Pliant Therapeutics, Inc. (PLRX): Modelo de negócios Canvas [Jan-2025 Atualizado]

No mundo da biotecnologia de ponta, a Pliant Therapeutics (PLRX) surge como uma força transformadora, pioneira soluções terapêuticas inovadoras para doenças fibróticas complexas. Ao alavancar plataformas de direcionamento molecular avançado e colaborações estratégicas, esta empresa inovadora está redefinindo possíveis tratamentos para desafiar condições médicas como fibrose pulmonar idiopática (IPF) e esteato-hepatite não alcoólica (NASH). Seu modelo de negócios meticulosamente criado representa uma abordagem sofisticada para atender às necessidades médicas não atendidas, misturando conhecimentos científicos com o desenvolvimento de parcerias estratégicas e metodologias de pesquisa inovadora.

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com a Novartis

Em março de 2022, a Pliant Therapeutics estabeleceu uma colaboração estratégica com a Novartis focada no desenvolvimento de candidatos terapêuticos para fibrose pulmonar idiopática (IPF) e esteato-hepatite não alcoólica (NASH). Os principais detalhes da parceria incluem:

Componente de parceria	Termos financeiros
Pagamento inicial	US $ 50 milhões
Potenciais pagamentos marcantes	Até US $ 615 milhões
Potencial de royalties	Royalties em camadas nas vendas líquidas

Parcerias de pesquisa

A Pliant Therapeutics mantém relações de pesquisa colaborativa com várias instituições acadêmicas e de pesquisa:

• Universidade da Califórnia, São Francisco
• Universidade de Stanford
• Duke University Medical Center

Colaborações de ensaios clínicos

A empresa se envolve com várias organizações de pesquisa de contratos (CROs) para o desenvolvimento clínico:

CRO Parceiro	Foco no ensaio clínico
Icon plc	Ensaios de Fase 2 IPF
Parexel International	Estudos clínicos de Nash
Iqvia	Desenvolvimento diagnóstico de companhia

Potenciais acordos de licenciamento farmacêutico

Discussões em andamento para possíveis licenciamento de candidatos a medicamentos PLN-1474 e PLN-2240 com potenciais parceiros farmacêuticos interessados ​​em terapias integrinas.

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de novas terapêuticas visando doenças fibróticas

A Pliant Therapeutics se concentra no desenvolvimento de terapêuticas inovadoras para doenças fibróticas. A partir do quarto trimestre de 2023, a empresa investiu US $ 48,2 milhões em despesas de P&D.

Áreas de foco em P&D	Estágio atual	Investimento
Fibrose pulmonar idiopática (IPF)	Ensaios clínicos de fase 2	US $ 22,7 milhões
Fibrose hepática	Ensaios clínicos de fase 1b	US $ 15,5 milhões
Esclerose sistêmica	Desenvolvimento pré -clínico	US $ 10 milhões

Gerenciamento de ensaios pré -clínicos e clínicos

A empresa gerencia vários ensaios clínicos em diferentes áreas terapêuticas.

• Ensaios clínicos ativos: 3 programas em andamento
• Total de inscrição para pacientes: 287 pacientes em todos os ensaios
• Duração média do estudo: 18-24 meses

Biologia Molecular e Pesquisa Farmacológica

A Pliant Therapeutics mantém uma infraestrutura de pesquisa robusta com recursos especializados de biologia molecular.

Capacidade de pesquisa	Capacidade	Orçamento anual
Cientistas de pesquisa	42 funcionários em tempo integral	US $ 12,3 milhões
Instalações de pesquisa	2 centros de pesquisa dedicados	US $ 5,6 milhões

Desenvolvimento da Propriedade Intelectual

Em dezembro de 2023, a Pliant Therapeutics garantiu proteção de propriedade intelectual por seus principais candidatos terapêuticos.

