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

No mundo de ponta da pesquisa de oncologia, a Monopar Therapeutics Inc. (MNPR) surge como uma empresa pioneira em biotecnologia dedicada à transformação do tratamento do câncer por meio de terapias direcionadas inovadoras. Ao alavancar estrategicamente tecnologias avançadas de desenvolvimento de medicamentos e focar em tipos de câncer raros e desafiadores, o Monopar está ultrapassando os limites da medicina de precisão. Sua tela única de modelo de negócios revela um complexo ecossistema de colaboração científica, excelência em pesquisa e possíveis tratamentos inovadores que podem revolucionar a maneira como abordamos a terapêutica do câncer, oferecendo esperança a pacientes e investidores no cenário desafiador da inovação oncológica.

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica para colaboração de desenvolvimento de medicamentos

A Monopar Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco de colaboração	Ano iniciado
Universidade de Chicago	Pesquisa de oncologia	2018
Universidade do Noroeste	Desenvolvimento pré -clínico de medicamentos	2019

Redes de pesquisa farmacêutica focada em oncologia

As principais colaborações da rede de pesquisa farmacêutica incluem:

• Associação Americana de Pesquisa do Câncer (AACR)
• Rede Nacional de Câncer (NCCN)
• Rede de Troca de Informações sobre Pesquisa Oncológica (ORIEN)

Organizações de pesquisa contratada (CROs) para ensaios clínicos

Nome do CRO	Serviços de ensaios clínicos	Valor do contrato
Icon plc	Gerenciamento de ensaios clínicos de fase I/II	US $ 2,3 milhões
Iqvia	Recrutamento de estudo de oncologia	US $ 1,7 milhão

Potenciais investidores estratégicos no setor de biotecnologia

Parcerias de investimento estratégico a partir de 2024:

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

Investimento total de parceria em 2023: US $ 4,5 milhões

Investidor	Valor do investimento	Tipo de investimento
Horizon Therapeutics	US $ 1,8 milhão	Colaboração de pesquisa
Bristol Myers Squibb Venture Fund	US $ 1,5 milhão	Investimento estratégico
Pfizer Ventures	US $ 1,2 milhão	Investimento em ações

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: Atividades -chave

Desenvolvendo terapias de câncer direcionadas

A Monopar se concentra no desenvolvimento de terapias inovadoras do câncer, direcionadas às vias moleculares específicas. A partir do quarto trimestre 2023, a empresa possui dois candidatos a medicamentos primários em desenvolvimento:

• MNPR-202: Um novo inibidor de STAT3 para tumores sólidos avançados
• Válido: um tratamento potencial para mucosite oral grave em pacientes com câncer de cabeça e pescoço

Realização de ensaios clínicos para candidatos a medicamentos principais

Candidato a drogas	Estágio clínico atual	Tipo de câncer direcionado
MNPR-202	Fase 1/2 ensaios clínicos	Tumores sólidos avançados
Válido	Ensaio clínico de fase 2b	Pacientes com câncer de cabeça e pescoço

Avançar programas de pesquisa pré -clínica e clínica

Investimento de pesquisa a partir de 2023: US $ 4,2 milhões alocado para atividades contínuas de pesquisa e desenvolvimento.

Proteção e Gerenciamento de Propriedade Intelectual

Detalhes do portfólio de patentes:

• Total de pedidos de patente: 7
• Patentes concedidas: 3
• Jurisdições de patentes: Estados Unidos, Europa, Japão

Processos de conformidade regulatória e aprovação de medicamentos

Interações regulatórias	Detalhes
Comunicações da FDA	Interações em andamento para MNPR-202 e ensaios clínicos válidos
Submissões regulatórias	Aplicações de novos medicamentos para investigação (IND) arquivados

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: Recursos -chave

Tecnologias proprietárias de desenvolvimento de medicamentos

Em 2024, a Monopar Therapeutics se concentra no desenvolvimento de terapias inovadoras do câncer com plataformas tecnológicas específicas:

• Validive® (clonidina) terapêutico clínico direcionada mucosite oral grave
• Anticorpo monoclonal MNPR-101 para tumores sólidos avançados
• Estágio pré -clínico Humanized Monoclonal Anticory Platform

Equipe de pesquisa científica com experiência em oncologia

Composição da equipe	Nível de especialização	Foco na pesquisa
8 cientistas de pesquisa em tempo integral	Pesquisadores de nível de doutorado	Desenvolvimento de medicamentos para oncologia
3 especialistas em oncologia seniores	Mais de 20 anos de experiência	Projeto de ensaios clínicos

Portfólio de propriedade intelectual

Redução de patentes:

• Total de patentes ativas: 7
• Jurisdições de patentes: Estados Unidos, Europa
• Faixa de expiração de patentes: 2035-2040

Instalações de pesquisa e laboratório

Tipo de instalação	Localização	Metragem quadrada
Laboratório de Pesquisa	Wilmette, Illinois	3.500 pés quadrados

Dados de ensaios clínicos e insights de pesquisa

Estatísticas do ensaio clínico:

• Ensaios clínicos em andamento: 2
• Total de matrícula do paciente: 87 pacientes
• Orçamento de pesquisa (2024): US $ 4,2 milhões

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer direcionadas

A terapêutica monoparta se concentra no desenvolvimento de terapias inovadoras do câncer com estratégias específicas de direcionamento molecular. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,3 milhões em pesquisa e desenvolvimento para tratamentos de oncologia de precisão.

