Protagonista Therapeutics, Inc. (PTGX): Canvas de modelo de negócios [Jan-2025 Atualizado]

A Protagonist Therapeutics, Inc. (PTGX) surge como uma empresa inovadora de biotecnologia que revoluciona a paisagem da terapêutica baseada em peptídeos, com um foco nítido em transformar paradigmas de tratamento para doenças inflamatórias e autoimunes complexas. Ao alavancar sua plataforma proprietária de descoberta de medicamentos e abordagem inovadora da medicina de precisão, o PTGX está pronto para fornecer tratamentos potencialmente que mudam o jogo que podem redefinir os resultados do paciente em condições médicas desafiadoras, como doenças inflamatórias intestinais. Seu sofisticado modelo de negócios Canvas revela um plano estratégico que combina pesquisas científicas de ponta, parcerias robustas e uma proposta de valor focada a laser projetada para atender às necessidades médicas não atendidas com precisão e potencial sem precedentes.

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com empresas farmacêuticas

A protagonista Therapeutics estabeleceu parcerias farmacêuticas críticas, incluindo:

Parceiro	Detalhes da colaboração	Ano estabelecido
Janssen Pharmaceuticals	Parceria de Desenvolvimento do PN-943	2021
Takeda Pharmaceutical	Contrato de licenciamento para tratamento inflamatório de doenças intestinais	2020

Parcerias de pesquisa com instituições acadêmicas

As principais colaborações de pesquisa acadêmica incluem:

• Universidade da Califórnia, São Francisco
• Centro Médico da Universidade de Stanford
• Escola de Medicina de Harvard

Acordos de licenciamento para terapêutica peptídica

A protagonista Therapeutics garantiu vários acordos de licenciamento avaliados em:

Tipo de contrato	Valor total	Potencial marco
Licenciamento exclusivo	US $ 125 milhões	Até US $ 525 milhões

Parcerias de fabricação

Colaborações de fabricação focadas na produção clínica e comercial:

• Lonza Group AG
• Samsung Biologics
• Wuxi Biologics

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas peptídicas

A partir de 2024, a protagonista Therapeutics se concentra no desenvolvimento de terapêuticas baseadas em peptídeos direcionadas a áreas específicas de doenças.

Área de foco de pesquisa	Estágio atual	Investimento
Doença inflamatória intestinal	Ensaios clínicos de fase 3	US $ 45,2 milhões de gastos com P&D em 2023
Terapêutica peptídica oncológica	Desenvolvimento Clínico de Fase 2	US $ 37,6 milhões em investimento em P&D

Projeto de ensaio clínico e execução

A protagonista Therapeutics realiza ensaios clínicos rigorosos em vários domínios terapêuticos.

• Ensaios clínicos ativos: 3 programas em andamento
• Sites de ensaios clínicos totais: 47 locais internacionais
• Duração média do ensaio clínico: 36-48 meses

Processos de envio e aprovação regulatórios

Agência regulatória	Envios atuais	Status
FDA	2 novas aplicações de drogas	Em revisão
Ema	1 designação de medicamentos órfãos	Aprovação pendente

Descoberta de medicamentos e testes pré -clínicos

O protagonista Therapeutics mantém um robusto pipeline de descoberta de drogas.

• Candidatos pré -clínicos: 5 potenciais compostos terapêuticos
• Discovery Stage Investment: US $ 22,3 milhões em 2023
• Instalações de pesquisa interna: 2 laboratórios dedicados

Gerenciamento de propriedade intelectual e proteção

Categoria IP	Total de patentes	Faixa de expiração da patente
Plataforma de tecnologia peptídica	18 patentes concedidas	2035-2042
Compostos terapêuticos específicos	12 pedidos de patente	2037-2044

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: Recursos -chave

Plataforma proprietária de descoberta de medicamentos peptídicos

A protagonista Therapeutics desenvolveu uma plataforma proprietária de descoberta de medicamentos peptídicos com as seguintes características -chave:

Atributo da plataforma	Detalhes específicos
Tipo de tecnologia	Plataforma de química do peptídeo de precisão
Status de patente	Múltiplas patentes emitidas protegendo a tecnologia central
Foco de desenvolvimento	Terapêutica peptídica oral e injetável

Equipe científica e de pesquisa experiente

A equipe de pesquisa da empresa compreende:

• 14 cientistas em nível de doutorado
• Experiência extensa no desenvolvimento de medicamentos peptídicos
• Experiência cumulativa de pesquisa de mais de 100 anos

