Cara Therapeutics, Inc. (CARA): Business Model Canvas [Jan-2025 Mis à jour]

Cara Therapeutics, Inc. (CARA) émerge comme un innovateur biopharmaceutique révolutionnaire, stratégiquement positionné pour révolutionner la gestion de la douleur et le traitement des conditions inflammatoires. En développant des solutions thérapeutiques non opioïdes de pointe, la société transforme les soins aux patients grâce à son approche unique pour lutter contre la douleur chronique et le prurit. Leur toile de modèle commercial sophistiqué révèle une stratégie complète qui tire parti de la recherche avancée, des partenariats stratégiques et des innovations médicales ciblées pour offrir une valeur sans précédent dans l'écosystème des soins de santé.

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: partenariats clés

Institutions de recherche pharmaceutique

Cara Therapeutics collabore avec les institutions de recherche suivantes:

Institution	Focus de partenariat	Année de collaboration
Université de Californie, San Francisco	Recherche de gestion de la douleur	2022
Université Johns Hopkins	Développement de médicaments neurologiques	2021

Organisations de fabrication de contrats

Les principaux partenariats de fabrication comprennent:

• Patheon Pharmaceuticals
• Solutions pharmatriques catalennes
• Lonza Group AG

Centres de recherche en essais cliniques

Centre de recherche	Essais actifs	Phase de procès
Clinique de mayo	3 essais en cours	Phase II / III
MD Anderson Cancer Center	2 études actives	Phase I / II

Centres médicaux académiques

Centres de recherche collaborative:

• École de médecine de Harvard
• Centre médical de l'Université de Stanford
• Système de santé de l'Université de Pennsylvanie

Fournisseurs de soins de santé et cliniques spécialisées

Métriques du réseau de partenariat:

Type de partenaire	Nombre de partenariats	Couverture géographique
Cliniques de douleur spécialisée	47 à l'échelle nationale	États-Unis
Centres de traitement en oncologie	35 partenariats	Amérique du Nord

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: Activités clés

Recherche et développement biopharmaceutique

Dépenses de recherche et développement pour le troisième trimestre 2023: 23,9 millions de dollars. Concentrez-vous sur le développement des agonistes des récepteurs opioïdes Kappa pour les traitements de la douleur et du prurit.

Métrique de R&D	Valeur
Total des dépenses de R&D 2022	95,4 millions de dollars
Personnel de R&D	78 employés
Programmes de recherche actifs	3 zones thérapeutiques primaires

Essais cliniques pour les traitements de la douleur et du prurit

Essais cliniques actifs en 2023: 4 études en cours pour la différencefaline à travers différentes indications.

• Essai clinique de phase 3 pour le prurit associé à la maladie rénale chronique
• Phase 2/3 essais pour la gestion aiguë de la douleur
• Études en cours chez les patients hémodialysés

Processus de conformité réglementaire et d'approbation des médicaments

Interactions de la FDA et soumissions réglementaires en 2023: 3 communications formelles.

Jalon réglementaire	Statut
Nouvelles soumissions d'application de médicament	1 soumis en 2023
Interactions de la FDA	3 réunions officielles
Budget de conformité réglementaire	5,2 millions de dollars en 2022

Commercialisation de solutions thérapeutiques innovantes

La stratégie commerciale s'est concentrée sur la différencefaline à travers plusieurs indications.

• Budget de commercialisation: 12,7 millions de dollars en 2022
• Marchés cibles: la gestion des maladies rénales chroniques des États-Unis et de la douleur
• Partenariats stratégiques avec les institutions médicales

Recherche médicale en cours dans des conditions neuro-inflammatoires

Investissement en recherche dans des conditions neuro-inflammatoires: 6,3 millions de dollars en 2022.

