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

Cara Therapeutics, Inc. (CARA) emerge como un innovador biofarmacéutico innovador, posicionado estratégicamente para revolucionar el manejo del dolor y el tratamiento de las afecciones inflamatorias. Al desarrollar soluciones terapéuticas no opioides de vanguardia, la compañía está transformando la atención del paciente a través de su enfoque único para abordar el dolor crónico y el prurito. Su sofisticado lienzo de modelo de negocio revela una estrategia integral que aprovecha la investigación avanzada, las asociaciones estratégicas y las innovaciones médicas dirigidas para ofrecer un valor sin precedentes en el ecosistema de atención médica.

Cara Therapeutics, Inc. (CARA) - Modelo de negocios: asociaciones clave

Instituciones de investigación farmacéutica

Cara Therapeutics colabora con las siguientes instituciones de investigación:

Institución	Enfoque de asociación	Año de colaboración
Universidad de California, San Francisco	Investigación del manejo del dolor	2022
Universidad de Johns Hopkins	Desarrollo de fármacos neurológicos	2021

Organizaciones de fabricación de contratos

Las asociaciones de fabricación clave incluyen:

• Patheon Pharmaceuticals
• Soluciones farmacéuticas catalent
• Grupo Lonza AG

Centros de investigación de ensayos clínicos

Centro de investigación	Pruebas activas	Fase de prueba
Clínica de mayonesa	3 pruebas en curso	Fase II/III
Centro de cáncer de MD Anderson	2 Estudios activos	Fase I/II

Centros médicos académicos

Centros de investigación colaborativos:

• Escuela de Medicina de Harvard
• Centro Médico de la Universidad de Stanford
• Sistema de Salud de la Universidad de Pensilvania

Proveedores de atención médica y clínicas especializadas

Métricas de red de asociación:

Tipo de socio	Número de asociaciones	Cobertura geográfica
Clínicas de dolor especializado	47 en todo el país	Estados Unidos
Centros de tratamiento oncológico	35 asociaciones	América del norte

Cara Therapeutics, Inc. (CARA) - Modelo de negocio: actividades clave

Investigación y desarrollo biofarmacéutico

Gastos de investigación y desarrollo para el tercer trimestre 2023: $ 23.9 millones. Concéntrese en desarrollar agonistas del receptor de opioides Kappa para el dolor y los tratamientos de prurito.

I + D Métrica	Valor
Gastos totales de I + D 2022	$ 95.4 millones
Personal de I + D	78 empleados
Programas de investigación activos	3 áreas terapéuticas primarias

Ensayos clínicos para el dolor y los tratamientos de prurito

Ensayos clínicos activos a partir de 2023: 4 estudios en curso para difelikefalina en diferentes indicaciones.

• Ensayo clínico de fase 3 para prurito asociado a la enfermedad renal crónica
• Ensayos de fase 2/3 para el manejo del dolor agudo
• Estudios en curso en pacientes con hemodiálisis

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Interacciones de la FDA y presentaciones regulatorias en 2023: 3 Comunicaciones formales.

Hito regulatorio	Estado
Nuevas presentaciones de solicitudes de drogas	1 enviado en 2023
Interacciones de la FDA	3 reuniones formales
Presupuesto de cumplimiento regulatorio	$ 5.2 millones en 2022

Comercialización de soluciones terapéuticas innovadoras

La estrategia comercial se centró en la difelikefalina en múltiples indicaciones.

• Presupuesto de comercialización: $ 12.7 millones en 2022
• Mercados objetivo: enfermedad renal crónica de los Estados Unidos y manejo del dolor
• Asociaciones estratégicas con instituciones médicas

Investigación médica en curso en afecciones neuroinflamatorias

Inversión de investigación en condiciones neuroinflamatorias: $ 6.3 millones en 2022.