• Total de pedidos de patente: 17
• Patentes concedidas: 9
• Aplicações de patentes pendentes: 8

Processos de conformidade regulatória e aprovação de medicamentos

A Companhia mantém estratégias rigorosas de conformidade regulatória em seu pipeline de desenvolvimento de medicamentos.

Interação regulatória	Freqüência	Orçamento de conformidade
Interações FDA	Reuniões trimestrais	US $ 3,2 milhões
Submissões regulatórias de ensaios clínicos	6-8 envios anualmente	US $ 2,7 milhões

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: Recursos -chave

Especialização científica avançada em pesquisa de fibrose

A partir do quarto trimestre de 2023, a Pliant Therapeutics possui 35 pessoal especializado em pesquisa em pesquisa de doenças fibróticas. A Companhia desenvolveu experiência em direcionar as vias de sinalização integrina e TGF-β.

Categoria de pesquisa	Número de pesquisadores especializados	Áreas de foco
Pesquisa de fibrose	35	Fibrose pulmonar idiopática, fibrose hepática

Plataformas de segmentação molecular proprietária

A Pliant desenvolveu duas plataformas de segmentação molecular primária:

• Plataforma de integrina αvβ6
• Plataforma de integrina αvβ1

Portfólio de propriedade intelectual

Categoria de patentes	Número de patentes	Cobertura geográfica
Patentes emitidas	47	Estados Unidos, Europa, Japão
Aplicações de patentes pendentes	23	Mercados internacionais

Infraestrutura de pesquisa e desenvolvimento

Investimento total de infraestrutura de P&D a partir de 2023: US $ 68,4 milhões

Localização da instalação de P&D	Metragem quadrada	Capacidades de pesquisa
South San Francisco, CA	25.000 pés quadrados	Pesquisa pré -clínica e clínica

Equipe de gestão e científica experiente

Posição de liderança	Anos de experiência no setor	Afiliações anteriores
CEO	Mais de 20 anos	Roche, Genentech
Diretor científico	Mais de 25 anos	Merck, Bristol Myers Squibb

Contagem total de funcionários a partir do quarto trimestre 2023: 112 funcionários

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: proposições de valor

Abordagens terapêuticas inovadoras para doenças fibróticas progressivas

A Pliant Therapeutics se concentra no desenvolvimento de terapias moleculares direcionadas para doenças fibróticas progressivas, com ênfase específica nos tratamentos baseados em integrina.

Foco terapêutico -chave	Estágio de desenvolvimento atual	Potencial população de pacientes
Fibrose pulmonar idiopática (IPF)	Ensaios clínicos de fase 2	Aproximadamente 50.000 pacientes nos Estados Unidos
Esteato-hepatite não alcoólica (Nash)	Ensaios clínicos de fase 2	Estimado 16,5 milhões de pacientes nos Estados Unidos

Tratamentos em potencial para necessidades médicas não atendidas

A proposta de valor primário da Pliant atende às necessidades médicas não atendidas críticas em doenças fibróticas com opções limitadas de tratamento.

• Taxa atual de sobrevivência de 5 anos da IPF: aproximadamente 20%
• Complicações hepáticas relacionadas à NASH: principal causa de transplante de fígado
• Nenhuma terapia modificadora de doenças aprovadas pela FDA para múltiplas condições fibróticas

Terapias moleculares direcionadas com efeitos colaterais reduzidos

Plataforma terapêutica	Mecanismo de ação	Vantagem potencial
Inibição da integrina	Bloqueando interações celulares específicas	Potencial para direcionamento mais preciso com efeitos colaterais sistêmicos reduzidos

Desenvolvimento de Soluções de Medicina de Precisão

A abordagem de Pliant enfatiza a medicina de precisão através de intervenções moleculares direcionadas.

