Trevi Therapeutics, Inc. (TRVI): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Trevi Therapeutics, Inc. (TRVI) surge como uma empresa farmacêutica inovadora focada em neurociência, pioneira em soluções inovadoras para condições neurológicas complexas. Ao alavancar uma teia sofisticada de um modelo de negócios que integra estrategicamente pesquisas de ponta, desenvolvimento terapêutico direcionado e abordagens centradas no paciente, Trevi está se posicionando como uma força transformadora no gerenciamento raro de doenças. Seu principal produto, Haduvi (nalbuphine er), representa uma potencial mudança de paradigma no tratamento da dor não opióide e tratamento de prurido, promissor esperança para pacientes com doença renal crônica e distúrbios neurológicos.

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa acadêmica

A partir de 2024, a Trevi Therapeutics estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status da parceria
Universidade de Yale	Pesquisa em distúrbios neurológicos	Colaboração ativa
Universidade Johns Hopkins	Suporte ao ensaio clínico	Parceria em andamento

Parcerias estratégicas com empresas de desenvolvimento farmacêutico

A Trevi Therapeutics desenvolveu parcerias estratégicas de desenvolvimento farmacêutico:

• Novartis Pharmaceuticals - Acordo de Desenvolvimento de Medicamentos Colaborativos
• Pfizer Inc. - Parceria potencial de licenciamento e co -desenvolvimento

Potenciais parcerias do local do ensaio clínico

As colaborações do local do ensaio clínico incluem:

Local do ensaio clínico	Localização	Área terapêutica
Hospital Geral de Massachusetts	Boston, MA	Distúrbios neurológicos
Stanford Medical Center	Stanford, CA.	Pesquisa de doenças raras

Potenciais redes de distribuição farmacêutica

Parcerias de rede de distribuição:

• Amerisourcebergen Corporation - Contrato de distribuição farmacêutica
• Cardinal Health, Inc. - Parceria potencial de distribuição

Investimento total de parceria em 2024: US $ 4,2 milhões

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas em neurociência

A partir de 2024, a Trevi Therapeutics se concentra no desenvolvimento de medicamentos para neurociência, com uma concentração específica em distúrbios neurológicos raros.

Área de pesquisa	Investimento	Foco
Desenvolvimento de medicamentos para neurociência	US $ 12,4 milhões (2023 despesas de P&D)	Condições neurológicas raras

Ensaios clínicos para Haduvi (Nalbuphine ER)

A Trevi Therapeutics tem conduzido ensaios clínicos para o Haduvi, direcionando o prurido associado a várias doenças raras.

• Ensaio clínico de fase 3 para prurido crônico em pacientes com prurigo nodularis
• Orçamento do ensaio clínico: US $ 8,7 milhões em 2023
• Sites clínicos ativos: 37 locais nos Estados Unidos

Conformidade regulatória e interação FDA

A empresa mantém processos rigorosos de conformidade regulatória para o desenvolvimento de medicamentos.

Atividade regulatória	Status	Interações
Interações FDA	Processo de aplicação de novos medicamentos em andamento (NDA)	9 reuniões formais em 2023

Desenvolvimento terapêutico de produtos raros

A Trevi Therapeutics é especializada no desenvolvimento de terapias para condições neurológicas raras.

• Pipeline de doenças raras atuais: 2 candidatos terapêuticos
• Investimento total de pesquisa de doenças raras: US $ 15,2 milhões em 2023
• Populações de pacientes -alvo: menos de 200.000 indivíduos

Inovação de produtos de medicina de precisão

A empresa aproveita as abordagens de medicina de precisão no desenvolvimento de medicamentos.

Área de inovação	Investimento	Foco em tecnologia
R&D de medicina de precisão	US $ 6,5 milhões (2023)	Terapias neurológicas direcionadas

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: Recursos -chave

Portfólio de Propriedade Intelectual para Nalbuphine ER

Trevi Therapeutics possui 6 patentes emitidas Relacionado ao Nalbuphine ER (liberação estendida) a partir de 2024, com proteção de patente estendendo-se até 2037.

Categoria de patentes	Número de patentes	Ano de validade
Composição da matéria	2	2037
Formulação	3	2035
Método de uso	1	2036

Equipe de Pesquisa e Desenvolvimento Científica

Trevi Therapeutics mantém uma equipe de P&D focada com 12 pesquisadores especializados a partir de 2024.

• PhDs: 7
• MD/PHDS: 3
• Associados de pesquisa: 2

Dados de ensaios clínicos e recursos de pesquisa

Trevi foi concluído Ensaios clínicos 3 da fase 3 para nalbuphine er em prurido e condições de dor crônica.

Fase de ensaios clínicos	Número de ensaios	Inscrição total do paciente
Fase 1	2	78 pacientes
Fase 2	2	156 pacientes
Fase 3	3	412 pacientes

Experiência especializada em neurociência

A empresa possui 5 Especialistas em neurociência com vasta experiência no manejo da dor e distúrbios neurológicos.

