Protagonist Therapeutics, Inc. (PTGX): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

El protagonista Therapeutics, Inc. (PTGX) emerge como una innovadora compañía de biotecnología que revoluciona el panorama de la terapéutica basada en péptidos, con un enfoque afilado en la transformación de paradigmas de tratamiento para enfermedades inflamatorias y autoinmunes complejas. Al aprovechar su plataforma patentada de descubrimiento de fármacos y su enfoque innovador para la medicina de precisión, PTGX está listo para ofrecer tratamientos potencialmente que cambian el juego que podrían redefinir los resultados de los pacientes en afecciones médicas desafiantes como la enfermedad inflamatoria intestinal. Su sofisticado lienzo de modelo de negocio revela un plan estratégico que combina investigación científica de vanguardia, asociaciones sólidas y una propuesta de valor centrada en el láser diseñada para abordar las necesidades médicas no satisfechas con precisión y potencial sin precedentes.

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas

Protagonist Therapeutics ha establecido asociaciones farmacéuticas críticas que incluyen:

Pareja	Detalles de colaboración	Año establecido
Janssen Pharmaceuticals	Asociación de desarrollo de PN-943	2021
Takeda Pharmaceutical	Acuerdo de licencia para el tratamiento de la enfermedad inflamatoria intestinal	2020

Asociaciones de investigación con instituciones académicas

Las colaboraciones clave de la investigación académica incluyen:

• Universidad de California, San Francisco
• Centro Médico de la Universidad de Stanford
• Escuela de Medicina de Harvard

Acuerdos de licencia para la terapéutica peptídica

Protagonist Therapeutics ha asegurado múltiples acuerdos de licencia valorados en:

Tipo de acuerdo	Valor total	Potencial de hito
Licencia exclusiva	$ 125 millones	Hasta $ 525 millones

Asociaciones de fabricación

Colaboraciones de fabricación centradas en la producción clínica y comercial:

• Grupo Lonza AG
• Biológicos de Samsung
• Wuxi Biologics

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas peptídicas

A partir de 2024, el protagonista Therapeutics se centra en el desarrollo de la terapéutica basada en péptidos dirigidos a áreas de enfermedades específicas.

Área de enfoque de investigación	Etapa actual	Inversión
Enfermedad inflamatoria intestinal	Ensayos clínicos de fase 3	$ 45.2 millones de gastos de I + D en 2023
Terapéutica de péptidos oncológicos	Desarrollo clínico de fase 2	$ 37.6 millones de inversión en I + D

Diseño y ejecución del ensayo clínico

Protagonista Therapeutics realiza ensayos clínicos rigurosos en múltiples dominios terapéuticos.

• Ensayos clínicos activos: 3 programas en curso
• Sitios de ensayos clínicos totales: 47 ubicaciones internacionales
• Duración promedio del ensayo clínico: 36-48 meses

Procesos de presentación y aprobación regulatoria

Agencia reguladora	Presentaciones actuales	Estado
FDA	2 nuevas aplicaciones de drogas	Bajo revisión
EMA	1 designación de drogas huérfanas	Aprobación pendiente

Descubrimiento de drogas y pruebas preclínicas

El protagonista Therapeutics mantiene una sólida tubería de descubrimiento de drogas.

• Candidatos preclínicos: 5 compuestos terapéuticos potenciales
• Inversión en la etapa de descubrimiento: $ 22.3 millones en 2023
• Instalaciones de investigación interna: 2 laboratorios dedicados

Gestión y protección de la propiedad intelectual

Categoría de IP	Patentes totales	Rango de vencimiento de patentes
Plataforma de tecnología peptídica	18 patentes concedidas	2035-2042
Compuestos terapéuticos específicos	12 solicitudes de patentes	2037-2044

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: recursos clave

Plataforma de descubrimiento de fármacos peptídicos patentados

Protagonist Therapeutics ha desarrollado una plataforma de descubrimiento de fármacos peptídicos patentados con las siguientes características clave:

Atributo de plataforma	Detalles específicos
Tipo de tecnología	Plataforma de química de péptidos de precisión
Estado de patente	Múltiples patentes emitidas que protegen la tecnología central
Enfoque de desarrollo	Terapéutica de péptidos orales e inyectables

Equipo científico e de investigación experimentado

El equipo de investigación de la compañía comprende:

• 14 científicos a nivel de doctorado
• Experiencia extensa en el desarrollo de fármacos péptidos
• Experiencia de investigación acumulativa de más de 100 años

Investigación avanzada e instalaciones de laboratorio

Atributo de instalación	Especificación
Espacio total de investigación	Aproximadamente 25,000 pies cuadrados
Ubicación	Newark, California
Inversión en equipos de investigación	$ 3.2 millones en instrumentación científica avanzada

Cartera de propiedad intelectual robusta

Detalles de la propiedad intelectual:

• 23 patentes emitidas a partir de 2023
• 15 solicitudes de patentes pendientes
• Protección de patentes que se extiende hasta 2040

Experiencia de desarrollo clínico en enfermedades inflamatorias

Métrico de desarrollo clínico	Estado actual
Ensayos clínicos activos	3 pruebas de fase 2/3 en curso
Áreas terapéuticas	Enfermedad inflamatoria intestinal, colitis ulcerosa
Inversión de investigación clínica	$ 47.3 millones en 2023 desarrollo clínico

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: propuestas de valor

Terapéutica innovadora basada en péptidos

Protagonista Therapeutics se centra en el desarrollo de la terapéutica basada en péptidos con capacidades de orientación molecular específicas. A partir del cuarto trimestre de 2023, la compañía tiene 3 candidatos de medicamentos principales en el desarrollo clínico.

Candidato a la droga	Indicación objetivo	Estadio clínico
PN-943	Enfermedad inflamatoria intestinal	Fase 2
PN-235	Colitis ulcerosa	Fase 2
PN-255	Enfermedad de Crohn	Preclínico

Tratamientos potenciales para las afecciones inflamatorias

La tubería terapéutica de la compañía se dirige a condiciones autoinmunes complejas con necesidades médicas no satisfechas. El potencial de mercado para los tratamientos de enfermedad inflamatoria intestinal se estima en $ 19.4 mil millones para 2026.

Mecanismo de acción único

• Desarrolla terapéutica de péptidos orales con interacciones moleculares dirigidas
• Plataforma de ingeniería péptidos patentada
• Potencial para reducir los efectos secundarios sistémicos

Enfoque de medicina de precisión

Protagonista Therapeutics utiliza Estrategias de orientación molecular avanzada para desarrollar terapias de precisión. El gasto de investigación y desarrollo en 2023 fue de aproximadamente $ 78.4 millones.

Métrica financiera	Valor 2023
Gastos de I + D	$ 78.4 millones
Ingresos totales	$ 37.2 millones
Pérdida neta	$ 132.6 millones

Resultados potenciales del paciente

Los datos clínicos sugieren mejoras potenciales en la eficacia del tratamiento para pacientes con enfermedades inflamatorias intestinales en comparación con las terapias existentes.

• Reducción potencial en la progresión de la enfermedad
• Mejor calidad de vida del paciente
• Intervención molecular dirigida

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con proveedores de atención médica

Protagonist Therapeutics mantiene la participación directa a través de canales de comunicación médica especializada:

Método de compromiso	Público objetivo	Frecuencia
Enlaces científicos médicos individuales	Especialistas en hematología/oncología	Interacciones trimestrales
Plataformas de comunicación digital	Practicantes de gastroenterología	Actualizaciones mensuales

Programas de apoyo al paciente

Las iniciativas integrales de apoyo al paciente incluyen:

• Programa personalizado de asistencia al paciente para Ropeginterferon alfa-2b
• Servicios de asesoramiento de apoyo financiero
• Asistencia de navegación de tratamiento

Conferencia científica y participación del simposio médico

Métricas de compromiso de la conferencia:

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias de hematología	4-6 Presentaciones científicas	Más de 500 profesionales de la salud
Simposios de gastroenterología	3-5 Sesiones de carteles de investigación	Aproximadamente 350 especialistas

Comunicación transparente sobre el progreso del ensayo clínico

Canales de comunicación para la transparencia del ensayo clínico:

• Sebinarios web trimestrales de inversores y analistas
• Publicaciones detalladas del resultado del ensayo clínico
• Actualizaciones en tiempo real en clinicaltrials.gov

Colaboración con grupos de defensa del paciente

Detalles de compromiso de defensa del paciente:

Focus del grupo de defensa	Asociaciones activas	Iniciativas de colaboración anuales
Neoplasias mieloproliferativas	2 organizaciones nacionales	6 programas de educación para pacientes
Enfermedad inflamatoria intestinal	3 redes de apoyo para pacientes	4 Campañas de concientización de investigación

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: canales

Equipo de ventas directo dirigido a especialistas en gastroenterología

A partir del cuarto trimestre de 2023, el protagonista Therapeutics mantiene una fuerza de ventas especializada de 37 representantes centrados exclusivamente en especialistas en gastroenterología. El equipo cubre aproximadamente 1,200 prácticas clave de gastroenterología en los Estados Unidos.

Métrica del equipo de ventas	Valor
Representantes de ventas totales	37
Cobertura geográfica	Estados Unidos
Prácticas médicas objetivo	1,200

Presentaciones de conferencia médica

El protagonista Therapeutics participa en 12-15 conferencias médicas principales anualmente, con un enfoque en eventos de gastroenterología e inmunología.

• Semana anual de la enfermedad digestiva (DDW)
• Conferencia de la Asociación Americana de la Asociación Gastroenterológica (AGA)
• Semana de la Gastroenterología Europea Unida

Publicaciones científicas revisadas por pares

En 2023, la compañía publicó 8 artículos científicos revisados ​​por pares en revistas que incluyen gastroenterología, Journal of Crohn's y Colitis, y enfermedades inflamatorias intestinales.

Plataformas de salud digital

Protagonista Therapeutics utiliza 3 plataformas primarias de compromiso de salud digital Para comunicarse con profesionales de la salud y pacientes:

Plataforma digital	Objetivo
Portal profesional	Intercambio de datos clínicos
Sitio web de apoyo para pacientes	Información sobre el tratamiento
Plataforma de reclutamiento de ensayos clínicos	Investigación de participación del participante

Asociaciones de la industria farmacéutica

A partir de 2024, el protagonista Therapeutics mantiene 2 asociaciones farmacéuticas activas:

• Takeda Pharmaceutical (colaboración estratégica para los tratamientos de enfermedades intestinales inflamatorias)
• Janssen Pharmaceuticals (Asociación de investigación en curso)

Ingresos de asociación total para 2023: $ 42.6 millones

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: segmentos de clientes

Gastroenterólogos

Grupo de clientes objetivo especializado en el tratamiento de la enfermedad inflamatoria intestinal (EII).

Características de segmento	Tamaño del mercado
Médicos de tratamiento de EII especializados	Aproximadamente 2.500 gastroenterólogos en los Estados Unidos
Volumen anual de manejo del paciente con EII	Promedio de 150-200 pacientes por gastroenterólogo

Pacientes con enfermedades inflamatorias intestinales

Población objetivo primaria para intervenciones terapéuticas.

Segmento de enfermedades	Población de pacientes
Enfermedad de Crohn	Aproximadamente 780,000 pacientes en los Estados Unidos
Colitis ulcerosa	Aproximadamente 1 millón de pacientes en los Estados Unidos

Sistemas hospitalarios

Instituciones de atención médica que ofrecen opciones de tratamiento avanzadas.

• Los 50 principales centros médicos académicos en los Estados Unidos
• Centros de tratamiento de gastroenterología especializados
• Redes integrales de atención de EII

Instituciones de investigación

Los centros académicos y de investigación se centraron en la terapéutica innovadora.