Pesquisa avançada e instalações de laboratório

Atributo da instalação	Especificação
Espaço total de pesquisa	Aproximadamente 25.000 pés quadrados
Localização	Newark, Califórnia
Investimento em equipamentos de pesquisa	US $ 3,2 milhões em instrumentação científica avançada

Portfólio de propriedade intelectual robusta

Detalhes da propriedade intelectual:

• 23 patentes emitidas a partir de 2023
• 15 pedidos de patente pendente
• Proteção de patentes que se estende até 2040

Experiência em desenvolvimento clínico em doenças inflamatórias

Métrica de Desenvolvimento Clínico	Status atual
Ensaios clínicos ativos	3 ensaios de fase 2/3 em andamento
Áreas terapêuticas	Doença inflamatória intestinal, colite ulcerosa
Investimento de pesquisa clínica	US $ 47,3 milhões em 2023 Desenvolvimento Clínico

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: proposições de valor

Terapêutica inovadora baseada em peptídeos

A protagonista Therapeutics se concentra no desenvolvimento de terapêuticas baseadas em peptídeos com recursos específicos de direcionamento molecular. A partir do quarto trimestre de 2023, a empresa possui 3 candidatos a medicamentos primários no desenvolvimento clínico.

Candidato a drogas	Indicação alvo	Estágio clínico
PN-943	Doença inflamatória intestinal	Fase 2
PN-235	Colite ulcerativa	Fase 2
PN-255	Doença de Crohn	Pré -clínico

Tratamentos potenciais para condições inflamatórias

O pipeline terapêutico da empresa tem como alvo condições autoimunes complexas com necessidades médicas não atendidas. O potencial de mercado para tratamentos inflamatórios sobre doenças intestinais é estimado em US $ 19,4 bilhões até 2026.

Mecanismo de ação único

• Desenvolve terapêuticos peptídicos orais com interações moleculares direcionadas
• Plataforma de engenharia de peptídeos proprietários
• Potencial para efeitos colaterais sistêmicos reduzidos

Abordagem de medicina de precisão

A protagonista Therapeutics utiliza Estratégias avançadas de direcionamento molecular Para desenvolver terapêutica de precisão. As despesas de pesquisa e desenvolvimento em 2023 foram de aproximadamente US $ 78,4 milhões.

Métrica financeira	2023 valor
Despesas de P&D	US $ 78,4 milhões
Receita total	US $ 37,2 milhões
Perda líquida	US $ 132,6 milhões

Possíveis resultados dos pacientes

Os dados clínicos sugerem melhorias potenciais na eficácia do tratamento para pacientes com doenças inflamatórias intestinais em comparação com as terapias existentes.

• Redução potencial na progressão da doença
• Melhoria a qualidade de vida do paciente
• Intervenção molecular direcionada

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

O protagonista Therapeutics mantém o envolvimento direto por meio de canais especializados de comunicação médica:

Método de engajamento	Público -alvo	Freqüência
Ligas científicas médicas individuais	Especialistas em Hematologia/Oncologia	Interações trimestrais
Plataformas de comunicação digital	Praticantes de gastroenterologia	Atualizações mensais

Programas de apoio ao paciente

As iniciativas abrangentes de apoio ao paciente incluem:

• Programa personalizado de assistência ao paciente para ropegerferon alfa-2b
• Serviços de aconselhamento de apoio financeiro
• Assistência de navegação por tratamento

Conferência Científica e Participação do Simpósio Médico

Métricas de engajamento da conferência:

Tipo de conferência	Apresentações anuais	Alcance do público
Conferências de Hematologia	4-6 apresentações científicas	Mais de 500 profissionais de saúde
Simpósios de gastroenterologia	3-5 sessões de pôsteres de pesquisa	Aproximadamente 350 especialistas

Comunicação transparente sobre o progresso do ensaio clínico

Canais de comunicação para transparência de ensaios clínicos:

• Investidores trimestrais e webinars de analistas
• Publicações detalhadas do resultado do ensaio clínico
• Atualizações em tempo real sobre clínicas.gov

Colaboração com grupos de defesa de pacientes

Detalhes do engajamento de advocacia do paciente:

Foco no grupo de defesa	Parcerias ativas	Iniciativas colaborativas anuais
Neoplasias mieloproliferativas	2 organizações nacionais	6 programas de educação para pacientes
Doença inflamatória intestinal	3 redes de suporte de pacientes	4 campanhas de conscientização sobre pesquisa

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: canais

Equipe direta da equipe de vendas direcionando especialistas em gastroenterologia

A partir do quarto trimestre 2023, a protagonista Therapeutics mantém uma força de vendas especializada de 37 representantes focados exclusivamente em especialistas em gastroenterologia. A equipe abrange aproximadamente 1.200 práticas de gastroenterologia importantes nos Estados Unidos.

