Pliant Therapeutics, Inc. (PLRX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de vanguardia de la biotecnología, la terapéutica Pliant (PLRX) emerge como una fuerza transformadora, pionera en soluciones terapéuticas innovadoras para enfermedades fibróticas complejas. Al aprovechar las plataformas de orientación molecular avanzada y las colaboraciones estratégicas, esta innovadora compañía está redefiniendo posibles tratamientos para afecciones médicas desafiantes como la fibrosis pulmonar idiopática (IPF) y la esteatohepatitis no alcohólica (NASH). Su modelo de negocio meticulosamente elaborado representa un enfoque sofisticado para abordar las necesidades médicas no satisfechas, combinando la experiencia científica con el desarrollo de la asociación estratégica y las metodologías de investigación innovadores.

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocios: asociaciones clave

Colaboración estratégica con Novartis

En marzo de 2022, Pliant Therapeutics estableció una colaboración estratégica con Novartis centrada en el desarrollo de candidatos terapéuticos para la fibrosis pulmonar idiopática (IPF) y la esteatohepatitis no alcohólica (NASH). Los detalles clave de la asociación incluyen:

Componente de asociación	Términos financieros
Pago por adelantado	$ 50 millones
Pagos potenciales de hitos	Hasta $ 615 millones
Potencial de regalías	Regalías escalonadas en ventas netas

Asociaciones de investigación

Pliant Therapeutics mantiene relaciones de investigación colaborativa con varias instituciones académicas y de investigación:

• Universidad de California, San Francisco
• Universidad de Stanford
• Centro Médico de la Universidad de Duke

Colaboraciones de ensayos clínicos

La Compañía se involucra con múltiples organizaciones de investigación de contratos (CRO) para el desarrollo clínico:

Socio de CRO	Enfoque de ensayo clínico
Ícono plc	Pruebas de Fase 2 IPF
Parexel International	Estudios clínicos de Nash
IQVIA	Desarrollo de diagnóstico complementario

Acuerdos potenciales de licencia farmacéutica

Discusiones continuas para posibles licencias de candidatos a medicamentos PLN-1474 y PLN-2240 con posibles socios farmacéuticos interesados ​​en las terapias de integrina.

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: actividades clave

Investigación y desarrollo de nuevas terapias dirigidas a enfermedades fibróticas

Pliant Therapeutics se centra en el desarrollo de la terapéutica innovadora para las enfermedades fibróticas. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 48.2 millones en gastos de I + D.

Áreas de enfoque de I + D	Etapa actual	Inversión
Fibrosis pulmonar idiopática (IPF)	Ensayos clínicos de fase 2	$ 22.7 millones
Fibrosis hepática	Ensayos clínicos de fase 1b	$ 15.5 millones
Esclerosis sistémica	Desarrollo preclínico	$ 10 millones

Gestión de ensayos preclínicos y clínicos

La compañía administra múltiples ensayos clínicos en diferentes áreas terapéuticas.

• Ensayos clínicos activos: 3 programas en curso
• Inscripción total de pacientes: 287 pacientes en todos los ensayos
• Duración promedio de prueba: 18-24 meses

Biología molecular e investigación farmacológica

Pliant Therapeutics mantiene una robusta infraestructura de investigación con capacidades especializadas de biología molecular.

Capacidad de investigación	Capacidad	Presupuesto anual
Investigar científicos	42 empleados a tiempo completo	$ 12.3 millones
Instalaciones de investigación	2 centros de investigación dedicados	$ 5.6 millones

Desarrollo de la propiedad intelectual

A partir de diciembre de 2023, Pliant Therapeutics ha asegurado la protección de la propiedad intelectual para sus candidatos terapéuticos clave.

• Solicitudes de patentes totales: 17
• Patentes otorgadas: 9
• Aplicaciones de patentes pendientes: 8

Cumplimiento regulatorio y procesos de aprobación de medicamentos

La compañía mantiene rigurosas estrategias de cumplimiento regulatorio en su tubería de desarrollo de fármacos.

Interacción regulatoria	Frecuencia	Presupuesto de cumplimiento
Interacciones de la FDA	Reuniones trimestrales	$ 3.2 millones
Presentaciones regulatorias de ensayos clínicos	6-8 presentaciones anualmente	$ 2.7 millones

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: recursos clave

Experiencia científica avanzada en investigación de fibrosis

A partir del cuarto trimestre de 2023, Pliant Therapeutics tiene 35 personal de investigación especializado centrado en la investigación de enfermedades fibróticas. La compañía ha desarrollado experiencia en dirigirse a las vías de señalización de integrina y TGF-β.