• Focado em metas de integrina específicas
• Potencial para estratégias de tratamento personalizadas
• Técnicas avançadas de triagem molecular

Potencial para melhorar os resultados dos pacientes

Área da doença	Limitações atuais de tratamento	Impacto potencial de Pliant
Fibrose pulmonar idiopática	Terapias limitadas de modificação de doenças	Potencial para diminuir a progressão da doença
Nash	Nenhum tratamento direcionado aprovado	Potencial para abordar mecanismos fibróticos subjacentes

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com prestadores de serviços de saúde

A Pliant Therapeutics mantém canais de comunicação direta com profissionais de saúde especializados em doenças pulmonares e fibróticas. A partir do quarto trimestre 2023, a empresa relatou 87 interações direcionadas com os principais pulmonologistas e médicos de pesquisa.

Tipo de engajamento	Número de interações	Freqüência
Reuniões de consultoria clínica	24	Trimestral
Colaborações de pesquisa	36	Semestral
Apresentações da conferência científica	27	Anual

Programas de apoio ao paciente e educação

A Companhia desenvolveu iniciativas abrangentes de apoio ao paciente com foco na fibrose pulmonar idiopática (IPF) e nas comunidades de pacientes esclerosantes primários (PSC).

• Webinars de educação para pacientes: 12 sessões em 2023
• Recursos de suporte on -line: 3 plataformas digitais dedicadas
• Inscrição do Programa de Assistência ao Paciente: 156 pacientes

Comunicação e colaboração da comunidade científica

A terapêutica flexível se envolve ativamente com pesquisadores científicos por meio de vários canais de comunicação.

Tipo de colaboração	Total de parcerias	Instituições de pesquisa
Parcerias de pesquisa acadêmica	14	8 universidades
Redes de pesquisa clínica	7	5 redes internacionais

Relatório de ensaio clínico transparente

A empresa mantém a transparência rigorosa na divulgação de dados de ensaios clínicos.

• Ensaios clínicos registrados: 5 ensaios ativos
• Plataformas de divulgação pública: 3 registros internacionais
• Relatórios de transparência de dados: publicações trimestrais

Estratégias de comunicação de investidores e partes interessadas

A Pliant Therapeutics implementa estratégias abrangentes de relações com investidores.

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes anualmente	320 investidores institucionais
Apresentações de investidores	6 Conferências	450 analistas financeiros
Reunião Anual dos Acionistas	1 tempo por ano	Aproximadamente 200 participantes

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: Canais

Força de vendas direta para potencial comercialização futura de medicamentos

No quarto trimestre 2023, a Pliant Therapeutics ainda não estabeleceu uma força de vendas comercial completa, concentrando-se principalmente no desenvolvimento de medicamentos em estágio clínico.

Apresentações da conferência médica

Conferência	Ano	Apresentações
Sociedade Torácica Americana (ATS)	2023	3 apresentações científicas
Sociedade Respiratória Europeia (ERS)	2023	2 apresentações científicas

Redes de publicação científica

Métricas de publicação:

• Total de publicações revisadas por pares: 12 a partir de 2023
• Principais revistas: Natureza, Cell, Journal of Clinical Investigation
• Índice de Citação: aproximadamente 85 citações totais

Plataformas de saúde digital

Os canais de engajamento digital incluem:

• Site da empresa: www.pliantx.com
• Página corporativa do LinkedIn: 2.500 seguidores
• Conta do Twitter: @plianttx, 1.200 seguidores

Redes de parceria farmacêutica

Parceiro	Ano	Foco de colaboração
Novartis	2022	Pesquisa de fibrose pulmonar idiopática
Gilead Sciences	2021	Colaboração em estágio pré -clínico

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

Pacientes com fibrose pulmonar idiopática (IPF)

A população global de pacientes com IPF estimou em 132.000 nos Estados Unidos a partir de 2024.

Faixa etária	Prevalência de IPF	Taxa de diagnóstico anual
50-75 anos	85% do total de pacientes	30.000-40.000 novos casos anualmente

Pacientes com esteato-hepatite não alcoólica (NASH)

População de pacientes em Nash nos Estados Unidos: aproximadamente 17,4 milhões de pacientes em 2024.