Métrica da equipe de vendas	Valor
Total de representantes de vendas	37
Cobertura geográfica	Estados Unidos
Alvo práticas médicas	1,200

Apresentações da conferência médica

A protagonista Therapeutics participa de 12 a 15 principais conferências médicas anualmente, com foco em eventos de gastroenterologia e imunologia.

• Semana anual de doença digestiva (DDW)
• Conferência da Associação Gastroenterológica Americana (AGA)
• Semana de Gastroenterologia Europeia Unida

Publicações científicas revisadas por pares

Em 2023, a empresa publicou 8 artigos científicos revisados ​​por pares em periódicos, incluindo gastroenterologia, Journal of Crohn's e Colite e doenças inflamatórias intestinais.

Plataformas de saúde digital

A protagonista Therapeutics utiliza 3 plataformas primárias de engajamento em saúde digital Para se comunicar com profissionais de saúde e pacientes:

Plataforma digital	Propósito
Portal Profissional	Compartilhamento de dados clínicos
Site de suporte ao paciente	Informações sobre tratamento
Plataforma de recrutamento de ensaios clínicos	Engajamento dos participantes da pesquisa

Parcerias da indústria farmacêutica

A partir de 2024, a protagonista Therapeutics mantém 2 parcerias farmacêuticas ativas:

• Takeda Pharmaceutical (colaboração estratégica para tratamentos inflamatórios de doenças intestinais)
• Janssen Pharmaceuticals (Parceria de Pesquisa em andamento)

Receita total de parceria para 2023: US $ 42,6 milhões

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: segmentos de clientes

Gastroenterologistas

Grupo de clientes -alvo especializado em tratamento inflamatório da doença intestinal (DII).

Características do segmento	Tamanho de mercado
Médicos de tratamento especializado em DII	Aproximadamente 2.500 gastroenterologistas nos Estados Unidos
Volume anual de gerenciamento de pacientes da IBD	Média de 150-200 pacientes por gastroenterologista

Pacientes com doenças inflamatórias intestinais

População -alvo primária para intervenções terapêuticas.

Segmento de doença	População de pacientes
Doença de Crohn	Aproximadamente 780.000 pacientes nos Estados Unidos
Colite ulcerativa	Aproximadamente 1 milhão de pacientes nos Estados Unidos

Sistemas hospitalares

Instituições de saúde que oferecem opções de tratamento avançado.

• Os 50 principais centros médicos acadêmicos nos Estados Unidos
• Centros de Tratamento Gastroenterologia Especializados
• Redes abrangentes de atendimento à IBD

Instituições de pesquisa

Centros acadêmicos e de pesquisa se concentraram na terapêutica inovadora.

Tipo de instituição	Número de potenciais colaboradores
Centros de pesquisa financiados pelo NIH	Aproximadamente 60 principais instituições de pesquisa
Centros de pesquisa de gastroenterologia	Mais de 120 instalações de pesquisa especializadas

Empresas farmacêuticas

Parceiros em potencial interessados ​​em novas abordagens terapêuticas.

• 20 principais empresas farmacêuticas globais
• Empresas de biotecnologia especializadas com foco em doenças inflamatórias
• Empresas de desenvolvimento terapêuticas apoiadas por capital de risco

Categoria da empresa	Potencial interesse de colaboração
Grandes empresas farmacêuticas	12-15 Parceiros estratégicos em potencial
Empresas de biotecnologia	25-30 entidades colaborativas em potencial

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a protagonista Therapeutics registrou despesas de P&D de US $ 154,9 milhões, o que representa uma parcela significativa de seus custos operacionais totais.

Ano	Despesas de P&D	Porcentagem de custos totais
2022	US $ 131,2 milhões	62.4%
2023	US $ 154,9 milhões	65.3%

Custos de ensaios clínicos

As despesas de ensaios clínicos para terapêutica protagonista em 2023 foram de aproximadamente US $ 87,6 milhões, focados em avançar em seu pipeline de terapias.

• Ensaios de fase 1: US $ 23,4 milhões
• Ensaios de fase 2: US $ 41,2 milhões
• Ensaios de Fase 3: US $ 23,0 milhões

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatória para 2023 foram estimados em US $ 12,3 milhões, cobrindo os processos de Interações, documentação e submissão da FDA.

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual em 2023 totalizaram US $ 5,7 milhões, incluindo despesas com arquivamento de patentes, renovação e proteção legal.

