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

Cara Therapeutics, Inc. (CARA) entwickelt sich zu einem bahnbrechenden biopharmazeutischen Innovator, der strategisch positioniert ist, um die Schmerzbehandlung und Behandlung entzündlicher Erkrankungen zu revolutionieren. Durch die Entwicklung modernster nicht-opioider Therapielösungen verändert das Unternehmen die Patientenversorgung durch seinen einzigartigen Ansatz zur Behandlung chronischer Schmerzen und Juckreiz. Ihr ausgefeiltes Geschäftsmodell offenbart eine umfassende Strategie, die fortschrittliche Forschung, strategische Partnerschaften und gezielte medizinische Innovationen nutzt, um einen beispiellosen Mehrwert im Gesundheitsökosystem zu schaffen.

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Wichtige Partnerschaften

Pharmazeutische Forschungseinrichtungen

Cara Therapeutics arbeitet mit folgenden Forschungseinrichtungen zusammen:

Institution	Partnerschaftsfokus	Jahr der Zusammenarbeit
Universität von Kalifornien, San Francisco	Forschung zur Schmerztherapie	2022
Johns Hopkins Universität	Entwicklung neurologischer Medikamente	2021

Auftragsfertigungsorganisationen

Zu den wichtigsten Fertigungspartnerschaften gehören:

• Patheon Pharmaceuticals
• Catalent Pharma-Lösungen
• Lonza Group AG

Forschungszentren für klinische Studien

Forschungszentrum	Aktive Versuche	Probephase
Mayo-Klinik	3 laufende Versuche	Phase II/III
MD Anderson Krebszentrum	2 aktive Studien	Phase I/II

Akademische medizinische Zentren

Sonderforschungsbereiche:

• Harvard Medical School
• Medizinisches Zentrum der Stanford University
• Gesundheitssystem der University of Pennsylvania

Gesundheitsdienstleister und Spezialkliniken

Kennzahlen zum Partnerschaftsnetzwerk:

Partnertyp	Anzahl der Partnerschaften	Geografische Abdeckung
Spezialkliniken für Schmerzen	47 bundesweit	Vereinigte Staaten
Onkologische Behandlungszentren	35 Partnerschaften	Nordamerika

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Hauptaktivitäten

Biopharmazeutische Forschung und Entwicklung

Forschungs- und Entwicklungsausgaben für das dritte Quartal 2023: 23,9 Millionen US-Dollar. Konzentrieren Sie sich auf die Entwicklung von Kappa-Opioid-Rezeptor-Agonisten zur Schmerz- und Juckreizbehandlung.

F&E-Metrik	Wert
Gesamte F&E-Ausgaben 2022	95,4 Millionen US-Dollar
F&E-Personal	78 Mitarbeiter
Aktive Forschungsprogramme	3 primäre Therapiebereiche

Klinische Studien zur Schmerz- und Pruritusbehandlung

Aktive klinische Studien ab 2023: 4 laufende Studien für Difelikefalin in verschiedenen Indikationen.

• Klinische Phase-3-Studie für chronischen Nierenerkrankungen-assoziierten Pruritus
• Phase-2/3-Studien zur Behandlung akuter Schmerzen
• Laufende Studien an Hämodialysepatienten

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Interaktionen mit der FDA und Zulassungsanträge im Jahr 2023: 3 formelle Mitteilungen.

Regulatorischer Meilenstein	Status
Einreichung neuer Arzneimittelanträge	1 eingereicht im Jahr 2023
FDA-Interaktionen	3 formelle Treffen
Budget zur Einhaltung gesetzlicher Vorschriften	5,2 Millionen US-Dollar im Jahr 2022

Kommerzialisierung innovativer therapeutischer Lösungen

Die kommerzielle Strategie konzentrierte sich auf Difelikefalin für mehrere Indikationen.

• Kommerzialisierungsbudget: 12,7 Millionen US-Dollar im Jahr 2022
• Zielmärkte: Chronische Nierenerkrankungen und Schmerzbehandlung in den USA
• Strategische Partnerschaften mit medizinischen Einrichtungen

Laufende medizinische Forschung zu neuroinflammatorischen Erkrankungen

Forschungsinvestitionen in neuroinflammatorische Erkrankungen: 6,3 Millionen US-Dollar im Jahr 2022.

