Monopar Therapeutics Inc. (MNPR): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de la investigación de la oncología de la vanguardia, MonoPar Therapeutics Inc. (MNPR) surge como una compañía pionera de biotecnología dedicada a transformar el tratamiento del cáncer a través de terapias innovadoras dirigidas. Al aprovechar estratégicamente las tecnologías avanzadas de desarrollo de fármacos y centrarse en tipos de cáncer raros y desafiantes, Monopar está empujando los límites de la medicina de precisión. Su lienzo de modelo de negocio único revela un complejo ecosistema de colaboración científica, excelencia en la investigación y posibles tratamientos innovadores que podrían revolucionar cómo abordamos la terapéutica del cáncer, ofreciendo esperanza a los pacientes e inversores por igual en el paisaje desafiante de la innovación oncológica.

MonoPar Therapeutics Inc. (MNPR) - Modelo de negocios: asociaciones clave

Instituciones de investigación académica para la colaboración del desarrollo de fármacos

Monopar Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de colaboración	Año iniciado
Universidad de Chicago	Investigación oncológica	2018
Universidad del Noroeste	Desarrollo preclínico de fármacos	2019

Redes de investigación farmacéutica centradas en la oncología

Las colaboraciones clave de la red de investigación farmacéutica incluyen:

• Asociación Americana para la Investigación del Cáncer (AACR)
• Red Nacional de Cáncer Integral (NCCN)
• Oncology Research Information Exchange Network (Orien)

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Nombre de Cro	Servicios de ensayos clínicos	Valor de contrato
Ícono plc	Gestión de ensayos clínicos de fase I/II	$ 2.3 millones
IQVIA	Reclutamiento de juicio de oncología	$ 1.7 millones

Posibles inversores estratégicos en sector de biotecnología

Asociaciones de inversión estratégica a partir de 2024:

• Terapéutica de horizonte
• Fondo de riesgo de Bristol Myers Squibb
• Pfizer Ventures

Inversión total de asociación en 2023: $ 4.5 millones

Inversor	Monto de la inversión	Tipo de inversión
Terapéutica de horizonte	$ 1.8 millones	Colaboración de investigación
Fondo de riesgo de Bristol Myers Squibb	$ 1.5 millones	Inversión estratégica
Pfizer Ventures	$ 1.2 millones	Inversión de capital

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: actividades clave

Desarrollo de terapias para el cáncer dirigidas

Monopar se centra en desarrollar terapias innovadoras contra el cáncer dirigidas a vías moleculares específicas. A partir del cuarto trimestre de 2023, la compañía tiene dos candidatos de drogas principales en desarrollo:

• MNPR-202: un nuevo inhibidor de STAT3 para tumores sólidos avanzados
• Validivo: un tratamiento potencial para la mucositis oral grave en pacientes con cáncer de cabeza y cuello

Realización de ensayos clínicos para candidatos a medicamentos con plomo

Candidato a la droga	Etapa clínica actual	Tipo de cáncer dirigido
MNPR-202	Ensayos clínicos de fase 1/2	Tumores sólidos avanzados
Válido	Fase 2B de ensayo clínico	Pacientes de cáncer de cabeza y cuello

Avanzar en programas de investigación preclínica y clínica

Investigación de investigación a partir de 2023: $ 4.2 millones asignado a actividades continuas de investigación y desarrollo.

Protección y gestión de la propiedad intelectual

Detalles de la cartera de patentes:

• Solicitudes de patentes totales: 7
• Patentes otorgadas: 3
• Jurisdicciones de patentes: Estados Unidos, Europa, Japón

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Interacciones regulatorias	Detalles
Comunicaciones de la FDA	Interacciones continuas para MNPR-202 y ensayos clínicos válidos
Presentaciones regulatorias	Solicitudes de nueva droga de investigación (IND) presentadas

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: recursos clave

Tecnologías de desarrollo de fármacos patentados

A partir de 2024, Monopar Therapeutics se centra en desarrollar terapias innovadoras de cáncer con plataformas tecnológicas específicas:

• Validive® (clonidina) orientación terapéutica clínica mucositis oral severa
• Anticuerpo monoclonal MNPR-101 para tumores sólidos avanzados
• Plataforma de anticuerpos monoclonales humanizados en etapa preclínica

Equipo de investigación científica con experiencia en oncología

Composición del equipo	Nivel de experiencia	Enfoque de investigación
8 científicos de investigación a tiempo completo	Investigadores a nivel de doctorado	Desarrollo de medicamentos oncológicos
3 especialistas en oncología senior	Más de 20 años de experiencia	Diseño de ensayo clínico

Cartera de propiedades intelectuales

Desglose de patentes:

• Patentes activas totales: 7
• Jurisdicciones de patentes: Estados Unidos, Europa
• Rango de vencimiento de patentes: 2035-2040

Investigación e instalaciones de laboratorio

Tipo de instalación	Ubicación	Pies cuadrados
Laboratorio de investigación	Wilmette, Illinois	3,500 pies cuadrados

Datos de ensayos clínicos e información de investigación

Estadísticas de ensayo clínico:

• Ensayos clínicos en curso: 2
• Inscripción total de pacientes: 87 pacientes
• Presupuesto de investigación (2024): $ 4.2 millones

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de cáncer dirigido

Monopar Therapeutics se enfoca en desarrollar terapias innovadoras contra el cáncer con estrategias de focalización molecular específicas. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 12.3 millones en investigación y desarrollo para tratamientos de oncología de precisión.