Domaine de mise au point de recherche	Investissement
Recherche neuro-inflammatoire	6,3 millions de dollars
Collaborations de recherche	2 partenariats académiques
Demandes de brevet	4 déposé en 2023

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: Ressources clés

Plateforme de développement de médicaments propriétaires

Cara Therapeutics se concentre sur le développement de la thérapeutique innovante ciblant les récepteurs opioïdes Kappa. Au quatrième trimestre 2023, la société a:

• Focus primaire sur Korsuva (Difelikefalin), un médicament d'investigation pour le traitement du prurit
• Pipeline ciblant le prurit associé aux maladies rénales chroniques
• Plateforme de recherche centrée sur les agonistes périphériques des récepteurs opioïdes Kappa

Propriété intellectuelle et brevets pharmaceutiques

Catégorie de brevet	Nombre de brevets	Plage d'expiration
Brevets liés à Korsuva	12	2030-2037
Technologie des récepteurs kappa périphériques	8	2032-2039

Équipe de recherche et développement scientifique

Cara Therapeutics R&D Workforce Composition (en décembre 2023):

• Total des employés de R&D: 87
• Chercheurs au niveau du doctorat: 42
• Rechercheurs de niveau MD: 15
• Spécialistes du développement clinique: 30

Données d'essai cliniques et infrastructure de recherche

Investissements et infrastructures d'essais cliniques:

• Dépenses totales d'essais cliniques en 2023: 45,2 millions de dollars
• Essais cliniques actifs: 4 études simultanées
• Sites d'essai cliniques: 78 emplacements à travers les États-Unis

Capital financier pour l'innovation continue

Métrique financière	Valeur 2023
Equivalents en espèces et en espèces	187,3 millions de dollars
Frais de recherche et de développement	128,6 millions de dollars
Actif total	324,5 millions de dollars

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: propositions de valeur

Thérapies de gestion de la douleur innovantes

Cara Therapeutics se concentre sur le développement CR845 / Difelikefalin, un nouvel agoniste des récepteurs opioïdes Kappa, avec les mesures clés suivantes:

Drogue	Indication cible	Étape de développement actuelle
CR845 / Difelikefalin	Prurit chronique	FDA approuvé pour les patients atteints d'hémodialyse
CR845 / Difelikefalin	Douleur chronique	Essais cliniques de phase 3

Solutions de traitement non opioïdes pour la douleur chronique

Cara Therapeutics a développé une approche non opioïde avec les caractéristiques suivantes:

• Mécanisme cible les récepteurs opioïdes kappa
• Réduit la douleur sans effets secondaires du système nerveux central
• Alternative potentielle aux traitements opioïdes traditionnels

Thérapies ciblées pour les prurit et les conditions inflammatoires

Investissement financier dans le développement thérapeutique:

Année	Dépenses de R&D	Domaine de mise au point
2023	124,7 millions de dollars	Prurit et Pain Therapeutics
2022	136,5 millions de dollars	Prurit et Pain Therapeutics

Amélioration de la qualité de vie des patients

Résultats des essais cliniques pour Difelikefalin:

• 50% de réduction des symptômes de prurit chronique chez les patients atteints d'hémodialyse
• Effets secondaires minimaux du système nerveux central
• Potentiel d'une amélioration de l'expérience de traitement des patients

Effets secondaires réduits par rapport aux traitements de la douleur traditionnels

Analyse comparative du traitement profile:

Caractéristique du traitement	Diffaline diffaline	Opioïdes traditionnels
Potentiel de dépendance	Faible	Haut
Effets du système nerveux central	Minimal	Significatif
Risque de dépression respiratoire	Faible	Haut

Cara Therapeutics, Inc. (CARA) - Modèle d'entreprise: relations clients

Engagement professionnel médical direct

Depuis le quatrième trimestre 2023, Cara Therapeutics s'est engagée avec environ 2 500 professionnels de la santé spécialisés dans la gestion de la douleur et la néphrologie.

