MEREO BioPharma Group Plc (MREO): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, o grupo mereo biofarma plc (MREO) emerge como uma força pioneira, navegando estrategicamente no complexo terreno do desenvolvimento de medicamentos para doenças raras. Ao alavancar pesquisas moleculares de ponta, parcerias estratégicas e uma abordagem inovadora para intervenções farmacêuticas, o MREO está redefinindo os limites das soluções terapêuticas. Sua tela de modelo de negócios meticulosamente criada revela uma estratégia abrangente que entrelaça a excelência científica, a pesquisa colaborativa e um profundo compromisso de atender às necessidades médicas não atendidas, posicionando a empresa na vanguarda da inovação transformadora de saúde.

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

O Mereo Biopharma Group Plc estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Universidade de Oxford	Descoberta de medicamentos oncológicos	2018
Imperial College London	Pesquisa terapêutica de doenças raras	2019

Parceria com a Novartis para o desenvolvimento de compostos terapêuticos

Detalhes -chave da parceria da Mereo Biopharma com a Novartis:

• Colaboração iniciada em 2020
• Concentre -se no desenvolvimento GRP-3058 Composto terapêutico
• Pagamentos em potencial total em até US $ 125 milhões

Alianças de pesquisa acadêmica Apoiando a descoberta de medicamentos

Aliança de Pesquisa	Área de pesquisa	Compromisso de financiamento
Universidade de Cambridge	Distúrbios metabólicos raros	US $ 2,3 milhões anualmente
University College London	Oncologia de precisão	US $ 1,7 milhão anualmente

Acordos de licenciamento com empresas de biotecnologia

Acordos de licenciamento atuais:

• Contrato de licenciamento com a Bayer AG para BGS-649 composto
• Direitos de licenciamento exclusivos com Pfizer para desenvolvimento terapêutico de doenças raras
• Receita total de licenciamento em 2023: US $ 8,6 milhões

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doenças raras e pesquisa clínica

Mereo Biopharma se concentra no desenvolvimento de terapias para doenças raras com necessidades médicas não atendidas significativas. A partir de 2024, a empresa possui:

• 3 programas terapêuticos em estágio clínico primário
• Foco especializado em distúrbios raros de ossos e músculos
• Investimento total de P&D de US $ 42,3 milhões em 2023

Programa de medicamentos	Alvo de doença	Fase atual	Custo estimado de desenvolvimento
SetRusumab	Osteogênese imperfeita	Fase 3	US $ 23,7 milhões
Alvelestat	Deficiência de antitripsina alfa-1	Fase 2	US $ 18,5 milhões

Gerenciamento de ensaios pré -clínicos e clínicos

A empresa gerencia processos complexos de ensaios clínicos com:

• 5 locais de ensaio clínico ativos globalmente
• Aproximadamente 120 pessoal de pesquisa clínica
• Duração média do ensaio clínico de 36-48 meses

Otimização do produto farmacêutico

Mereo Biopharma emprega estratégias de otimização avançada:

• Técnicas proprietárias de engenharia molecular
• 3 equipes de pesquisa de otimização dedicadas
• Investimento anual de otimização de US $ 12,6 milhões

Processos de conformidade regulatória e aprovação de medicamentos

A estratégia regulatória envolve:

• Engajamento contínuo com FDA e EMA
• Orçamento abrangente de envio regulatório de US $ 7,4 milhões
• Equipe dedicada de assuntos regulatórios de 15 profissionais

Marco regulatório	Custo estimado de conformidade	Duração típica
Aplicação de novos medicamentos para investigação	US $ 2,1 milhões	6-9 meses
Nova aplicação de medicamentos	US $ 5,3 milhões	12-18 meses

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: Recursos -chave

Capacidades avançadas de pesquisa molecular

O grupo Mereo Biopharma mantém a infraestrutura de pesquisa molecular especializada focada em doenças raras e desenvolvimento terapêutico de oncologia.

