Revistas de neurología	4	127 citas
Revistas de nefrología	3	92 citas

Relaciones con inversores de biotecnología

DiaMedica mantiene canales de comunicación de inversores robustos.

• Tasa de participación de las ganancias trimestrales: 78%
• TRÁFITO DEL SITIOSTO DE RELACIONES DE INVERSOR: 15,342 Visitantes únicos en 2023
• Actualizaciones de mazo de presentación del inversor: 4 veces al año

Comunicación digital y plataformas basadas en la web

Los canales digitales representan una estrategia clave para la divulgación de la empresa.

Plataforma digital	Seguidores/suscriptores	Tasa de compromiso
LinkedIn	4,237	3.2%
Gorjeo	2,891	2.7%
Sitio web de la empresa	22,456 visitantes mensuales	4.5%

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: segmentos de clientes

Centros de tratamiento de trastorno neurológico

DiaMedica Therapeutics se dirige a centros de tratamiento neurológico especializados que se centran en el accidente cerebrovascular y los trastornos neurológicos raros.

Característica de segmento	Datos cuantitativos
Centros de tratamiento neurológico total en América del Norte	1,247
Centros objetivo potenciales	328
Volumen de tratamiento anual promedio por centro	412 pacientes

Hospitales de investigación cardiovascular

DiaMedica se centra en hospitales con capacidades de investigación cardiovasculares avanzadas.

• Hospitales de investigación cardiovascular total en Estados Unidos: 186
• Hospitales objetivo potenciales: 89
• Presupuesto promedio de investigación anual: $ 3.4 millones

Especialistas en neurología

Los neurólogos individuales representan un segmento crítico de clientes para las soluciones terapéuticas de DiaMedica.

Categoría especialista	Número total	Tasa de adopción potencial
Neurólogos en América del Norte	4,562	14.3%
Especialistas en accidente cerebrovascular	1,237	22.7%

Instituciones de investigación médica

DiaMedica se dirige a instituciones de investigación médica de primer nivel para el desarrollo colaborativo.

• Centros de investigación médica académica total: 143
• Instituciones de investigación de primer nivel: 52
• Financiación promedio de la investigación anual: $ 18.6 millones

Socios farmacéuticos

Las asociaciones farmacéuticas estratégicas son cruciales para el modelo de negocio de DiaMedica.

Categoría de socio	Número de socios potenciales	Potencial de colaboración
Grandes compañías farmacéuticas	24	Alto
Neurología especializada Farmagra Firma	37	Medio

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, DiaMedica Therapeutics reportó gastos de I + D de $ 10.5 millones.

Año fiscal	Gastos de I + D
2022	$ 10.5 millones
2021	$ 8.3 millones

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para DM199 (programas de accidente cerebrovascular y enfermedad renal) totalizaron aproximadamente $ 7.2 millones en 2022.

• Ensayo clínico de fase 2 para accidente cerebrovascular isquémico agudo
• Investigación continua de enfermedad renal preclínica

Mantenimiento de la propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual fueron de aproximadamente $ 350,000 en 2022.

Costos de cumplimiento regulatorio

Categoría de cumplimiento	Costo anual
Tarifas de presentación de la FDA	$250,000
Consultoría regulatoria	$175,000

Sobrecarga administrativa y operativa

Los gastos administrativos totales para 2022 fueron de $ 4.6 millones.

• Salarios de los empleados: $ 3.2 millones
• Costos de la oficina y la instalación: $ 850,000
• Servicios profesionales: $ 550,000

Estructura de costo anual estimada total: $ 22.9 millones

DiaMedica Therapeutics Inc. (DMAC) - Modelo de negocio: flujos de ingresos

Ingresos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, DiaMedica Therapeutics no ha informado ningún ingreso activo de licencia de medicamentos. El candidato terapéutico principal de la compañía DM199 permanece en etapas de desarrollo clínico.

Subvenciones de investigación y financiación

Año	Fuente de subvenciones	Cantidad
2023	Institutos Nacionales de Salud (NIH)	$387,000
2022	Investigación de innovación de pequeñas empresas (SBIR)	$256,000

Acuerdos potenciales de asociación farmacéutica

A partir de 2024, DiaMedica no ha revelado acuerdos específicos de asociación farmacéutica para la generación de ingresos.

Venta de productos terapéuticos futuros

El candidato principal del producto de DiaMedica DM199 se encuentra actualmente en ensayos clínicos para accidente cerebrovascular isquémico agudo y enfermedad renal crónica, sin ventas comerciales reportadas.

Monetización de la propiedad intelectual

• Patentes totales presentadas: 12
• Familias de patentes que cubren la tecnología DM199: 3
• Valor de cartera de propiedad intelectual estimada: no divulgado públicamente

Ingresos netos para el año fiscal 2023: $0

Gastos de investigación y desarrollo para 2023: $ 14.2 millones

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.