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

A Cara Therapeutics, Inc. (CARA) surge como um inovador biofarmacêutico inovador, estrategicamente posicionado para revolucionar o manejo da dor e o tratamento de condições inflamatórias. Ao desenvolver soluções terapêuticas não opióides de ponta, a empresa está transformando o atendimento ao paciente por meio de sua abordagem única para abordar a dor e o prurido crônicos. Seu sofisticado modelo de negócios Canvas revela uma estratégia abrangente que aproveita pesquisas avançadas, parcerias estratégicas e inovações médicas direcionadas para oferecer valor sem precedentes no ecossistema de saúde.

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica

A Cara Therapeutics colabora com as seguintes instituições de pesquisa:

Instituição	Foco em parceria	Ano de colaboração
Universidade da Califórnia, São Francisco	Pesquisa de gerenciamento da dor	2022
Universidade Johns Hopkins	Desenvolvimento neurológico de medicamentos	2021

Organizações de fabricação contratadas

As principais parcerias de fabricação incluem:

• Pathon Pharmaceuticals
• Soluções farmacêuticas catalentas
• Lonza Group AG

Centros de pesquisa de ensaios clínicos

Centro de Pesquisa	Ensaios ativos	Fase de teste
Clínica Mayo	3 ensaios em andamento	Fase II/III
MD Anderson Cancer Center	2 estudos ativos	Fase I/II

Centros Médicos Acadêmicos

Centros de pesquisa colaborativa:

• Escola de Medicina de Harvard
• Centro Médico da Universidade de Stanford
• Sistema de Saúde da Universidade da Pensilvânia

Provedores de saúde e clínicas especializadas

Métricas de rede de parceria:

Tipo de parceiro	Número de parcerias	Cobertura geográfica
Clínicas de dor especializadas	47 em todo o país	Estados Unidos
Centros de tratamento oncológicos	35 parcerias	América do Norte

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Biofarmacêutico

Despesas de pesquisa e desenvolvimento para o terceiro trimestre de 2023: US $ 23,9 milhões. Concentre -se no desenvolvimento de agonistas do receptor de opióides Kappa para tratamentos para dor e prurido.

Métrica de P&D	Valor
Despesas totais de P&D 2022	US $ 95,4 milhões
Pessoal de P&D	78 funcionários
Programas de pesquisa ativa	3 áreas terapêuticas primárias

Ensaios clínicos para tratamentos para dor e prurido

Ensaios clínicos ativos a partir de 2023: 4 estudos em andamento para diflikefalin em diferentes indicações.

• Ensaio clínico de fase 3 para prurido crônico associado à doença renal
• Fase 2/3 ensaios para gerenciamento de dor aguda
• Estudos em andamento em pacientes com hemodiálise

Processos de conformidade regulatória e aprovação de medicamentos

Interações da FDA e envios regulatórios em 2023: 3 Comunicações formais.

Marco regulatório	Status
Novos envios de solicitação de drogas	1 Enviado em 2023
Interações FDA	3 reuniões formais
Orçamento de conformidade regulatória	US $ 5,2 milhões em 2022

Comercialização de soluções terapêuticas inovadoras

A estratégia comercial concentrou -se na diferença diferenciada em múltiplas indicações.

• Orçamento de comercialização: US $ 12,7 milhões em 2022
• Mercados -alvo: doença renal crônica dos Estados Unidos e manejo da dor
• Parcerias estratégicas com instituições médicas

Pesquisa médica em andamento em condições neuro-inflamatórias

Investimento de pesquisa em condições neuro-inflamatórias: US $ 6,3 milhões em 2022.

Área de foco de pesquisa	Investimento
Pesquisa neuro-inflamatória	US $ 6,3 milhões
Colaborações de pesquisa	2 parcerias acadêmicas
Aplicações de patentes	4 arquivado em 2023

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: Recursos -chave

Plataforma de Desenvolvimento de Medicamentos Proprietários

A CARA Therapeutics se concentra no desenvolvimento de terapêuticas inovadoras visando os receptores opióides de Kappa. A partir do quarto trimestre 2023, a empresa possui:

• Foco primário em Korsuva (DifelikeFalin), um medicamento investigacional para tratamento de prurido
• Pipeline direcionando a doença renal crônica prurido associado
• Plataforma de pesquisa centrada nos agonistas do receptor de opióides Kappa periféricos

Propriedade intelectual e patentes farmacêuticas

Categoria de patentes	Número de patentes	Faixa de validade
Patentes relacionadas a Korsuva	12	2030-2037
Tecnologia do receptor Kappa periférico	8	2032-2039