Categoría de investigación	Número de investigadores especializados	Áreas de enfoque
Investigación de fibrosis	35	Fibrosis pulmonar idiopática, fibrosis hepática

Plataformas de orientación molecular patentada

Pliant ha desarrollado dos plataformas de orientación molecular primaria:

• Plataforma de integrina αvβ6
• Plataforma de integrina αvβ1

Cartera de propiedades intelectuales

Categoría de patente	Número de patentes	Cobertura geográfica
Patentes emitidos	47	Estados Unidos, Europa, Japón
Aplicaciones de patentes pendientes	23	Mercados internacionales

Infraestructura de investigación y desarrollo

Inversión total en infraestructura de I + D a partir de 2023: $ 68.4 millones

Ubicación de la instalación de I + D	Pies cuadrados	Capacidades de investigación
South San Francisco, CA	25,000 pies cuadrados	Investigación preclínica y clínica

Equipo de gestión y científico experimentado

Posición de liderazgo	Años de experiencia en la industria	Afiliaciones anteriores
CEO	Más de 20 años	Roche, Genentech
Oficial científico	Más de 25 años	Merck, Bristol Myers Squibb

Cuenta total de empleados a partir del cuarto trimestre 2023: 112 empleados

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: propuestas de valor

Enfoques terapéuticos innovadores para enfermedades fibróticas progresivas

La terapéutica Pliant se centra en el desarrollo de terapias moleculares dirigidas para enfermedades fibróticas progresivas, con énfasis específico en los tratamientos basados ​​en integrina.

Enfoque terapéutico clave	Etapa de desarrollo actual	Potencial de población de pacientes
Fibrosis pulmonar idiopática (IPF)	Ensayos clínicos de fase 2	Aproximadamente 50,000 pacientes en los Estados Unidos
Esteatohepatitis no alcohólica (NASH)	Ensayos clínicos de fase 2	Estimado de 16.5 millones de pacientes en los Estados Unidos

Tratamientos potenciales para necesidades médicas no satisfechas

La propuesta de valor principal de Pliant aborda las necesidades médicas críticas insatisfechas en enfermedades fibróticas con opciones de tratamiento limitadas.

• Tasa actual de supervivencia a 5 años de IPF: aproximadamente el 20%
• Complicaciones hepáticas relacionadas con NASH: la principal causa de trasplante de hígado
• No hay terapias modificadoras de enfermedad aprobadas por la FDA para múltiples afecciones fibróticas

Terapias moleculares dirigidas con efectos secundarios reducidos

Plataforma terapéutica	Mecanismo de acción	Ventaja potencial
Inhibición de la integrina	Bloqueando interacciones celulares específicas	Potencial para una orientación más precisa con efectos secundarios sistémicos reducidos

Desarrollo de soluciones de medicina de precisión

El enfoque de Pliant enfatiza la medicina de precisión a través de intervenciones moleculares específicas.

• Centrado en objetivos de integrina específicos
• Potencial para estrategias de tratamiento personalizadas
• Técnicas avanzadas de detección molecular

Potencial para mejorar los resultados del paciente

Área de enfermedades	Limitaciones de tratamiento actuales	El impacto potencial de Pliant
Fibrosis pulmonar idiopática	Terapias modificadoras de enfermedades limitadas	Potencial para ralentizar la progresión de la enfermedad
Nash	No hay tratamientos dirigidos aprobados	Potencial para abordar los mecanismos fibróticos subyacentes

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con proveedores de atención médica

La terapéutica Pliant mantiene canales de comunicación directa con profesionales de la salud que se especializan en enfermedades pulmonares y fibróticas. A partir del cuarto trimestre de 2023, la compañía reportó 87 interacciones específicas con pulmonólogos clave y médicos de investigación.

Tipo de compromiso	Número de interacciones	Frecuencia
Reuniones de asesoramiento clínico	24	Trimestral
Colaboraciones de investigación	36	Semestral
Presentaciones de conferencias científicas	27	Anual

Programas de apoyo y educación del paciente

La compañía ha desarrollado iniciativas integrales de apoyo al paciente que se centran en la fibrosis pulmonar idiopática (IPF) y las comunidades de pacientes de colangitis esclerosante primaria (PSC).