Capacidade de pesquisa	Detalhes específicos	Investimento atual
Plataformas de pesquisa molecular	Direcionamento terapêutico de precisão	US $ 12,4 milhões (2023)
Sistemas de análise genômica	Tecnologias de seqüenciamento de próxima geração	US $ 3,7 milhões (2023)

Equipe especializada de pesquisa de biotecnologia

Composição e experiência em equipe de pesquisa:

• Pessoal de pesquisa total: 37 cientistas
• Pesquisadores de doutorado: 24
• Áreas especializadas:
  • Pesquisa de oncologia
  • Terapêutica de doenças raras
  • Biologia Molecular

Portfólio de propriedade intelectual

Categoria IP	Total de ativos	Valor estimado
Famílias de patentes	8 famílias de patentes distintas	US $ 45,2 milhões
Compostos terapêuticos proprietários	3 candidatos a drogas principais	US $ 62,7 milhões

Infraestrutura do ensaio clínico

Recursos de desenvolvimento clínico:

• Ensaios clínicos ativos: 4
• Orçamento total do ensaio clínico: US $ 22,6 milhões (2023)
• Fases de estudo em andamento:
  • Fase I: 1 Trial
  • Fase II: 2 ensaios
  • Fase III: 1 Trial

Equipamento especializado em laboratório e teste

Categoria de equipamento	Quantidade	Investimento total
Sistemas de cromatografia líquida de alta eficiência (HPLC)	6 unidades	US $ 3,9 milhões
Espectrômetros de massa	4 unidades	US $ 5,2 milhões
Instalações de cultura de células	2 laboratórios dedicados	US $ 6,7 milhões

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: proposições de valor

Soluções terapêuticas inovadoras para doenças raras

Mereo Biopharma se concentra no desenvolvimento de terapias direcionadas para doenças raras com necessidades médicas não atendidas significativas. A partir de 2024, o pipeline da empresa inclui:

Área terapêutica	Candidato a drogas	Estágio de desenvolvimento
Distúrbios metabólicos raros	SetRusumab	Ensaios clínicos de fase 3
Oncologia	Navicixizumab	Ensaios clínicos de fase 2

Intervenções farmacêuticas direcionadas

A estratégia farmacêutica da Mereo Biopharma se concentra na medicina de precisão com direcionamento molecular específico.

• Investimento total de P&D em 2023: US $ 42,3 milhões
• Número de programas de pesquisa ativos: 4
• Portfólio de patentes: 17 patentes concedidas

Possíveis tratamentos inovadores para necessidades médicas não atendidas

A abordagem de desenvolvimento de medicamentos da empresa tem como alvo condições médicas críticas com opções limitadas de tratamento.

Doença	Porcentagem de necessidade não atendida	Tamanho potencial de mercado
Osteogênese imperfeita	85%	US $ 650 milhões
Indicações oncológicas raras	70%	US $ 450 milhões

Plataformas avançadas de pesquisa biotecnológica

Mereo Biopharma aproveita plataformas de biotecnologia de ponta para descoberta e desenvolvimento de medicamentos.

• Plataformas de tecnologia de pesquisa: 3 plataformas proprietárias
• Investimento de biologia computacional: US $ 12,7 milhões em 2023
• Parcerias de colaboração: 2 parcerias farmacêuticas ativas

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com a comunidade de pesquisa médica

Mereo Biopharma mantém o envolvimento direto por meio de métricas específicas de interação de pesquisa:

Tipo de engajamento	Frequência anual	Público -alvo
Conferências científicas	8-12 Conferências	Pesquisadores de oncologia
Simpósios de pesquisa	4-6 eventos	Especialistas em doenças raras
Envios de publicação revisados ​​por pares	6-9 publicações	Revistas médicas acadêmicas

Parcerias colaborativas com profissionais de saúde

A estrutura de parceria colaborativa inclui:

• Acordos de colaboração de ensaios clínicos: 3-5 parcerias ativas
• Parcerias de instituição de pesquisa: 2-4 centros médicos acadêmicos
• Engajamento da rede hospitalar: 7-10 centros de tratamento especializados

Abordagem de desenvolvimento de medicamentos focados no paciente

Estratégia de envolvimento do paciente	Detalhes da implementação
Conselhos de consultoria de pacientes	2 reuniões anuais com grupos de pacientes com doenças raras
Recrutamento de pacientes de ensaio clínico	Inscrição alvo: 50-100 pacientes por estudo
Programas de apoio ao paciente	Suporte dedicado a 3 áreas terapêuticas

Comunicação científica e transparência

As métricas de comunicação incluem:

• Atualizações trimestrais de investidor/analista: 4 apresentações anualmente
• Resultado do ensaio clínico Transparência: 100% Registro público em clínicos.gov
• Canais de comunicação digital: presença ativa em 3 redes profissionais

Grupo Mereo Biopharma PLC (MREO) - Modelo de Negócios: Canais

Apresentações de pesquisa médica direta

O Mereo Biopharma Group PLC utiliza apresentações diretas de pesquisa médica como um canal -chave para comunicar os avanços científicos e os resultados dos ensaios clínicos.