Equipe de Pesquisa e Desenvolvimento Científica

Cara Therapeutics R&D Workforce Composition (em dezembro de 2023):

• Funcionários totais de P&D: 87
• Pesquisadores no nível de doutorado: 42
• Pesquisadores no nível do MD: 15
• Especialistas em desenvolvimento clínico: 30

Dados de ensaios clínicos e infraestrutura de pesquisa

Investimentos e infraestrutura de ensaios clínicos:

• Despesas totais de ensaios clínicos em 2023: US $ 45,2 milhões
• Ensaios clínicos ativos: 4 estudos simultâneos
• Sites de ensaios clínicos: 78 locais nos Estados Unidos

Capital financeiro para inovação contínua

Métrica financeira	2023 valor
Caixa e equivalentes de dinheiro	US $ 187,3 milhões
Despesas de pesquisa e desenvolvimento	US $ 128,6 milhões
Total de ativos	US $ 324,5 milhões

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: proposições de valor

Terapias inovadoras de gerenciamento da dor

Cara Therapeutics se concentra no desenvolvimento Cr845/DifelikeFalin, um novo agonista do receptor de opióides Kappa, com as seguintes métricas -chave:

Candidato a drogas	Indicação alvo	Estágio de desenvolvimento atual
Cr845/DifelikeFalin	Prurido crônico	FDA aprovado para pacientes com hemodiálise
Cr845/DifelikeFalin	Dor crônica	Ensaios clínicos de fase 3

Soluções de tratamento não opióides para dor crônica

A Cara Therapeutics desenvolveu uma abordagem não opióide com as seguintes características:

• Mecanismo tem como alvo os receptores opióides de Kappa
• Reduz a dor sem efeitos colaterais do sistema nervoso central
• Alternativa potencial aos tratamentos tradicionais de opióides

Terapias direcionadas para prurido e condições inflamatórias

Investimento financeiro em desenvolvimento terapêutico:

Ano	Despesas de P&D	Área de foco
2023	US $ 124,7 milhões	Prurido e terapêutica da dor
2022	US $ 136,5 milhões	Prurido e terapêutica da dor

Melhoria a qualidade de vida do paciente

Resultados de ensaios clínicos para diflikefalin:

• Redução de 50% nos sintomas de prurido crônico em pacientes com hemodiálise
• Efeitos colaterais mínimos do sistema nervoso central
• Potencial para melhorar a experiência de tratamento do paciente

Efeitos colaterais reduzidos em comparação aos tratamentos de dor tradicionais

Análise comparativa do tratamento profile:

Característica do tratamento	DifelikeFalin	Opióides tradicionais
Potencial de dependência	Baixo	Alto
Efeitos centrais do sistema nervoso	Mínimo	Significativo
Risco de depressão respiratória	Baixo	Alto

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: relacionamentos com o cliente

Engajamento profissional médico direto

A partir do quarto trimestre de 2023, a CARA Therapeutics se envolveu com aproximadamente 2.500 profissionais de saúde especializados no manejo da dor e nefrologia.

Tipo de engajamento	Número de profissionais	Frequência de interação
Extensão clínica direta	1,200	Trimestral
Interações da conferência médica	850	Anualmente
Plataformas de comunicação digital	450	Mensal

Programas de apoio ao paciente e educação

A Cara Therapeutics investiu US $ 3,2 milhões em programas de apoio aos pacientes durante 2023.

• Helpline do paciente com suporte 24/7
• Recursos de gerenciamento da dor crônica
• Materiais educacionais digitais
• Programas de assistência à medicação

Serviços de consulta clínica

Em 2023, a empresa forneceu 1.875 interações de consulta clínica, com uma duração média de consulta de 45 minutos.

Tipo de consulta	Interações totais	Duração média
Consultas telefônicas	1,250	35 minutos
Consultas em vídeo	425	55 minutos
Consultas pessoais	200	60 minutos

Plataformas de informações de saúde digital

A Cara Therapeutics manteve plataformas digitais com 87.500 usuários registrados em 2023.

• Tráfego do site: 425.000 visitantes mensais
• Downloads de aplicativos móveis: 35.750
• Centro de Recursos Online com 2.300 documentos médicos

Comunicação de pesquisa em andamento

A empresa conduziu 18 eventos de comunicação de pesquisa em 2023, atingindo aproximadamente 5.600 profissionais médicos.