• Sebinarios web de educación para pacientes: 12 sesiones en 2023
• Recursos de soporte en línea: 3 plataformas digitales dedicadas
• Inscripción del programa de asistencia al paciente: 156 pacientes

Comunicación y colaboración de la comunidad científica

La terapéutica Pliant se involucra activamente con investigadores científicos a través de múltiples canales de comunicación.

Tipo de colaboración	Total de asociaciones	Instituciones de investigación
Asociaciones de investigación académica	14	8 universidades
Redes de investigación clínica	7	5 redes internacionales

Informes de ensayos clínicos transparentes

La compañía mantiene una transparencia rigurosa en la divulgación de datos de ensayos clínicos.

• Ensayos clínicos registrados: 5 ensayos activos
• Plataformas de divulgación pública: 3 registros internacionales
• Informes de transparencia de datos: publicaciones trimestrales

Estrategias de comunicación de inversores y partes interesadas

La terapéutica Pliant implementa estrategias integrales de relaciones con los inversores.

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces anualmente	320 inversores institucionales
Presentaciones de inversores	6 conferencias	450 analistas financieros
Reunión anual de accionistas	1 vez por año	Aproximadamente 200 participantes

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: canales

Fuerza de ventas directa para la futura comercialización futura de medicamentos

A partir del cuarto trimestre de 2023, Pliant Therapeutics aún no ha establecido una fuerza de ventas comercial completa, centrándose principalmente en el desarrollo de fármacos en etapa clínica.

Presentaciones de conferencia médica

Conferencia	Año	Presentaciones
Sociedad Torácica Americana (ATS)	2023	3 presentaciones científicas
Sociedad Respiratoria Europea (ERS)	2023	2 presentaciones científicas

Redes de publicación científica

Métricas de publicación:

• Publicaciones totales revisadas por pares: 12 a partir de 2023
• Revistas clave: Nature, Cell, Journal of Clinical Research
• Índice de citas: aproximadamente 85 citas totales

Plataformas de salud digital

Los canales de participación digital incluyen:

• Sitio web de la compañía: www.pliantx.com
• Página corporativa de LinkedIn: 2.500 seguidores
• Cuenta de Twitter: @plianttx, 1.200 seguidores

Redes de asociación farmacéutica

Pareja	Año	Enfoque de colaboración
Novartis	2022	Investigación de fibrosis pulmonar idiopática
Gilead Sciences	2021	Colaboración de etapa preclínica

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: segmentos de clientes

Pacientes con fibrosis pulmonar idiopática (IPF)

La población global de pacientes de IPF estimada en 132,000 en los Estados Unidos a partir de 2024.

Grupo de edad	Prevalencia de IPF	Tasa de diagnóstico anual
50-75 años	85% del total de pacientes	30,000-40,000 casos nuevos anualmente

Pacientes con esteatohepatitis no alcohólica (NASH)

Población de pacientes de NASH en los Estados Unidos: aproximadamente 17.4 millones de pacientes en 2024.

Severidad de Nash	Distribución del paciente
Etapa temprana	12.6 millones de pacientes
Fibrosis avanzada	4.8 millones de pacientes

Especialistas médicos de hepatología y pulmonología

• Hepatólogos totales en EE. UU.: 3.200
• Pulmonólogos totales en EE. UU.: 4.500
• Especialistas de objetivos potenciales para la terapéutica Pliant: 7.700

Instituciones de atención médica

Tipo de institución	Total de instituciones	Objetivo potencial
Centros de fibrosis especializados	87	62 centros
Principales centros médicos académicos	141	98 centros

Organizaciones de investigación

Organizaciones de investigación interesadas en los enfoques terapéuticos de la Terapéutica de Pliant.

Tipo de organización de investigación	Organizaciones totales
Instituciones de investigación académica	276
Fundamentos de investigación privada	43

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Pliant Therapeutics informó gastos de investigación y desarrollo de $ 106.7 millones para el año fiscal 2022.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 106.7 millones	78.4%
2021	$ 85.3 millones	75.2%

Costos de gestión de ensayos clínicos

Los gastos de ensayos clínicos para la terapéutica Pliant en 2022 fueron de aproximadamente $ 62.4 millones.

• Ensayos clínicos de fase 2 para tratamiento con fibrosis pulmonar idiopática (FPI)
• Desarrollo clínico en curso para GLPG4716
• Nuevo medicamento en investigación (IND) Habilitar estudios

Gastos de protección de la propiedad intelectual

Los costos de protección de la propiedad de patentes e intelectuales para 2022 se estimaron en $ 3.2 millones.