Tipo de institución	Número de colaboradores potenciales
Centros de investigación financiados por NIH	Aproximadamente 60 instituciones de investigación importantes
Centros de investigación de gastroenterología	Más de 120 instalaciones de investigación especializadas

Compañías farmacéuticas

Socios potenciales interesados ​​en nuevos enfoques terapéuticos.

• Top 20 compañías farmacéuticas globales
• Empresas de biotecnología especializadas que se centran en enfermedades inflamatorias
• Empresas de desarrollo terapéutico respaldado por capital de riesgo

Categoría de empresa	Interés potencial de colaboración
Grandes compañías farmacéuticas	12-15 posibles socios estratégicos
Empresas de biotecnología	25-30 entidades colaborativas potenciales

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, el protagonista Therapeutics reportó gastos de I + D de $ 154.9 millones, lo que representa una porción significativa de sus costos operativos totales.

Año	Gastos de I + D	Porcentaje de costos totales
2022	$ 131.2 millones	62.4%
2023	$ 154.9 millones	65.3%

Costos de ensayo clínico

Los gastos de ensayos clínicos para la terapéutica protagonista en 2023 fueron de aproximadamente $ 87.6 millones, centrados en avanzar en su tubería de terapias.

• Pruebas de fase 1: $ 23.4 millones
• Pruebas de fase 2: $ 41.2 millones
• Pruebas de fase 3: $ 23.0 millones

Procesos de cumplimiento y aprobación regulatoria

Los costos de cumplimiento regulatorio para 2023 se estimaron en $ 12.3 millones, que cubren interacciones, documentación y procesos de presentación de la FDA.

Mantenimiento de la propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual en 2023 totalizaron $ 5.7 millones, incluida la presentación de patentes, la renovación y los gastos de protección legal.

Categoría de IP	Costo	Número de patentes
Presentación de patentes	$ 3.2 millones	24
Renovación de patente	$ 2.5 millones	18

Sobrecarga administrativa y operativa

Los gastos generales administrativos y operativos para el protagonista Therapeutics en 2023 fueron de $ 43.5 millones.

• Costos del personal: $ 28.2 millones
• Gastos de la instalación: $ 7.6 millones
• Infraestructura tecnológica: $ 4.7 millones
• Otros gastos administrativos: $ 3.0 millones

Estructura de costos totales para 2023: $ 303.0 millones

Protagonist Therapeutics, Inc. (PTGX) - Modelo de negocio: flujos de ingresos

Pagos potenciales de hitos de los acuerdos de asociación

Protagonist Therapeutics tiene acuerdos de asociación estratégica con los siguientes pagos potenciales de hitos:

Pareja	Pago potencial de hito	Área terapéutica
Janssen Pharmaceuticals	Hasta $ 530 millones	Enfermedad inflamatoria intestinal
Takeda Pharmaceutical	Hasta $ 495 millones	Enfermedad inflamatoria intestinal

Ingresos futuros de licencias de productos

Posibles ingresos de licencias para candidatos terapéuticos clave:

• PN-943: Ingresos potenciales de licencia estimados en $ 250-350 millones
• PN-235: Ingresos potenciales de licencia estimados en $ 200-300 millones

Posibles ventas de medicamentos después de la aprobación regulatoria

Posibles posibles ventas anuales de drogas para candidatos principales:

Candidato a la droga	Ventas anuales proyectadas	Potencial de mercado
PN-943	$ 500-750 millones	Enfermedad inflamatoria intestinal
PN-235	$ 400-600 millones	Enfermedad inflamatoria intestinal

Subvenciones de investigación y fondos colaborativos

Fuentes de financiación de investigación:

• Subvenciones de los Institutos Nacionales de Salud (NIH): $ 2-3 millones anuales
• Financiación de la investigación colaborativa: $ 1-2 millones por año

Posibles ingresos de regalías de la terapéutica desarrollada

Ingresos potenciales de regalías estimados:

Candidato terapéutico	Porcentaje de regalías potencial	Regalías anuales estimadas
PN-943	8-12%	$ 40-90 millones
PN-235	7-10%	$ 30-70 millones

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.