Tipo de apresentação	Frequência (2023)	Público -alvo
Resultados do ensaio clínico	7 apresentações	Especialistas em oncologia
Metodologia de pesquisa	4 apresentações	Pesquisadores acadêmicos
Progresso no desenvolvimento de medicamentos	5 apresentações	Investidores farmacêuticos

Participação da conferência científica

A empresa se envolve ativamente em conferências científicas para mostrar pesquisas e rede com profissionais do setor.

• Participou de 12 grandes conferências internacionais em 2023
• Apresentado na Reunião Anual da ASCO (Sociedade Americana de Oncologia Clínica)
• Participou da Conferência da Associação Europeia de Hematologia

Networking da indústria farmacêutica

Os canais estratégicos de rede incluem:

Plataforma de rede	Conexões (2023)	Propósito
Rede Profissional do LinkedIn	1.247 conexões do setor	Colaboração profissional
Convenção Bio Internacional	53 parcerias farmacêuticas diretas	Desenvolvimento de negócios
Table Roundables executivos farmacêuticos	8 reuniões executivas	Discussões estratégicas

Plataformas de comunicação digital

Mereo Biopharma emprega várias estratégias de comunicação digital.

• Site corporativo com seção de relações com investidores
• Webinars trimestrais para investidores
• Distribuição de comunicado de imprensa através de vários canais digitais

Plataforma digital	Métricas de engajamento (2023)	Função primária
Site corporativo	127.456 visitantes únicos	Disseminação da informação
Webinars de relações com investidores	4 webinars, 892 participantes	Comunicação financeira
Canais de mídia social	8.743 seguidores	Reconhecimento da marca

Mereo Biopharma Group plc (MREO) - Modelo de negócios: segmentos de clientes

Populações de pacientes com doenças raras

Mereo Biopharma concentra -se em populações de pacientes com doenças raras com necessidades médicas não atendidas específicas:

Categoria de doença rara	População estimada de pacientes	Mercado -alvo
Osteogênese imperfeita	50.000-60.000 pacientes nos EUA/UE	Pacientes pediátricos e adultos
Distúrbios metabólicos raros	Aproximadamente 25.000 a 30.000 pacientes	Grupos de tratamento especializados

Instituições de Pesquisa Clínica

Principais segmentos de clientes no ecossistema de pesquisa:

• Centros Médicos Acadêmicos
• Institutos Nacionais de Pesquisa
• Centros de pesquisa de doenças raras especializadas

Tipo de instituição de pesquisa	Número de parceiros colaborativos
Centros Médicos Acadêmicos	8-12 Parcerias ativas
Centros de pesquisa especializados	5-7 Colaborações em andamento

Profissionais de saúde

Segmentos profissionais de saúde -alvo:

• Especialistas pediátricos
• Geneticistas de doenças raras
• Especialistas em Transtorno Metabólico

Partes interessadas da indústria farmacêutica

Segmentos de parceria farmacêutica estratégica:

Categoria de partes interessadas	Escopo potencial de colaboração
Grandes empresas farmacêuticas	Acordos de licenciamento e co-desenvolvimento
Empresas farmacêuticas especializadas	Desenvolvimento de medicamentos para doenças raras
Empresas de biotecnologia	Colaboração de pesquisa e transferência de tecnologia

MEREO BIOPHARMA GRUPO PLC (MREO) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, o Mereo Biopharma Group Plc relatou despesas totais de pesquisa e desenvolvimento de US $ 27,4 milhões.

Ano	Despesas de P&D
2022	US $ 27,4 milhões
2021	US $ 33,7 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para o Mereo Biopharma Group PLC em 2022 foram de aproximadamente US $ 15,2 milhões.

• Ensaios clínicos de oncologia: US $ 8,5 milhões
• Ensaios clínicos de doenças raras: US $ 6,7 milhões

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual da empresa em 2022 totalizaram US $ 2,1 milhões.

Categoria IP	Custo
Registro de patentes	US $ 1,3 milhão
Renovação de patentes	US $ 0,8 milhão

Custos de conformidade regulatória

As despesas de conformidade regulatória do Mereo Biopharma Group Plc foram de US $ 3,6 milhões em 2022.