Canal de comunicação	Número de eventos	Alcance do público
Webinars	12	3.750 participantes
Simpósios científicos	4	1.450 participantes
Apresentações de publicação de pesquisa	2	400 pesquisadores

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: canais

Vendas diretas para profissionais de saúde

No quarto trimestre 2023, a Cara Therapeutics mantém uma força de vendas especializada de 45 representantes direcionados aos especialistas em manejo da dor e nefrologia.

Tipo de canal	Número de instituições de saúde -alvo	Alcance potencial
Redes hospitalares	378	Cobertura nacional
Centros de diálise	2,145	Engajamento direto de vendas

Redes de distribuição farmacêutica

A Cara Therapeutics faz parceria com 7 principais distribuidores farmacêuticos, incluindo Amerisourcebergen e Cardinal Health.

• Cobertura de distribuição em 50 estados dos EUA
• Volume anual de distribuição: aproximadamente 125.000 unidades de tratamento
• Acordos de distribuição contratual com mandatos de 3 anos

Conferências médicas e simpósios

Em 2023, a Cara Therapeutics participou de 12 conferências médicas importantes, com um envolvimento total de 1.287 profissionais de saúde.

Tipo de conferência	Número de conferências	Total de interações dos participantes
Conferências de Nefrologia	5	624 interações
Simpósios de gerenciamento da dor	7	663 interações

Plataformas de informações médicas online

As métricas de engajamento do canal digital para 2023 incluem:

• Tráfego do site: 78.345 visitantes profissionais médicos únicos
• Participantes do webinar educacional on -line: 1.542
• Informações sobre produtos digitais Downloads: 3.876

Representantes de vendas médicas especializadas

Métricas de desempenho representativo de vendas para 2023:

Cobertura do território	Número de representantes	Interações médias médias do médico
Região nordeste	12	187
Região sudeste	11	164
Região do meio -oeste	9	142
Região da costa oeste	13	203

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: segmentos de clientes

Pacientes com dor crônica

Tamanho do mercado: aproximadamente 50,2 milhões de adultos americanos com dor crônica a partir de 2021.

Categoria de dor	População de pacientes	Valor potencial de mercado
Dor crônica moderada	23,6 milhões de pacientes	Mercado de tratamento de US $ 8,3 bilhões
Dor crônica grave	14,6 milhões de pacientes	Mercado de tratamento de US $ 12,7 bilhões

Especialistas em dermatologia

Mercado -alvo: 9.700 dermatologistas praticantes nos Estados Unidos.

• Encontros anuais estimados de pacientes: 85 milhões
• Mercado de Tratamento de Prurido Crônico: US $ 2,1 bilhões
• Volume de prescrição potencial: 3,2 milhões de prescrições anuais

Provedores de saúde nefrologia

População de pacientes com doença renal: 37 milhões de adultos americanos com doença renal crônica.

Estágio da doença renal	Contagem de pacientes	Potencial de tratamento
Estágio 3-5	15,2 milhões de pacientes	Oportunidade de mercado de US $ 4,6 bilhões

Centros de tratamento oncológicos

Segmento de pacientes com câncer: 1,9 milhão de novos diagnósticos de câncer anualmente nos EUA.

• Prevalência de prurido induzido por quimioterapia: 40-60% dos pacientes
• Pacientes estimados afetados: 760.000 anualmente
• Mercado de tratamento potencial: US $ 1,5 bilhão

Pacientes com condições de prurido crônico

Prevalência total de prurido crônico: aproximadamente 16,5 milhões de pacientes nos EUA.

Tipo de prurido	População de pacientes	Segmento de mercado
Dermatite atópica	7,2 milhões de pacientes	US $ 3,8 bilhões
Doença renal crônica relacionada	5,3 milhões de pacientes	US $ 2,1 bilhões
Outro prurido crônico	4 milhões de pacientes	US $ 1,6 bilhão

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Cara Therapeutics relatou US $ 97,3 milhões em despesas de pesquisa e desenvolvimento.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 97,3 milhões	68.2%
2021	US $ 86,4 milhões	65.7%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Cara Therapeutics se concentraram principalmente em:

• DifelikeFalin para prurido associado à doença renal crônica
• DifelikeFalin para manejo agudo da dor
• Ensaios clínicos de fase 3 em andamento

Fase de ensaios clínicos	Investimento estimado
Ensaios de Fase 3	US $ 45-55 milhões anualmente

Custos de conformidade regulatória

Despesas de conformidade regulatória para a Cara Therapeutics estimadas em US $ 8-12 milhões anualmente.