Categoría de IP	Costo anual estimado
Presentación de patentes	$ 1.5 millones
Mantenimiento de patentes	$ 1.7 millones

Sobrecarga administrativa y operativa

Los gastos administrativos totales para la Terapéutica Pliant en 2022 fueron de $ 24.5 millones.

• Costos generales de personal administrativo
• Gastos de infraestructura de oficina
• Inversiones de tecnología y software

Gastos de marketing y comunicación

Los gastos de marketing y comunicación para 2022 fueron de aproximadamente $ 5.6 millones.

Canal de marketing	Presupuesto asignado
Participación de la conferencia científica	$ 2.1 millones
Marketing digital	$ 1.5 millones
Relaciones con inversores	$ 2.0 millones

Pliant Therapeutics, Inc. (PLRX) - Modelo de negocios: flujos de ingresos

Pagos potenciales de hitos de asociaciones farmacéuticas

A partir del cuarto trimestre de 2023, Pliant Therapeutics ha establecido asociaciones farmacéuticas clave con posibles pagos de hitos:

Pareja	Pago potencial de hito	Programa
Novartis	Hasta $ 1.3 mil millones	Programas de IPF y NASH
Bristol Myers Squibb	Hasta $ 1.2 mil millones	Colaboración de la enfermedad fibrótica

Ingresos futuros de comercialización de drogas

Posibles ingresos comerciales de candidatos a drogas principales:

• PLN-74809 (tratamiento con IPF): tamaño potencial estimado del mercado de $ 3.4 mil millones anuales
• PLN-1474 (tratamiento NASH): valor de mercado potencial de $ 2.8 mil millones

Acuerdos de licencia

Detalles del acuerdo de licencia actual:

Socio de licencia	Valor de acuerdo	Área de enfoque
Novartis	Pago por adelantado de $ 80 millones	Programa de inhibidores de integrina αvβ6

Subvenciones de investigación y financiación del gobierno

Fuentes de financiación de investigación para 2023-2024:

• NIH Subvenciones: $ 2.5 millones
• SBIR/STTR otorga: $ 1.2 millones

Ingresos de regalías potenciales de desarrollos de drogas

Rangos de ingresos de regalías proyectados:

Candidato a la droga	Rango de regalías potencial	Etapa de comercialización
PLN-74809	8-12% de las ventas netas	Ensayos clínicos de fase 2
PLN-1474	10-15% de las ventas netas	Ensayos clínicos de fase 1b

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Value Propositions

You're looking at the core value Pliant Therapeutics, Inc. (PLRX) offers across its pipeline, which is heavily focused on integrin-based therapeutics for high-need areas. The value is grounded in novel mechanisms and clinical signals, supported by a financial structure positioned for execution.

Novel oral, small molecule therapy (PLN-101095) for ICI-refractory solid tumors.

PLN-101095, an oral, small molecule, dual selective inhibitor of $\alpha v\beta 8$ and $\alpha v\beta 1$ integrins, is showing anti-tumor activity in patients who have not responded to immune checkpoint inhibitors (ICIs). As of November 30th, 2025, interim data from the Phase 1 trial showed:

• One confirmed Complete Response (CR) and three Partial Responses (PR) across the three highest dose cohorts out of 10 secondary ICI refractory patients evaluated.
• 60% of these secondary refractory patients demonstrated stable disease or tumor reduction.
• Responding patients exhibited large increases, specifically 4- to 13-fold versus baseline, in plasma interferon gamma (IFN-γ) after a 14-day monotherapy run-in.
• The median time on treatment for these responders was 15 months.

This positions PLN-101095 as a potential option where current standards fail, with plans to accelerate development via a Phase 1b indication expansion trial starting in 2026.

Potential to stabilize or improve liver fibrosis markers in Primary Sclerosing Cholangitis (PSC).

While development for Idiopathic Pulmonary Fibrosis (IPF) was discontinued, Pliant Therapeutics, Inc. (PLRX) is assessing potential next steps for bexotegrast, which could include new indications such as liver diseases. The underlying science for this class of drug has been validated:

Study/Data Point	Target/Measure	Patient Cohort Size	Key Finding
Phase 2a PET Imaging Trial (Bexotegrast)	Collagen deposition in lungs	10 patients with IPF	Positive results using PET and magnetic resonance imaging to evaluate antifibrotic mechanism.

Addressing high unmet medical needs in rare fibrotic diseases and advanced cancers.