• Custos de envio da FDA: US $ 1,9 milhão
• Despesas de conformidade da EMA: US $ 1,7 milhão

Estrutura de custo total para 2022: US $ 48,3 milhões

Mereo Biopharma Group plc (MREO) - Modelo de negócios: fluxos de receita

Receitas potenciais de licenciamento farmacêutico

A partir de 2024, o Mereo Biopharma possui possíveis receitas de licenciamento de seu portfólio terapêutico:

Candidato a drogas	Potencial receita de licenciamento	Status atual
SetRusumab (BPS-804)	Potencial inicial de US $ 20-50 milhões	Indicação rara de doença óssea
Alvelestat (MPH-966)	Potencial de licenciamento de US $ 15-35 milhões	Deficiência de antitripsina alfa-1

Bolsas de pesquisa

As receitas de concessão de pesquisa para mereo biopharma incluem:

• Grant do National Institutes of Health (NIH): US $ 2,5 milhões em 2023
• Financiamento do Conselho Europeu de Pesquisa: 1,8 milhão de euros em 2023

Acordos de parceria estratégica

Detalhes financeiros de parceria estratégica:

Parceiro	Valor do acordo	Ano
Ultragenyx Pharmaceutical	US $ 25 milhões antecipadamente	2022
Colaboração de pesquisa oncológica	Potencial de US $ 12 milhões	2023

Futuro potencial de comercialização de medicamentos

Receitas de comercialização projetadas:

• Potencial do mercado de setrusumab: US $ 500-750 milhões anualmente
• Alvestestat Projetado Pico de vendas: US $ 300-450 milhões
• Lançamento estimado do primeiro produto comercial: 2025-2026

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Value Propositions

You're looking at the core value Mereo BioPharma Group plc offers to its customers-the patients and healthcare systems-driven by its specialized pipeline. The value proposition centers on delivering first-in-class or best-in-class therapies for conditions where the unmet medical need is significant, which is typical for rare and ultra-rare diseases.

The company's value is intrinsically tied to the clinical success and regulatory status of its lead assets, setrusumab and alvelestat. For instance, the potential market opportunity for setrusumab is substantial, with the global osteogenesis imperfecta treatment market projected to reach $873.81 million by 2031.

Mereo BioPharma Group plc's strategic focus is clearly on developing innovative therapeutics for rare and ultra-rare diseases. This focus allows for premium pricing and specialized market access, which is supported by regulatory advantages already secured for its pipeline:

• Setrusumab has Orphan designation from the European Commission (EC) and the FDA.
• Setrusumab also holds PRIME designation from the EMA and Breakthrough Therapy designation and rare pediatric disease designation from the FDA.
• Alvelestat has received European Commission Orphan Designation for Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), in addition to US FDA Orphan Drug and Fast Track designations.

The financial commitment to these programs reflects their importance; Research and development (R&D) expenses specifically for setrusumab increased by $0.9 million in the three months ended September 30, 2025, compared to the same period in 2024, showing continued investment ahead of expected data readouts around the end of 2025.

The structure of Mereo BioPharma Group plc's partnerships is designed to maximize value capture, which is a core part of the value proposition to shareholders. They are not just developing drugs; they are structuring deals to retain high-value territories.

Here's a quick look at the key pipeline assets driving this value:

Asset	Indication	Development Status/Key Value Point	Financial Impact Data Point
Setrusumab	Osteogenesis Imperfecta (OI)	Phase 3 Orbit and Cosmic studies data expected around the end of 2025. Potential to reduce fractures and improve bone density.	Potential additional milestone payments from partner Ultragenyx up to $245 million.
Alvelestat	Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	First-in-class oral small molecule; partnering discussions advancing for Phase 3 trial funding.	R&D expenses increased by $0.5 million in Q3 2025 vs Q3 2024, showing active advancement.
Vantictumab	Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Promising preclinical data presented at the ASBMR Annual Meeting.	Mereo has retained European commercial rights in the partnership deal with āshibio.

The retention of European commercial rights for key assets allows Mereo BioPharma Group plc to capture a larger share of the potential revenue stream in these markets, which is a direct enhancement of the value proposition over a fully out-licensed model. Specifically, Mereo has retained EU and UK commercial rights for setrusumab through its partnership with Ultragenyx. Also, the company retained European commercial rights for vantictumab in its deal with āshibio.