Forschungsschwerpunktbereich	Investition
Neuroinflammatorische Forschung	6,3 Millionen US-Dollar
Forschungskooperationen	2 akademische Partnerschaften
Patentanmeldungen	4 eingereicht im Jahr 2023

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelentwicklungsplattform

Cara Therapeutics konzentriert sich auf die Entwicklung innovativer Therapeutika, die auf Kappa-Opioidrezeptoren abzielen. Im vierten Quartal 2023 verfügt das Unternehmen über:

• Der Schwerpunkt liegt auf Korsuva (Difelikefalin), einem Prüfpräparat zur Behandlung von Pruritus
• Pipeline zur Bekämpfung von Pruritus im Zusammenhang mit chronischen Nierenerkrankungen
• Forschungsplattform mit Schwerpunkt auf peripheren Kappa-Opioidrezeptor-Agonisten

Geistiges Eigentum und pharmazeutische Patente

Patentkategorie	Anzahl der Patente	Ablaufbereich
Korsuva-bezogene Patente	12	2030-2037
Periphere Kappa-Rezeptor-Technologie	8	2032-2039

Wissenschaftliches Forschungs- und Entwicklungsteam

Zusammensetzung der Forschungs- und Entwicklungsmitarbeiter von Cara Therapeutics (Stand Dezember 2023):

• Gesamtzahl der F&E-Mitarbeiter: 87
• Doktoranden: 42
• Forscher auf MD-Ebene: 15
• Spezialisten für klinische Entwicklung: 30

Daten und Forschungsinfrastruktur für klinische Studien

Investitionen und Infrastruktur für klinische Studien:

• Gesamtausgaben für klinische Studien im Jahr 2023: 45,2 Millionen US-Dollar
• Aktive klinische Studien: 4 gleichzeitige Studien
• Standorte für klinische Studien: 78 Standorte in den Vereinigten Staaten

Finanzielles Kapital für kontinuierliche Innovation

Finanzkennzahl	Wert 2023
Zahlungsmittel und Zahlungsmitteläquivalente	187,3 Millionen US-Dollar
Forschungs- und Entwicklungskosten	128,6 Millionen US-Dollar
Gesamtvermögen	324,5 Millionen US-Dollar

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Wertversprechen

Innovative Therapien zur Schmerzbehandlung

Cara Therapeutics konzentriert sich auf die Entwicklung CR845/Difelikefalin, ein neuartiger Kappa-Opioid-Rezeptor-Agonist, mit den folgenden Schlüsselkennzahlen:

Arzneimittelkandidat	Zielanzeige	Aktueller Entwicklungsstand
CR845/Difelikefalin	Chronischer Pruritus	Von der FDA für Hämodialysepatienten zugelassen
CR845/Difelikefalin	Chronischer Schmerz	Klinische Studien der Phase 3

Nicht-Opioid-Behandlungslösungen für chronische Schmerzen

Cara Therapeutics hat einen nicht-opioiden Ansatz mit den folgenden Merkmalen entwickelt:

• Der Mechanismus zielt auf Kappa-Opioidrezeptoren ab
• Reduziert Schmerzen ohne Nebenwirkungen auf das Zentralnervensystem
• Mögliche Alternative zu herkömmlichen Opioidbehandlungen

Gezielte Therapien bei Pruritus und entzündlichen Erkrankungen

Finanzielle Investition in die therapeutische Entwicklung:

Jahr	F&E-Ausgaben	Fokusbereich
2023	124,7 Millionen US-Dollar	Pruritus- und Schmerztherapeutika
2022	136,5 Millionen US-Dollar	Pruritus- und Schmerztherapeutika

Verbesserte Lebensqualität der Patienten

Ergebnisse klinischer Studien für Difelikefalin:

• 50 %ige Reduzierung der chronischen Juckreizsymptome bei Hämodialysepatienten
• Minimale Nebenwirkungen auf das Zentralnervensystem
• Potenzial für eine verbesserte Patientenbehandlungserfahrung

Reduzierte Nebenwirkungen im Vergleich zu herkömmlichen Schmerzbehandlungen

Vergleichende Analyse der Behandlung profile:

Behandlungsmerkmal	Difelikefalin	Traditionelle Opioide
Suchtpotenzial	Niedrig	Hoch
Auswirkungen auf das Zentralnervensystem	Minimal	Bedeutend
Risiko einer Atemdepression	Niedrig	Hoch

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Kundenbeziehungen

Direktes medizinisches Fachpersonal-Engagement

Im vierten Quartal 2023 arbeitete Cara Therapeutics mit rund 2.500 medizinischen Fachkräften zusammen, die auf Schmerztherapie und Nephrologie spezialisiert sind.

Engagement-Typ	Anzahl der Fachkräfte	Interaktionshäufigkeit
Direkte klinische Kontaktaufnahme	1,200	Vierteljährlich
Interaktionen bei medizinischen Konferenzen	850	Jährlich
Digitale Kommunikationsplattformen	450	Monatlich

Patientenunterstützungs- und Aufklärungsprogramme

Cara Therapeutics investierte im Jahr 2023 3,2 Millionen US-Dollar in Patientenunterstützungsprogramme.

