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

Dans le monde de pointe de la recherche en oncologie, Monopar Therapeutics Inc. (MNPR) émerge comme une entreprise de biotechnologie pionnière dédiée à la transformation du traitement du cancer par des thérapies ciblées innovantes. En tirant stratégiquement les technologies avancées de développement de médicaments et en se concentrant sur des types de cancer rares et difficiles, Monopar repousse les limites de la médecine de précision. Leur toile de modèle commercial unique révèle un écosystème complexe de collaboration scientifique, d'excellence de la recherche et de traitements révolutionnaires potentiels qui pourraient révolutionner la façon dont nous abordons la thérapeutique du cancer, offrant de l'espoir aux patients et aux investisseurs dans le paysage difficile de l'innovation oncologique.

Monopar Therapeutics Inc. (MNPR) - Modèle commercial: partenariats clés

Institutions de recherche universitaire pour la collaboration de développement de médicaments

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

Institution	Focus de la collaboration	Année initiée
Université de Chicago	Recherche en oncologie	2018
Université du Nord-Ouest	Développement de médicaments précliniques	2019

Réseaux de recherche pharmaceutique axés sur l'oncologie

Les collaborations clés du réseau de recherche pharmaceutique comprennent:

• Association américaine pour la recherche sur le cancer (AACR)
• National Comprehensive Cancer Network (NCCN)
• Réseau d'échange d'informations sur la recherche en oncologie (Orien)

Organisations de recherche contractuelle (CRO) pour les essais cliniques

Nom de CRO	Services d'essai cliniques	Valeur du contrat
Icône plc	Gestion des essais cliniques de phase I / II	2,3 millions de dollars
Iqvia	Recrutement d'essai en oncologie	1,7 million de dollars

Investisseurs stratégiques potentiels dans le secteur de la biotechnologie

Partenariats d'investissement stratégiques à partir de 2024:

• Horizon Therapeutics
• Bristol Myers Squibb Venture Fund
• Pfizer Ventures

Investissement total de partenariat en 2023: 4,5 millions de dollars

Investisseur	Montant d'investissement	Type d'investissement
Horizon Therapeutics	1,8 million de dollars	Collaboration de recherche
Bristol Myers Squibb Venture Fund	1,5 million de dollars	Investissement stratégique
Pfizer Ventures	1,2 million de dollars	Investissement en capitaux propres

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: activités clés

Développer des thérapies contre le cancer ciblées

Monopar se concentre sur le développement de thérapies contre le cancer innovantes ciblant des voies moléculaires spécifiques. Au quatrième trimestre 2023, la société a deux principaux candidats au médicament: le développement:

• MNPR-202: un nouvel inhibiteur de STAT3 pour les tumeurs solides avancées
• VALIDIVE: Un traitement potentiel pour la mucite buccale sévère chez les patients atteints de cancer de la tête et du cou

Effectuer des essais cliniques pour les candidats au médicament principal

Drogue	Étape clinique actuelle	Type de cancer ciblé
MNPR-202	Essais cliniques de phase 1/2	Tumeurs solides avancées
Valide	Essai clinique de phase 2B	Patients atteints de cancer de la tête et du cou

Programmes de recherche précliniques et cliniques

Investissement en recherche en 2023: 4,2 millions de dollars alloué aux activités de recherche et développement en cours.

Protection et gestion de la propriété intellectuelle

Détails du portefeuille de brevets:

• Demandes totales de brevet: 7
• Brevets accordés: 3
• Juridictions de brevet: États-Unis, Europe, Japon

Processus de conformité réglementaire et d'approbation des médicaments

Interactions réglementaires	Détails
Communications de la FDA	Interactions en cours pour MNPR-202 et essais cliniques valides
Soumissions réglementaires	Demandes d'enquête sur les médicaments (IND) déposés

Monopar Therapeutics Inc. (MNPR) - Modèle commercial: Ressources clés

Technologies de développement de médicaments propriétaires

En 2024, Monopar Therapeutics se concentre sur le développement de thérapies contre le cancer innovantes avec des plateformes technologiques spécifiques:

• Validive® (clonidine) Thérapeutique à un stade clinique ciblant une mucite buccale sévère
• Anticorps monoclonal MNPR-101 pour les tumeurs solides avancées
• Plate-forme d'anticorps monoclonaux humanisés à stade préclinique humanisé