This strategy is supported by a financial runway that suggests stability through key milestones; as of September 30, 2025, the cash balance was $48.7 million, which management guided would fund operations into 2027. This cash runway is crucial as it allows the company to execute on its European commercial readiness activities for setrusumab without immediate external financing pressure, which is a value driver in itself. The net loss for Q3 2025 was $7.0 million, an improvement from the $15.0 million loss in Q3 2024.

The value proposition is also about being a partner of choice, evidenced by the existing relationships and the ability to structure deals that maintain upside, such as the retained rights. The company had 795,484,404 total ordinary shares issued as of September 30, 2025, meaning the value generated from these propositions is spread across a defined share base.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Relationships

You're managing a portfolio where the relationship with external entities-partners, investors, and the medical community-is the engine driving value realization, especially when you're pre-revenue on core assets. For Mereo BioPharma Group plc (MREO), customer relationships center on maximizing the value of its pipeline through strategic alliances and transparent communication with the financial markets.

Strategic, Collaborative Management of Key Development Partners

The management of key development partners is crucial, as these relationships often carry the financial burden of late-stage development and commercialization outside Mereo BioPharma Group plc's core territories. The collaboration with Ultragenyx Pharmaceutical, Inc. on setrusumab (UX143) for osteogenesis imperfecta (OI) is a prime example. Ultragenyx leads the global development, which includes the Phase 3 Orbit study (patients aged 5 to 25 years) and the Phase 3 Cosmic study (pediatric patients aged 2 to <7 years), both progressing toward final analyses around the end of 2025. This partnership structure includes potential additional milestone payments to Mereo BioPharma Group plc of up to $245 million, plus royalties on Ultragenyx territories' commercial sales. Conversely, Mereo BioPharma Group plc retains the EU and UK commercial rights, for which it will pay Ultragenyx royalties on sales.

The focus on asset-centric deals continues to simplify the business focus. Mereo BioPharma Group plc announced an exclusive global license agreement in August 2025 with āshibio for vantictumab (investigated in autosomal dominant osteopetrosis type 2, ADO2), where Mereo retained the European commercial rights. Furthermore, the oncology asset navicixizumab is partnered with Feng Biosciences, Inc. under a global licensing agreement that includes milestone payments and royalties. Alvelestat, which is Phase 3 ready, remains a focus for ongoing partnering discussions.

Here's a look at the current partnership landscape for key assets:

Asset	Partner	Mereo BioPharma Group plc Territory Rights	Potential Milestones (Max)
Setrusumab (UX143)	Ultragenyx Pharmaceutical, Inc.	EU and UK	$245 million (plus royalties)
Vantictumab	āshibio, Inc.	European commercial rights	Not specified in recent filings
Navicixizumab	Feng Biosciences, Inc.	Not specified	Not specified (agreement includes milestones/royalties)
Leflutrozole	ReproNovo SA	Not specified (exclusive global license)	Not specified

Investor Relations Focused on Clinical Milestones and Cash Runway

Investor communication is tightly linked to the clinical timeline, particularly the setrusumab Phase 3 data readout expected around the end of 2025. The primary focus for financial stability is the cash runway. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million. Management has consistently guided that this balance, based on current operational plans, is expected to fund committed clinical trials, operating expenses, and capital expenditure requirements into 2027. This guidance explicitly excludes any potential upfront payments from a partnership for alvelestat or business development activity related to non-core programs.

The burn rate is a key metric for this relationship. The cash balance has been decreasing from $69.8 million at the end of 2024 to $62.5 million at the end of Q1 2025, and then to $56.1 million at the end of Q2 2025, before settling at $48.7 million in Q3 2025. The cash burn in the last year (implied 2024) was reported as $33 million, which suggested a runway of around 20 months as of October 2025. For the third quarter of 2025, the company reported a net loss of $7.0 million, resulting in a loss per share (Non-GAAP) of $0.01, which was better than the analyst estimate of a $0.0248 loss per share. The total number of ordinary shares issued as of September 30, 2025, stood at 795,484,404, with 159,096,880 ADS equivalents.

Key financial communication points to investors include:

• Cash on hand as of September 30, 2025: $48.7 million.
• Projected funding for operations into 2027.
• Q3 2025 Net Loss: $7.0 million.
• Analyst sales estimate for Full Year 2025: $28.4 million.
• Total ordinary shares issued (Sept 30, 2025): 795,484,404.