Área de enfoque de investigación	Inversión
Investigación neuroinflamatoria	$ 6.3 millones
Colaboraciones de investigación	2 asociaciones académicas
Solicitudes de patentes	4 Archivado en 2023

Cara Therapeutics, Inc. (CARA) - Modelo de negocios: recursos clave

Plataforma de desarrollo de fármacos patentados

Cara Therapeutics se centra en el desarrollo de la terapéutica innovadora dirigida a los receptores de opioides Kappa. A partir del cuarto trimestre de 2023, la compañía tiene:

• Enfoque principal en Korsuva (Difelikefalin), un medicamento en investigación para el tratamiento con prurito
• Tubería dirigida al prurito asociado a la enfermedad renal crónica
• Plataforma de investigación centrada en agonistas periféricos de receptores de opioides kappa

Propiedad intelectual y patentes farmacéuticas

Categoría de patente	Número de patentes	Rango de vencimiento
Patentes relacionadas con Korsuva	12	2030-2037
Tecnología de receptores kappa periféricos	8	2032-2039

Equipo de Investigación y Desarrollo Científico

Composición de la fuerza laboral de I + D de Cara Therapeutics (a diciembre de 2023):

• Empleados totales de I + D: 87
• Investigadores a nivel de doctorado: 42
• Investigadores de nivel MD: 15
• Especialistas en desarrollo clínico: 30

Datos de ensayos clínicos e infraestructura de investigación

Inversiones e infraestructura de ensayos clínicos:

• Gastos totales de ensayos clínicos en 2023: $ 45.2 millones
• Ensayos clínicos activos: 4 estudios concurrentes
• Sitios de ensayos clínicos: 78 ubicaciones en todo Estados Unidos

Capital financiero para innovación continua

Métrica financiera	Valor 2023
Equivalentes de efectivo y efectivo	$ 187.3 millones
Gastos de investigación y desarrollo	$ 128.6 millones
Activos totales	$ 324.5 millones

Cara Therapeutics, Inc. (CARA) - Modelo de negocio: propuestas de valor

Terapias innovadoras de manejo del dolor

Cara Therapeutics se enfoca en desarrollar CR845/Difelikefalin, un noveloso agonista del receptor de opioides Kappa, con las siguientes métricas clave:

Candidato a la droga	Indicación objetivo	Etapa de desarrollo actual
CR845/Difelikefalin	Prurito crónico	FDA aprobado para pacientes con hemodiálisis
CR845/Difelikefalin	Dolor crónico	Ensayos clínicos de fase 3

Soluciones de tratamiento no opioides para dolor crónico

CARA Therapeutics ha desarrollado un enfoque no opioide con las siguientes características:

• El mecanismo se dirige a los receptores de opioides kappa
• Reduce el dolor sin efectos secundarios del sistema nervioso central
• Potencial alternativa a los tratamientos opioides tradicionales

Terapias dirigidas para prurito y afecciones inflamatorias

Inversión financiera en desarrollo terapéutico:

Año	Gastos de I + D	Área de enfoque
2023	$ 124.7 millones	Prurito y terapéutica del dolor
2022	$ 136.5 millones	Prurito y terapéutica del dolor

Mejor calidad de vida del paciente

Resultados del ensayo clínico para difelikefalin:

• Reducción del 50% en los síntomas de prurito crónico en pacientes con hemodiálisis
• Efectos secundarios mínimos del sistema nervioso central
• Potencial para mejorar la experiencia del tratamiento del paciente

Efectos secundarios reducidos en comparación con los tratamientos de dolor tradicionales

Análisis comparativo del tratamiento profile:

Característica del tratamiento	Difelikefalin	Opioides tradicionales
Potencial de adicción	Bajo	Alto
Efectos del sistema nervioso central	Mínimo	Significativo
Riesgo de depresión respiratoria	Bajo	Alto

Cara Therapeutics, Inc. (CARA) - Modelo de negocios: relaciones con los clientes

Compromiso médico directo

A partir del cuarto trimestre de 2023, Cara Therapeutics se dedicó a aproximadamente 2.500 profesionales de la salud que se especializan en el manejo del dolor y la nefrología.