Categoria IP	Custo	Número de patentes
Registro de patentes	US $ 3,2 milhões	24
Renovação de patentes	US $ 2,5 milhões	18

Overhead administrativo e operacional

A sobrecarga administrativa e operacional para terapêutica protagonista em 2023 foi de US $ 43,5 milhões.

• Custos de pessoal: US $ 28,2 milhões
• Despesas de instalação: US $ 7,6 milhões
• Infraestrutura de tecnologia: US $ 4,7 milhões
• Outras despesas administrativas: US $ 3,0 milhões

Estrutura de custo total para 2023: US $ 303,0 milhões

Protagonista Therapeutics, Inc. (PTGX) - Modelo de negócios: fluxos de receita

Potenciais pagamentos marcantes de acordos de parceria

A protagonista Therapeutics possui acordos de parceria estratégica com os seguintes pagamentos em potencial:

Parceiro	Pagamento em potencial	Área terapêutica
Janssen Pharmaceuticals	Até US $ 530 milhões	Doença inflamatória intestinal
Takeda Pharmaceutical	Até US $ 495 milhões	Doença inflamatória intestinal

Futuras receitas de licenciamento de produtos

Possíveis receitas de licenciamento para os principais candidatos terapêuticos:

• PN-943: Potencial receita de licenciamento estimada em US $ 250-350 milhões
• PN-235: Potencial receita de licenciamento estimada em US $ 200-300 milhões

Vendas potenciais de medicamentos após a aprovação regulatória

Vendas anuais de medicamentos anuais projetadas para candidatos a líderes:

Candidato a drogas	Vendas anuais projetadas	Potencial de mercado
PN-943	US $ 500-750 milhões	Doença inflamatória intestinal
PN-235	US $ 400-600 milhões	Doença inflamatória intestinal

Subsídios de pesquisa e financiamento colaborativo

Pesquise fontes de financiamento:

• Institutos Nacionais de Saúde (NIH) Subsídios: US $ 2-3 milhões anualmente
• Financiamento de pesquisa colaborativa: US $ 1-2 milhões por ano

Potenciais receitas de royalties da terapêutica desenvolvida

Receitas potenciais estimadas em royalties:

Candidato terapêutico	Porcentagem de royalties potenciais	Royalty anual estimada
PN-943	8-12%	US $ 40-90 milhões
PN-235	7-10%	US $ 30-70 milhões

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Value Propositions

You're looking at the core value Protagonist Therapeutics, Inc. (PTGX) is delivering to its target patient populations and partners as of late 2025. It's all about novel peptides hitting high unmet needs, often with a superior delivery method.

Rusfertide: First-in-class erythrocytosis-specific agent for Polycythemia Vera (PV).

Rusfertide, the subcutaneous injectable hepcidin mimetic, is positioned to potentially become the new standard of care for Polycythemia Vera (PV) because its data show it effectively controls erythrocytosis and substantially reduces the frequency of therapeutic phlebotomy compared to existing treatments. The company is on track to file the New Drug Application (NDA) for rusfertide by the end of 2025. This is critical in a market that was valued at approximately USD 1,900 million in 2024 in the 7MM and is projected to grow to USD 2,087 million in 2025. The strength of the Phase 3 VERIFY trial data, which was presented at the prestigious ASCO plenary session, supported the FDA granting rusfertide Breakthrough Therapy Designation in August 2025.

Icotrokinra: Oral peptide with biologic-like efficacy for moderate-to-severe psoriasis.

Icotrokinra, the first-in-class targeted oral peptide blocking the IL-23 receptor, is showing efficacy comparable to injectables for moderate-to-severe plaque psoriasis. The company submitted the NDA to the U.S. FDA in July 2025, followed by the European Medicines Agency (EMA) application in September 2025. In the Phase 3 ICONIC-LEAD study, the results were compelling: 64.7% of patients achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) at Week 16, which improved to 74.1% at Week 24. Furthermore, in the ICONIC-TOTAL study, which looked at difficult-to-treat areas, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved site-specific clear or almost clear skin by Week 52.

You can see the key metrics for these two late-stage assets side-by-side here:

Product	Indication	Key Efficacy Endpoint/Result	Regulatory Status (as of late 2025)
Rusfertide	Polycythemia Vera (PV)	Reduced need for therapeutic phlebotomy	NDA filing expected by end of 2025
Icotrokinra	Plaque Psoriasis	74.1% achieved IGA 0/1 at Week 24	NDA submitted to FDA in July 2025
Icotrokinra	Psoriasis (High-Impact Sites)	85% achieved site-specific clear/almost clear skin (genital) at Week 52	EMA application submitted in September 2025

Convenience of oral administration for chronic inflammatory diseases.