Medical Affairs Engagement with European KOLs and Patient Groups

For the setrusumab program, where Mereo BioPharma Group plc holds the European commercial rights, the company is actively engaged in pre-commercial readiness. This involves direct engagement with regulatory and HTA (Health Technology Assessment) bodies in Europe. The company is also investing in real-world data collection efforts through the SATURN program to support a potential launch following regulatory approvals. The relationship with the medical community is framed as a collaborative effort, working 'Together with patient communities, healthcare professionals, partners and investors.' Alvelestat also received Orphan Designation from the European Commission in the first quarter of 2025.

Licensing Deals for Non-Core Assets to Simplify Focus and Reduce Burn

The strategy involves structuring deals for non-core assets to maintain focus on setrusumab and alvelestat while generating non-dilutive capital or future revenue streams. The recent deal for vantictumab with āshibio in August 2025 is a clear example of simplifying focus by retaining European rights while offloading U.S. and rest of world development/commercialization. The oncology asset navicixizumab is partnered with Feng Biosciences, Inc., which includes milestone payments and royalties. The company also has an exclusive global license agreement for leflutrozole with ReproNovo SA. The ongoing partnering discussions for alvelestat are critical, but any potential upfront payments are not factored into the 2027 cash runway guidance, meaning the current burn rate is managed independently of these potential transactions.

The company's asset focus as of late 2025 includes:

• Setrusumab (OI) - Partnered with Ultragenyx.
• Alvelestat (AATD-LD) - Phase 3 ready, partnering discussions ongoing.
• Vantictumab (ADO2) - Partnered with āshibio, EU rights retained.
• Etigilimab - Unpartnered oncology candidate.

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Channels

You're looking at how Mereo BioPharma Group plc gets its value proposition-developing rare disease treatments-to the end user or partner. For a clinical-stage company, the channels are heavily weighted toward partnerships and clinical infrastructure right now, but the EU/UK commercial path is definitely on the roadmap.

Partner-led Global Clinical Development and Regulatory Submissions

The primary channel for global development and regulatory execution for setrusumab (UX143) is the partnership with Ultragenyx Pharmaceutical, Inc. Under this arrangement, Ultragenyx leads and funds the global development plan, which includes Chemistry, Manufacturing, and Controls (CMC) activities that started in December 2020. Mereo BioPharma Group plc retains the commercial rights for Europe and the UK, while Ultragenyx holds the rights for the USA and the Rest of the World. This structure means clinical trial execution, like the Phase 3 Orbit and Cosmic studies, is managed by the partner. The final analyses for these pivotal setrusumab studies are on track to read out around the end of 2025. This partnership has already delivered financial flow to Mereo BioPharma Group plc; the upfront payment was $50 million, plus a $9 million milestone payment. Furthermore, there is potential for up to an additional $245 million in milestone payments, plus royalties on commercial sales in Ultragenyx territories. The increase in Research and Development (R&D) expenses for setrusumab in Q3 2025 was primarily driven by amounts due under the manufacturing and supply agreement with Ultragenyx. This collaboration is definitely the engine for global setrusumab progress.

• Ultragenyx leads and funds global development for setrusumab.
• Mereo BioPharma Group plc retains EU/UK commercial rights.
• Potential milestone payments to Mereo BioPharma Group plc: up to $245 million.
• Phase 3 final data expected around year-end 2025.

Direct Commercial Sales Force and Distribution Network in EU/UK (Future Channel)

For the territories where Mereo BioPharma Group plc has retained commercial rights-the EU and UK-the channel shifts from partnership to direct engagement, though this is a future state contingent on regulatory approval. Pre-commercial efforts are continuing in Europe, which is a key preparatory step for this channel. These activities include the ongoing SATURN program, which works with existing Osteogenesis Imperfecta (OI) datasets to build a better understanding of the natural history and the unmet medical need. This data is crucial to support the health economic model required for assessment by Regulatory and Health Technology Assessment (HTA) bodies and payors. The strategy is to build a small, targeted sales infrastructure to commercialize the product once approved in these select markets. It's a classic biotech pivot: from R&D focus to market access focus.

• Mereo BioPharma Group plc holds setrusumab commercial rights in EU/UK.
• Pre-commercial efforts include the SATURN program.
• Focus on generating data to support HTA and payor assessment.