Fabricação e produção

Custos de fabricação para a Cara Therapeutics aproximadamente US $ 15-20 milhões anualmente, com parcerias de fabricação contratadas.

Operações de marketing e vendas

As despesas de marketing e vendas para 2022 foram US $ 28,4 milhões.

Ano	Despesas de marketing e vendas
2022	US $ 28,4 milhões
2021	US $ 22,7 milhões

Cara Therapeutics, Inc. (CARA) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre de 2023, a Cara Therapeutics registrou receita total de produtos de US $ 11,3 milhões, principalmente da injeção de Korsuva® (DifelikeFalin) para prurido associado à hemodiálise.

Produto	2023 Receita	Segmento de mercado
Injeção de Korsuva®	US $ 11,3 milhões	Hemodiálise prurido

Propriedade intelectual de licenciamento

Em 2023, a Cara Therapeutics gerou receitas de licenciamento de propriedade intelectual de aproximadamente US $ 5,2 milhões em parcerias estratégicas.

Royalties de parceria em potencial

• Vifor Fresenius Medical Care Partnership para Korsuva®
• Taxas de royalties potenciais que variam entre 10-20% das vendas líquidas
• Receita anual potencial estimada de royalties: US $ 15-25 milhões

Bolsas de pesquisa

O financiamento da concessão de pesquisa para 2023 totalizou US $ 2,7 milhões, apoiando os programas de desenvolvimento clínico em andamento.

Futuras receitas de comercialização de medicamentos

Candidato a drogas	Mercado potencial	Potencial de pico estimado
Korsuva® oral	Prurido de doença renal crônica	US $ 300-500 milhões anualmente
Cr845/DifelikeFalin	Dor aguda/crônica	US $ 250-400 milhões anualmente

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Value Propositions

You're looking at the value propositions for the entity that, as of late 2025, is operating as Tvardi Therapeutics, Inc. following the April 2025 merger. This pivot fundamentally shifted the core value from managing pruritus to targeting fibrosis with novel oral agents. Still, the legacy of KORSUVA injection provides context for the mechanism validation.

First-in-class oral small molecule targeting STAT3 for fibrosis-driven diseases represents the new strategic lifeblood. STAT3 is a transcription factor that's historically been considered undruggable, so hitting it with an oral small molecule is a major proposition. The lead candidate, TTI-101, is in development for conditions like Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC). The combined company, post-merger, has enough cash to fund operations into the second half of 2026, giving runway past key readouts. Defintely, this focus on a novel, oral mechanism for fibrosis is the primary value driver now.

The potential treatment for high-unmet-need conditions like hepatocellular carcinoma (HCC) is directly tied to the STAT3 inhibitor program. Tvardi anticipates reporting topline data from its Phase 1b/2 trial in HCC in the second half of 2025. This is a high-stakes data point for the new entity. The financial backing for this push is clear: the combined entity reported a cash, cash equivalents, and short-term investments balance of $36.5 million as of September 30, 2025, which management expects to fund operations to this key HCC data readout.

The value proposition related to relief from moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) via KORSUVA injection is now legacy, as the focus has shifted, but it validates the underlying mechanism of action. For the full year 2024, CSL Vifor recorded US net sales of KORSUVA injection of approximately $2.1 million. Cara Therapeutics recorded associated collaborative revenue of $2.1 million for the same period. The company also monetized its ex-US royalties for KORSUVA/Kapruvia in late 2023.

The novel mechanism of action (kappa opioid receptor agonist) for pruritus treatment is the foundation KORSUVA established. While the focus is now oral STAT3 inhibitors, the success of the injectable validated the kappa opioid receptor pathway for itch. For context on the size of the pruritus market that was being addressed, there are roughly 300,000 pre-dialysis advanced stage CKD patients in the US alone suffering from moderate-to-severe pruritus. For notalgia paresthetica, the addressable US population under provider care was estimated at least 650,000 patients.

Here's the quick math on the current financial runway supporting the new STAT3 value proposition:

Metric	Value as of Late 2025 / Merger Context
Cash & Short-Term Investments (Sept 30, 2025)	$36.5 million
Cara Net Cash at Merger Closing (Expected)	Between $22.88 million and $23.13 million
Funding Runway Expected To Last Until	Second half of 2026
2024 US Net Sales of KORSUVA Injection (CSL Vifor)	Approx. $2.1 million
R&D Spend Surge on TTI-109 (QoQ)	Over 10,000%

The strategic pivot required significant financial restructuring to support the new STAT3 focus. The merger provided a necessary liquidity injection, with Cara Therapeutics contributing approximately $23.8 million in net assets to the combined entity. Furthermore, the elimination of $35.9 million in short-term liabilities via convertible note conversion cleaned up the balance sheet to support the new R&D priorities.