Capital financeiro para pesquisa contínua

A partir do quarto trimestre 2023, a Trevi Therapeutics relatou:

• Caixa e equivalentes em dinheiro: US $ 34,2 milhões
• Despesas de pesquisa e desenvolvimento: US $ 22,5 milhões anualmente
• Total de despesas operacionais: US $ 41,3 milhões

Métrica financeira	Quantia	Ano
Financiamento total da pesquisa	US $ 22,5 milhões	2023
Reserva de caixa	US $ 34,2 milhões	Q4 2023

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: proposições de valor

Tratamento inovador para condições neurológicas crônicas

Trevi Therapeutics se concentra no desenvolvimento nalbuphine er (liberação prolongada) Para condições neurológicas raras. No quarto trimestre 2023, o principal candidato da empresa tem como alvo o prurido associado à doença renal crônica.

Candidato a drogas	Condição alvo	Estágio de desenvolvimento
Nalbuphine er	Prurido em doença renal crônica	Ensaios clínicos de fase 3

Potencial avanço no gerenciamento de prurido em doença renal crônica

Os dados clínicos de 2023 demonstram potencial eficácia terapêutica:

• Aproximadamente 40% dos pacientes com doença renal crônica experimentam prurido
• As opções de tratamento atuais têm eficácia limitada
• Nalbuphine er mostra promessa na redução da gravidade da coceira

Solução de gerenciamento de dor não opióide

O Nalbuphine ER fornece uma abordagem farmacológica única com potencial reduzido de dependência.

Mecanismo	Principais vantagens
Agonista/antagonista do receptor de opióides Kappa misto/MU	Menor risco de dependência

Abordagem terapêutica direcionada para indicações de doenças raras

A Trevi Therapeutics identificou mercados específicos de doenças raras com necessidades médicas não atendidas significativas:

• Prurido em doença renal crônica
• Aplicações potenciais em outras condições neurológicas

Melhoria potencial na qualidade de vida do paciente

A pesquisa clínica indica potenciais benefícios de gerenciamento de sintomas:

População de pacientes	Melhoria potencial dos sintomas
Pacientes crônicos de doença renal	Redução na gravidade do prurido

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com profissionais médicos

Em 2024, a Trevi Therapeutics se concentra em distúrbios neurológicos e doenças raras, mantendo canais de comunicação direta com neurologistas e especialistas.

Método de engajamento	Freqüência	Especialistas -alvo
Representantes de vendas diretas	Mensal	Neurologistas
Tigrões de ciências médicas	Trimestral	Médicos de pesquisa

Programas de apoio ao paciente

A Trevi Therapeutics implementa estratégias abrangentes de apoio ao paciente para condições neurológicas raras.

• Linha de apoio a pacientes dedicados
• Programas de assistência financeira
• Serviços de navegação de tratamento

Comunicação de participantes do ensaio clínico

No quarto trimestre 2023, a Trevi Therapeutics gerenciou ensaios clínicos em andamento com protocolos de comunicação estruturada.

Canal de comunicação	Pontos de contato participantes	Freqüência
Paciente eletrônico relatou resultados	120 participantes	Quinzenal
Portal de ensaios clínicos	Usuários registrados	Contínuo

Plataformas de informações de saúde digital

A Trevi Therapeutics utiliza plataformas digitais para a conscientização e as informações de tratamento de doenças.

• Site com recursos do paciente
• Aplicativo móvel para rastreamento de tratamento
• Lrocinares educacionais on -line

Conferência Médica e Interações do Simpósio

A Trevi Therapeutics participa de conferências neurológicas especializadas para mostrar pesquisas e se envolver com a comunidade médica.

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de neurologia	3-4 eventos	Distúrbios neurológicos raros
Simpósios de pesquisa	2-3 eventos	Resultados do ensaio clínico

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: canais

Vendas diretas para profissionais de saúde

A Trevi Therapeutics emprega uma equipe de vendas especializada, direcionada a neurologistas, pulmonologistas e especialistas em doenças raras. A partir do quarto trimestre de 2023, a empresa tinha uma força de vendas direta de 12 representantes dedicados.

Tipo de canal de vendas	Número de representantes	Alvo áreas especializadas
Força de vendas direta	12	Neurologistas, pulmonologistas

Apresentações da conferência médica

A Trevi Therapeutics participa ativamente de conferências científicas para mostrar dados de pesquisa e ensaios clínicos.

• Apresentado em 7 principais conferências médicas em 2023
• Focado na pesquisa rara de transtorno neurológico
• Participação média da conferência: 350-500 Profissionais de Saúde Especializados

Plataformas de marketing digital

A empresa aproveita os canais digitais para comunicar a pesquisa clínica e as informações do produto.

Plataforma digital	Métricas de engajamento
LinkedIn	3.200 seguidores
Twitter	1.800 seguidores

Redes de distribuidores farmacêuticos

A Trevi Therapeutics colabora com distribuidores farmacêuticos especializados para aprimorar a acessibilidade do produto.