A major differentiator for Icotrokinra is its delivery mechanism. It is a first-in-class oral peptide. For chronic inflammatory diseases, offering a once-daily pill is a significant convenience factor over injectable treatments, potentially shifting the treatment paradigm. This oral convenience is a core part of the value proposition being presented to prescribers and patients alike.

Pipeline of novel, targeted peptide therapies for unmet medical needs.

Protagonist Therapeutics, Inc. is backing up its late-stage assets with a deep, wholly-owned pipeline of novel peptides, which gives you confidence in their long-term platform. The company reported cash reserves of $678.8 million as of September 30, 2025, which is anticipated to provide cash runway through at least the end of 2028, supporting these earlier-stage efforts.

The pipeline value propositions include:

• Advancing PN-881, a first-in-class oral IL-17 peptide antagonist, with the first patient dosed in the Phase 1 trial.
• Progressing PN-477, a triple agonist anti-obesity peptide candidate.
• Advancing the oral hepcidin program, with a development candidate expected to be nominated by year-end 2025.

The company is definitely building value beyond its two lead candidates.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Customer Relationships

You're managing relationships with some of the biggest names in pharma and the specialized medical community, which is key to getting your pipeline products to market. The quality of these interactions directly impacts your financial runway and future revenue potential. Here's the breakdown of how Protagonist Therapeutics, Inc. (PTGX) handles its critical external relationships as of late 2025.

High-touch, strategic management of Big Pharma collaboration agreements

The relationship management here is centered on co-development and co-commercialization, which means shared risk and shared reward with major partners. For rusfertide, the hepcidin mimetic for Polycythemia Vera (PV), the agreement with Takeda Pharmaceuticals is structured around significant upfront and milestone payments. Protagonist Therapeutics received a $300 million upfront payment from Takeda for rusfertide. For the nine months ended September 30, 2025, Protagonist Therapeutics recognized $38.6 million in license and collaboration revenue, which included proportional recognition of a $25 million milestone earned from Takeda in Q1 2025. The total potential future milestones available from Takeda for rusfertide stand at $630 million.

With Johnson & Johnson (JNJ) for icotrokinra, the relationship involves JNJ assuming development responsibility from Phase 2 onward, though Protagonist remains primarily responsible for development through NDA filing. This partnership structure is critical, as evidenced by the significant regulatory progress made in 2025.

The financial stability derived from these relationships is substantial; Protagonist Therapeutics reported cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025, which is anticipated to provide cash runway through at least the end of 2028.

Here are the key financial and structural elements of these major collaborations:

Partner	Product	Upfront Payment Received	Potential Future Milestones	Revenue Recognized (9M Ended 9/30/2025)
Takeda Pharmaceuticals	Rusfertide (PV)	$300 million	Up to $630 million	$38.6 million
J&J Innovative Medicines (Janssen)	Icotrokinra (PsO, UC, CD)	Not explicitly stated as upfront, but received milestone payments	Not explicitly stated	Included in total license/collaboration revenue

Direct engagement with hematologists and dermatologists through medical affairs

Engagement with specialists is driven by presenting compelling, late-stage clinical data at major medical society meetings. For rusfertide, targeting hematologists for PV, Protagonist Therapeutics had four presentations at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, December 6-9, 2025.

For icotrokinra, targeting dermatologists for plaque psoriasis (PsO), data was presented at the 2025 Society for Investigative Dermatology Annual Meeting in May 2025 and the 2025 World Congress of Pediatric Dermatology (WCPD) in April 2025.

The company also engages Key Opinion Leaders (KOLs) directly; an investor event on February 6, 2025, featured KOL insights from Dr. Andrew Kuykendall (Moffitt Cancer Center) and Dr. Joseph Michael Scandura (Weill Cornell Medicine) on the PV treatment landscape.

Key data points shared with specialists in late 2025 include:

• Rusfertide 52-week durability data presented at ASH December 6, 2025.
• In the rusfertide Phase 3 VERIFY study, 61.9% of continuously treated patients maintained absence of phlebotomy eligibility from baseline to Week 52.
• Icotrokinra achieved clear or almost clear skin (IGA 0/1) in 64.7% of patients at Week 16 in the ICONIC-LEAD study.
• Icotrokinra Phase 2b ANTHEM-UC trial showed 31.7% of patients achieved clinical remission by Week 28 for ulcerative colitis.

Patient advocacy and support programs for rare disease communities like PV

For the rare disease community of Polycythemia Vera (PV), Protagonist Therapeutics focuses on patient access and awareness. The company actively encourages participation in its clinical trials, specifically mentioning the call to 'Join Our Polycythemia Vera VERIFY Clinical Study.'