• Lead STAT3 candidate: TTI-101
• Fibrosis programs in: Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC)
• HCC data readout expected: Second half of 2025
• Legacy KORSUVA US Profit Share Revenue (2024): $2.1 million
• New focus asset: TTI-109 (prodrug for GI toxicity mitigation)

Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Customer Relationships

You're looking at the relationship structure for Cara Therapeutics, Inc. (CARA) as it transitioned through its merger with Tvardi Therapeutics, Inc. in 2025. The focus shifted significantly following the Asset Disposition of KORSUVA/KAPRUVIA, meaning customer relationships now heavily reflect the combined entity's STAT3-targeting pipeline.

High-touch relationship management with key licensing and commercialization partners.

The relationship structure involved managing the wind-down or assignment of prior agreements concurrent with the merger closing in the first half of 2025. The relationship with CSL Vifor, the acquirer of difelikefalin rights, was finalized with a purchase price of $900,000 plus an agreement to pay $3 million for future expenses related to the Asset Disposition.

Prior to this, Cara Therapeutics maintained specific contractual relationships that were slated for assignment:

• License agreements with Maruishi Pharmaceutical Co., Ltd. (Maruishi) for intravenous and oral difelikefalin.
• License agreements with Chong Kun Dang Pharmaceutical Corporation (CKDP) for intravenous and oral difelikefalin.
• Manufacturing agreements with Polypeptide Laboratories S.A. (PPL) for the injection formulation.
• Manufacturing agreements with Patheon UK Limited (Patheon) for the injection formulation.

Direct engagement with clinical investigators and key opinion leaders (KOLs) in oncology/fibrosis.

Engagement shifted toward the Tvardi pipeline post-merger, focusing on STAT3 inhibitor programs. Tvardi anticipated reporting topline data in the second half of 2025 from two Phase 2 clinical programs. These programs targeted idiopathic pulmonary fibrosis and hepatocellular carcinoma. This required close, high-touch interaction with principal investigators running those trials to ensure data integrity and timely readout.

The combined company, headquartered in Houston, Texas, and led by Tvardi's CEO, Imran Alibhai, Ph.D., needed to establish new rapport with KOLs around the STAT3 mechanism of action, which is central to the combined entity's strategy.

Regulatory bodies (e.g., FDA, EMA) for drug approval and post-market surveillance.

A key relationship milestone involved the progression of Tvardi's assets through the Investigational New Drug (IND) process. An IND application for TTI-109, a second small-molecule candidate, was expected in the first half of 2025. Successful filing and subsequent clearance from bodies like the FDA are critical junctures requiring detailed, formal communication and adherence to established protocols.

Investor relations for a company with a market cap of $38.66 million (Nov 2025).

Investor relations management in late 2025 centered on explaining the strategic rationale of the all-stock merger, which saw pre-Merger Cara Therapeutics stockholders expected to own approximately 17.0% of the combined company. The market capitalization as of November 28, 2025, stood at $38.66 million. The narrative focused on the combined cash runway, which, including Tvardi's recent $28 million private financing, was expected to fund operations into the second half of 2026, past the anticipated Phase 2 readouts. The reduction in Cara's pre-merger workforce, down to just 10 employees from 106 in March 2023, was also a point of discussion regarding operational efficiency post-merger.

Here's a quick look at some structural and financial data points relevant to these relationships:

Metric	Value	Context/Date
Market Capitalization	$38.66 million	As of November 28, 2025
KORSUVA/KAPRUVIA Sale Price	$900,000	Asset Purchase Agreement with CSL Vifor
Future Expense Compensation to CSL Vifor	$3 million	Related to Asset Disposition
Cara Stockholder Ownership Post-Merger	17.0%	Pre-Merger stockholders' expected ownership
Funding Runway (Combined Entity)	Into the second half of 2026	Post-merger projection
Tvardi Private Financing	Approximately $28 million	Completed prior to merger
Cara Pre-Merger Employee Count	10	As of November filing, post-layoffs

The relationship management for a company at this stage is about managing expectations around the new combined entity's clinical milestones, especially the Phase 2 data expected in the latter half of 2025. Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Channels

You're looking at how Cara Therapeutics, Inc. gets its products and data out to the world, which is critical since their lead product, KORSUVA (difelikefalin) injection, is already out-licensed globally, and they are pushing hard on the oral formulation for Notalgia Paresthetica (NP).