Pliant Therapeutics, Inc. (PLRX) targets patient populations with limited or no effective options. For advanced cancers, the value is in overcoming resistance to immune checkpoint inhibitors. For fibrotic diseases, the company is looking to pivot following the discontinuation of the IPF program, aiming at other fibrotic conditions like liver diseases. The company's financial position supports this focus:

• Cash, cash equivalents, and short-term investments were $243.3 million as of September 30, 2025.
• This strong cash position is noted to support planned operations through 2028.
• The Q3 2025 net loss was $26.3 million, a reduction from $57.8 million in the prior year period, reflecting cost management.

Demonstrated antifibrotic mechanism of action through PET imaging data.

The mechanism of action for the discontinued bexotegrast was scientifically validated. Results from a Phase 2a positron emission tomography (PET) imaging trial were published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). This publication reviewed positive results showing the drug's effect on collagen deposition in the lungs of 10 IPF patients.

Potential for a first-in-class treatment for muscular dystrophies (PLN-101325).

PLN-101325 is being developed as a monoclonal antibody agonist of integrin $\alpha 7\beta 1$ for muscular dystrophies. This program has advanced to a point where Pliant Therapeutics, Inc. (PLRX) has received regulatory clearance for a Phase 1 study, with a Clinical Trial Approval (CTA) open in Australia.

Finance: review Q4 2025 cash burn projections by next Tuesday.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Customer Relationships

For Pliant Therapeutics, Inc. (PLRX), customer relationships are segmented across three primary groups: the scientific/clinical community (KOLs and investigators), the investment community, and patient advocacy organizations relevant to their pipeline candidates.

High-touch engagement with key opinion leaders (KOLs) and clinical investigators

Engagement with the clinical community centers on validating the integrin platform and managing the transition following the BEACON-IPF trial. While the development of bexotegrast in idiopathic pulmonary fibrosis (IPF) was discontinued in Q2 2025 due to an unfavorable risk-benefit profile, the commitment to scientific transparency remains. Full results from the global, multinational BEACON-IPF Phase 2b/3 clinical trial are slated for future publication, and close-out activities were expected to be completed in the fourth quarter of 2025. This commitment to sharing data, even from a discontinued program, serves to maintain credibility with investigators. Furthermore, the ongoing Phase 1 trial for PLN-101095 in solid tumors, which completed enrollment across all five dose cohorts by the third quarter of 2025, requires close collaboration with oncology investigators. The company presented research at ATS in May 2025, including an Oral Presentation on 'Characterizing the antifibrotic activity of bexotegrast on distinct fibroblast populations in PCLS from multiple ILD subtypes,' demonstrating continued scientific dialogue with the pulmonology community.

Investor relations and public communications to manage shareholder expectations post-IPF setback

Investor communication has been focused on navigating the significant shift following the August 7, 2025, announcement of the bexotegrast IPF discontinuation. Management, led by CEO Bernard Coulie, M.D., Ph.D., immediately pivoted to emphasizing the advancement of the oncology program and the maintenance of core capabilities. Following a strategic realignment in May 2025 that included an approximately 45% reduction in workforce, the company provided regular updates to manage the cash runway, which stood at $264.4 million in cash, cash equivalents, and short-term investments as of June 30, 2025, decreasing to $243.3 million by September 30, 2025. The commitment to shareholders was explicitly stated: 'We remain committed to delivering shareholder value and look forward to providing updates in the future,' following the Q2 2025 results. The focus for the remainder of 2025 was on delivering data from the PLN-101095 trial by year-end.

Direct communication with patient advocacy groups for rare diseases

Pliant Therapeutics, Inc. is developing PLN-101325, a monoclonal antibody agonist of integrin $\alpha_7\beta_1$, specifically targeting muscular dystrophies, which falls under the rare disease category. While specific partnership metrics for Pliant Therapeutics, Inc. are not public, the operational necessity for such engagement is clear, as patient advocacy groups (PAGs) are increasingly vital partners. For PAGs serving diseases without an approved therapy, 51% reported no clinical trials in progress at the time of a recent industry survey, highlighting the need for industry collaboration to initiate trials. Furthermore, 79% of surveyed PAGs reported research engagement in some capacity, including registries and clinical trials, underscoring that active participation from these groups is essential for trial success and enrollment. For Pliant Therapeutics, Inc., engaging these groups is critical to support the Phase 1 study of PLN-101325.