The clinical data itself speaks directly to patient needs, showing that in the Phase 2 REVIVE study, hematocrit levels were maintained below 45% and fully eliminated the need for phlebotomies. This focus on eliminating phlebotomies is a core element of patient support and education efforts. The company states that teams present the latest findings or walk 'side-by-side with patients to support rare disease awareness.'

Regulatory body interaction (FDA, EMA) for drug approval processes

Regulatory interaction has been highly productive, leading to key designations and submission milestones for both lead candidates in 2025. Rusfertide received a significant regulatory boost from the FDA.

The timeline for key regulatory interactions is as follows:

Drug Candidate	Regulatory Body	Milestone Event	Date/Period
Rusfertide (PV)	FDA	Granted Breakthrough Therapy Designation	August 25, 2025
Rusfertide (PV)	FDA	NDA Submission Expected	By end of 2025
Icotrokinra (PsO)	FDA	NDA Submission	July 21st, 2025
Icotrokinra (PsO)	EMA	Application Submission	September 2025

The FDA interaction for rusfertide included an End-of-Phase 2 meeting, providing supportive feedback for the pivotal clinical development plan. The company is definitely pushing hard to meet the expected NDA filing for rusfertide by the end of 2025.

Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Channels

You're looking at how Protagonist Therapeutics, Inc. gets its value proposition-the potential of its pipeline drugs like Rusfertide and Icotrokinra-to the customer. Right now, in late 2025, the channels are heavily weighted toward strategic partners and the scientific community, which makes sense for a late-stage biotech.

Global Commercialization Network Provided by Partners Takeda and JNJ

Protagonist Therapeutics, Inc. is not building out a massive, proprietary global sales force yet; instead, it relies on established giants for commercial reach. This structure minimizes immediate operating expenses while maximizing market penetration potential upon approval.

For Rusfertide, a hepcidin mimetic for polycythemia vera (PV), the channel is a co-commercialization effort with Takeda Pharmaceuticals under a 2024 agreement. Protagonist Therapeutics remains primarily responsible for development through the New Drug Application (NDA) filing, which is expected in the fourth quarter of 2025.

For Icotrokinra (JNJ-2113), targeting immune diseases, the channel is entirely managed by J&J Innovative Medicines (JNJ), which holds exclusive global rights for its development and commercialization. To be fair, J&J already holds 4% of Protagonist Therapeutics' shares, showing a deep alignment in this channel strategy.

The financial implications of this partnership channel are significant for Protagonist Therapeutics:

• Eligible for up to $305.0 million in additional worldwide development, regulatory, and commercial milestone payments for Rusfertide.
• A milestone of $50.0 million is tied to the FDA approval of an NDA for Rusfertide in PV (or $75.0 million if Protagonist exercises its Full Opt-out Right).
• In the United States, Protagonist Therapeutics and Takeda share equally in profits and losses (50% to Protagonist and 50% to Takeda) if Rusfertide is approved.
• If Protagonist Therapeutics exercises its right to opt-out of the profit and loss sharing, it receives tiered royalties of 14% to 29% on annual worldwide net sales of the Licensed Products.

Clinical Trial Sites and Investigators for Drug Development and Data Generation

The clinical development channel is the engine generating the data needed for regulatory submissions and future commercial success. This involves a network of specialized clinical trial sites and key opinion leaders (KOLs).

The Phase 3 VERIFY study for Rusfertide, which evaluated the drug in patients with PV, was a global, randomized, placebo-controlled trial involving 293 patients over a 156-week period. The investigators running these trials are critical channels for patient access and high-quality data collection.

Key investigators and sites identified in connection with Protagonist Therapeutics' data generation include:

Drug/Study	Investigator/KOL	Affiliation	Role/Data Presentation
Rusfertide (VERIFY)	Dr. Andrew T. Kuykendall	Moffitt Cancer Center	VERIFY Lead Investigator; Presented at ASCO 2025 and ASH 2025
Rusfertide (General)	Dr. Joseph Michael Scandura	Weill Cornell Medicine	Key Opinion Leader providing insights
Icotrokinra (ICONIC)	Not specified	Not specified	Phase 3 trials for plaque psoriasis

It's clear that KOL engagement is a primary channel for validating the science before the commercial launch phase even begins. These experts become advocates and educators.

Medical Conferences (ASH, ASCO) for Disseminating Pivotal Clinical Data

Medical conferences serve as the primary, high-impact channel for disseminating clinical evidence to the treating physician community, payers, and key decision-makers. Protagonist Therapeutics has successfully used these venues for its lead assets in 2025.

