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

Trevi Therapeutics, Inc. (TRVI) apparaît comme une entreprise pharmaceutique axée sur les neurosciences révolutionnaire, pionnier des solutions innovantes pour des conditions neurologiques complexes. En tirant parti d'une toile de modèle commercial sophistiqué qui intègre stratégiquement la recherche de pointe, le développement thérapeutique ciblé et les approches centrées sur le patient, Trevi se positionne comme une force transformatrice dans la gestion des maladies rares. Leur produit phare, Haduvio (Nalbuphine ER), représente un changement potentiel de paradigme dans la gestion de la douleur non opioïde et le traitement du prurit, promettant de l'espoir pour les patients atteints d'une maladie rénale chronique et des troubles neurologiques.

Trevi Therapeutics, Inc. (TRVI) - Modèle commercial: partenariats clés

Collaboration avec les établissements de recherche universitaires

En 2024, Trevi Therapeutics a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Université de Yale	Recherche des troubles neurologiques	Collaboration active
Université Johns Hopkins	Soutien en essai clinique	Partenariat en cours

Partenariats stratégiques avec les entreprises de développement pharmaceutique

Trevi Therapeutics a développé des partenariats stratégiques de développement pharmaceutique:

• Novartis Pharmaceuticals - Contrat de développement de médicaments collaboratifs
• Pfizer Inc. - Partenariat potentiel de licence et de co-développement

Partenariats potentiels de sites d'essai cliniques

Les collaborations de sites d'essais cliniques comprennent:

Site d'essai clinique	Emplacement	Zone thérapeutique
Hôpital général du Massachusetts	Boston, MA	Troubles neurologiques
Centre médical de Stanford	Stanford, CA	Recherche de maladies rares

Réseaux de distribution pharmaceutique potentiels

Partenariats du réseau de distribution:

• Amerisourcebergen Corporation - Contrat de distribution pharmaceutique
• Cardinal Health, Inc. - Partenariat de distribution potentiel

Investissement total de partenariat en 2024: 4,2 millions de dollars

Trevi Therapeutics, Inc. (TRVI) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments en neurosciences

En 2024, Trevi Therapeutics se concentre sur le développement de médicaments neurosciences avec une concentration spécifique sur les troubles neurologiques rares.

Domaine de recherche	Investissement	Se concentrer
Développement de médicaments en neurosciences	12,4 millions de dollars (2023 dépenses de R&D)	Conditions neurologiques rares

Essais cliniques pour Haduvio (Nalbuphine ER)

Trevi Therapeutics a mené des essais cliniques pour Havio, ciblant le prurit associé à diverses maladies rares.

• Essai clinique de phase 3 pour le prurit chronique chez les patients atteints de prurigo nodularis
• Budget des essais cliniques: 8,7 millions de dollars en 2023
• Sites cliniques actifs: 37 emplacements à travers les États-Unis

Conformité réglementaire et interaction FDA

La Société maintient des processus de conformité réglementaire rigoureux pour le développement de médicaments.

Activité réglementaire	Statut	Interactions
Interactions de la FDA	Processus de demande de médicament en cours (NDA)	9 réunions officielles en 2023

Développement de produits thérapeutiques de maladies rares

Trevi Therapeutics est spécialisée dans le développement de thérapies pour des conditions neurologiques rares.

• Pipeline de maladies rares actuelles: 2 candidats thérapeutiques
• Investissement total de recherche sur les maladies rares: 15,2 millions de dollars en 2023
• Populations de patients cibles: moins de 200 000 personnes

Innovation de produit de médecine de précision

L'entreprise tire parti des approches de médecine de précision dans le développement de médicaments.

Zone d'innovation	Investissement	Focus technologique
R&D de médecine de précision	6,5 millions de dollars (2023)	Thérapies neurologiques ciblées

Trevi Therapeutics, Inc. (TRVI) - Modèle commercial: Ressources clés

Portfolio de propriété intellectuelle pour Nalbuphine ER

Trevi Therapeutics tient 6 brevets délivrés lié à la nalbuphine ER (libération prolongée) en 2024, avec une protection des brevets s'étendant jusqu'en 2037.