Academic and Clinical Trial Sites for Patient Recruitment and Data Generation

The clinical trial sites serve as the essential channel for generating the data required for regulatory submissions and establishing efficacy. The Phase 3 Orbit study, which evaluates setrusumab in patients aged 5 to 25 years, has enrolled 159 patients across 45 sites in 11 countries. The parallel Cosmic study, for younger patients aged 2 to less than 7 years, also contributes to this data generation channel. Historically, prior R&D for setrusumab included four clinical trials conducted by Novartis involving 106 patients and healthy volunteers, plus a Phase 2b (ASTEROID) study in 112 adult patients. The Phase 2 portion of the Orbit study itself involved 24 pediatric and young adult patients. These sites are the physical touchpoints for the product's clinical journey.

Trial/Study Component	Patient Count (Approximate)	Site Count (Approximate)	Countries (Approximate)
Phase 3 Orbit Study (Enrolled)	159	45	11
Phase 2 Orbit Portion	24	N/A	N/A
Phase 2b ASTEROID Study	112	N/A	N/A
Prior Novartis Trials	106	N/A	N/A

Investor Presentations and Financial Reporting (NASDAQ: MREO)

The financial markets and investor community are a critical channel for capital formation and maintaining public listing status on NASDAQ. The company communicates through regular financial reporting and investor presentations. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million, which management expects will support operations into 2027. This financial stability is key to sustaining the channels above. The total ordinary shares issued as of that date were 795,484,404, with 159,096,880 total ADS equivalents. The market capitalization as of November 2025 was reported around $288 million. The Q3 2025 results showed a net loss of $7.0 million, an improvement from the $15.0 million loss in Q3 2024, with R&D expenses at $4.3 million and General and Administrative expenses at $6.0 million for the quarter. These figures are the direct output of the company's operational channels.

Here's a quick look at the latest reported balance sheet snapshot:

Financial Metric	Amount as of September 30, 2025 (In thousands)	Amount as of December 31, 2024 (In thousands)
Cash and Cash Equivalents	$48,700	$69,800
Net Loss (Q3)	$(7,000)	$(15,000) (Q3 2024)
R&D Expenses (Q3)	$4,300	N/A
G&A Expenses (Q3)	$6,000	N/A

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Segments

You're looking at the distinct groups Mereo BioPharma Group plc targets with its rare disease assets as of late 2025. This is a focused approach, centered on patient populations where current treatment options are limited.

The primary patient segments are defined by the rare diseases targeted by their clinical-stage product candidates:

• Global patients with Osteogenesis Imperfecta (OI), a brittle bone disease, who are candidates for setrusumab.
• Patients suffering from Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), the target for alvelestat.
• Patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2) for vantictumab.

The fourth key customer segment involves external entities looking to acquire or partner on these late-stage assets:

• Large pharmaceutical and biotech companies seeking late-stage rare disease assets.

Here's a look at the estimated patient populations for the core indications, based on available data:

Disease Indication	Product Candidate	Geographic Scope	Estimated Patient Population
Osteogenesis Imperfecta (OI)	Setrusumab	U.S. and Europe	60,000 people
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	North America	Estimated 50,000 people with severe deficiency
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	Europe	Estimated 60,000 people with severe deficiency
Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Vantictumab	Not specified	Data not available

For the segment of large pharmaceutical and biotech companies, Mereo BioPharma Group plc's financial position and pipeline maturity define the attractiveness of a potential transaction. The company's cash position as of September 30, 2025, was $48.7 million, with guidance to fund operations into 2027. This runway supports execution through key milestones, such as the expected final analyses for the setrusumab Phase 3 studies around the end of 2025. The company is actively advancing partnering discussions for alvelestat. The total ordinary shares issued as of September 30, 2025, stood at 795,484,404. The net loss for the third quarter ended September 30, 2025, was $7.0 million.

The customer segment seeking vantictumab is defined by the rare bone disease ADO2. Mereo BioPharma Group plc retained European commercial rights in a partnership deal with āshibio for this asset, following promising preclinical data presented at the 2025 ASBMR Annual Meeting.

The OI patient segment is being addressed through the setrusumab program, partnered with Ultragenyx, with final analyses for the Phase 3 Orbit and Cosmic studies expected around the end of 2025. The statistical threshold for success in the Orbit study was set at p<0.039.

For AATD-LD patients, alvelestat is being advanced, with the company finalizing start-up activities for a Phase 3 pivotal study, which is key to ongoing partnering processes. Alvelestat has Orphan Designation from both the EMA and the FDA.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Mereo BioPharma Group plc's operations as of late 2025. For a clinical-stage company, the cost structure is heavily weighted toward advancing its pipeline, meaning R&D is the dominant factor.