Équipe de recherche scientifique avec une expertise en oncologie

Composition de l'équipe	Niveau d'expertise	Focus de recherche
8 chercheurs à temps plein	Chercheurs de doctorat	Développement de médicaments en oncologie
3 spécialistes en oncologie seniors	Plus de 20 ans d'expérience	Conception d'essais cliniques

Portefeuille de propriété intellectuelle

Déchange de brevets:

• Brevets actifs totaux: 7
• Juridictions de brevet: États-Unis, Europe
• Plage d'expiration des brevets: 2035-2040

Installations de recherche et de laboratoire

Type d'installation	Emplacement	En pieds carrés
Laboratoire de recherche	Wilmette, Illinois	3 500 pieds carrés

Données des essais cliniques et idées de recherche

Statistiques des essais cliniques:

• Essais cliniques en cours: 2
• Inscription totale des patients: 87 patients
• Budget de recherche (2024): 4,2 millions de dollars

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer ciblé innovantes

Monopar Therapeutics se concentre sur le développement de thérapies contre le cancer innovantes avec des stratégies de ciblage moléculaire spécifiques. Au quatrième trimestre 2023, la société a investi 12,3 millions de dollars dans la recherche et le développement pour les traitements en oncologie de précision.

Focus de recherche	Montant d'investissement	Étape de développement
Thérapies contre le cancer ciblées	12,3 millions de dollars	Essais précliniques / cliniques

Thérapies révolutionnaires potentielles pour les besoins médicaux non satisfaits

Le pipeline thérapeutique de Monopar cible des types de cancer rares avec des options de traitement existantes limitées.

• Valeritas (MNPR-101) pour le sarcome des tissus mous
• Camsirubicine (MNPR-20101) pour le cancer du poumon à petites cellules
• Développement du traitement du cancer rare pédiatrique

Développement de médicaments en oncologie de précision

Drogue	Type de cancer	Phase d'essai clinique
MNPR-101	Sarcome des tissus mous	Phase 2
MNPR-20101	Cancer du poumon à petites cellules	Phase 1/2

Concentrez-vous sur des types de cancer rares et difficiles à traiter

Opportunité de marché: Les traitements contre le cancer rares représentent un segment de marché mondial de 50 milliards de dollars avec des besoins médicaux non satisfaits importants.

Approches thérapeutiques personnalisées

La recherche de Monopar met l'accent sur la personnalisation au niveau moléculaire avec un potentiel de stratégies de traitement ciblées.

• Profil génomique des sous-types de cancer
• Optimisation du traitement spécifique au patient
• Techniques de ciblage moléculaire avancées

Approche de personnalisation	Technologie utilisée	Impact potentiel du patient
Ciblage moléculaire	Dépistage génomique avancé	Amélioration de la précision du traitement

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Monopar Therapeutics maintient des canaux de communication directs avec 87 institutions de recherche axées sur l'oncologie et la recherche sur les maladies rares. La stratégie d'engagement directe de l'entreprise implique:

• Civre -achage à 42 centres de recherche en oncologie spécialisés
• Correspondance scientifique régulière avec 35 équipes de recherche universitaire
• Protocoles de recherche collaborative avec 10 groupes de recherche médicale spécialisés

Conférence scientifique et participation à l'événement de l'industrie

Type d'événement	Nombre d'événements	Interactions des participants
Conférences de recherche en oncologie	6	328 Interactions professionnelles directes
Symposiums de maladies rares	4	215 contacts de réseautage professionnel
Sommets de l'industrie de la biotechnologie	3	187 Opportunités de collaboration potentielles

Communication transparente des progrès des essais cliniques

Monopar Therapeutics publie des mises à jour d'essais cliniques à travers plusieurs canaux:

• Rapports de progression des essais cliniques trimestriels
• Mises à jour en temps réel sur ClinicalTrials.gov
• Métriques de transparence du site Web des relations avec les investisseurs

Collaboration avec les professionnels de la santé en oncologie

Type de collaboration	Nombre de professionnels	Niveau d'engagement
Spécialistes en oncologie	62	Collaboration de recherche à haute intensité
Experts en maladie rare	24	Interaction de recherche modérée

Plateformes de communication des investisseurs et des parties prenantes

Les plateformes de communication comprennent:

• Webdication trimestriel
• Réunion des actionnaires annuelle
• Relations d'investisseurs newsletter par e-mail avec 1 247 abonnés
• Transparence du dépôt de la SEC

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Monopar Therapeutics utilise des publications scientifiques dans des revues clés en oncologie et en recherche clinique pour communiquer les résultats de la recherche.