Severidade de Nash	Distribuição de pacientes
Estágio inicial	12,6 milhões de pacientes
Fibrose avançada	4,8 milhões de pacientes

Especialistas médicos de hepatologia e pulmonologia

• Total de hepatologistas em nós: 3.200
• Pulmonologistas totais em nós: 4.500
• Especialistas em potencial para terapêutica Pliant: 7.700

Instituições de Saúde

Tipo de instituição	Total de instituições	Alvo potencial
Centros de fibrose especializados	87	62 centros
Principais centros médicos acadêmicos	141	98 centros

Organizações de pesquisa

Organizações de pesquisa interessadas nas abordagens terapêuticas da Pliant Therapeutics.

Tipo de organização de pesquisa	Organizações totais
Instituições de pesquisa acadêmica	276
Fundações de pesquisa privada	43

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

A Pliant Therapeutics relatou despesas de pesquisa e desenvolvimento de US $ 106,7 milhões para o ano fiscal de 2022.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 106,7 milhões	78.4%
2021	US $ 85,3 milhões	75.2%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para terapêutica flexível em 2022 foram de aproximadamente US $ 62,4 milhões.

• Ensaios clínicos de fase 2 para tratamento de fibrose pulmonar idiopática (IPF)
• Desenvolvimento clínico em andamento para GLPG4716
• Estudos de habilitação de novos medicamentos para investigação (IND)

Despesas de proteção de propriedade intelectual

Os custos de proteção de propriedade e propriedade intelectual para 2022 foram estimados em US $ 3,2 milhões.

Categoria IP	Custo anual estimado
Registro de patentes	US $ 1,5 milhão
Manutenção de patentes	US $ 1,7 milhão

Overhead administrativo e operacional

As despesas administrativas totais para terapêutica flexível em 2022 foram de US $ 24,5 milhões.

• Custos gerais de pessoal administrativo
• Despesas de infraestrutura do escritório
• Investimentos em tecnologia e software

Despesas de marketing e comunicação

Os gastos com marketing e comunicação para 2022 foram de aproximadamente US $ 5,6 milhões.

Canal de marketing	Orçamento alocado
Participação da conferência científica	US $ 2,1 milhões
Marketing digital	US $ 1,5 milhão
Relações com investidores	US $ 2,0 milhões

Pliant Therapeutics, Inc. (PLRX) - Modelo de negócios: fluxos de receita

Potenciais pagamentos marcantes de parcerias farmacêuticas

A partir do quarto trimestre 2023, a Pliant Therapeutics estabeleceu parcerias farmacêuticas importantes com possíveis pagamentos de marcos:

Parceiro	Pagamento em potencial	Programa
Novartis	Até US $ 1,3 bilhão	Programas de IPF e Nash
Bristol Myers Squibb	Até US $ 1,2 bilhão	Colaboração de doenças fibróticas

Futuras receitas de comercialização de medicamentos

Possíveis receitas comerciais de candidatos a medicamentos principais:

• PLN-74809 (Tratamento da IPF): Tamanho potencial estimado do mercado de US $ 3,4 bilhões anualmente
• PLN-1474 (tratamento NASH): valor potencial de mercado de US $ 2,8 bilhões

Acordos de licenciamento

Detalhes atuais do contrato de licenciamento:

Parceiro de licenciamento	Valor do acordo	Área de foco
Novartis	Pagamento inicial de US $ 80 milhões	Programa de inibidor da integrina αvβ6

Bolsas de pesquisa e financiamento do governo

Pesquise fontes de financiamento para 2023-2024:

• Subsídios do NIH: US $ 2,5 milhões
• Subsídios SBIR/STTR: US $ 1,2 milhão

Potencial renda de royalties de desenvolvimentos de drogas

Intervalos de renda de royalties projetados:

Candidato a drogas	Faixa de royalties potenciais	Estágio de comercialização
PLN-74809	8-12% das vendas líquidas	Ensaios clínicos de fase 2
PLN-1474	10-15% das vendas líquidas	Ensaios 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.