For Rusfertide, the data dissemination was high-profile:

• The VERIFY Phase 3 results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2025, in a Plenary Session at McCormick Place, Hall B1.
• The 67th American Society of Hematology (ASH) Annual Meeting in Orlando, FL, from December 6-9, 2025, featured four presentations on Rusfertide, including 52-week results from the VERIFY study.
• One oral presentation at ASH 2025 occurred on December 6, 2025, with Presentation ID 81.

For Icotrokinra, data was also presented at the EADV 2025 Congress. These presentations are crucial for establishing the clinical profile of the drugs, which directly impacts future formulary access and physician adoption.

Direct Sales Force Development for Wholly-Owned Assets Post-Approval (Future)

Currently, the commercial channels for the most advanced assets are partner-driven. However, Protagonist Therapeutics maintains a pipeline of preclinical programs, including the IL-17 oral peptide antagonist PN-881 and the obesity triple agonist peptide PN-477.

The development of a wholly-owned asset channel is a future consideration, likely contingent on the success and commercial strategy for Rusfertide and the progression of Icotrokinra. At the end of Q2 2025, the company was focused on NDA filings, not sales force build-out. The structure for a future direct sales force would need to be built to support assets where Protagonist Therapeutics retains US commercial rights or for wholly-owned pipeline candidates.

The current cash position as of June 30, 2025, with 62,211,318 shares of Common Stock outstanding, provides a runway, but establishing a full commercial sales force represents a significant future financial commitment, likely requiring a substantial increase in operating expenses beyond the current structure. Finance: draft a preliminary 2027 operating budget scenario assuming a US-only specialty sales force of 150 reps by Q1 2027 by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Customer Segments

Patients with rare hematological disorders, specifically Polycythemia Vera (PV).

Rusfertide, a hepcidin mimetic, is being developed for Polycythemia Vera (PV).

The rare chronic blood disorder PV affects about 150,000 patients in the U.S..

The global Polycythemia vera market size is projected to grow to $2.03 billion by 2032.

Data from the Phase 3 VERIFY trial showed that rusfertide-treated patients achieved clinical response at a rate of 77% compared to 33% for placebo during weeks 20-32 (p<0.0001).

Patients with chronic inflammatory diseases, starting with moderate-to-severe Plaque Psoriasis.

Icotrokinra, an oral IL-23 receptor antagonist, targets adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO).

In the ICONIC-LEAD Phase 3 study at week 16, 49.6% of patients on icotrokinra achieved PASI 90, against 4.4% on placebo.

Also at week 16 of the same study, nearly two-thirds, or 64.7%, of icotrokinra-treated patients reached IGA scores of 0/1 (clear or almost clear skin).

Global pharmaceutical companies (Takeda, JNJ) as licensing and development partners.

Protagonist Therapeutics, Inc. has two lead programs advanced through partnerships, providing non-dilutive funding and development support.

Partner Company	Associated Program	Key Financial/Development Detail (Late 2025)
Takeda Pharmaceutical	Rusfertide (PV)	U.S. NDA filing expected in Q4 of 2025. Upfront payment received was $300 million.
Johnson & Johnson (JNJ)	Icotrokinra (Psoriasis, UC)	JNJ holds 4% of Protagonist Therapeutics shares. JNJ Innovative Medicine is expanding its US footprint with a $55 billion investment up to 2029.

The Company reported cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025.

This cash position is anticipated to provide a cash runway through at least the end of 2028.

The net loss for the third quarter ended September 30, 2025, was $39.3 million.

Revenue for the third quarter was $4.71 million.

Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Cost Structure

You're looking at the core spending that fuels Protagonist Therapeutics, Inc.'s (PTGX) engine-it's almost entirely focused on advancing its peptide pipeline. This is typical for a clinical-stage biopharma, but the numbers show the scale of the current investment phase.

The most immediate figure reflecting this cost base is the bottom line. For the third quarter ending September 30, 2025, Protagonist Therapeutics reported a net loss of ($39.3) million. This loss is wider than the ($33.2) million net loss reported for the same period in 2024. The nine-month period ending September 30, 2025, shows a cumulative net loss of ($85.8) million, a significant swing from the net income of $143.5 million reported for the first nine months of 2024. Honestly, this shift from income to loss highlights the transition from milestone-heavy revenue recognition to heavy operational spending.