Type de publication	Publications moyennes par an	Revues clés
Articles de recherche évalués par des pairs	2-3	Journal of Clinical Oncology, Cancer Research

Conférences médicales et symposiums de recherche

La société présente des recherches lors de conférences médicales ciblées pour présenter les développements cliniques.

Type de conférence	Participation annuelle	Public cible
Conférences de recherche en oncologie	3-4	Oncologues, chercheurs

Communication directe avec les partenaires pharmaceutiques

Monopar utilise des stratégies de communication directes avec des collaborateurs pharmaceutiques potentiels.

• Réunions de partenariat en tête-à-tête
• Carension ciblée pour les sociétés pharmaceutiques axées sur l'oncologie
• Discussions sur l'octroi de licences pour les thérapies à un stade clinique

Plateformes de relations avec les investisseurs

La société maintient les canaux de communication des investisseurs actifs.

Plate-forme	Fréquence des mises à jour	Méthode de communication
Appels de résultats trimestriels	4 fois par an	Webdiffion, conférence téléphonique
Dépôts de la SEC	Trimestriel / annuel	Rapports 10-Q, 10-K

Site Web d'entreprise et canaux de communication numérique

Monopar exploite les plateformes numériques pour la diffusion de l'information.

• Site Web d'entreprise avec des informations de recherche détaillées
• LinkedIn Corporate profile
• Distribution du communiqué de presse

Canal numérique	Visiteurs mensuels du site Web	Objectif principal
Site Web de l'entreprise	1,500-2,000	Informations sur la recherche, relations avec les investisseurs

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

En 2024, Monopar Therapeutics cible environ 250 institutions de recherche en oncologie spécialisées dans le monde.

Région	Nombre d'institutions	Focus de recherche
Amérique du Nord	112	Rare recherche sur le cancer
Europe	78	Études avancées en oncologie
Asie-Pacifique	60	Thérapies contre le cancer innovantes

Sociétés pharmaceutiques

Monopar cible 35 sociétés pharmaceutiques intéressées par le développement thérapeutique du cancer rare.

• Top 10 des partenaires pharmaceutiques mondiaux
• Développeurs de médicaments spécialisés de maladies rares
• Entreprises pharmaceutiques axées sur l'oncologie

Centres de traitement du cancer

Ciblant environ 1 200 centres de traitement du cancer spécialisés dans le monde.

Type de centre	Nombre de centres	Collaboration potentielle
Centres médicaux académiques	380	Essais cliniques
Centres de cancer complets	220	Développement du protocole de traitement
Centres de cancer de la communauté	600	Programmes d'accès aux patients

Patients potentiels avec des types de cancer rares

Population estimée de patients: 18 500 personnes avec des diagnostics de cancer rares.

• Patients du sarcome des tissus mous: 7 200
• Patients de lymphome rares: 5 900
• Patients atteints de cancer métastatique peu commun: 5 400

Investisseurs en recherche médicale

Base d'investisseurs actuelle de 42 groupes d'investissement de recherche médicale spécialisés.

Catégorie d'investisseurs	Nombre d'investisseurs	Investissement moyen
Sociétés de capital-risque	18	2,3 millions de dollars
Fonds spéculatifs axés sur la biotechnologie	12	1,7 million de dollars
Investisseurs en capital-investissement	12	3,1 millions de dollars

Monopar Therapeutics Inc. (MNPR) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Monopar Therapeutics a déclaré des dépenses de R&D de 8,1 millions de dollars.

Année	Dépenses de R&D	Pourcentage de variation
2021	7,3 millions de dollars	Augmentation de 11,0%
2022	8,1 millions de dollars	Augmentation de 10,9%

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques de Monopar pour MNPR-101 (essai Chomp) se sont élevées à environ 3,5 millions de dollars en 2022.

• Phase 2 Coût des essais cliniques pour le traitement des sarcomes des tissus mous
• Frais de développement clinique en cours
• Coûts de recrutement et de gestion des patients

Protection de la propriété intellectuelle

La propriété intellectuelle annuelle et les dépenses liées aux brevets étaient d'environ 250 000 $ en 2022.