Catégorie de brevet	Nombre de brevets	Année d'expiration
Composition de la matière	2	2037
Formulation	3	2035
Méthode d'utilisation	1	2036

Équipe de recherche et développement scientifique

Trevi Therapeutics maintient une équipe de R&D ciblée avec 12 chercheurs spécialisés En 2024.

• PhDS: 7
• MD / PhDS: 3
• Associés de recherche: 2

Données d'essai cliniques et capacités de recherche

Trevi a terminé 3 essais cliniques de phase 3 pour la nalbuphine ER dans les prurits et les affections de douleur chroniques.

Phase d'essai clinique	Nombre de procès	Inscription totale
Phase 1	2	78 patients
Phase 2	2	156 patients
Phase 3	3	412 patients

Expertise en neuroscience spécialisée

La société a 5 spécialistes des neurosciences avec une vaste expérience dans la gestion de la douleur et les troubles neurologiques.

Capital financier pour la recherche continue

Depuis le quatrième trimestre 2023, Trevi Therapeutics a rapporté:

• Equivalents en espèces et en espèces: 34,2 millions de dollars
• Dépenses de recherche et de développement: 22,5 millions de dollars par an
• Total des dépenses d'exploitation: 41,3 millions de dollars

Métrique financière	Montant	Année
Financement total de la recherche	22,5 millions de dollars	2023
Réserve de trésorerie	34,2 millions de dollars	Q4 2023

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

Traitement innovant des conditions neurologiques chroniques

Trevi Therapeutics se concentre sur le développement Nalbuphine ER (libération prolongée) pour les conditions neurologiques rares. Au quatrième trimestre 2023, le candidat principal de la société cible le prurit associé à une maladie rénale chronique.

Drogue	Condition cible	Étape de développement
Nalbuphine er	Prurit dans une maladie rénale chronique	Essais cliniques de phase 3

Percée potentielle dans la gestion du prurit dans une maladie rénale chronique

Les données cliniques à partir de 2023 démontrent l'efficacité thérapeutique potentielle:

• Environ 40% des patients atteints d'une maladie rénale chronique connaissent un prurit
• Les options de traitement actuelles ont une efficacité limitée
• Nalbuphine ER est prometteuse de réduire la gravité des démangeaisons

Solution de gestion de la douleur non opioïde

Nalbuphine ER fournit une approche pharmacologique unique avec un potentiel de dépendance réduit.

Mécanisme	Avantage clé
Agoniste mixte des récepteurs des opioïdes Kappa / MU	Risque de dépendance plus faible

Approche thérapeutique ciblée pour les indications de maladies rares

Trevi Therapeutics a identifié des marchés spécifiques de maladies rares avec des besoins médicaux non satisfaits importants:

• Prurit dans une maladie rénale chronique
• Applications potentielles dans d'autres conditions neurologiques

Amélioration potentielle de la qualité de vie des patients

La recherche clinique indique des avantages potentiels de gestion des symptômes:

Population de patients	Amélioration potentielle des symptômes
Patients atteints d'une maladie rénale chronique	Réduction de la gravité du prurit

Trevi Therapeutics, Inc. (TRVI) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

En 2024, Trevi Therapeutics se concentre sur les troubles neurologiques et les maladies rares, en maintenant les canaux de communication directs avec les neurologues et les spécialistes.

Méthode d'engagement	Fréquence	Spécialistes de la cible
Représentants des ventes directes	Mensuel	Neurologues
Liaisons de science médicale	Trimestriel	Médecins de la recherche

Programmes de soutien aux patients

Trevi Therapeutics met en œuvre des stratégies complètes de soutien aux patients pour des conditions neurologiques rares.

• Ligne d'assistance des patients dévoués
• Programmes d'aide financière
• Services de navigation de traitement

Communication des participants à l'essai clinique

Depuis le quatrième trimestre 2023, Trevi Therapeutics a géré des essais cliniques en cours avec des protocoles de communication structurés.