Enfoque de investigación	Monto de la inversión	Etapa de desarrollo
Terapias de cáncer dirigidas	$ 12.3 millones	Ensayos preclínicos/clínicos

Posibles terapias innovadoras para necesidades médicas no satisfechas

La tubería terapéutica de Monopar se dirige a tipos de cáncer raro con opciones de tratamiento existentes limitadas.

• Valeritas (MNPR-101) para sarcoma de tejidos blandos
• Camsirubicina (MNPR-201) para cáncer de pulmón de células pequeñas
• Desarrollo pediátrico de tratamiento del cáncer raro

Desarrollo de medicamentos oncológicos de precisión

Candidato a la droga	Tipo de cáncer	Fase de ensayo clínico
MNPR-101	Sarcoma de tejido blando	Fase 2
MNPR-2011	Cáncer de pulmón de células pequeñas	Fase 1/2

Centrarse en los tipos de cáncer raros y difíciles de tratar

Oportunidad de mercado: Los tratamientos de cáncer raros representan un segmento de mercado global de $ 50 mil millones con importantes necesidades médicas no satisfechas.

Enfoques terapéuticos personalizados

La investigación de Monopar enfatiza la personalización a nivel molecular con potencial para estrategias de tratamiento específicas.

• Perfil genómico de subtipos de cáncer
• Optimización del tratamiento específica del paciente
• Técnicas de orientación molecular avanzada

Enfoque de personalización	Tecnología utilizada	Impacto potencial para el paciente
Orientación molecular	Detección genómica avanzada	Precisión de tratamiento mejorada

Monopar Therapeutics Inc. (MNPR) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Monopar Therapeutics mantiene canales de comunicación directa con 87 instituciones de investigación centradas en la oncología y la investigación de enfermedades raras. La estrategia de participación directa de la compañía implica:

• Alcance dirigido a 42 centros de investigación de oncología especializada
• Correspondencia científica regular con 35 equipos de investigación académica
• Protocolos de investigación colaborativa con 10 grupos de investigación médica especializada

Conferencia científica y participación en eventos de la industria

Tipo de evento	Número de eventos	Interacciones de los asistentes
Conferencias de investigación oncológica	6	328 interacciones profesionales directas
Simposios de enfermedades raras	4	215 contactos de redes profesionales
Cumbres de la industria de biotecnología	3	187 Oportunidades potenciales de colaboración

Comunicación transparente del progreso del ensayo clínico

Monopar Therapeutics publica actualizaciones de ensayos clínicos a través de múltiples canales:

• Informes de progreso de ensayos clínicos trimestrales
• Actualizaciones en tiempo real en clinicaltrials.gov
• Métricas de transparencia del sitio web de relaciones con los inversores

Colaboración con profesionales de la salud oncológica

Tipo de colaboración	Número de profesionales	Nivel de compromiso
Especialistas en oncología	62	Colaboración de investigación de alta intensidad
Expertos en enfermedades raras	24	Interacción de investigación moderada

Plataformas de comunicación de inversores y partes interesadas

Las plataformas de comunicación incluyen:

• Transmisión web de ganancias trimestrales
• Reunión anual de accionistas
• Boletín de correo electrónico de Relaciones de Inversores con 1.247 suscriptores
• SEC que presenta transparencia

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: canales

Publicaciones científicas y revistas revisadas por pares

Monopar Therapeutics utiliza publicaciones científicas en revistas clave de oncología e investigación clínica para comunicar los resultados de la investigación.

Tipo de publicación	Publicaciones promedio por año	Diarios clave
Documentos de investigación revisados ​​por pares	2-3	Journal of Clinical Oncology, Cancer Research

Conferencias médicas y simposios de investigación

La compañía presenta investigaciones en conferencias médicas dirigidas para mostrar desarrollos clínicos.

Tipo de conferencia	Participación anual	Público objetivo
Conferencias de investigación oncológica	3-4	Oncólogos, científicos investigadores

Comunicación directa con socios farmacéuticos

Monopar emplea estrategias de comunicación directa con posibles colaboradores farmacéuticos.

• Reuniones de asociación individuales
• Extensión dirigida a compañías farmacéuticas centradas en la oncología
• Discusiones de licencia para terapéutica en etapa clínica

Plataformas de relaciones con los inversores

La compañía mantiene canales de comunicación de inversores activos.