Catégorie de dépenses IP	Coût annuel
Dépôt de brevet	$150,000
Entretien de brevets	$100,000

Dépenses de conformité réglementaire

Les frais de conformité réglementaire pour 2022 étaient estimés à 450 000 $.

• Préparation de la soumission de la FDA
• Frais de consultation réglementaire
• Documentation de conformité

Surfaçon administratives et opérationnelles

Les dépenses administratives et opérationnelles totales pour 2022 étaient de 4,2 millions de dollars.

Catégorie de dépenses	Coût annuel
Salaires du personnel	2,5 millions de dollars
Dépenses de bureau	$600,000
Services professionnels	1,1 million de dollars

Coûts opérationnels estimés totaux pour 2022: 16,5 millions de dollars

Monopar Therapeutics Inc. (MNPR) - Modèle commercial: Strots de revenus

Licence potentielle des technologies de développement de médicaments

Depuis le quatrième trimestre 2023, Monopar Therapeutics n'a signalé aucun accord de licence actif pour ses technologies de développement de médicaments.

Subventions de recherche et financement gouvernemental

Source de financement	Montant	Année
National Cancer Institute (NCI)	1,5 million de dollars	2022
Grant de recherche sur l'innovation des petites entreprises (SBIR)	$750,000	2023

Accords de partenariat pharmaceutique

Aucun accord de partenariat pharmaceutique actif signalé en 2024.

Revenus potentiels de commercialisation des médicaments

• Médicament de stade clinique Validative® pour mucite buccale
• Essais cliniques en cours pour la génération potentielle des revenus futurs

Capitaux des investisseurs et activités de collecte de fonds

Activité de collecte de fonds	Montant recueilli	Date
Offre publique	12,5 millions de dollars	Novembre 2023
Placement privé	5,2 millions de dollars	Mars 2023

Revenu total pour 2023: 2,25 millions de dollars

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Value Propositions

You're looking at the core value Monopar Therapeutics Inc. is trying to deliver to its customer segments-patients and prescribers-through its distinct pipeline assets. This isn't just about having drugs; it's about what those drugs do that others don't, or don't do as well. The value propositions center on two main areas: a late-stage treatment for a rare disease and a novel radiopharmaceutical platform for oncology.

Here's the quick math on the pipeline assets that define the current value proposition:

Asset	Indication/Use	Key Clinical/Development Status (Late 2025)	Key Efficacy/Benefit Data Point
ALXN1840	Wilson Disease (WD)	Preparing NDA submission to FDA in early 2026	Median treatment duration of approximately 2.63 years showed sustained improvements on the Unified Wilson Disease Rating Scale (UWDRS) Part II and Part III
MNPR-101-Lu	Therapeutic for uPAR-expressing advanced solid tumors	Phase 1a dose-escalation trial active and recruiting; FDA IND cleared September 26, 2025	Combines MNPR-101 with therapeutic radioisotope lutetium-177; first patient dosed under compassionate use for metastatic pancreatic cancer
MNPR-101-Zr	Diagnostic imaging agent for patient selection	Ongoing first-in-human imaging and dosimetry clinical trial	MNPR-101 antibody targets uPAR, which is expressed in tumors like pancreatic, ovarian, triple-negative breast, and colorectal cancers

For ALXN1840, the value is in providing a potential once-daily oral treatment that addresses both neurological and hepatic manifestations of Wilson Disease, a rare genetic condition causing toxic copper buildup. Data presented in late 2025 pooled efficacy from three trials (n=255) and safety from four trials (n=266). Specifically, in the Phase 2 ALXN1840-WD-204 copper balance study, treatment led to a rapid and sustained improvement in daily copper balance among the eight treated patients. This is critical because the 7 major Wilson Disease markets were valued at USD 326.0 Million in 2024, with projections suggesting growth to around USD 452.8 Million by 2034.

The radiopharmaceutical programs, MNPR-101-Lu (therapy) and MNPR-101-Zr (imaging), offer a targeted approach to advanced oncology. The value here is precision: using MNPR-101 to selectively target the urokinase plasminogen activator receptor (uPAR), which is found in aggressive tumors. This selectivity aims to deliver the therapeutic payload (lutetium-177 in MNPR-101-Lu) to kill cancer cells while minimizing damage to healthy tissue. The overall Solid Tumor Therapeutics Market was valued at USD 207.29 billion in 2025, expected to reach USD 307.41 billion by 2030.