Tipo de compromiso	Número de profesionales	Frecuencia de interacción
Extensión clínica directa	1,200	Trimestral
Interacciones de la conferencia médica	850	Anualmente
Plataformas de comunicación digital	450	Mensual

Programas de apoyo y educación del paciente

Cara Therapeutics invirtió $ 3.2 millones en programas de apoyo al paciente durante 2023.

• Limpieza del paciente con soporte las 24 horas del día, los 7 días de la semana,
• Recursos de manejo del dolor crónico
• Materiales educativos digitales
• Programas de asistencia con medicamentos

Servicios de consulta clínica

En 2023, la compañía proporcionó 1,875 interacciones de consulta clínica, con una duración de consulta promedio de 45 minutos.

Tipo de consulta	Interacciones totales	Duración promedio
Consultas telefónicas	1,250	35 minutos
Consultas de video	425	55 minutos
Consultas en persona	200	60 minutos

Plataformas de información de salud digital

Cara Therapeutics mantuvo plataformas digitales con 87,500 usuarios registrados en 2023.

• Tráfico del sitio web: 425,000 visitantes mensuales
• Descargas de aplicaciones móviles: 35,750
• Centro de recursos en línea con 2.300 documentos médicos

Comunicación de investigación en curso

La compañía realizó 18 eventos de comunicación de investigación en 2023, llegando a aproximadamente 5.600 profesionales médicos.

Canal de comunicación	Número de eventos	Alcance de la audiencia
Seminarios web	12	3.750 participantes
Simposios científicos	4	1.450 asistentes
Presentaciones de publicación de investigación	2	400 investigadores

Cara Therapeutics, Inc. (CARA) - Modelo de negocio: canales

Ventas directas a proveedores de atención médica

A partir del cuarto trimestre de 2023, Cara Therapeutics mantiene una fuerza de ventas especializada de 45 representantes dirigidos a los especialistas en manejo del dolor y nefrología.

Tipo de canal	Número de instituciones de atención médica objetivo	Alcance potencial
Redes hospitalarias	378	Cobertura nacional
Centros de diálisis	2,145	Compromiso de ventas directas

Redes de distribución farmacéutica

Cara Therapeutics se asocia con 7 principales distribuidores farmacéuticos, incluidos AmerisourceBergen y Cardinal Health.

• Cobertura de distribución en 50 estados de EE. UU.
• Volumen de distribución anual: aproximadamente 125,000 unidades de tratamiento
• Acuerdos de distribución contractual con términos de 3 años

Conferencias y simposios médicos

En 2023, Cara Therapeutics participó en 12 conferencias médicas clave, con una participación total de 1,287 profesionales de la salud.

Tipo de conferencia	Número de conferencias	Interacciones totales de los asistentes
Conferencias de nefrología	5	624 interacciones
Simposios de manejo del dolor	7	663 interacciones

Plataformas de información médica en línea

Las métricas de participación del canal digital para 2023 incluyen:

• Tráfico del sitio web: 78,345 visitantes médicos únicos
• Participantes de seminarios web educativos en línea: 1,542
• Descargas de información del producto digital: 3,876

Representantes de ventas médicas especializadas

Representante de ventas Métricas de rendimiento para 2023:

Cobertura de territorio	Número de representantes	Interacciones médicas mensuales promedio
Región noreste	12	187
Región sudeste	11	164
Región del medio oeste	9	142
Región de la costa oeste	13	203

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

Pacientes de dolor crónico

Tamaño del mercado: aproximadamente 50,2 millones de adultos estadounidenses que experimentan dolor crónico a partir de 2021.

Categoría de dolor	Población de pacientes	Valor de mercado potencial
Dolor crónico moderado	23,6 millones de pacientes	Mercado de tratamiento de $ 8.3 mil millones
Dolor crónico severo	14,6 millones de pacientes	Mercado de tratamiento de $ 12.7 mil millones

Especialistas en dermatología

Mercado objetivo: 9,700 dermatólogos en ejercicio en los Estados Unidos.

