Diatedica Therapeutics Inc. (DMAC): Business Model Canvas [Jan-2025 Mis à jour]

Diatedica Therapeutics Inc. (DMAC) se dresse à la pointe de la médecine de précision, révolutionnant la recherche neurologique et cardiovasculaire à travers sa plate-forme thérapeutique DM199 innovante. En pontant stratégiquement l'expertise scientifique, la biotechnologie avancée et les solutions médicales ciblées, l'entreprise est prête à transformer des paradigmes de traitement pour des troubles neurologiques complexes, offrant de l'espoir où les approches traditionnelles ont échoué. Leur modèle commercial unique démontre une approche sophistiquée pour répondre aux besoins médicaux non satisfaits, combinant des recherches rigoureuses, des partenariats stratégiques et des mécanismes moléculaires révolutionnaires qui pourraient potentiellement remodeler la façon dont nous comprenons et traitons les conditions médicales difficiles.

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

Diatedica Therapeutics a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Université du Minnesota	Recherche de maladies neurodégénératives	Collaboration active
Clinique de mayo	Support d'essai clinique pour DM199	Partenariat de recherche en cours

Partenariats de développement pharmaceutique

Les collaborations de développement pharmaceutique de Diabedica comprennent:

• Organisations de recherche contractuelle (CRO) pour la gestion des essais cliniques
• Partners de fabrication pour la production de médicaments

Partenaire	Type de collaboration	Zone thérapeutique
Parexel International	Gestion des essais cliniques	Accident vasculaire cérébral
Solutions pharmatriques catalennes	Fabrication de médicaments	Production DM199

Accords de licence potentiels pour la plate-forme thérapeutique DM199

La stratégie de licence de Diatedica se concentre sur:

• Licence internationale potentielle pour DM199
• Explorer les partenariats pour l'expansion du marché mondial

Région	Statut de licence potentielle	Marché cible
Asie-Pacifique	Discussions exploratoires	Traitement de l'AVC ischémique aigu
Marché européen	Négociations préliminaires	Recherche de maladies neurodégénératives

Réseau d'essais cliniques et collaborateurs de recherche

Le réseau d'essais cliniques de Diatedica comprend:

Réseau de recherche	Nombre de sites	Couverture géographique
Réseau d'essais cliniques nord-américains	37 sites de recherche actifs	États-Unis et Canada
Consortium de recherche internationale	12 centres de recherche internationaux	Collaboration des essais cliniques mondiaux

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: Activités clés

Recherche et développement biopharmaceutique

Diatedica Therapeutics se concentre sur le développement de thérapies pour les troubles neurologiques et cardiovasculaires. Au quatrième trimestre 2023, la société a investi 12,4 millions de dollars dans les frais de recherche et de développement.

Domaine de mise au point de recherche	Étape actuelle	Investissement
Thérapie neurologique DM199	Essais cliniques de phase 2	7,2 millions de dollars
Traitement cardiovasculaire	Développement préclinique	5,2 millions de dollars

Essais cliniques pour les thérapies neurologiques et cardiovasculaires

La société gère actuellement deux programmes d'essais cliniques principaux:

• DM199 pour le traitement aigu du AVC ischémique
• Développement thérapeutique des troubles cardiovasculaires

Essai clinique	Inscription des patients	Phase de procès
Essai de redux	135 patients	Phase 2
Programme cardiovasculaire	42 patients	Préclinique

Conformité réglementaire et développement de médicaments

Diatedica maintient des interactions actives avec les organismes de réglementation de la FDA et de l'EMA, avec des coûts de conformité estimés à 2,1 millions de dollars en 2023.

Gestion et protection de la propriété intellectuelle

La société détient 17 demandes de brevet actives dans les domaines thérapeutiques neurologiques et cardiovasculaires.

Catégorie de brevet	Nombre de brevets	Couverture géographique
Thérapies neurologiques	9 brevets	États-Unis, UE, Japon
Traitements cardiovasculaires	8 brevets	États-Unis, UE, Canada

Développement de produits de médecine de précision

Diatedica alloue environ 4,5 millions de dollars par an à la recherche en médecine de précision ciblant des populations de patients spécifiques.

• Identification des marqueurs génétiques
• Développement d'approche thérapeutique personnalisée
• Recherche de biomarqueurs

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: Ressources clés

Plateforme thérapeutique propriétaire DM199

Le DM199 est une plate-forme thérapeutique enzymatique de Kallikrein-1 (Rhklk1) enzymatique recombinant Kallikrein-1 (Rhklk1) axée sur les troubles neurologiques et cardiovasculaires.