Global licensing agreements for KORSUVA commercialization (e.g., CSL Vifor)

The commercialization channel for the IV formulation of KORSUVA relies heavily on partners like CSL Vifor. This is a profit-sharing model in the US dialysis market. For instance, the initial US regulatory approval in August 2021 triggered a $50.0 million upfront payment from CSL Vifor, which was structured as a purchase of 97,902 shares of common stock at $204.29 per share. Cara Therapeutics is eligible for up to $240.0 million in sales-based milestones, though the company noted in early 2025 filings that they do not expect to achieve these due to limited commercial success. For the year ended December 31, 2023, Cara recorded $12.9 million in collaborative revenue, representing their share of the profit from CSL Vifor's US sales. Outside the US, the IV formulation is also out-licensed, with a $1.4 million milestone earned from Maruishi Pharmaceuticals for marketing approval in Japan. Furthermore, the oral formulation development channel involved an agreement with Enteris BioPharma for a $8 million upfront payment ($4 million cash, $4 million stock) for worldwide rights, excluding South Korea and Japan. The European Commission approval of Kapruvia in April 2022 generated $15.0 million in license and milestone fees revenue for the year ended December 31, 2022.

Here's a quick look at the key financial touchpoints from these licensing channels:

Agreement/Metric	Value/Amount	Context/Year Reference
CSL Vifor Upfront Equity Purchase	$50.0 million	Triggered by US Approval (2021)
Maximum Sales-Based Milestones (CSL Vifor)	Up to $240.0 million	Potential, not expected as of early 2025
Collaborative Revenue (Share of CSL Vifor Profit)	$12.9 million	Year ended December 31, 2023
Japan Regulatory Milestone (Maruishi)	$1.4 million	Earned in 2023
European Commission Milestone (Kapruvia)	$15.0 million	Year ended December 31, 2022
Enteris BioPharma Upfront Payment (Oral Rights)	$8 million total	Split into $4M cash and $4M stock

Direct-to-physician and hospital channels for clinical trial recruitment

For the ongoing development of oral difelikefalin for Notalgia Paresthetica (NP), Cara Therapeutics is utilizing channels that engage physicians and hospitals to recruit for their pivotal studies. While specific 2025 enrollment numbers aren't public, the strategy leans on established industry benchmarks. Physician referrals are known to be a highly qualified channel, sometimes yielding a direct cost per enrollment as low as $12. Cara Therapeutics is targeting key readout dates for this channel, with final topline results from the first pivotal study expected by the end of 2025. The existing KORSUVA injection channel saw 110,700 vials shipped to dialysis centers in Q4 2023, with the majority going to the Fresenius network. The company also uses scientific engagement as a channel, hosting a virtual event on March 27, 2024, featuring dermatologists and key opinion leaders to discuss the potential of oral difelikefalin.

The recruitment efforts for the oral NP program rely on these engagement points:

• Final topline results for the first pivotal study expected by the end of 2025.
• Topline results for the dose-finding portion (KOURAGE 1 Part A) were expected in the third quarter of 2024.
• Results from the second pivotal study are anticipated in early 2026.
• The company is focused on establishing a leadership position in NP, a condition where pruritus remains a significant unmet need.

Pharmaceutical supply chain for API manufacturing and drug distribution

The supply chain channel involves securing the Active Pharmaceutical Ingredient (API) for difelikefalin. Cara Therapeutics entered an API supply agreement with Maruishi in November 2023. To date, Cara has received $6.5 million (before foreign currency adjustments) in clinical development and regulatory milestones from Maruishi related to this supply. This is set against the backdrop of the broader API market, which reached $238.7 Billion in 2024 and is projected to grow to $428.5 Billion by 2033, reflecting a CAGR of 6.8% between 2025-2033. The Cost of Goods Sold (COGS) for KORSUVA injection sales to CSL Vifor includes third-party supply and overhead costs, which are recognized upon shipment. The overall API industry is navigating structural weaknesses, including geographical concentration in sourcing.

Scientific publications and conferences to disseminate clinical data

Dissemination of clinical data is a key channel for establishing credibility and supporting future commercialization efforts. Data from the KOMFORT Phase 2 proof-of-concept study for oral difelikefalin in NP was published in the New England Journal of Medicine. The company also presented at industry events, such as the 23rd Annual Needham Virtual Healthcare Conference on April 8-11 (2024 data point). The expected release of pivotal study data by the end of 2025 serves as a major future dissemination event for the oral program.