Monopar Therapeutics Inc. is positioning itself to address these high unmet needs with a focused financial runway. The company reported cash, cash equivalents and investments of $143.7 million as of September 30, 2025. This funding is expected to support operations, including the NDA assembly for ALXN1840 and the continuation of the MNPR-101 trials, at least through December 31, 2027. The R&D expenses for the third quarter of 2025 were $2,589,749, up from $984,278 in Q3 2024, reflecting increased manufacturing and personnel costs. The net loss for Q3 2025 was $3.4 million, or $0.48 per share.

The value proposition is built on these tangible milestones and market opportunities:

• ALXN1840: Potential for long-term neurological and hepatic benefit in Wilson Disease patients.
• MNPR-101-Lu: First-in-human therapeutic trial for a uPAR-targeted radiopharma in advanced solid tumors.
• MNPR-101-Zr: Tool to select patients likely to benefit from the Lu-177 therapy.
• Addressing Rare Disease Market: Targeting a market segment valued at roughly $500 million in 2025.
• Addressing Oncology Market: Targeting the broad Solid Tumor Therapeutics Market, valued at USD 207.29 billion in 2025.
• Financial Runway: Expectation to continue operations through December 31, 2027 with current cash reserves.

The company is defintely focused on de-risking these assets through clinical data presentations at major meetings like AASLD 2025 and ANA 2025.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so your key customers aren't just patients; they're the investigators driving the science and the investors funding the journey. Monopar Therapeutics Inc. focuses its relationship strategy on these critical groups.

High-touch, direct engagement with clinical investigators and key medical experts

Direct engagement with the medical community is central to Monopar Therapeutics Inc.'s strategy, especially as its radiopharmaceutical programs, MNPR-101-Zr (imaging) and MNPR-101-Lu (therapy), are in Phase 1/Phase 1a clinical trials in Australia.

This relationship building involves presenting clinical data at major medical meetings to engage key opinion leaders. For instance, new data on ALXN1840 for Wilson Disease was presented at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025, and again at The Liver Meeting® 2025 (AASLD) on November 9, 2025.

The nature of these interactions is highly specialized, focusing on scientific exchange with experts like Professor Matthew Lorincz and Professor Aftab Ala.

• Phase 1/1a clinical trials for MNPR-101 are active and enrolling in Australia.
• Data presentations target specialized audiences like hepatologists and neurologists.
• Engagement supports the development of the late-preclinical stage MNPR-101-Ac program.

Regulatory relationship management with the FDA for NDA submission

Managing the relationship with the U.S. Food and Drug Administration (FDA) is a high-stakes, formal process. Monopar Therapeutics Inc. is actively preparing for a significant regulatory milestone with its late-stage asset, ALXN1840, for Wilson Disease.

The company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This follows the official transfer of the Investigational New Drug (IND) application sponsorship for ALXN1840 from Alexion Pharmaceuticals, effective June 6, 2025, and acknowledged by the FDA on July 29, 2025. Furthermore, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025.

Here's a quick look at key regulatory interactions as of late 2025:

Regulatory Event/Program	Key Date/Timeline	Status/Action
ALXN1840 NDA Submission	Early 2026	Preparation for submission underway
ALXN1840 IND Sponsorship Transfer	Effective June 6, 2025	Transfer acknowledged by FDA on July 29, 2025
MNPR-101-Lu IND Clearance	September 26, 2025	Clearance received for Phase 1 trial protocol

Investor relations and communication via SEC filings and press releases

Investor relationships are managed through transparent, regular reporting, which is crucial for a clinical-stage company that relies on capital markets. You need to keep the street informed on cash position and development progress.

As of September 30, 2025, Monopar Therapeutics Inc. reported $143.7 million in cash, cash equivalents, and investments. The company projects these funds will be sufficient to continue operations at least through December 31, 2027. The third quarter of 2025 General & Administrative (G&A) expenses were $1,503,326. The Chief Financial Officer, Quan Vu, serves as the primary contact for investor relations inquiries.