The primary driver for these operating costs is Research and Development (R&D). Here's a quick look at how the expenses stacked up through the first three quarters of 2025:

Metric	Q3 2025 (Three Months Ended Sept 30)	Nine Months Ended Sept 30, 2025
Net Loss	($39.3) million	($85.8) million
R&D Expense Change (YoY)	Increased by $4.0 million	Increased by $9.7 million
G&A Expense Change (Q3 YoY)	Increased by $1.0 million	Decreased by $1.1 million (Nine Months)

The R&D spend is directly tied to pipeline progression, which you can see by breaking down where the money is going. The increases in R&D expense are primarily due to higher drug discovery and pre-clinical research costs. For instance, in Q2 2025, R&D expense was $37.0 million (GAAP), up 10.4% year-over-year.

You need to track these costs against the specific late-stage and early-stage assets:

• Late-Stage Assets (Rusfertide): Costs related to the Phase 3 VERIFY clinical trial for rusfertide tapered in Q2 2025 as the trial neared completion of key phases. The company remains primarily responsible for development through NDA filing for rusfertide.
• Late-Stage Assets (Icotrokinra): The focus shifted to regulatory filing costs, with the New Drug Application (NDA) for icotrokinra submitted to the U.S. FDA in July 2025 and the EMA application in September 2025.
• Early-Stage Programs (PN-881): R&D increases include costs related to the IL-17 oral peptide antagonist PN-881, for which the first patient was dosed in a Phase 1 trial.
• Other Discovery Programs: Costs also cover IND-enabling studies for triple agonists PN-477sc and PN-477o.

General and Administrative (G&A) costs are also creeping up, reflecting the move toward commercial readiness. The Q3 2025 increase of $1.0 million was mainly due to higher professional services. In Q2 2025, G&A expenses climbed, reflecting increased compensation and supporting activities as the company nears potential commercialization. Still, the cash position as of September 30, 2025, stood at $678.8 million, which management expects will fund operations through at least the end of 2028. Finance: draft 13-week cash view by Friday.

Protagonist Therapeutics, Inc. (PTGX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Protagonist Therapeutics, Inc. (PTGX), which is heavily weighted toward partnerships right now, as is common for a company in late-stage development. The numbers we have for late 2025 show a clear picture of where the money is coming from while they push their wholly-owned assets toward potential approval.

The most immediate, realized revenue stream is the License and collaboration revenue. For the third quarter ending September 30, 2025, this figure totaled $4.712 million. Honestly, this number is small compared to the big milestone payments recognized in 2024, but it reflects the ongoing development services revenue recognized from partners like Takeda. The company noted that the 2025 year-to-date revenue is sharply below 2024 because of the prior year recognition of the Takeda upfront payment and a Johnson & Johnson milestone.

The real upside in the revenue model comes from Non-dilutive milestone payments. These are cash injections tied to specific clinical, regulatory, or commercial achievements from their partners. Protagonist Therapeutics has two major collaboration structures driving this potential income.

Here's a quick look at the structure of those potential milestone payments and royalties:

Revenue Component	Partner	Asset	Potential Future Milestones (Total)	Royalty Structure
Regulatory/Development Milestones	Johnson & Johnson (JNJ)	Icotrokinra	Up to $630 million available, including $50 million on any marketing approval and $25 million on NDA acceptance.	Tiered royalties on net sales, e.g., 6-10% on icotrokinra.
Development/Sales Milestones	Takeda Pharmaceuticals	Rusfertide	Up to $330.0 million, following the $300.0 million upfront payment received in April 2024.	Royalties on net sales outside the U.S.; 50:50 profit share in the U.S. (with an opt-out right).

You can see the structure is designed to reward success at every stage. For instance, on the icotrokinra side, Protagonist Therapeutics is eligible for $45 million upon receipt of a marketing approval in a second indication, which is a clear, tangible target. The cash position as of September 30, 2025, was strong at $678.8 million, which helps them fund their wholly-owned programs independently.

The third major revenue stream is the Future tiered royalties on net sales of partnered products. This is the long-term, sustainable income once these drugs are commercialized. The royalty rate for icotrokinra is specified as 6-10% on net sales, with the 10% tier kicking in once worldwide net sales reach $4 billion or more. This structure aligns Protagonist Therapeutics' long-term financial success directly with the ultimate market performance of their partners' products.

Finally, the fourth stream is the Potential product sales revenue from wholly-owned assets post-approval. This is where Protagonist Therapeutics transitions from a pure collaboration-based revenue model to a commercial entity for its own assets. The key asset here is rusfertide for polycythemia vera (PV).

Key points on the wholly-owned revenue potential include:

• Rusfertide received FDA Breakthrough Therapy Designation in August 2025.
• The U.S. New Drug Application (NDA) filing for rusfertide is expected by the end of 2025.
• The company plans to nominate a development candidate from its oral hepcidin program by year-end 2025.
• The company has a cash runway extending through at least the end of 2028, supporting the development of these internal assets.