Scientific publications to validate the integrin platform and drug mechanism

Validation of the core integrin platform is driven by peer-reviewed publications and conference presentations. The company has published results from a Phase 2a positron emission tomography (PET) imaging trial in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The platform itself is supported by a proprietary library of over 15,000 integrin binding molecules. The oncology program's interim data, released in December 2025, further validates the mechanism, showing that responders in the PLN-101095 trial had 4- to 13-fold increases in plasma IFN-$\gamma$ after a 14-day monotherapy run-in. The platform's broad applicability is also highlighted by its use in developing PLN-101095 (dual selective inhibitor of $\alpha_v\beta_8$ and $\alpha_v\beta_1$) and PLN-101325 (agonist of integrin $\alpha_7\beta_1$).

Here is a summary of key quantitative data points relevant to these relationships:

Relationship Metric Area	Data Point	Context/Date
Platform Validation Asset Size	15,000+	Proprietary integrin binding molecules in the screening library.
Investor Relations Context	45%	Workforce reduction announced in May 2025 to extend cash runway.
Investor Relations Financials	$243.3 million	Cash, cash equivalents, and short-term investments as of September 30, 2025.
Scientific Validation (Oncology)	4	Responders (1 CR, 3 PR) out of 10 secondary ICI-refractory patients in highest PLN-101095 dose cohorts (Interim data as of Nov 30, 2025).
Scientific Validation (Oncology)	60%	Secondary refractory patients showing stable disease or tumor reduction with PLN-101095 (Interim data as of Nov 30, 2025).
Scientific Validation (Oncology)	15 months	Median time on treatment for PLN-101095 responders as of November 30, 2025.
Patient Advocacy Context	79%	Patient advocacy groups reporting research engagement in some capacity (General Rare Disease Data).

You'll want Finance to track the burn rate closely against the $243.3 million cash position at the end of Q3 2025, especially given the shift in R&D focus post-IPF. Operations: confirm the final BEACON-IPF close-out is complete by the end of Q4 2025 as planned.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Channels

You're looking at how Pliant Therapeutics, Inc. gets its science and potential products to the relevant stakeholders-from clinical sites to potential partners and, eventually, patients. The channels are heavily weighted toward research and external partnerships right now, which makes sense given the late-stage clinical focus.

Global clinical trial networks for patient enrollment and drug testing

Pliant Therapeutics, Inc. relies on established clinical trial infrastructure to test its integrin-based candidates. While the BEACON-IPF Phase 2b/3 trial, which evaluated bexotegrast, was a global effort, it involved approximately 360 patients across 262 international sites before its discontinuation. Currently, the channel focus is on the oncology program, specifically the Phase 1 dose-escalation trial for PLN-101095 in solid tumors resistant to immune checkpoint inhibitors. This trial has completed enrollment of all five planned dose cohorts. In the earlier stages of this trial, 16 patients with nine different tumour types were enrolled across five dosing groups to test various regimens, such as 1,000 mg BID (twice daily) for six subjects and 2,000 mg BID for three patients. The company is positioned to execute advanced trials, maintaining a deeply experienced late-stage clinical and regulatory development organization.

Here's a snapshot of the recent clinical trial channel activity:

Trial/Program	Status as of Late 2025	Key Metric/Scope
BEACON-IPF (Bexotegrast)	Close out activities expected in Q4 2025	Approx. 360 patients across 262 international sites
PLN-101095 Phase 1 Oncology	Enrollment of five dose cohorts completed	16 patients enrolled across five groups in initial cohorts
PLN-101325 (Muscular Dystrophies)	Received regulatory clearance for Phase 1 study	Early-stage platform asset

Scientific and medical conferences (e.g., AASLD) to present clinical data

Presenting data at key scientific venues is a primary channel for validating science and engaging the medical community. Pliant Therapeutics, Inc. presented at the American Thoracic Society (ATS) 2025 International Conference in May 2025. This included a featured oral presentation and three scientific posters covering bexotegrast and biomarker analysis in Interstitial Lung Disease (ILD) subtypes. The company makes these presentations available on its website under the Publications section.

• ATS 2025 Conference attendance: May 16-21, 2025.
• Number of scientific posters presented at ATS 2025: Three.
• Data presented included evaluation of bexotegrast in human precision-cut lung slices (PCLS).

Licensing and collaboration agreements (e.g., Novartis) for non-core assets or territories

External partnerships serve as a crucial channel for advancing non-core assets or leveraging global reach for specific indications. The strategic collaboration and license agreement with Novartis for PLN-1474 (for NASH-related liver fibrosis) and up to three additional integrin targets, originally signed in October 2019, is a prime example. Pliant completed the Phase 1 development for PLN-1474, after which Novartis assumed all future development, manufacturing, and commercialization.