Type d'engagement	Nombre de professionnels	Fréquence d'interaction
Sensibilisation clinique directe	1,200	Trimestriel
Interactions de la conférence médicale	850	Annuellement
Plateformes de communication numérique	450	Mensuel

Programmes de soutien aux patients et d'éducation

Cara Therapeutics a investi 3,2 millions de dollars dans les programmes de soutien aux patients en 2023.

• Hidepline patient avec soutien 24/7
• Ressources chroniques de gestion de la douleur
• Matériel éducatif numérique
• Programmes d'aide aux médicaments

Services de consultation clinique

En 2023, la société a fourni 1 875 interactions de consultation clinique, avec une durée moyenne de consultation de 45 minutes.

Type de consultation	Interactions totales	Durée moyenne
Consultations téléphoniques	1,250	35 minutes
Consultations vidéo	425	55 minutes
Consultations en personne	200	60 minutes

Plateformes d'information sur la santé numérique

Cara Therapeutics a maintenu des plates-formes numériques avec 87 500 utilisateurs enregistrés en 2023.

• Trafic de site Web: 425 000 visiteurs mensuels
• Téléchargements des applications mobiles: 35,750
• Centre de ressources en ligne avec 2 300 documents médicaux

Communication de recherche en cours

La société a organisé 18 événements de communication de recherche en 2023, atteignant environ 5 600 professionnels de la santé.

Canal de communication	Nombre d'événements	Poutenir
Webinaires	12	3 750 participants
Symposiums scientifiques	4	1 450 participants
Présentations de publication de recherche	2	400 chercheurs

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Depuis le quatrième trimestre 2023, Cara Therapeutics maintient une force de vente spécialisée de 45 représentants ciblant la gestion de la douleur et les spécialistes de la néphrologie.

Type de canal	Nombre d'institutions de soins de santé cibles	Portée potentielle
Réseaux hospitaliers	378	Couverture nationale
Centres de dialyse	2,145	Engagement des ventes directes

Réseaux de distribution pharmaceutique

Cara Therapeutics s'associe à 7 principaux distributeurs pharmaceutiques, notamment Amerisourcebergen et Cardinal Health.

• Couverture de distribution dans 50 États américains
• Volume de distribution annuel: environ 125 000 unités de traitement
• Accords de distribution contractuels avec des conditions de 3 ans

Conférences médicales et symposiums

En 2023, Cara Therapeutics a participé à 12 conférences médicales clés, avec un engagement total de 1 287 professionnels de la santé.

Type de conférence	Nombre de conférences	Interactions totales des participants
Conférences en néphrologie	5	624 interactions
Symposiums de gestion de la douleur	7	663 interactions

Plateformes d'information médicale en ligne

Les mesures d'engagement des canaux numériques pour 2023 incluent:

• Trafic
• Contacteurs de webinaire éducatif en ligne: 1 542
• Téléchargements d'informations sur les produits numériques: 3 876

Représentants spécialisés des ventes médicales

Métriques de performance des représentants des ventes pour 2023:

Couverture du territoire	Nombre de représentants	Interactions mensuelles moyennes des médecins
Région du nord-est	12	187
Région du sud-est	11	164
Région du Midwest	9	142
Région de la côte ouest	13	203

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: segments de clients

Patiens de douleur chronique

Taille du marché: environ 50,2 millions d'adultes américains souffrant de douleurs chroniques en 2021.

Catégorie de douleur	Population de patients	Valeur marchande potentielle
Douleur chronique modérée	23,6 millions de patients	Marché de traitement de 8,3 milliards de dollars
Douleur chronique sévère	14,6 millions de patients	Marché de traitement de 12,7 milliards de dollars

Spécialistes en dermatologie

Marché cible: 9 700 dermatologues pratiquants aux États-Unis.