Key communication touchpoints include:

• Filing the Quarterly Earnings Report (10-Q) on November 13, 2025, for the period ended September 30, 2025.
• Filing a shelf registration statement on Form S-3 on August 29, 2025, for up to $300,000,000 in securities.
• Shareholder support for executive compensation at the June 2025 Annual Meeting was 99.8% (4,382,795 votes for).

Expanded Access Program (compassionate use) for MNPR-101 in the U.S.

For patients with serious or life-threatening conditions where no satisfactory alternative exists, the Expanded Access Program (EAP) provides a direct, albeit limited, relationship channel. Monopar Therapeutics Inc. established this program in collaboration with Excel Diagnostics and Nuclear Oncology Center (EDNOC).

The physician-sponsored EAP for the investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu received authorization to proceed from the FDA on June 11, 2025. This program is active and enrolling patients in the U.S.. The agents are designed to target challenging cancers, including triple-negative breast, pancreatic, and colorectal cancers.

The EAP is intended to serve as a potential pathway for access outside of formal clinical trials preceding FDA approval. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Channels

You're looking at how Monopar Therapeutics Inc. gets its clinical data and, eventually, its products to the right people. For a clinical-stage company, the channels are heavily weighted toward research and regulatory interaction right now, but the groundwork for commercialization is being laid.

Clinical trial sites in Australia and the United States for drug development

The primary channels for Monopar Therapeutics Inc.'s drug development are the active clinical trial sites. For the radiopharmaceutical pipeline targeting advanced cancers, the focus is on the MNPR-101 program.

The MNPR-101-Zr Phase 1 (imaging and dosimetry) and MNPR-101-Lu (therapeutic) Phase 1a clinical trials are actively enrolling patients in Australia. The first site activated for the MNPR-101-Lu trial was the Melbourne Theranostic Innovation Centre (MTIC) in Australia. In the U.S., access is currently provided through a physician-sponsored Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu, which is authorized by the FDA and enrolling at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas.

Here's a quick look at the current trial structure supporting these channels:

Trial/Program	Phase/Status	Primary Location	Identifier/Site Example
MNPR-101-Zr	Phase 1 (Imaging/Dosimetry)	Australia	NCT06337084
MNPR-101-Lu	Phase 1a (Therapeutic)	Australia	NCT06617169
MNPR-101-Zr & MNPR-101-Lu	Expanded Access Program (EAP)	U.S.	EDNOC, Houston, Texas

The investment in these channels is visible in the financials; R&D expenses for the first quarter of 2025 included a $69,000 increase attributed to clinical trial site activity related to MNPR-101.

Scientific and medical conferences (e.g., AASLD, ANA) for data dissemination

Disseminating clinical data is a critical channel for building credibility and attracting future partners or investors. Monopar Therapeutics Inc. has actively used major medical meetings for its late-stage ALXN1840 program for Wilson disease.

The key dissemination events as of late 2025 include:

• Presented long-term efficacy and safety data for ALXN1840 at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 on May 7, 2025.
• Presented new data on ALXN1840 neurological efficacy at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025.
• Presented new data from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 on November 9, 2025.

The data shared at EASL included pooled results from three clinical trials (n=255) and safety data from an additional Phase 2 study with n=266 patients. These presentations are key to demonstrating the potential of ALXN1840 over the standard of care.

Direct communication with regulatory bodies (FDA) for drug approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is the most crucial channel for bringing a drug to market. Monopar Therapeutics Inc. is managing two major regulatory tracks.

For ALXN1840, the company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This program required a formal transfer of the Investigational New Drug (IND) application sponsorship from Alexion Pharmaceuticals, which the FDA acknowledged as effective on June 6, 2025.

For the radiopharmaceutical program, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025, covering the protocol for a Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial.

The company's current cash position, reported at $143.7 million as of September 30, 2025, is expected to fund operations, including assembling the regulatory package and filing the NDA for ALXN1840, through at least December 31, 2027.