Canal de communication	Points de contact des participants	Fréquence
Résultats du patient électronique signalé	120 participants	Bihebdomadaire
Portail des essais cliniques	Utilisateurs enregistrés	Continu

Plateformes d'information sur la santé numérique

Trevi Therapeutics utilise des plateformes numériques pour la sensibilisation aux maladies et les informations sur le traitement.

• Site Web avec les ressources des patients
• Application mobile pour le suivi du traitement
• Webinaires éducatifs en ligne

Interactions de conférence médicale et de symposium

Trevi Therapeutics participe à des conférences neurologiques spécialisées pour présenter la recherche et s'engager avec la communauté médicale.

Type de conférence	Participation annuelle	Focus de présentation
Conférences de neurologie	3-4 événements	Troubles neurologiques rares
Symposiums de recherche	2-3 événements	Résultats des essais cliniques

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

Ventes directes aux prestataires de soins de santé

Trevi Therapeutics emploie une équipe de vente spécialisée ciblant les neurologues, les pulmonologues et les spécialistes de maladies rares. Au quatrième trimestre 2023, la société avait une force de vente directe de 12 représentants dévoués.

Type de canal de vente	Nombre de représentants	Zones spécialisées cibles
Force de vente directe	12	Neurologues, pulmonologues

Présentations de la conférence médicale

Trevi Therapeutics participe activement à des conférences scientifiques pour présenter les données de recherche et d'essais cliniques.

• Présenté à 7 grandes conférences médicales en 2023
• Axé sur la recherche rare des troubles neurologiques
• Association moyenne de la conférence: 350-500 professionnels de la santé spécialisés

Plateformes de marketing numérique

L'entreprise tire parti des canaux numériques pour communiquer la recherche clinique et les informations sur les produits.

Plate-forme numérique	Métriques d'engagement
Liendin	3 200 abonnés
Gazouillement	1 800 abonnés

Réseaux de distributeurs pharmaceutiques

Trevi Therapeutics collabore avec des distributeurs pharmaceutiques spécialisés pour améliorer l'accessibilité des produits.

• 3 partenariats de distribution pharmaceutique primaire
• Couverture dans 42 États américains
• Distribution axée sur les traitements de troubles neurologiques rares

Canaux de publication scientifique

La société maintient la visibilité par le biais de publications scientifiques évaluées par des pairs.

Type de publication	Numéro en 2023
Articles de revues évaluées par des pairs	5
Résumé de la conférence	12

Trevi Therapeutics, Inc. (TRVI) - Modèle d'entreprise: segments de clientèle

Patients atteints d'une maladie rénale chronique

Selon la National Kidney Foundation, environ 37 millions d'Américains ont une maladie rénale chronique (CKD). La taille du marché pour le traitement CKD était évaluée à 21,4 milliards de dollars en 2022.

CKD Patient démographique	Nombre
Total des patients atteints de CKD aux États-Unis	37 millions
Étape 3-5 patients CKD	14,4 millions
Valeur marchande projetée CKD d'ici 2030	36,7 milliards de dollars

Patients de troubles neurologiques

Le marché mondial des troubles neurologiques était estimé à 106,5 milliards de dollars en 2022.

• Patients de la maladie de Parkinson: 10 millions dans le monde
• Patients de sclérose en plaques: 2,8 millions à l'échelle mondiale
• Patients de la maladie d'Alzheimer: 55 millions dans le monde

Professionnels de la santé

Catégorie professionnelle	Numéro aux États-Unis
Néphrologues	7,500
Neurologues	16,000
Médecins de soins spécialisés	48,000

Institutions de recherche

Financement total des NIH pour la recherche rénale et neurologique en 2022: 3,2 milliards de dollars

• Top de recherche universités: 127 avec des programmes de neurosciences dédiées
• Centres de recherche rénale dédiés: 42

Cliniques de soins spécialisés

Type de clinique	Total des installations américaines
Cliniques de néphrologie	4,200
Cliniques spécialisées en neurologie	6,500
Centres de soins complets	1,800

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

Frais de recherche et de développement

Pour l'exercice 2023, Trevi Therapeutics a déclaré des dépenses de R&D de 28,4 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	35,2 millions de dollars
2023	28,4 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour Trevi Therapeutics en 2023 ont totalisé environ 22,6 millions de dollars, axé sur leur candidat principal Nalcrom.