The financial structure of this channel included:

• Initial payment from Novartis: $80 million (upfront payment and equity investment commitments).
• Total potential milestone payments: Up to $416 million.
• Royalty structure: Tiered royalties on product sales ranging from the mid-single digits to low double digits.

This structure allowed Pliant Therapeutics, Inc. to fund R&D activities related to the deal while transferring late-stage risk and commercialization responsibility externally.

Future specialty pharmacy and direct-to-physician sales channels post-approval

For Pliant Therapeutics, Inc.'s current pipeline assets, particularly PLN-101095 in oncology, the commercial channel strategy is still in the planning phase, contingent on successful later-stage data. The company is accelerating development of PLN-101095 with the initiation of a Phase 1b indication expansion trial planned for 2026. The company's current financial position, with cash, cash equivalents, and short-term investments reported at $243.3 million as of September 30, 2025, supports planned operations through 2028. This runway is intended to support execution of clinical trials, including any late-stage trials, following a workforce realignment that reduced personnel by approximately 45% in May 2025. The actual structure for specialty pharmacy or direct-to-physician sales for an approved oncology product would be determined after positive data from the planned 2026 expansion trial and subsequent Phase 3 studies.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Customer Segments

Oncology patients with advanced solid tumors resistant to immune checkpoint inhibitors.

This segment is targeted by the investigational drug PLN-101095, which is being evaluated in combination with pembrolizumab for patients refractory to immune checkpoint inhibitors (ICI). Interim data from the Phase 1 dose escalation trial showed antitumor activity in this heavily pretreated population. Across the three highest dose cohorts, there were four responders out of the 10 secondary ICI refractory patients. Specifically, 60% of secondary refractory patients demonstrated stable disease or tumor reduction. The median time on treatment in these patients was 15 months, as of November 30th, 2025. Clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer (NSCLC). Final data from this trial, including the two highest dose cohorts, is expected by the end of 2025.

Patients diagnosed with Primary Sclerosing Cholangitis (PSC).

PSC is a rare, progressive liver disease. The estimated patient population is over 100,000 patients worldwide and more than 30,000 patients in the United States. Currently, there are no FDA or EMA-approved therapies for patients with PSC. Pliant Therapeutics evaluated bexotegrast in the INTEGRIS-PSC Phase 2a trial. The 320 mg dose cohort enrolled 27 patients in the active arm and 9 patients in the placebo arm. Pliant Therapeutics had a cash position of $243.3 million as of September 30, 2025, to support ongoing pipeline advancement.

Patients with muscular dystrophies (future segment for PLN-101325).

PLN-101325 targets $\alpha7\beta1$ integrin, a receptor upregulated in Duchenne muscular dystrophy (DMD) and other forms of muscular dystrophy. This therapy is Phase 1 ready with a Clinical Trial Approval (CTA) open in Australia. Preclinical data in mouse models showed improved diaphragm strength and function, addressing a leading cause of death in muscular dystrophy patients. Pliant Therapeutics reported a net loss of $26.3 million in Q3 2025, with a strategic restructuring involving a ~45% workforce reduction to extend cash runway for future clinical execution.

Specialist physicians: oncologists, hepatologists, and rare disease experts.

The specialist physician segment is defined by their practice focus on the target indications:

• Oncologists treating advanced solid tumors.
• Hepatologists managing Primary Sclerosing Cholangitis.
• Rare disease experts focused on muscular dystrophies.

The company's cash, cash equivalents and short-term investments were $264.4 million as of June 30, 2025, supporting the clinical development necessary to engage these specialists.

Indication/Program	Target Population Metric	Value/Status (Late 2025)
Oncology (PLN-101095)	Confirmed Partial Responses (3rd Cohort)	3 out of 6 patients
Oncology (PLN-101095)	Secondary Refractory Patients with Stable Disease/Reduction	60%
PSC (Bexotegrast)	US Patient Estimate	More than 30,000
PSC (Bexotegrast)	FDA/EMA Approved Therapies	None
Muscular Dystrophy (PLN-101325)	Development Status	Phase 1 ready (CTA open in Australia)
Corporate Cash Position (Q3 2025)	Cash, Cash Equivalents, and Short-Term Investments	$243.3 million (as of September 30, 2025)

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Pliant Therapeutics, Inc. (PLRX) operations as of late 2025. The structure is heavily weighted toward R&D, which is typical for a clinical-stage biopharma, but the recent strategic moves have clearly tightened the burn rate.