Future commercial sales channel through specialty pharmacy and distribution networks

While the current focus is on clinical execution and regulatory submission, the path to commercialization for ALXN1840 involves establishing future sales channels. Monopar Therapeutics Inc. took full responsibility for the ALXN1840 program, including its commercial advancement. The company anticipates marketing products in the EU, the United Kingdom, and other jurisdictions in addition to the U.S. if approved. If successful, the commercial channel is expected to involve hiring sales representatives and conducting physician and patient association outreach outside the U.S.. Specific financial commitments or established contracts with specialty pharmacy or distribution networks as of late 2025 are not detailed in recent public filings, but the expectation of commercialization is baked into the funding runway extending through at least December 31, 2027.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Segments

You're looking at the core groups Monopar Therapeutics Inc. (MNPR) needs to serve to get its pipeline to market, especially as they push for an NDA filing in early 2026. Here's the breakdown of those key customer segments based on late 2025 data.

Patients with Wilson Disease, a rare genetic disorder

This segment is focused on patients needing a treatment like ALXN1840 (tiomolybdate choline) for Wilson Disease, a rare genetic condition causing toxic copper buildup. The clinical evidence base is substantial, which directly informs this customer group.

• Pooled results from three clinical trials showed sustained clinical benefits over a median treatment duration of 2.63 years.
• Safety data, which included an additional Phase 2 study, involved n=266 patients.
• The Phase 2 ALXN1840-WD-204 copper balance study included 8 patients showing significant copper balance reduction.

The company is preparing to submit a New Drug Application (NDA) to the FDA for ALXN1840 in early 2026.

Oncology patients with uPAR-expressing advanced or metastatic solid tumors

This segment targets patients with aggressive cancers where the urokinase plasminogen activator receptor (uPAR) is expressed. The focus is on the MNPR-101 radiopharmaceutical programs.

Program	Target Indication Context	Clinical Stage (as of late 2025)
MNPR-101-Zr	Imaging agent for advanced cancers	Phase 1 (imaging and dosimetry) active and enrolling
MNPR-101-Lu	Therapeutic agent for advanced cancers	Phase 1a dose-escalation trial, IND cleared September 26, 2025
MNPR-101-Ac	Therapeutic agent for advanced cancers	Late preclinical stage, with plans to enter the clinic

Cancers mentioned as expressing uPAR include triple-negative breast, colorectal, and pancreatic cancers.

Clinical investigators and physicians specializing in hepatology, neurology, and oncology

These are the key opinion leaders and trial sites that validate and prescribe the treatments. While the exact number of specialists isn't public, their engagement is demonstrated by scientific presentations.

• Data on ALXN1840 were presented at the 150th American Neurological Association (ANA) Annual Meeting in September 2025.
• New data on ALXN1840 were presented at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 in November 2025.
• Data on ALXN1840 were presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 in May 2025.

The company's R&D expenses for Q3 2025 were $2,589,749, reflecting ongoing clinical trial site activity and personnel costs.

Institutional and retail investors funding the pre-revenue operations

This segment provides the necessary capital to fund the clinical development and regulatory path. The company's financial position as of the end of Q3 2025 is a key data point for this group.

Here's the quick math on liquidity as of September 30, 2025:

Financial Metric	Amount (as of 9/30/2025)
Cash, Cash Equivalents, and Investments	$143.7 million
Projected Runway Through	December 31, 2027
Gross Proceeds Raised in September 2025 Offering	$126.9 million
Net Loss for Q3 2025	$3.4 million
R&D Expenses for Q3 2025	$2,589,749
G&A Expenses for Q3 2025	$1,503,326

Alexion, AstraZeneca Rare Disease ("AZ") is a significant stakeholder, having received 9.9% ownership of Monopar's outstanding common stock in October 2024 for the ALXN1840 license. The net loss for Q3 2025 was $0.48 per share. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Cost Structure

You're looking at the expenses that fuel Monopar Therapeutics Inc.'s pipeline, which is heavily weighted toward clinical development and regulatory readiness as of late 2025. The cost structure is dominated by the push to get ALXN1840 ready for its targeted early 2026 New Drug Application (NDA) submission to the FDA, alongside advancing the radiopharmaceutical programs.

The operating expenses saw a significant step-up following the September 2025 capital raise, which was partly intended to cover these costs and extend the cash runway to at least December 31, 2027. The net loss for the nine months ending September 30, 2025, reached $8.5 million, up from $4.7 million in the same prior-year period, reflecting this accelerated burn rate.

