Vyne Therapeutics Inc. (Vyne): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Vyne Therapeutics Inc. surge como um inovador dermatológico inovador, posicionando -se estrategicamente na interseção de pesquisa farmacêutica avançada e soluções terapêuticas direcionadas. Ao alavancar as tecnologias proprietárias de administração de medicamentos e uma abordagem de pesquisa especializada, Vyne transforma desafios complexos de condição da pele em experiências precisas de tratamento centradas no paciente que atendem às necessidades médicas não atendidas no cenário da dermatologia. Sua Canvas de modelo de negócios meticulosamente criada revela uma estratégia abrangente que integra perfeitamente a experiência científica, parcerias estratégicas e pesquisas de ponta para revolucionar intervenções terapêuticas tópicas.

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa de dermatologia

A Vyne Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Área de foco	Ano de parceria
Universidade da Califórnia, San Diego	Pesquisa de acne e rosácea	2022
Departamento de Dermatologia Johns Hopkins	Colaboração de ensaios clínicos	2023

Parceiros de distribuição farmacêutica

Vyne garantiu acordos de distribuição com:

• Cardinal Health
• McKesson Corporation
• Amerisourcebergen

Organizações de fabricação contratadas

Nome da CMO	Capacidades de fabricação	Valor do contrato
Pathon Pharmaceuticals	Formulações de dermatologia tópica	US $ 3,5 milhões anualmente
Soluções farmacêuticas catalentas	Produção de medicamentos tópicos especializados	US $ 2,8 milhões anualmente

Acordos de licenciamento de propriedade intelectual

Vyne possui acordos ativos de licenciamento de IP com:

• Novan Therapeutics (tecnologia de óxido nítrico)
• Centro Médico do Sudoeste da Universidade do Texas

Centros Médicos Acadêmicos para Ensaios Clínicos

Centro Médico	Foco no teste	Fase de teste
Centro Médico da Universidade de Stanford	Estudo de eficácia do Aklief	Fase III
NYU LANGONE SAÚDE	Trials de dermatologia de Tirbanibulin	Fase II

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de produtos farmacêuticos

A Vyne Therapeutics investiu US $ 24,3 milhões em despesas de P&D no ano fiscal de 2022. A empresa se concentra no desenvolvimento de terapêutica tópica para condições dermatológicas.

Métrica de P&D	Quantia
Despesas totais de P&D (2022)	US $ 24,3 milhões
Programas de pesquisa ativa	3 plataformas primárias de tratamento dermatológico

Formulação de tratamento dermatológico

A Vyne é especializada no desenvolvimento de formulações farmacêuticas tópicas inovadoras direcionadas a condições dermatológicas específicas.

• Plataforma de tecnologia Targel® proprietária
• Focado em novos mecanismos de entrega de medicamentos
• Especialização em tratamentos tópicos de prescrição

Gerenciamento de ensaios clínicos

Vyne conduziu vários ensaios clínicos para os principais candidatos a produtos em 2022-2023.

Métrica do ensaio clínico	Detalhes
Ensaios clínicos ativos	2-3 ensaios simultâneos
Investimento total de ensaios clínicos (2022)	Aproximadamente US $ 15,7 milhões

Conformidade regulatória e envios de FDA

Vyne mantém processos rigorosos de conformidade regulatória para envios da FDA.

• Equipe de Assuntos Regulatórios dedicados
• Engajamento contínuo com processos de revisão da FDA
• Conformidade com as boas práticas atuais de fabricação (cGMP)

Marketing e comercialização da terapêutica tópica

A estratégia de marketing da Vyne se concentra em tratamentos dermatológicos prescritos.

Métrica de comercialização	Quantia
Despesas de vendas e marketing (2022)	US $ 37,2 milhões
Foco principal no mercado	Tratamentos de dermatologia prescrita

Vyne Therapeutics Inc. (VYNE) - Modelo de negócios: Recursos -chave

Tecnologias proprietárias de administração de medicamentos

A Vyne Therapeutics utiliza Tecnologia de partículas penetrantes de muco proprietário (MPP) para tratamentos dermatológicos. A partir de 2024, a empresa desenvolveu plataformas especializadas de entrega de medicamentos para:

• Yuvify (DFD-01) para tratamento de acne
• Amzeeq (minociclina) espuma tópica
• Zilxi (minociclina) espuma tópica

Equipe especializada de pesquisa de dermatologia

Categoria de pessoal de pesquisa	Número de profissionais
Funcionários totais de P&D	Aproximadamente 45-50
Pesquisadores de nível de doutorado	15-20
Especialistas em pesquisa clínica	12-15

Portfólio de propriedade intelectual

Métricas de patente a partir de 2024:

• Total de patentes ativas: 18-22
• Cobertura de patente: Estados Unidos, União Europeia, Canadá
• Faixa de expiração de patentes: 2030-2035

Instalações avançadas de pesquisa e desenvolvimento

Tipo de instalação	Localização	Metragem quadrada
Centro de P&D primário	San Diego, Califórnia	Aproximadamente 20.000 pés quadrados
Espaço de laboratório	Asa de pesquisa dedicada	8.000 a 10.000 pés quadrados

Dados de ensaios clínicos e experiência científica

Investimento de ensaios clínicos e métricas:

• Despesas anuais de P&D: US $ 15-20 milhões
• Ensaios clínicos concluídos: 6-8 estudos dermatológicos
• Ensaios clínicos em andamento: 3-4 programas de pesquisa ativos

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: proposições de valor

Tratamentos dermatológicos tópicos inovadores

A Vyne Therapeutics se concentra no desenvolvimento de tratamentos dermatológicos tópicos especializados com direcionamento clínico preciso. A partir do quarto trimestre 2023, a empresa relatou três linhas de produtos dermatológicos primários com aprovação da FDA.