• Patienten-Helpline mit 24/7-Support
• Ressourcen zur Behandlung chronischer Schmerzen
• Digitale Lehrmaterialien
• Programme zur Medikamentenunterstützung

Klinische Beratungsdienste

Im Jahr 2023 führte das Unternehmen 1.875 klinische Beratungsgespräche mit einer durchschnittlichen Beratungsdauer von 45 Minuten durch.

Beratungstyp	Gesamtinteraktionen	Durchschnittliche Dauer
Telefonische Beratungen	1,250	35 Minuten
Videoberatungen	425	55 Minuten
Persönliche Beratungen	200	60 Minuten

Digitale Gesundheitsinformationsplattformen

Cara Therapeutics unterhielt im Jahr 2023 digitale Plattformen mit 87.500 registrierten Nutzern.

• Website-Verkehr: 425.000 monatliche Besucher
• Downloads mobiler Anwendungen: 35.750
• Online-Ressourcenzentrum mit 2.300 medizinischen Dokumenten

Laufende Forschungskommunikation

Das Unternehmen führte im Jahr 2023 18 Forschungskommunikationsveranstaltungen durch und erreichte damit rund 5.600 medizinische Fachkräfte.

Kommunikationskanal	Anzahl der Ereignisse	Zielgruppenreichweite
Webinare	12	3.750 Teilnehmer
Wissenschaftliche Symposien	4	1.450 Teilnehmer
Präsentationen von Forschungspublikationen	2	400 Forscher

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitsdienstleister

Seit dem vierten Quartal 2023 unterhält Cara Therapeutics ein spezialisiertes Vertriebsteam von 45 Vertretern, die sich an Spezialisten für Schmerztherapie und Nephrologie richten.

Kanaltyp	Anzahl der Zielgesundheitseinrichtungen	Potenzielle Reichweite
Krankenhausnetzwerke	378	Bundesweite Abdeckung
Dialysezentren	2,145	Engagement im Direktvertrieb

Pharmazeutische Vertriebsnetze

Cara Therapeutics arbeitet mit sieben großen Pharmahändlern zusammen, darunter AmerisourceBergen und Cardinal Health.

• Vertriebsabdeckung in 50 US-Bundesstaaten
• Jährliches Vertriebsvolumen: ca. 125.000 Behandlungseinheiten
• Vertragliche Vertriebsvereinbarungen mit 3-Jahres-Laufzeit

Medizinische Konferenzen und Symposien

Im Jahr 2023 nahm Cara Therapeutics an 12 wichtigen medizinischen Konferenzen teil, an denen insgesamt 1.287 medizinische Fachkräfte teilnahmen.

Konferenztyp	Anzahl der Konferenzen	Gesamtzahl der Teilnehmerinteraktionen
Nephrologie-Konferenzen	5	624 Interaktionen
Symposien zur Schmerztherapie	7	663 Interaktionen

Online-Plattformen für medizinische Informationen

Zu den Kennzahlen zum digitalen Kanal-Engagement für 2023 gehören:

• Website-Traffic: 78.345 einzelne Besucher von medizinischen Fachkräften
• Teilnehmer an Online-Bildungswebinaren: 1.542
• Downloads digitaler Produktinformationen: 3.876

Spezialisierte medizinische Vertriebsmitarbeiter

Leistungskennzahlen für Vertriebsmitarbeiter für 2023:

Gebietsabdeckung	Anzahl der Vertreter	Durchschnittliche monatliche Arztinteraktionen
Nordostregion	12	187
Südostregion	11	164
Region Mittlerer Westen	9	142
Westküstenregion	13	203

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Kundensegmente

Patienten mit chronischen Schmerzen

Marktgröße: Ungefähr 50,2 Millionen Erwachsene in den USA leiden im Jahr 2021 an chronischen Schmerzen.

Schmerzkategorie	Patientenpopulation	Potenzieller Marktwert
Mäßiger chronischer Schmerz	23,6 Millionen Patienten	Behandlungsmarkt im Wert von 8,3 Milliarden US-Dollar
Starke chronische Schmerzen	14,6 Millionen Patienten	Behandlungsmarkt im Wert von 12,7 Milliarden US-Dollar

Fachärzte für Dermatologie

Zielmarkt: 9.700 praktizierende Dermatologen in den Vereinigten Staaten.