Plataforma	Frecuencia de actualizaciones	Método de comunicación
Llamadas de ganancias trimestrales	4 veces al año	Transmisión web, conferencia telefónica
Presentación de la SEC	Trimestral/anual	Informes de 10-Q, 10-K

Sitio web corporativo y canales de comunicación digital

Monopar aprovecha las plataformas digitales para la difusión de información.

• Sitio web corporativo con información detallada de investigación
• LinkedIn corporativo profile
• Distribución de comunicaciones de prensa

Canal digital	Visitantes mensuales del sitio web	Propósito principal
Sitio web corporativo	1,500-2,000	Información de investigación, Relaciones con los inversores

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: segmentos de clientes

Instituciones de investigación de oncología

A partir de 2024, Monopar Therapeutics se dirige a aproximadamente 250 instituciones de investigación de oncología especializada a nivel mundial.

Región	Número de instituciones	Enfoque de investigación
América del norte	112	Investigación del cáncer raro
Europa	78	Estudios avanzados de oncología
Asia-Pacífico	60	Terapias innovadoras del cáncer

Compañías farmacéuticas

Monopar se dirige a 35 compañías farmacéuticas interesadas en el desarrollo terapéutico del cáncer raro.

• Top 10 socios farmacéuticos globales
• Desarrolladores especializados de drogas de enfermedades raras
• Empresas farmacéuticas centradas en la oncología

Centros de tratamiento del cáncer

Dirigido a aproximadamente 1,200 centros de tratamiento de cáncer especializados en todo el mundo.

Tipo central	Número de centros	Colaboración potencial
Centros médicos académicos	380	Ensayos clínicos
Centros de cáncer integrales	220	Desarrollo del protocolo de tratamiento
Centros de cáncer comunitario	600	Programas de acceso al paciente

Pacientes potenciales con tipos de cáncer raros

Población de pacientes estimada: 18.500 personas con diagnósticos de cáncer raros.

• Pacientes con sarcoma de tejido blando: 7,200
• Pacientes de linfoma raros: 5,900
• Pacientes de cáncer metastásico poco común: 5.400

Inversores de investigación médica

Base de inversores actual de 42 grupos especializados de inversión de investigación médica.

Categoría de inversionista	Número de inversores	Inversión promedio
Empresas de capital de riesgo	18	$ 2.3 millones
Fondos de cobertura centrados en la biotecnología	12	$ 1.7 millones
Inversores de capital privado	12	$ 3.1 millones

Monopar Therapeutics Inc. (MNPR) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Monopar Therapeutics reportó gastos de I + D de $ 8.1 millones.

Año	Gastos de I + D	Cambio porcentual
2021	$ 7.3 millones	Aumento del 11.0%
2022	$ 8.1 millones	Aumento del 10,9%

Costos de gestión de ensayos clínicos

Los gastos de ensayos clínicos de Monopar para MNPR-101 (ensayo CHOMP) fueron de aproximadamente $ 3.5 millones en 2022.

• Fase 2 Costos de ensayo clínico para el tratamiento con sarcoma de tejidos blandos
• Gastos continuos de desarrollo clínico
• Costos de reclutamiento y gestión de pacientes

Protección de propiedad intelectual

La propiedad intelectual anual y los gastos relacionados con las patentes fueron de aproximadamente $ 250,000 en 2022.

Categoría de gastos de IP	Costo anual
Presentación de patentes	$150,000
Mantenimiento de patentes	$100,000

Gastos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2022 se estimaron en $ 450,000.

• Preparación de sumisión de la FDA
• Tarifas de consulta regulatoria
• Documentación de cumplimiento

Sobrecarga administrativa y operativa

Los gastos administrativos y operativos totales para 2022 fueron de $ 4.2 millones.

Categoría de gastos	Costo anual
Salarios de personal	$ 2.5 millones
Gastos de oficina	$600,000
Servicios profesionales	$ 1.1 millones

Costos operativos estimados totales para 2022: $ 16.5 millones

Monopar Therapeutics Inc. (MNPR) - Modelo de negocios: flujos de ingresos

Licencias potenciales de tecnologías de desarrollo de fármacos

A partir del cuarto trimestre de 2023, Monopar Therapeutics no ha informado ningún acuerdos de licencia activa para sus tecnologías de desarrollo de fármacos.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
Instituto Nacional del Cáncer (NCI)	$ 1.5 millones	2022
Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$750,000	2023

Acuerdos de asociación farmacéutica

No se informaron acuerdos activos de asociación farmacéutica a partir de 2024.

Ingresos potenciales de comercialización de drogas

• Medicamento de etapa clínica de Validive® para mucositis oral
• Ensayos clínicos en curso para una potencial generación de ingresos futuros

Actividades de capital y recaudación de fondos de los inversores

Actividad de recaudación de fondos	Cantidad recaudada	Fecha
Ofrenda pública	$ 12.5 millones	Noviembre de 2023
Colocación privada	$ 5.2 millones	Marzo de 2023

Ingresos totales para 2023: $ 2.25 millones

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.