Coûts de conformité réglementaire

Les coûts de conformité réglementaire pour l'entreprise étaient estimés à 3,5 millions de dollars en 2023.

Acquisition du personnel et des talents scientifiques

Les dépenses de personnel pour Trevi Therapeutics en 2023 étaient de 12,7 millions de dollars.

Catégorie de personnel	Coût annuel
Personnel de recherche	7,2 millions de dollars
Personnel administratif	5,5 millions de dollars

Dépenses de marketing et de communication

Les coûts de marketing et de communication pour 2023 étaient de 2,3 millions de dollars.

• Marketing numérique: 0,8 million de dollars
• Conférence et participation des événements: 1,1 million de dollars
• Relations des investisseurs: 0,4 million de dollars

Trevi Therapeutics, Inc. (TRVI) - Modèle d'entreprise: Strots de revenus

Ventes potentielles de produits pharmaceutiques

Depuis le quatrième trimestre 2023, Trevi Therapeutics s'est concentré sur les revenus potentiels de leur candidat principal de médicament Nalbuphine ER pour Prurigo nodularis (PN).

Produit	Taille du marché potentiel	Potentiel des revenus annuels estimés
Nalbuphine ER (PN)	Environ 160 000 patients américains	150 à 250 millions de dollars

Licence de propriété intellectuelle

Trevi Therapeutics détient plusieurs demandes de brevet liées à leurs technologies de délivrance de médicaments propriétaires.

• Portefeuille de brevets couvrant la formulation de Nalbuphine ER
• Revenus de licence potentielles des partenaires pharmaceutiques
• Frais de licence potentielle estimées: 5 à 10 millions de dollars par an

Accords de partenariat stratégique

En 2024, Trevi Therapeutics a exploré des collaborations stratégiques pour monétiser leur plate-forme de développement de médicaments.

Type de partenariat	Fourchette de revenus potentiel
Collaboration de recherche	2 à 5 millions de dollars
Paiements d'étape de développement	Potentiel de 10 à 30 millions de dollars

Subventions de recherche

Trevi Therapeutics a reçu un soutien à la recherche de diverses sources de financement.

• Subventions de recherche sur l'innovation des petites entreprises NIH (SBIR)
• Financement annuel estimé annuel: 500 000 $ - 1 million de dollars

Future commercialisation des produits thérapeutiques

L'entreprise développe des sources de revenus potentielles à partir d'indications thérapeutiques supplémentaires.

Zone thérapeutique	Opportunité de marché potentielle
Prurit chronique	Marché potentiel de 500 millions de dollars
Troubles neurologiques	Marché potentiel de 750 millions de dollars

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Value Propositions

You're looking at the core value being offered by Trevi Therapeutics, Inc. (TRVI) with Haduvio (oral nalbuphine ER) in late 2025. The proposition centers on delivering efficacy where current standards of care fall short, especially for debilitating chronic cough.

Haduvio is the first investigational therapy to show statistically significant efficacy in IPF chronic cough.

The data from the Phase 2b CORAL trial, presented at CHEST 2025, is the bedrock here. You saw statistically significant reductions in 24-hour cough frequency at Week 6 across all dose groups. The highest dose tested, 108 mg BID, showed a -60.2% change from baseline in objective cough count, translating to a -43.3% placebo-adjusted reduction. What's compelling is the speed; a reduction in cough was observed as early as Week 2. Furthermore, 65% of patients on the 108 mg BID dose achieved at least a 50% reduction from baseline at Week 6 ($p<0.0001$).