• Geschätzte jährliche Patientenkontakte: 85 Millionen
• Markt für die Behandlung von chronischem Pruritus: 2,1 Milliarden US-Dollar
• Mögliches Verordnungsvolumen: 3,2 Millionen Jahresverordnungen

Gesundheitsdienstleister für Nephrologie

Patientenpopulation mit Nierenerkrankungen: 37 Millionen Erwachsene in den USA mit chronischer Nierenerkrankung.

Stadium der Nierenerkrankung	Patientenzahl	Behandlungspotenzial
Stufe 3-5	15,2 Millionen Patienten	Marktchance in Höhe von 4,6 Milliarden US-Dollar

Onkologische Behandlungszentren

Krebspatientensegment: 1,9 Millionen neue Krebsdiagnosen jährlich in den USA.

• Prävalenz von durch Chemotherapie verursachtem Pruritus: 40–60 % der Patienten
• Geschätzte betroffene Patienten: 760.000 jährlich
• Potenzieller Behandlungsmarkt: 1,5 Milliarden US-Dollar

Patienten mit chronischen Pruritus-Erkrankungen

Gesamtprävalenz von chronischem Pruritus: Ungefähr 16,5 Millionen US-Patienten.

Pruritus-Typ	Patientenpopulation	Marktsegment
Atopische Dermatitis	7,2 Millionen Patienten	3,8 Milliarden US-Dollar
Chronische Nierenerkrankungen im Zusammenhang	5,3 Millionen Patienten	2,1 Milliarden US-Dollar
Anderer chronischer Pruritus	4 Millionen Patienten	1,6 Milliarden US-Dollar

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 berichtete Cara Therapeutics 97,3 Millionen US-Dollar bei den Forschungs- und Entwicklungskosten.

Jahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2022	97,3 Millionen US-Dollar	68.2%
2021	86,4 Millionen US-Dollar	65.7%

Investitionen in klinische Studien

Die Investitionen in klinische Studien für Cara Therapeutics konzentrierten sich hauptsächlich auf:

• Difelikefalin gegen Pruritus im Zusammenhang mit einer chronischen Nierenerkrankung
• Difelikefalin zur Behandlung akuter Schmerzen
• Laufende klinische Studien der Phase 3

Klinische Studienphase	Geschätzte Investition
Phase-3-Studien	45–55 Millionen US-Dollar pro Jahr

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften für Cara Therapeutics werden auf geschätzt 8-12 Millionen Dollar jährlich.

Herstellung und Produktion

Herstellungskosten für Cara Therapeutics ca 15-20 Millionen Dollar jährlich, mit Auftragsfertigungspartnerschaften.

Marketing- und Vertriebsaktivitäten

Die Marketing- und Vertriebsaufwendungen für 2022 betrugen 28,4 Millionen US-Dollar.

Jahr	Marketing- und Vertriebskosten
2022	28,4 Millionen US-Dollar
2021	22,7 Millionen US-Dollar

Cara Therapeutics, Inc. (CARA) – Geschäftsmodell: Einnahmequellen

Vertrieb pharmazeutischer Produkte

Im vierten Quartal 2023 meldete Cara Therapeutics einen Gesamtproduktumsatz von 11,3 Millionen US-Dollar, hauptsächlich aus der Injektion von KORSUVA® (Difelikefalin) gegen hämodialysebedingten Pruritus.

Produkt	Umsatz 2023	Marktsegment
KORSUVA® Injektion	11,3 Millionen US-Dollar	Hämodialyse Pruritus

Lizenzierung von geistigem Eigentum

Im Jahr 2023 erzielte Cara Therapeutics aus strategischen Partnerschaften Einnahmen aus der Lizenzierung von geistigem Eigentum in Höhe von etwa 5,2 Millionen US-Dollar.

Mögliche Lizenzgebühren für Partnerschaften

• Vifor Fresenius Medical Care Renal Pharma-Partnerschaft für KORSUVA®
• Mögliche Lizenzgebühren liegen zwischen 10 und 20 % des Nettoumsatzes
• Geschätzte potenzielle jährliche Lizenzeinnahmen: 15–25 Millionen US-Dollar

Forschungsstipendien

Die Forschungsstipendien für 2023 beliefen sich auf insgesamt 2,7 Millionen US-Dollar und unterstützten laufende klinische Entwicklungsprogramme.

Zukünftige Einnahmen aus der Arzneimittelvermarktung

Arzneimittelkandidat	Potenzieller Markt	Geschätztes Spitzenumsatzpotenzial
KORSUVA® Oral	Chronische Nierenerkrankung Pruritus	300–500 Millionen US-Dollar pro Jahr
CR845/Difelikefalin	Akuter/chronischer Schmerz	250–400 Millionen US-Dollar pro Jahr

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.