The most dominant expense category is Research and Development (R&D). For the third quarter of 2025, R&D expenses were reported at $17.9 million. This figure reflects a significant step-down from the prior-year quarter's $47.8 million, largely because the company is winding down the BEACON-IPF trial for bexotegrast. Still, this R&D spend supports the ongoing advancement of other pipeline assets.

General and Administrative (G&A) costs followed R&D as the next largest component. In Q3 2025, G&A totaled $10.3 million, down from $14.3 million in the prior-year quarter. This reduction signals the direct impact of the May 2025 strategic realignment.

Here's a quick look at those key operating expenses for the quarter:

Cost Component	Q3 2025 Amount (USD Millions)	Context
Research and Development (R&D)	17.9	Driven down by BEACON-IPF discontinuation
General and Administrative (G&A)	10.3	Reflects post-restructuring personnel cost savings
Total Operating Expenses (Implied)	28.2 (approx.)	Excludes other minor costs not explicitly detailed

Personnel costs saw a major adjustment following the May 2025 strategic realignment. That restructuring involved a reduction of approximately 45% of Pliant Therapeutics, Inc.'s current workforce. This action was specifically designed to minimize costs and preserve cash reserves, which stood at $243.3 million as of September 30, 2025, extending the cash runway.

Beyond the direct personnel and trial costs, the cost structure necessarily includes ongoing operational expenditures essential for maintaining the company's platform and future optionality. These include:

• Intellectual property maintenance fees for core patents.
• Legal fees associated with ongoing corporate and clinical matters.
• Manufacturing costs for clinical trial materials for active programs like PLN-101095.
• Site costs and vendor management for the ongoing Phase 1 trial in solid tumors.

The costs for clinical trial execution and manufacturing of drug candidates remain significant, even with the BEACON-IPF wind-down. The focus has shifted to executing the Phase 1 trial of PLN-101095, which completed enrollment, meaning future costs will be tied to data analysis and potential subsequent trial planning, rather than large-scale patient enrollment and drug supply for the discontinued IPF program.

To be fair, the October prepayment of outstanding amounts under the Oxford Finance loan agreement also impacts the balance sheet and future cash flow, reducing debt-related obligations, which is a form of future cost management.

Pliant Therapeutics, Inc. (PLRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Pliant Therapeutics, Inc. (PLRX) as of late 2025. Honestly, for a clinical-stage company, the revenue streams are almost entirely non-product related right now, which is typical.

Zero product revenue is the reality, as Pliant Therapeutics, Inc. is still deep in clinical development and has not achieved regulatory approval for any therapeutic candidate. Reported revenue was zero for Q3 2025, consistent with analyst expectations.

The current, tangible income comes from the balance sheet. You see interest and other income generated from their cash reserves. For the third quarter of 2025, this totaled approximately $2.8 million.

This cash position, as of September 30, 2025, stood at $243.3 million in cash, cash equivalents, and short-term investments. That cash is what generates the interest income you see.

The next layer of revenue is tied up in the success of their partnerships, specifically the one with Novartis. These are milestone payments from existing strategic collaborations. The agreement for PLN-1474, which has already transitioned to Novartis after Phase 1 completion, allows Pliant Therapeutics, Inc. to earn milestone payments up to $416 million upon the achievement of specified development, regulatory, and commercial milestones. Also, under the 2019 collaboration, Pliant Therapeutics, Inc. received a $4 million milestone payment for advancing another integrin target into development.

Here's a quick look at the structure of that key Novartis deal:

Payment Type	PLN-1474 Potential Amount	Status/Notes
Upfront Fee	$50 million	Received for worldwide exclusive license
Equity Investment	$30 million	Commitments from Novartis
Development/Regulatory/Commercial Milestones	Up to $416 million	Contingent on achievement

Also, you have to factor in the future potential royalties from licensed candidates like PLN-1474. Upon commercialization, Pliant Therapeutics, Inc. is eligible for tiered royalties ranging from the mid-single digit to low double-digit percentages on product sales.

Finally, the big, long-term, high-risk stream is future product sales revenue. This is entirely contingent on successful regulatory approval and market launch for their pipeline assets, such as PLN-101095 in solid tumors or PLN-101325 for muscular dystrophies.

The current revenue-generating activities can be summarized:

• Zero product sales revenue as clinical-stage.
• Interest income from cash reserves, totaling $2.8 million in Q3 2025.
• Potential milestone payments from the Novartis collaboration.
• Future tiered royalties on licensed assets.
• Contingent future revenue from pipeline product sales.

Finance: draft 13-week cash view by Friday.