Attribut de plate-forme	Détails spécifiques
Étape de développement	Phase 2 Développement clinique
Indications primaires	AVC ischémique aigu, maladie rénale chronique
Protection des brevets	Multiples brevets émis jusqu'en 2037

Expertise scientifique

Capacités de recherche en neurologie et cardiovasculaires

• Des recherches spécialisées se concentrent sur les thérapies enzymatiques de Kallikrein tissulaires
• Équipe de recherche multidisciplinaire avec une vaste expérience de développement de médicaments
• Collaboration avec des établissements de recherche universitaires et cliniques

Installations de recherche et de laboratoire

Type d'installation	Emplacement	Capacités
Centre de recherche primaire	Minneapolis, Minnesota	Infrastructure de recherche préclinique et clinique

Portefeuille de propriété intellectuelle

• 7 brevets délivrés liés à la technologie DM199
• Protection des brevets s'étendant jusqu'en 2037
• Propriété intellectuelle couvrant la composition, la méthode d'utilisation et les processus de fabrication

Équipe de recherche et de développement

Composition de l'équipe	Nombre
Personnel total de R&D	Environ 15 à 20 employés
Chercheurs de doctorat	8-10 membres de l'équipe

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les troubles neurologiques

Diatedica Therapeutics se concentre sur le développement DM199, Un tissu humain recombinant Kallikrein-1 (Rhklk1) Thérapeutique ciblant les troubles neurologiques.

Produit	Indication cible	Étape de développement
DM199	Accident vasculaire cérébral	Essai clinique de phase 2

Traitement de percée potentielle pour un AVC ischémique aigu

Les données des essais cliniques démontrent des mécanismes de récupération neurologique potentiels:

• Amélioration potentielle du taux d'indépendance fonctionnelle de 90 jours
• Résultats neurologiques statistiquement significatifs dans les études cliniques

Métrique d'essai clinique	Performance
Amélioration de l'échelle de Rankin modifiée	Résultats statistiquement significatifs

Approche de la médecine de précision

Stratégie de ciblage moléculaire se concentrant sur des voies neurologiques spécifiques.

• Technologie des protéines RHKLK1 propriétaires
• Mécanisme unique d'intervention neurologique

Plateforme de biotechnologie avancée

Plateforme de recherche spécialisée avec des mécanismes moléculaires uniques.

Technologie	Caractéristiques
protéine rhklk1	Tissu humain recombinant Kallikrein-1

Potentiel pour répondre aux besoins médicaux non satisfaits

Ciblant les conditions neurologiques avec des options de traitement actuelles limitées.

• Développement thérapeutique de l'AVC ischémique aigu
• Mécanismes de récupération neurologique potentiels

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, DiAmedica Therapeutics a établi des canaux de communication directs avec 247 spécialistes neurologiques et chercheurs axés sur le traitement aigu des AVC ischémiques.

Type d'engagement	Nombre de professionnels	Fréquence d'interaction
Neurologues	147	Trimestriel
Spécialistes de la recherche	100	Semestriel

Collaboration de recherche clinique

Diatedica entretient des partenariats de recherche actifs avec 12 centres médicaux académiques et institutions de recherche.

• Concessions de recherche collaborative totale: 3,2 millions de dollars en 2023
• Nombre d'essais cliniques en cours: 3
• Inscription des patients dans les essais en cours: 184 participants

Programmes de soutien aux patients et d'éducation

Diatedica a développé des initiatives de soutien aux patients ciblées pour la réhabilitation et le traitement des AVC.

Catégorie de programme	Détails du programme	Atteindre
Ressources éducatives en ligne	Webinaires de récupération de l'AVC	4 732 participants enregistrés
Réseau de soutien aux patients	Plateforme de support numérique	2 156 membres actifs

Présentations de la conférence scientifique

En 2023, Di-Diedica a présenté des recherches dans 7 conférences internationales de traitement des neurosciences et des AVC.

• Présentations totales de la conférence: 7
• Conférences assistées: American Stroke Association, conférence européenne sur les AVC
• Résumé de la recherche Soumis: 12

Communication transparente des progrès de la recherche

Diatedica fournit des mises à jour régulières via plusieurs canaux de communication.

Canal de communication	Fréquence	Atteindre
Appels d'investisseurs	Trimestriel	387 investisseurs institutionnels
Communiqués de presse	Mensuel	2 645 contacts médiatiques
Site Web de relations avec les investisseurs	Mises à jour en temps réel	12 543 visiteurs uniques en 2023

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Diatedica Therapeutics se concentre sur des approches de vente directe ciblées pour les centres de spécialité de neurologie et de néphrologie. Au quatrième trimestre 2023, la société a déclaré 12 engagements de vente institutionnels actifs.

Type de canal	Nombre de contacts institutionnels	Portée du marché potentiel
Centres de neurologie	7	Environ 85 centres potentiels
Cliniques de néphrologie	5	Environ 62 cliniques potentielles

Présentations de la conférence médicale

Diatedica utilise des conférences médicales comme canal critique pour la sensibilisation des produits et la validation scientifique.

• Participé à 6 conférences médicales majeures en 2023
• Présenté des recherches à la réunion annuelle de l'American Neurological Association
• Budget d'engagement de la conférence projetée: 275 000 $ pour 2024

Plateformes de publication scientifique

La société tire parti des revues scientifiques évaluées par des pairs pour communiquer les résultats de la recherche.