• Encuentros de pacientes anuales estimados: 85 millones
• Mercado de tratamiento de prurito crónico: $ 2.1 mil millones
• Volumen de prescripción potencial: 3.2 millones de recetas anuales

Proveedores de salud de la nefrología

Enfermedad renal Población de pacientes: 37 millones de adultos estadounidenses con enfermedad renal crónica.

Etapa de enfermedad renal	Contar con el paciente	Potencial de tratamiento
Etapa 3-5	15,2 millones de pacientes	Oportunidad de mercado de $ 4.6 mil millones

Centros de tratamiento oncológico

Segmento de pacientes con cáncer: 1.9 millones de diagnósticos de cáncer nuevos anualmente en los EE. UU.

• Prevalencia del prurito inducido por quimioterapia: 40-60% de los pacientes
• Pacientes afectados estimados: 760,000 anuales
• Mercado de tratamiento potencial: $ 1.5 mil millones

Pacientes con afecciones crónicas de prurito

Prevalencia total del prurito crónico: aproximadamente 16.5 millones de pacientes estadounidenses.

Tipo de prurito	Población de pacientes	Segmento de mercado
Dermatitis atópica	7,2 millones de pacientes	$ 3.8 mil millones
Relacionado con la enfermedad renal crónica	5.3 millones de pacientes	$ 2.1 mil millones
Otro prurito crónico	4 millones de pacientes	$ 1.6 mil millones

Cara Therapeutics, Inc. (CARA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2022, Cara Therapeutics informó $ 97.3 millones en gastos de investigación y desarrollo.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 97.3 millones	68.2%
2021	$ 86.4 millones	65.7%

Inversiones de ensayos clínicos

Inversiones de ensayos clínicos para la terapéutica CARA centradas principalmente en:

• Difelikefalina para prurito asociado a la enfermedad renal crónica
• Difelikefalin para el manejo del dolor agudo
• Ensayos clínicos de fase 3 en curso

Fase de ensayo clínico	Inversión estimada
Pruebas de fase 3	$ 45-55 millones anualmente

Costos de cumplimiento regulatorio

Gastos de cumplimiento regulatorio para CARA Therapeutics estimados en $ 8-12 millones anualmente.

Fabricación y producción

Costos de fabricación para Cara Therapeutics aproximadamente $ 15-20 millones Anualmente, con asociaciones de fabricación por contrato.

Operaciones de marketing y ventas

Los gastos de marketing y ventas para 2022 fueron $ 28.4 millones.

Año	Gastos de marketing y ventas
2022	$ 28.4 millones
2021	$ 22.7 millones

Cara Therapeutics, Inc. (CARA) - Modelo de negocio: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Cara Therapeutics reportó ingresos totales del producto de $ 11.3 millones, principalmente de la inyección de Korsuva® (difelikefalin) para prurito asociado a la hemodiálisis.

Producto	2023 ingresos	Segmento de mercado
Inyección Korsuva®	$ 11.3 millones	Hemodiálisis prurito

Licencia de propiedad intelectual

En 2023, Cara Therapeutics generó ingresos por licencias de propiedad intelectual de aproximadamente $ 5.2 millones de asociaciones estratégicas.

Posibles regalías de asociación

• Vifor Fresenius Medical Care Pharma Partnership para Korsuva®
• Posibles tasas de regalías que oscilan entre el 10-20% de las ventas netas
• Ingresos anuales de regalías anuales estimados: $ 15-25 millones

Subvenciones de investigación

La financiación de la subvención de investigación para 2023 totalizaron $ 2.7 millones, apoyando programas de desarrollo clínico en curso.

Ingresos futuros de comercialización de drogas

Candidato a la droga	Mercado potencial	Potencial de ventas máximo estimado
Korsuva® Oral	Enfermedad renal crónica Prurito	$ 300-500 millones anualmente
CR845/Difelikefalin	Dolor agudo/crónico	$ 250-400 millones 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.