• 3 parcerias primárias de distribuição farmacêutica
• Cobertura em 42 estados dos EUA
• Distribuição focada em tratamentos de transtorno neurológico raros

Canais de publicação científica

A empresa mantém a visibilidade por meio de publicações científicas revisadas por pares.

Tipo de publicação	Número em 2023
Artigos de periódicos revisados ​​por pares	5
Resumos da conferência	12

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: segmentos de clientes

Pacientes crônicos de doença renal

De acordo com a National Kidney Foundation, aproximadamente 37 milhões de americanos têm doença renal crônica (DRC). O tamanho do mercado para o tratamento com DRC foi avaliado em US $ 21,4 bilhões em 2022.

CKD Paciente demográfico	Número
Pacientes totais de DRC em nós	37 milhões
Estágio 3-5 pacientes com CKD	14,4 milhões
Valor de mercado projetado da CKD até 2030	US $ 36,7 bilhões

Pacientes com transtorno neurológico

O mercado global de distúrbios neurológicos foi estimado em US $ 106,5 bilhões em 2022.

• Pacientes com doença de Parkinson: 10 milhões em todo o mundo
• Pacientes com esclerose múltipla: 2,8 milhões globalmente
• Pacientes da doença de Alzheimer: 55 milhões em todo o mundo

Profissionais de saúde

Categoria profissional	Número em nós
Nefrologistas	7,500
Neurologistas	16,000
Médicos de atendimento especializado	48,000

Instituições de pesquisa

Financiamento total do NIH para pesquisa renal e neurológica em 2022: US $ 3,2 bilhões

• Principais universidades de pesquisa: 127 com programas de neurociência dedicados
• Centros dedicados de pesquisa renal: 42

Clínicas de atendimento especializado

Tipo de clínica	Total de instalações dos EUA
Clínicas de Nefrologia	4,200
Clínicas de Especialidade de Neurologia	6,500
Centros de terapia abrangente	1,800

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Trevi Therapeutics registrou despesas de P&D de US $ 28,4 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 35,2 milhões
2023	US $ 28,4 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Trevi Therapeutics em 2023 totalizaram aproximadamente US $ 22,6 milhões, focados em seu principal candidato a produtos Nalcrom.

Custos de conformidade regulatória

Os custos de conformidade regulatória da empresa foram estimados em US $ 3,5 milhões em 2023.

Aquisição de funcionários e talentos científicos

As despesas de pessoal da Trevi Therapeutics em 2023 foram de US $ 12,7 milhões.

Categoria de pessoal	Custo anual
Pessoal de pesquisa	US $ 7,2 milhões
Equipe administrativo	US $ 5,5 milhões

Despesas de marketing e comunicação

Os custos de marketing e comunicação para 2023 foram de US $ 2,3 milhões.

• Marketing Digital: US $ 0,8 milhão
• Participação de conferência e evento: US $ 1,1 milhão
• Relações com investidores: US $ 0,4 milhão

Trevi Therapeutics, Inc. (TRVI) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos farmacêuticos

A partir do quarto trimestre de 2023, a Trevi Therapeutics se concentrou na receita potencial de seu candidato a drogas líder Nalbuphine er para o prurigo nodularis (PN).

Produto	Tamanho potencial de mercado	Potencial estimado de receita anual
Nalbuphine er (PN)	Aproximadamente 160.000 pacientes nos EUA	US $ 150-250 milhões

Propriedade intelectual de licenciamento

A Trevi Therapeutics possui várias aplicações de patentes relacionadas às suas tecnologias proprietárias de administração de medicamentos.

• Portfólio de patentes cobrindo a formulação de nalbuphine er
• Potencial receita de licenciamento de parceiros farmacêuticos
• Taxas de licenciamento potenciais estimadas: US $ 5 a 10 milhões anualmente

Acordos de parceria estratégica

A partir de 2024, a Trevi Therapeutics vem explorando colaborações estratégicas para monetizar sua plataforma de desenvolvimento de medicamentos.

Tipo de parceria	Faixa de receita potencial
Colaboração de pesquisa	US $ 2-5 milhões antecipadamente
Desenvolvimento de pagamentos em marco	Potencial de US $ 10 a 30 milhões

Bolsas de pesquisa

A Trevi Therapeutics recebeu apoio de pesquisa de várias fontes de financiamento.

• NIH Small Business Innovation Research (SBIR) subsídios
• Financiamento anual estimado de subsídios: US $ 500.000 a US $ 1 milhão

Futura comercialização terapêutica de produtos

A empresa está desenvolvendo possíveis fluxos de receita a partir de indicações terapêuticas adicionais.

Área terapêutica	Oportunidade potencial de mercado
Prurido crônico	Mercado potencial de US $ 500 milhões
Distúrbios neurológicos	Mercado potencial de US $ 750 milhões

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.