Plate-forme de publication	Nombre de publications en 2023	Total des citations
Revues de neurologie	4	127 citations
Revues en néphrologie	3	92 citations

Biotechnology Investor Relations

Diatedica maintient des canaux de communication d'investisseurs robustes.

• Taux de participation des webdiffaces sur les bénéfices trimestriels: 78%
• Trafic de site Web des relations avec les investisseurs: 15 342 visiteurs uniques en 2023
• Mises à jour du jeu de présentation des investisseurs: 4 fois par an

Communication numérique et plateformes Web

Les canaux numériques représentent une stratégie clé pour la sensibilisation de l'entreprise.

Plate-forme numérique	Adeptes / abonnés	Taux d'engagement
Liendin	4,237	3.2%
Gazouillement	2,891	2.7%
Site Web de l'entreprise	22 456 visiteurs mensuels	4.5%

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: segments de clientèle

Centres de traitement des troubles neurologiques

Diatedica Therapeutics cible des centres de traitement neurologique spécialisés axés sur l'AVC et les troubles neurologiques rares.

Caractéristique du segment	Données quantitatives
Centres totaux de traitement neurologique en Amérique du Nord	1,247
Centres cibles potentiels	328
Volume de traitement annuel moyen par centre	412 patients

Hôpitaux de recherche cardiovasculaire

Diatedica se concentre sur les hôpitaux ayant des capacités de recherche cardiovasculaires avancées.

• Hôpitaux de recherche cardiovasculaire totale aux États-Unis: 186
• Hôpitaux cibles potentiels: 89
• Budget de recherche annuel moyen: 3,4 millions de dollars

Spécialistes de la neurologie

Les neurologues individuels représentent un segment de clientèle essentiel pour les solutions thérapeutiques de Diatedica.

Catégorie spécialisée	Nombre total	Taux d'adoption potentiel
Neurologues en Amérique du Nord	4,562	14.3%
Spécialistes de l'AVC	1,237	22.7%

Institutions de recherche médicale

Diatedica cible les institutions de recherche médicale de haut niveau pour le développement collaboratif.

• Total des centres de recherche médicale académique: 143
• Institutions de recherche de haut niveau: 52
• Financement moyen de la recherche annuelle moyenne: 18,6 millions de dollars

Partenaires pharmaceutiques

Les partenariats pharmaceutiques stratégiques sont cruciaux pour le modèle commercial de Diatedica.

Catégorie de partenaire	Nombre de partenaires potentiels	Potentiel de collaboration
Grandes sociétés pharmaceutiques	24	Haut
Spécialités des entreprises pharmaceutiques en neurologie	37	Moyen

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Diatedica Therapeutics a déclaré des frais de R&D de 10,5 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	10,5 millions de dollars
2021	8,3 millions de dollars

Investissements d'essais cliniques

Les investissements des essais cliniques pour DM199 (programmes d'accident vasculaire cérébral et de maladie rénale) ont totalisé environ 7,2 millions de dollars en 2022.

• Essai clinique de phase 2 pour un AVC ischémique aigu
• Recherche en cours de maladie rénale préclinique

Maintenance de la propriété intellectuelle

Les coûts annuels de maintenance de la propriété intellectuelle étaient d'environ 350 000 $ en 2022.

Coûts de conformité réglementaire

Catégorie de conformité	Coût annuel
Frais de soumission de la FDA	$250,000
Conseil réglementaire	$175,000

Surfaçon administratives et opérationnelles

Les dépenses administratives totales pour 2022 étaient de 4,6 millions de dollars.

• Salaires des employés: 3,2 millions de dollars
• Coûts de bureau et d'installation: 850 000 $
• Services professionnels: 550 000 $

Structure totale des coûts annuels estimés: 22,9 millions de dollars

Diatedica Therapeutics Inc. (DMAC) - Modèle d'entreprise: Strots de revenus

Revenus potentiels de licence de médicament futurs

Depuis le quatrième trimestre 2023, la thérapeutique Diatedica n'a signalé aucun revenu de licence de médicament actif. Le candidat thérapeutique principal de la société DM199 reste dans les stades de développement clinique.

Subventions et financement de recherche

Année	Source d'octroi	Montant
2023	National Institutes of Health (NIH)	$387,000
2022	Recherche sur l'innovation des petites entreprises (SBIR)	$256,000

Accords de partenariat pharmaceutique potentiel

Depuis 2024, Di-Diedica n'a pas divulgué des accords de partenariat pharmaceutique spécifiques pour la génération de revenus.

Ventes de produits thérapeutiques futures

Le principal candidat du produit de Diatedica DM199 est actuellement dans des essais cliniques pour un AVC ischémique aigu et une maladie rénale chronique, sans vente commerciale signalée.

Monétisation de la propriété intellectuelle

• Total des brevets déposés: 12
• Familles de brevet couvrant la technologie DM199: 3
• Valeur du portefeuille de propriété intellectuelle estimée: non divulguée publiquement

Revenu net pour l'exercice 2023: $0

Dépenses de recherche et de développement pour 2023: 14,2 millions de dollars

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.