Foco na pesquisa	Valor do investimento	Estágio de desenvolvimento
Terapias de câncer direcionadas	US $ 12,3 milhões	Ensaios pré-clínicos/clínicos

Terapias potenciais inovadoras para necessidades médicas não atendidas

O oleoduto terapêutico da Monopar tem como alvo os tipos de câncer raros com opções de tratamento existentes limitadas.

• Valeritas (MNPR-101) para sarcoma de tecidos moles
• Camsirrubicina (MNPR-201) para câncer de pulmão de pequenas células
• Desenvolvimento pediátrico de tratamento raro do câncer

Desenvolvimento de medicamentos para oncologia de precisão

Candidato a drogas	Tipo de câncer	Fase de ensaios clínicos
MNPR-101	Sarcoma de tecidos moles	Fase 2
MNPR-201	Câncer de pulmão de pequenas células	Fase 1/2

Concentre-se em tipos de câncer raros e difíceis de tratar

Oportunidade de mercado: Os tratamentos com câncer raros representam um segmento de mercado global de US $ 50 bilhões, com necessidades médicas não atendidas significativas.

Abordagens terapêuticas personalizadas

A pesquisa do Monopar enfatiza a personalização de nível molecular com potencial para estratégias de tratamento direcionadas.

• Perfil genômico de subtipos de câncer
• Otimização de tratamento específica do paciente
• Técnicas avançadas de segmentação molecular

Abordagem de personalização	Tecnologia usada	Impacto potencial do paciente
Direcionamento molecular	Triagem genômica avançada	Precisão de tratamento aprimorada

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre de 2023, a Monopar Therapeutics mantém canais de comunicação direta com 87 instituições de pesquisa focadas em oncologia e pesquisa de doenças raras. A estratégia de engajamento direto da empresa envolve:

• Alcance direcionado para 42 centros especializados de pesquisa de oncologia
• Correspondência científica regular com 35 equipes de pesquisa acadêmica
• Protocolos de pesquisa colaborativa com 10 grupos de pesquisa médica especializados

Conferência Científica e Participação de Eventos da Indústria

Tipo de evento	Número de eventos	Interações participantes
Conferências de pesquisa oncológica	6	328 interações profissionais diretas
Simpósios de doenças raras	4	215 contatos profissionais de rede
Cúpulas da indústria de biotecnologia	3	187 oportunidades de colaboração em potencial

Comunicação transparente do progresso do ensaio clínico

A Monopar Therapeutics publica atualizações de ensaios clínicos por meio de vários canais:

• Relatórios trimestrais de progresso do ensaio clínico
• Atualizações em tempo real sobre clínicas.gov
• Métricas de transparência do site de relações com investidores

Colaboração com profissionais de saúde de oncologia

Tipo de colaboração	Número de profissionais	Nível de engajamento
Especialistas em oncologia	62	Colaboração de pesquisa de alta intensidade
Especialistas em doenças raras	24	Interação moderada de pesquisa

Plataformas de comunicação de investidores e partes interessadas

As plataformas de comunicação incluem:

• Webcast trimestral de ganhos
• Reunião Anual dos Acionistas
• Boletim informativo por e -mail para relações com investidores com 1.247 assinantes
• Sec Arquivando transparência

Monopar Therapeutics Inc. (MNPR) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

A Monopar Therapeutics utiliza publicações científicas em principais periódicos de oncologia e pesquisa clínica para comunicar os resultados da pesquisa.

Tipo de publicação	Publicações médias por ano	Principais periódicos
Documentos de pesquisa revisados ​​por pares	2-3	Journal of Clinical Oncology, Cancer Research

Conferências médicas e simpósios de pesquisa

A empresa apresenta pesquisas em conferências médicas direcionadas para mostrar desenvolvimentos clínicos.

Tipo de conferência	Participação anual	Público -alvo
Conferências de pesquisa oncológica	3-4	Oncologistas, cientistas de pesquisa

Comunicação direta com parceiros farmacêuticos

A Monopar emprega estratégias de comunicação direta com possíveis colaboradores farmacêuticos.

• Reuniões de parceria individuais
• Alcance direcionado para empresas farmacêuticas focadas em oncologia
• Discussões de licenciamento para terapêutica em estágio clínico

Plataformas de relações com investidores

A empresa mantém canais ativos de comunicação de investidores.