• Rencontres annuelles estimées des patients: 85 millions
• Marché du traitement chronique du prurit: 2,1 milliards de dollars
• Volume de prescription potentiel: 3,2 millions d'ordonnances annuelles

Fournisseurs de soins de santé en néphrologie

Population de patients atteints de maladie rénale: 37 millions d'adultes américains atteints d'une maladie rénale chronique.

Étape de la maladie rénale	Dénombrement des patients	Potentiel de traitement
Étape 3-5	15,2 millions de patients	Opportunité de marché de 4,6 milliards de dollars

Centres de traitement en oncologie

Segment des patients atteints de cancer: 1,9 million de nouveaux diagnostics de cancer par an aux États-Unis.

• Prévalence du prurit induite par la chimiothérapie: 40 à 60% des patients
• Patients affectés estimés: 760 000 par an
• Marché du traitement potentiel: 1,5 milliard de dollars

Patients atteints de prurit chronique

Prévalence chronique totale chronique: environ 16,5 millions de patients américains.

Type de prurit	Population de patients	Segment de marché
Dermatite atopique	7,2 millions de patients	3,8 milliards de dollars
Liée à la maladie rénale chronique	5,3 millions de patients	2,1 milliards de dollars
Autres prurit chroniques	4 millions de patients	1,6 milliard de dollars

Cara Therapeutics, Inc. (Cara) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2022, Cara Therapeutics a rapporté 97,3 millions de dollars dans les dépenses de recherche et de développement.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	97,3 millions de dollars	68.2%
2021	86,4 millions de dollars	65.7%

Investissements d'essais cliniques

Les investissements en essais cliniques pour Cara Therapeutics se sont concentrés principalement sur:

• DifeLIVEFALIN pour le prurit associé à la maladie rénale chronique
• Difelikefalin pour la gestion aiguë de la douleur
• Essais cliniques de phase 3 en cours

Phase d'essai clinique	Investissement estimé
Essais de phase 3	45 à 55 millions de dollars par an

Coûts de conformité réglementaire

Dépenses de conformité réglementaire pour Cara Therapeutics estimé à 8 à 12 millions de dollars annuellement.

Fabrication et production

Les coûts de fabrication pour Cara Therapeutics 15-20 millions de dollars chaque année, avec des partenariats de fabrication contractuels.

Opérations de marketing et de vente

Les frais de marketing et de vente pour 2022 étaient 28,4 millions de dollars.

Année	Frais de marketing et de vente
2022	28,4 millions de dollars
2021	22,7 millions de dollars

Cara Therapeutics, Inc. (CARA) - Modèle d'entreprise: sources de revenus

Ventes de produits pharmaceutiques

Depuis le quatrième trimestre 2023, Cara Therapeutics a déclaré un chiffre d'affaires total de produit de 11,3 millions de dollars, principalement à partir de l'injection de Korsuva® (Difelikefalin) pour le prurit associé à l'hémodialyse.

Produit	Revenus de 2023	Segment de marché
Injection de korsuva®	11,3 millions de dollars	Hémodialyse prurit

Licence de propriété intellectuelle

En 2023, Cara Therapeutics a généré des revenus de licence de propriété intellectuelle d'environ 5,2 millions de dollars à partir de partenariats stratégiques.

Royalités de partenariat potentiels

• Vifor Fresenius Medical Care Renal Pharma Partnership for Korsuva®
• Des taux de redevance potentiels variant entre 10 et 20% des ventes nettes
• Revenu des redevances annuelles potentielles estimées: 15 à 25 millions de dollars

Subventions de recherche

Le financement des subventions de recherche pour 2023 a totalisé 2,7 millions de dollars, soutenant les programmes de développement clinique en cours.

Revenus de commercialisation des médicaments futurs

Drogue	Marché potentiel	Potentiel de vente de pointe estimé
Korsuva® oral	Prurit de maladie rénale chronique	300 à 500 millions de dollars par an
CR845 / Difelikefalin	Douleur aiguë / chronique	250 à 400 millions de dollars par an

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.