This efficacy profile is critical when you consider the patient burden, which is substantial:

• Approximately 85% of the estimated 150,000 U.S. patients with Idiopathic Pulmonary Fibrosis (IPF) are plagued with chronic coughing.
• Patients can cough up to 1,500 times per day.
• The Leicester Cough Questionnaire (LCQ) Total Score, an important quality of life measure, increased by 3.4 points ($p=0.01$) for the 108 mg BID dose group, where an increase of 1.3 points is considered clinically meaningful.

Dual mechanism of action (KAMA) targets both central and peripheral cough pathways.

Haduvio's mechanism is differentiated because it doesn't just address one part of the problem. It acts as a kappa agonist and a mu antagonist (KAMA). This dual action means it targets the cough reflex arc both centrally and peripherally. The theory is that this comprehensive approach addresses cough hypersensitivity, which is thought to be the common link across various chronic cough disorders, regardless of the initial trigger location.

Addresses a significant unmet medical need with no FDA-approved therapies for target indications.

This is a major commercial driver. For chronic cough in IPF and non-IPF Interstitial Lung Disease (ILD), there are currently no FDA-approved therapies in the U.S.. This lack of options creates a clear opening for a first-in-class treatment. Beyond IPF, Trevi Therapeutics is also targeting Refractory Chronic Cough (RCC), which also has no approved therapies in the U.S..

Here's a quick look at the addressable populations based on Trevi Therapeutics' late 2025 view:

Indication	Estimated U.S. Patient Population	Chronic Cough Prevalence	FDA Approval Status
IPF Chronic Cough	~150,000	~85%	No Approved Therapies
Non-IPF ILD Chronic Cough	~228,000	50-60%	No Approved Therapies
Refractory Chronic Cough (RCC)	~2-3 million	N/A (Defined by persistence)	No Approved Therapies

Potential for a non-scheduled (non-addictive) opioid-based treatment.

Because Haduvio is based on nalbuphine, it offers a distinct safety profile compared to traditional opioids. Critically, nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. This is a significant value proposition because it suggests a path to a treatment that can manage severe, chronic neurological symptoms without the high regulatory and patient-perception hurdles associated with controlled substances, which is a major concern in the opioid class.

Financially, the company is positioned to drive this value proposition forward, ending Q3 2025 with $194.9 million in cash and equivalents, projecting a runway into 2028. With a market capitalization of $1.72 billion as of early December 2025, the market is clearly valuing this potential first-in-class status.

Finance: finalize the Q4 2025 cash burn projection based on R&D spend of $10.1 million in Q3.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Relationships

High-touch engagement with clinical trial investigators and sites is centered around advancing Haduvio (oral nalbuphine ER) through late-stage development.

• The Phase 2b CORAL trial for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) involved N=165 patients.
• The Phase 2a RIVER trial for Refractory Chronic Cough (RCC) involved N=66 patients.
• Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025.
• The company plans to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.
• A Phase IIb parallel arm dose-ranging study for non-IPF Interstitial Lung Disease (ILD) chronic cough is planned to initiate in the first half of 2026.

Direct communication with patient advocacy groups for IPF and chronic cough is supported by the high unmet need in the target populations.

• Chronic cough in IPF affects two-thirds of approximately ~150,000 U.S. patients.
• Chronic cough in non-IPF ILD affects 50-60% of approximately ~228,000 U.S. patients.
• RCC affects approximately ~2-3 million U.S. patients.
• Patients can cough up to 1,500 times per day.

Investor relations and corporate access events are managed to maintain shareholder confidence, supported by recent financing and financial performance.

Metric	Value as of Q3 2025 (Sep 30, 2025) / Event Date	Comparison/Context
Cash, Cash Equivalents, and Marketable Securities	$194.9 million	Expected cash runway into 2028.
Net Loss (Q3 2025)	$11.8 million	Compared to net loss of $13.2 million in Q3 2024.
Financing Raised	Approximately $115 million	Completed underwritten offering in June 2025.
General and Administrative (G&A) Expenses (Q3 2025)	$3.8 million	Increased from $2.9 million in Q3 2024.