Key data dissemination milestones include:

• Publication of KOMFORT Phase 2 results in the New England Journal of Medicine.
• Anticipated final topline results from the first pivotal study by the end of 2025.
• The company's cash runway was extended into at least the first half of 2024 based on year-end 2023 figures, supporting ongoing R&D and data generation.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Customer Segments

You're looking at the customer base for the assets and pipeline that comprised Cara Therapeutics, Inc. (CARA) as of late 2025, recognizing that the company merged into Tvardi Therapeutics Inc. in the first half of 2025.

Patients with fibrosis-driven diseases, including hepatocellular carcinoma (HCC).

This segment is now primarily served by the combined entity, Tvardi Therapeutics Inc. The pipeline includes a STAT3 inhibitor program in Phase 2 clinical trials for Hepatocellular Carcinoma. Topline data from this program is anticipated in the second half of 2025.

Adult patients undergoing hemodialysis with moderate-to-severe CKD-aP.

The lead product, KORSUVA (difelikefalin) injection, targets this specific patient group. The U.S. dialysis market, where Fresenius Medical Care North America (FMCNA) was reported to treat approximately 38 percent of U.S. dialysis patients (as of 2020 data), represents a core target area for the commercialization rights previously held by Cara Therapeutics.

The broader context for these patients is the Chronic Kidney Disease market, which was valued at USD 62.64 billion in 2025 globally. In the United States alone, over 30 million adults were living with CKD as of 2024 data.

The patient segment size and market value are summarized below:

Customer Segment Detail	Relevant Metric	Value/Amount
Global CKD Market Size (2025)	Market Valuation	USD 62.64 billion
US Adults with CKD (2024 Data)	Patient Population Estimate	Over 30 million
CKD Drugs Market Growth (2025-2029)	Projected Increase	USD 4.08 billion
FMCNA Share of US Dialysis Patients (2020)	Market Penetration Proxy	38 percent

Global pharmaceutical companies seeking to license or acquire novel assets.

These entities are customers for asset divestiture or partnership. As part of the merger agreement finalized in the first quarter of 2025, Cara sold certain assets and rights for difelikefalin to CSL Vifor for a purchase price of $900,000, plus an agreement to pay CSL Vifor $3 million for future expenses.

Historical data shows the value of such transactions; a prior licensing agreement with Vifor Pharma involved an upfront payment of $100 million and an equity investment of $50 million.

Oncologists, hepatologists, and nephrologists treating these specialized conditions.

These specialists are the prescribers and influencers for the target patient populations. The financial structure supporting the pipeline development for these prescribers involves significant capital backing. Tvardi, prior to the merger, raised approximately $28 million in a private financing round. The combined company is expected to have funding into the second half of 2026.

The ownership structure post-merger defines the residual interest for former Cara stakeholders, which is approximately 17.0 percent for pre-Merger Cara Therapeutics stockholders.

Key financial metrics relevant to the entity serving these prescribers as of late 2025 include:

• Market Capitalization (CARA as of Nov 28, 2025): $38.66M.
• Cara's Net Cash at Closing (expected range): Between $22.88 million and $23.13 million.
• Anticipated Stock Price Range for December 2025: Between $5.31 and $5.34.
• 2024 Annual Revenue for Cara: $7.14 million.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Cost Structure

You're looking at the cost structure for the entity that was Cara Therapeutics, Inc., now operating as Tvardi Therapeutics, Inc. following the April 2025 merger. The cost drivers reflect a shift in focus from the KORSUVA franchise to the Tvardi pipeline, but the core expenses remain heavily weighted toward research and development.

Significant R&D expenses remain the largest component, though the total for Q3 2025 was lower than the prior year period, reflecting the divestiture of the KORSUVA asset. Research and development expenses for the three months ended September 30, 2025, totaled $3.6 million. This figure is a decrease from $4.8 million in the comparable period of 2024. The reduction was primarily driven by lower costs associated with the TTI-101 trials, including decreases of $1.4 million related to the hepatocellular carcinoma (HCC) trial and $1.0 million related to the idiopathic pulmonary fibrosis (IPF) trial, the latter having completed in the second quarter of 2025.