Heavy investment in Research and Development (R&D) for clinical trials represents a major cash outflow. For the three months ended September 30, 2025, total Research and Development expenses were reported at $4.3 million. This R&D spend is concentrated on key programs.

The cost structure includes significant spending tied to the setrusumab program, which is in Phase 3 trials. The R&D expenses for setrusumab specifically increased by $0.9 million in the third quarter of 2025 compared to the prior year period. Also contributing to R&D was alvelestat, with an increase of $0.5 million in Q3 2025 R&D expenses.

Manufacturing and supply costs for setrusumab, paid to Ultragenyx, are embedded within the R&D figures. The increase in R&D expenses for setrusumab during the third quarter of 2025 was primarily driven by amounts due under the manufacturing and supply agreement with the partner, Ultragenyx.

General and Administrative (G&A) expenses showed some cost control in the quarter. For the third quarter of 2025, General and Administrative expenses were $6.0 million. This was a decrease of $0.2 million compared to the third quarter of 2024, which the company attributed primarily to lower professional fees.

Regarding personnel costs for a lean team focused on R&D and business development, while the structure implies a focus on keeping headcount low, the specific dollar amount for personnel costs is not broken out separately from G&A or R&D in the provided data. However, the overall operating discipline is evident in the net loss figures.

The cumulative effect of these costs is reflected in the bottom line for the longer reporting period. The Net loss for the nine months ended September 30, 2025, was $34.53 million.

Here's a quick look at the key cost and loss metrics for the period:

Financial Metric	Period	Amount (USD)
General and Administrative Expenses	Three Months Ended September 30, 2025	$6.0 million
Total Research and Development Expenses	Three Months Ended September 30, 2025	$4.3 million
Net Loss	Nine Months Ended September 30, 2025	$34.53 million
Setrusumab R&D Expense Increase (YoY)	Three Months Ended September 30, 2025	$0.9 million

The company's cash position as of September 30, 2025, was $48.7 million, which management expected to support operations into 2027.

You can see the quarterly loss trajectory, which helps frame the burn rate:

• Net Loss for Q3 2025 was $7.0 million.
• Net Loss for Q3 2024 was $15.0 million.
• The Q3 2025 loss benefited from a foreign currency transaction gain of $1.9 million.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Revenue Streams

You're looking at how Mereo BioPharma Group plc brings in cash right now, late in 2025, which is heavily weighted toward development achievements rather than product sales, given the pipeline stage. Honestly, the revenue quality right now is non-recurring, which is typical for a clinical-stage company awaiting key data readouts.

The core of the current revenue recognition comes from the deals already struck, particularly the one with Ultragenyx for setrusumab, and the smaller licensing arrangements for non-core assets.

Here's a quick look at the financial components driving the top line:

Revenue Source Category	Specific Component/Asset	Reported/Potential Amount	Period/Status
Milestone Payments (Non-Core)	Leflutrozole Clinical Milestone	$0.5 million	Recognized in Q2 2025
Milestone Payments (Core)	Setrusumab Development Progress (Ultragenyx)	Up to $245 million potential	Contingent on future progress
Royalties (Future Sales)	Setrusumab Commercial Sales (Ultragenyx Territories)	Tiered Royalties	Contingent on commercial launch
Product Sales (Future)	Setrusumab EU/UK Commercial Sales	Analyst Estimate: $22.0 million for Q4 2025	Post-approval expectation
Total Recognized Revenue	Cumulative Sales to Date	$0.5 million	For the nine months ended September 30, 2025

You should note that for the third quarter ended September 30, 2025, Mereo BioPharma reported $0.0 million in revenue, as the Q2 figure was driven by that one-time milestone event.

The structure of the setrusumab partnership dictates how future cash flows will be split. It's important to track these potential payments as they are significant drivers for the company's non-dilutive funding potential.

The revenue streams are clearly segmented by asset and partner responsibility:

• Milestone payments from Ultragenyx for setrusumab development progress.
• Royalties on future commercial sales of setrusumab in Ultragenyx territories.
• Licensing revenue from non-core assets, exemplified by the $0.5 million milestone in Q2 2025 from leflutrozole.
• Future direct product sales in the EU/UK for setrusumab post-approval, where Mereo BioPharma Group plc has retained commercial rights.

To be fair, analyst models suggest that if the pipeline progresses as hoped, the full year 2025 sales estimate is $28.4 million, which would represent a major shift from the current run rate.

Finance: draft 13-week cash view by Friday.