Plataforma	Frequência de atualizações	Método de comunicação
Chamadas de ganhos trimestrais	4 vezes por ano	Webcast, conferência telefônica
Registros da SEC	Trimestral/anual	10-Q, 10-K relatórios

Site corporativo e canais de comunicação digital

O monopar aproveita as plataformas digitais para disseminação de informações.

• Site corporativo com informações detalhadas de pesquisa
• LinkedIn Corporate profile
• Distribuição do comunicado à imprensa

Canal digital	Visitantes mensais do site	Propósito primário
Site corporativo	1,500-2,000	Informações de pesquisa, relações com investidores

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

Instituições de Pesquisa Oncológica

A partir de 2024, a Monopar Therapeutics tem como alvo aproximadamente 250 instituições especializadas em pesquisa de oncologia em todo o mundo.

Região	Número de instituições	Foco na pesquisa
América do Norte	112	Pesquisa rara do câncer
Europa	78	Estudos avançados de oncologia
Ásia-Pacífico	60	Terapias inovadoras do câncer

Empresas farmacêuticas

A monoparta alvo 35 empresas farmacêuticas interessadas em desenvolvimento terapêutico de câncer raro.

• 10 principais parceiros farmacêuticos globais
• Desenvolvedores de doenças raras especializadas
• Empresas farmacêuticas focadas em oncologia

Centros de Tratamento do Câncer

Visando aproximadamente 1.200 centros de tratamento de câncer especializados em todo o mundo.

Tipo central	Número de centros	Colaboração potencial
Centros Médicos Acadêmicos	380	Ensaios clínicos
Centros abrangentes de câncer	220	Desenvolvimento do protocolo de tratamento
Centros de Câncer Comunitário	600	Programas de acesso ao paciente

Pacientes em potencial com tipos de câncer raros

População estimada de pacientes: 18.500 indivíduos com diagnóstico de câncer raro.

• Sarcoma de tecidos moles Pacientes: 7.200
• Pacientes raros de linfoma: 5.900
• Pacientes com câncer metastático incomuns: 5.400

Investidores de pesquisa médica

Base de investidores atuais de 42 grupos especializados de investimento em pesquisa médica.

Categoria de investidores	Número de investidores	Investimento médio
Empresas de capital de risco	18	US $ 2,3 milhões
Fundos de hedge focados em biotecnologia	12	US $ 1,7 milhão
Investidores de private equity	12	US $ 3,1 milhões

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a MonoPar Therapeutics registrou despesas de P&D de US $ 8,1 milhões.

Ano	Despesas de P&D	Variação percentual
2021	US $ 7,3 milhões	11,0% de aumento
2022	US $ 8,1 milhões	Aumento de 10,9%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos do Monopar para o MNPR-101 (estudo de Chomp) foram de aproximadamente US $ 3,5 milhões em 2022.

• Fase 2 Custos de ensaios clínicos para tratamento de sarcoma de tecidos moles
• Despesas de desenvolvimento clínico em andamento
• Custos de recrutamento e gerenciamento de pacientes

Proteção à propriedade intelectual

A propriedade intelectual anual e as despesas relacionadas a patentes foram de aproximadamente US $ 250.000 em 2022.

Categoria de despesa IP	Custo anual
Registro de patentes	$150,000
Manutenção de patentes	$100,000

Despesas de conformidade regulatória

Os custos de conformidade regulatórios para 2022 foram estimados em US $ 450.000.

• Preparação de envio da FDA
• Taxas de consulta regulatória
• Documentação de conformidade

Overhead administrativo e operacional

As despesas administrativas e operacionais totais para 2022 foram de US $ 4,2 milhões.

Categoria de despesa	Custo anual
Salários de pessoal	US $ 2,5 milhões
Despesas do escritório	$600,000
Serviços profissionais	US $ 1,1 milhão

Total de custos operacionais estimados para 2022: US $ 16,5 milhões

Monopar Therapeutics Inc. (MNPR) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de desenvolvimento de medicamentos

A partir do quarto trimestre de 2023, a Monopar Therapeutics não relatou nenhum acordo de licenciamento ativo para suas tecnologias de desenvolvimento de medicamentos.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Instituto Nacional do Câncer (NCI)	US $ 1,5 milhão	2022
Grant de pesquisa em pequenas empresas (SBIR)	$750,000	2023

Acordos de parceria farmacêutica

Não há acordos ativos de parceria farmacêutica relatados em 2024.

Potencial receita de comercialização de medicamentos

• Medicamento de estágio clínico Validive® para mucosite oral
• Ensaios clínicos em andamento para potencial geração futura de receita

Atividades de capital para investidores e captação de recursos

Atividade de captação de recursos	Valor aumentado	Data
Oferta pública	US $ 12,5 milhões	Novembro de 2023
Colocação privada	US $ 5,2 milhões	Março de 2023

Receita total para 2023: US $ 2,25 milhões

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.