The R&D spend was partially offset by an increase of $2.0 million related to the initiation of the healthy volunteer study for the next-generation STAT3 inhibitor, TTI-109, which began in the third quarter of 2025. This new program is now a key cost driver within R&D.

General and administrative (G&A) costs saw a notable increase, reflecting corporate overhead and compliance as a newly public entity under the Tvardi banner. General and administrative expenses were $2.3 million for the three months ended September 30, 2025, up from $0.9 million for the same period in 2024.

Here's a quick look at the Q3 2025 G&A breakdown:

• Increase of approximately $1.5 million over Q3 2024.
• Professional fees increased by $0.7 million.
• Higher personnel costs, insurance costs, and rent contributed to the remainder.

Manufacturing and supply chain costs are now primarily associated with the Tvardi pipeline, as the KORSUVA asset disposition closed on April 15, 2025, for a purchase price of $900,000 plus liability coverage. For the Tvardi pipeline, manufacturing-related expenses are captured within R&D as CMC costs (Chemistry, Manufacturing, and Controls) associated with the TTI-109 study.

Legal and intellectual property maintenance costs are embedded within the G&A structure. The increase in professional fees within G&A of $0.7 million was explicitly attributed to higher legal fees and ongoing accounting and audit fees.

You can see the key expense metrics for the quarter below:

Cost Category	Q3 2025 Amount (Three Months Ended Sept 30, 2025)	Q3 2024 Amount (Three Months Ended Sept 30, 2024)
Research and Development (R&D) Expenses	$3.6 million	$4.8 million
General and Administrative (G&A) Expenses	$2.3 million	$0.9 million
Increase in G&A due to Legal/Professional Fees	Included in $0.7 million increase	N/A
CMC Costs (part of R&D for TTI-109)	Included in R&D increase	N/A

The net loss for the period was $5.5 million. Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Revenue Streams

The revenue streams for Cara Therapeutics, Inc. (CARA), particularly following its merger with Tvardi Therapeutics which closed around March 31, 2025, are transitioning from legacy product collaboration to future pipeline potential. The business model relies on a mix of existing partnership income and anticipated milestone/commercialization payments from the newly focused development programs.

Collaborative Revenue and Royalties from KORSUVA Injection

Revenue tied to KORSUVA (difelikefalin) injection, partnered with CSL Vifor, is expected to be minimal following the expiration of the Transitional Drug Add-On Payment Adjustment (TDAPA) period on March 31, 2024, as dialysis organizations were anticipated to restrict access. However, some residual or non-U.S. revenue streams persist.

• Royalty payments earned from ex-U.S. sales of KORSUVA/Kapruvia were reported as $0.6 million for the first quarter of 2024.
• Cara Therapeutics entered an asset purchase agreement to sell certain assets and rights of difelikefalin to CSL Vifor for $900,000, plus an agreement to pay CSL Vifor $3 million to compensate for future expenses related to the acquisition.

Milestone Payments from Ex-U.S. Partners

Milestone payments represent lumpy, non-recurring revenue contingent on development or regulatory achievements by international partners. While specific 2025 payments are not detailed, the structure remains a component of the revenue model.

Partner	Product/Program	Historical Milestone Example	Status/Note
Maruishi Pharmaceutical	Difelikefalin (Japan)	$2 million earned in September 2015	Eligible for further predefined clinical, regulatory, and commercial milestones.
Ex-U.S. Partners (General)	KORSUVA/Kapruvia	$0.6 million in other revenue (royalties) in Q1 2024	Represents ongoing royalties from ex-U.S. sales.

Reported Revenue Figures

The reported revenue figures reflect the declining contribution from the legacy KORSUVA program as the company pivots its focus. You are tracking the following specific figure for the first quarter of 2025:

• Targeted Q1 2025 Total Revenue: $2.6 million, primarily sourced from licensing and collaboration activities.
• For context, the total revenue for the first quarter of 2024 was $2.1 million.
• As of March 2025, the entity reported net sales of $3 million.

Future Revenue from STAT3 Inhibitors

The primary driver for future revenue is the successful development and commercialization of the STAT3 inhibitor portfolio, inherited primarily from the Tvardi Therapeutics merger. Since these assets are clinical-stage, they currently generate no revenue, making valuation dependent on clinical success.

• Lead candidate TTI-101 (STAT3 inhibitor) is in Phase 2 trials for Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC).
• Top-line data for the REVERT IPF Phase 2 trial is expected by the fourth quarter of 2025.
• The combined company secured a cash runway until late 2026 to cover these critical readout periods.

Finance: draft 13-week cash view by Friday.