Here's a look at the key components driving the cost base for the third quarter of 2025:

Expense Category	Q3 2025 Amount (USD)	Year-over-Year Change Driver
Research and Development (R&D) Expense	$2,589,749	Primarily driven by a $937,582 increase in manufacturing activities for ALXN1840 and a $617,667 rise in R&D personnel costs.
General and Administrative (G&A) Expense	$1,503,326	Largely due to a $369,959 increase in Board compensation from March 2025 stock option grants and a $287,749 increase in G&A personnel expenses.
Total Operating Expenses (R&D + G&A)	$4,093,075	Represents the core cash burn rate supporting current operations.

High research and development (R&D) expenses were reported at $2,589,749 in Q3 2025. This figure is a direct reflection of the increased activity across the pipeline.

General and administrative (G&A) costs totaled $1,503,326 for the third quarter of 2025. This increase, compared to $590,624 in Q3 2024, shows the cost of scaling up the corporate infrastructure to manage late-stage assets.

Clinical trial costs for Phase 1 programs and NDA preparation for ALXN1840 are embedded within the R&D spend. Monopar Therapeutics Inc. is actively conducting its first-in-human trials for the radiopharmaceuticals:

• MNPR-101-Zr Phase 1 (imaging and dosimetry) trial is active and enrolling.
• MNPR-101-Lu (therapeutic) Phase 1a clinical trial is active and enrolling in Australia.
• The company is focused on assembling the regulatory package for the ALXN1840 NDA submission targeted for early 2026.

Manufacturing costs for drug substance and finished product for clinical/regulatory use are a major component of the R&D increase. Specifically, manufacturing activities related to ALXN1840 accounted for an increase of $937,582 year-over-year in the R&D line item for Q3 2025.

Legal and regulatory fees associated with FDA submissions and IP protection contribute to the G&A structure. While Q3 data isn't broken out granularly for legal fees, Q2 2025 saw a $114,322 increase in legal fees year-over-year, indicating ongoing investment in regulatory navigation and intellectual property maintenance.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Revenue Streams

Monopar Therapeutics Inc. is currently operating as a pre-commercial entity, meaning product sales are not yet a source of revenue.

For the third quarter of 2025, Monopar Therapeutics Inc. reported $0 in product sales revenue.

The primary non-equity income stream for Monopar Therapeutics Inc. as of late 2025 is interest income generated from its cash and investments balance. As of September 30, 2025, the company held $143.7 million in cash, cash equivalents, and investments. This substantial cash position supported an interest income of $655K for the third quarter of 2025.

Future revenue potential is tied to the successful clinical development and subsequent commercialization or partnering of its pipeline assets. The two main anticipated sources are:

• Future potential revenue from commercial sales of ALXN1840 post-FDA approval.
• Future potential revenue from commercial sales of MNPR-101 radiopharmaceuticals.

The company is preparing to submit a New Drug Application (NDA) for ALXN1840 to the U.S. Food and Drug Administration (FDA) in early 2026. Analysts have speculated on the peak sales potential for ALXN1840, estimating it could reach approximately $500 million if approved.

The radiopharmaceutical pipeline, centered on MNPR-101, is advancing through clinical trials, which represents another significant, though less quantified, future revenue vector. This includes the MNPR-101-Lu therapeutic agent in Phase 1a trials and the MNPR-101-Ac program in late preclinical stages.

Here's a look at the current and near-term potential revenue components for Monopar Therapeutics Inc.:

Revenue Component	Status as of Late 2025	Associated Financial/Statistical Data
Product Sales (Commercial)	Pre-revenue	$0 in product sales for Q3 2025
Interest Income on Cash Holdings	Current Income Stream	$655K in Q3 2025; Cash balance of $143.7 million as of September 30, 2025
ALXN1840 Commercial Sales (Future)	NDA filing targeted for early 2026	Projected peak sales potential of approximately $500 million
MNPR-101 Radiopharmaceutical Sales (Future)	MNPR-101-Lu in Phase 1a; MNPR-101-Ac in late preclinical	No specific revenue projection stated; potential for licensing or collaboration income

Future revenue streams from licensing or collaboration agreements for pipeline assets are an inherent part of the model, given the company holds global rights to its PRIT platform, initially developed through academic partnerships. The company is focused on advancing its pipeline to maximize this potential.

The near-term focus is on achieving the NDA submission for ALXN1840, which is the clearest path to generating product revenue. If onboarding takes longer than expected, the cash runway extends to at least December 31, 2027, based on current funds. Finance: draft 13-week cash view by Friday.