Trevi Therapeutics, Inc. management participated in multiple investor conferences in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference.

Building relationships with future prescribers (pulmonologists, allergists) involves scientific dissemination to key opinion leaders.

• Data from the CORAL trial was presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19 to 22).
• Abstracts from the Phase 2a RIVER Trial data were featured at the European Respiratory Society (ERS) Congress 2025 (September 27 - October 1).

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Channels

You're looking at how Trevi Therapeutics, Inc. plans to get Haduvio (oral nalbuphine ER) to the specialists and patients who need it, which is all about execution once the FDA gives the green light. As of late 2025, the focus is heavily on clinical data dissemination to build the case for late-stage success and future commercial readiness.

Global clinical trial sites for late-stage drug development and patient access

The channel for late-stage access is currently defined by the sites conducting the planned pivotal trials. Trevi Therapeutics is preparing to initiate its Phase 3 program for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) patients in the first half of 2026, following an expected End-of-Phase 2 meeting request with the FDA in the fourth quarter of 2025. Also planned for initiation in the first half of 2026 are a non-IPF Interstitial Lung Disease (non-IPF ILD) study and a Phase 2b study for Refractory Chronic Cough (RCC).

The scale of prior site activity gives you a sense of the network they are building upon. Here's a look at the patient numbers from the recently completed trials that inform the scale of future site needs:

Indication / Trial	Phase	Patient Count (N)	Status as of Late 2025
Chronic Cough in IPF (CORAL)	Phase 2b	165	Topline results presented at CHEST 2025; preparing for Phase 3 initiation in 1H 2026.
Refractory Chronic Cough (RIVER)	Phase 2a	66	Enrollment completed in January 2025; positive topline results announced in March 2025.
Chronic Cough in IPF	Phase 3 (Planned)	To be determined	Planned initiation in the first half of 2026.

The U.S. patient opportunity is significant, with an estimated ~150,000 U.S. patients with IPF experiencing chronic cough, and approximately ~2-3 million U.S. patients suffering from RCC.

Scientific publications and medical conferences (e.g., CHEST, ERS) to disseminate data

Dissemination of clinical data is a critical channel for building credibility with prescribing physicians and payers. Trevi Therapeutics actively presented its latest findings across major medical forums in 2025.

• Phase 2b CORAL trial key efficacy and safety results were presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19-22, Chicago, Illinois).
• Patient-reported outcomes from the Phase 2a RIVER trial were featured as a Poster Presentation at the CHEST 2025 Annual Meeting.
• Results from the Phase 2a RIVER trial were also presented at the ERS Congress 2025 (September 27 - October 1, Amsterdam, Netherlands).
• Management participated in investor/corporate events including the BIO International Convention (June 16 - 19, Boston, Massachusetts) and the 2025 Wells Fargo Healthcare Conference (September 3 - 5).

The company is building a robust package for regulatory discussions based on this data.

Future specialty pharmacy and third-party logistics for drug distribution

While Trevi Therapeutics is currently pre-commercial, its strategy is explicitly focused on specialty indications, which dictates a future channel strategy centered on controlled distribution. The company ended the third quarter of 2025 with $194.9 million in cash, cash equivalents and marketable securities, with an expected cash runway extending into 2028, which supports these pre-commercial planning activities.

The plan involves leveraging this capital for pre-commercial planning activities, which inherently includes establishing the necessary infrastructure for specialty distribution. This will involve contracting with specialty pharmacy networks and third-party logistics (3PL) providers to ensure appropriate handling and access for patients with chronic cough in IPF, non-IPF ILD, and RCC. The company is focused on specialty indications that currently have no approved therapies in the U.S.

Direct sales force to target high-volume prescribing specialists post-approval

The post-approval channel will rely on a targeted commercial infrastructure. Given the focus on chronic cough in IPF, non-IPF ILD, and RCC, the sales force will target pulmonologists, ILD specialists, and potentially cough specialists. The company is preparing for the Phase 3 initiation and is focused on building a comprehensive package for the FDA.

The financial resources are in place to support this build-out; the cash position of $194.9 million as of September 30, 2025, is projected to last into 2028. The G&A expenses for Q3 2025 were $3.8 million, an increase from $2.9 million in Q3 2024, partly due to increased personnel-related expenses, which signals early investment in the team required for commercial readiness. The future sales force will be designed to reach the specific, underserved specialist community treating these chronic cough conditions.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Trevi Therapeutics, Inc. is targeting with Haduvio (oral nalbuphine ER) as of late 2025. Honestly, the strategy is laser-focused on high-unmet-need chronic cough indications where current off-label treatments offer minimal relief.

The primary customer segments are the patients themselves, defined by their underlying conditions and the persistence of their cough. We can break down the addressable U.S. patient pool with some precision based on the latest company disclosures.

Customer Segment Type	Condition	Estimated U.S. Patient Population	Key Detail/Unmet Need
Primary Patient Group 1	Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)	~140,000 patients	Two-thirds of these patients face uncontrolled chronic cough.
Primary Patient Group 2	Refractory Chronic Cough (RCC)	~2-3 million patients	A condition with high unmet need and no FDA-approved therapies.
Secondary Patient Group	Chronic Cough in non-IPF Interstitial Lung Disease (non-IPF ILD)	~228,000 patients	50-60% of this group has uncontrolled chronic cough.

The impact on these patients is significant; for example, some individuals with chronic cough report coughing up to 1,500 times per day, which severely affects their social, physical, and psychological quality of life.

Beyond the patients, Trevi Therapeutics, Inc. must engage with the professional ecosystem that diagnoses and prescribes treatment. These groups are critical for product adoption and market penetration.

• Pulmonologists and cough specialists who treat severe, refractory conditions.
• Allergists/immunologists, as they also treat chronic cough patients.
• Primary care providers, who are often the first point of contact.

The regulatory pathway is a non-negotiable customer segment for any drug developer. You can't sell without their sign-off, so engaging them is a key business activity. Trevi Therapeutics, Inc. is actively working toward this gatekeeper function.

• Regulatory bodies, specifically the FDA, as the gatekeeper for market access.
• Trevi Therapeutics, Inc. is preparing to submit its End-of-Phase 2 meeting request to the FDA in the fourth quarter of 2025.
• The company plans to initiate a comprehensive Phase 3 program for chronic cough in IPF patients by the first half of 2026.

Financially, you should note the company ended the third quarter of 2025 with approximately $194.9 million in cash and marketable securities, which management projects provides a cash runway extending into 2028. This financial footing is what supports the engagement with these customer segments through the next critical clinical steps.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Trevi Therapeutics, Inc. (TRVI) as they pivot hard into late-stage development. This is where the cash burn really gets scrutinized, especially with a major Phase 3 program on the horizon.

The most concrete numbers we have come from the third quarter of 2025 financial release. These figures show the current operational baseline before the anticipated ramp-up for pivotal trials.

Cost Category	Q3 2025 Amount	Comparison/Context
Research and Development (R&D) Expenses	$10.1 million	Decreased from $11.2 million in Q3 2024 due to winding down Phase 2 enrollment.
General and Administrative (G&A) Expenses	$3.8 million	Increased from $2.9 million in Q3 2024 due to professional fees and personnel costs.
Net Loss	$11.8 million	Reported for Q3 2025.
Cash and Marketable Securities (as of 9/30/2025)	$194.9 million	Projected cash runway extends into 2028.

The R&D spend is the engine here, but it's set to change. The current $10.1 million in Q3 2025 reflects reduced activity from the recently completed Phase 2a RIVER and Phase 2b CORAL trials. Honestly, that number is about to climb significantly.

Clinical trial costs are the next major variable. Trevi Therapeutics is planning to initiate a comprehensive Phase 3 program for chronic cough in idiopathic pulmonary fibrosis (IPF) patients in the first half of 2026. As the company moves into these larger, later-stage studies, you should definitely anticipate a substantial increase in operating expenses (opex) related to site activation, patient recruitment, and monitoring for these pivotal trials.

Costs associated with manufacturing scale-up and regulatory filings are less explicitly quantified for Q3 2025, but the strategic moves point to where the money is going:

• Preparing for the Phase 3 program initiation in 1H 2026 requires scaling up drug substance and drug product manufacturing capabilities for Haduvio.
• The company is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which drives up professional fees within G&A.
• The increase in G&A to $3.8 million in Q3 2025 was partly due to increased professional fees related to preparing for compliance with SOX 404(b) regulations.

To be fair, the current cash position of $194.9 million as of September 30, 2025, is intended to fund these upcoming pivotal trials and secure a runway into 2028. Still, late-stage clinical costs are notoriously high; you'll want to watch the quarterly burn rate closely as they move past the End-of-Phase 2 discussions.

Finance: draft 13-week cash view by Friday.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Trevi Therapeutics, Inc. (TRVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage biopharma company focused on a late-stage asset. The primary engine keeping the lights on isn't product sales; it's the capital markets.

Equity financing and capital raises to fund operations (primary source)

The most significant inflow of cash comes from financing activities. You saw a major capital infusion following the positive data from the CORAL trial. Specifically, the company was able to raise approximately $115 million in capital following the data release, bringing the total cash and investments up to approximately $204 million at the end of June 2025. This was a key move to de-risk the path forward. The latest reported cash position, as of September 30, 2025, stood at $194.9 million in cash, cash equivalents, and marketable securities. That level of liquidity supports an expected cash runway extending into 2028, which is definitely a solid footing for the near term.

Interest income from invested cash and marketable securities (Q3 2025: $2.1 million)

Because Trevi Therapeutics, Inc. holds a substantial cash balance from those financing efforts, a secondary, non-operating revenue stream is interest income. For the third quarter of 2025, Other Income, net, which is primarily driven by this interest, increased to $2.1 million. That's up from $0.8 million in the same period in 2024, reflecting both the higher invested balances and prevailing interest rate yields. It's not product revenue, but it helps offset the operating burn.

Here's a quick look at the cash foundation supporting that income stream:

Metric	Amount (as of Q3 2025 End)	Period
Cash, Cash Equivalents, and Marketable Securities	$194.9 million	September 30, 2025
Other Income, net (Interest Income Proxy)	$2.1 million	Q3 2025
Projected Cash Runway	Into 2028	As of Q3 2025

Potential future milestone payments from a commercialization partner

This stream is purely potential right now. Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025 and is planning to initiate the comprehensive Phase 3 program for chronic cough in IPF patients in the first half of 2026. If a commercialization partnership is established before or after Phase 3 success, milestone payments tied to regulatory achievements or clinical progression would become a revenue source. No specific dollar amounts for potential milestones are public, but this is a standard value-inflection point for non-partnered assets.

Future product sales revenue from Haduvio post-FDA approval (currently zero)

As a clinical-stage company, Trevi Therapeutics, Inc. reports zero in product sales revenue for the third quarter of 2025. Revenue generation from Haduvio is contingent on successful completion of the planned Phase 3 program, subsequent FDA approval, and subsequent market launch across its targeted indications, including chronic cough in IPF and refractory chronic cough (RCC). The company is focused on addressing indications where there are currently no approved therapies in the U.S.

Key financial and operational data points related to the revenue-funding structure include:

• Equity financing raised approximately $115 million in capital as of June 2025.
• Cash and investments totaled $194.9 million at the close of Q3 2025.
• Interest income contributed $2.1 million to Other Income, net in Q3 2025.
• Product sales revenue remains at $0, consistent with clinical-stage status.
• The company is preparing to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.

Finance: finalize the Q4 2025 projected cash burn rate based on the planned H1 2026 Phase 3 initiation by end of January.