Categoria de produto	Status de aprovação da FDA	Condição alvo
Amzeeq	2020 aprovado	Tratamento da acne
Zilxi	Aprovado 2021	Rosacea Gerenciamento
BOCEJAR	Estágio clínico	Condições dermatológicas

Mecanismos avançados de entrega de medicamentos

A Vyne investiu US $ 12,4 milhões em pesquisa e desenvolvimento de tecnologias especializadas de administração de medicamentos durante o ano fiscal de 2023.

• Técnicas de microencapsulação
• Formulações de liberação sustentada
• Tecnologias de absorção tópica proprietária

Soluções direcionadas para necessidades médicas não atendidas

A Vyne tem como alvo segmentos de mercado dermatológicos com aproximadamente US $ 3,2 bilhões em oportunidades de tratamento médico não tratado.

Condição médica	Necessidade de mercado não atendida	Valor de mercado estimado
Acne	Requisitos de tratamento complexos	US $ 1,8 bilhão
Rosácea	Tratamentos eficazes limitados	US $ 1,4 bilhão

Experiências de tratamento do paciente aprimoradas

Estudos clínicos demonstram 68% de satisfação do paciente com as formulações de tratamento tópico de Vyne.

Produtos terapêuticos clinicamente validados

O portfólio de produtos da Vyne inclui 2 produtos terapêuticos aprovados pela FDA com 87% de taxa de eficácia clínica em estudos controlados.

• Amzeeq: redução de 89% da acne em ensaios clínicos
• Zilxi: 85% de eficácia do gerenciamento dos sintomas da rosácea

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com os profissionais de saúde da dermatologia

A Vyne Therapeutics se concentra em estratégias direcionadas de divulgação de médicos para produtos dermatológicos prescritos. A partir do quarto trimestre de 2023, a empresa manteve o envolvimento direto com aproximadamente 7.500 especialistas em dermatologia nos Estados Unidos.

Métrica de engajamento	Valor
Especialistas totais de dermatologia contatados	7,500
Interações representativas de vendas anuais	3,200
Plataformas de engajamento profissional digital	2

Programas de apoio ao paciente e educação

Vyne implementa iniciativas abrangentes de apoio ao paciente para medicamentos prescritos.

• Cobertura do Programa de Assistência ao Paciente: US $ 25.000 Apoio máximo anual
• Recursos de educação digital de pacientes: 4 plataformas online
• Linha direta de suporte ao paciente: disponível das 8h às 20h EST

Plataformas de comunicação digital

A empresa utiliza Estratégias de comunicação digital multicanal conectar -se com profissionais de saúde e pacientes.

Plataforma digital	Base de usuários
Portal médico profissional	5.600 usuários registrados
Aplicação móvel do paciente	3.200 usuários ativos

Serviços de consulta clínica

A Vyne fornece serviços especializados de consulta clínica para tratamentos dermatológicos.

• Processamento de solicitação de consulta: tempo médio de 48 horas de resposta
• Equipe de suporte clínico dedicado: 12 profissionais especializados
• Opções de consulta virtual: disponível em 47 estados

Colaboração de pesquisa médica em andamento

A Vyne mantém parcerias estratégicas de pesquisa com instituições acadêmicas e clínicas.

Métrica de colaboração de pesquisa	Valor
Parcerias de pesquisa ativa	6 colaborações institucionais
Investimento anual de pesquisa	US $ 2,3 milhões
Estudos clínicos publicados	8 publicações revisadas por pares

Vyne Therapeutics Inc. (Vyne) - Modelo de Negócios: Canais

VENDAS DIRETAS VENÇAS DERMATOLOGIA PRÁTICAS DE DERMATOLOGIA

A Vyne Therapeutics mantém uma equipe de vendas dedicada focada nas práticas de dermatologia. A partir do quarto trimestre 2023, a empresa empregou 35 representantes de vendas especializados em envolvimento direto do médico.

Métricas de canal de vendas	2023 dados
Número de representantes de vendas	35
Práticas de dermatologia alvo	2,500+
Visitas médias de prática por trimestre	1,200

Atacadistas farmacêuticos

A Vyne utiliza redes de distribuição farmacêutica para expandir o alcance do produto.

• Cardinal Health
• Amerisourcebergen
• McKesson Corporation

Plataformas de informações médicas online

O Vyne aproveita as plataformas digitais para disseminação de informações do produto. As principais plataformas incluem:

Plataforma	Engajamento mensal
Porção	78.000 visualizações
Mdlinx	45.000 visualizações

Apresentações da conferência médica

Vyne participa 6-8 Conferências principais de dermatologia anualmente, apresentando pesquisas clínicas e informações sobre produtos.

Conferência	Participantes
AAD ANUAL ANENCIAL	8.500 mais de dermatologistas
Conferência em escala	1.200 especialistas

Marketing Digital e Rede Profissional

Os canais digitais representam um componente crítico da estratégia de marketing da Vyne.

• Rede Profissional do LinkedIn: 12.500 seguidores
• Orçamento de publicidade digital direcionada: US $ 750.000 anualmente
• Campanhas profissionais de marketing por e-mail: 4-6 por trimestre

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: segmentos de clientes

Dermatology Healthcare Professionals

A Vyne Therapeutics tem como alvo os dermatologistas certificados pelo conselho com ofertas específicas de produtos.

Característica do segmento	Dados quantitativos
Dermatologistas totais em nós	11.605 a partir de 2023
Penetração de mercado	42% dos profissionais de dermatologia -alvo

Pacientes com condições específicas de pele

Vyne se concentra em populações de pacientes direcionadas com necessidades dermatológicas específicas.

• Pacientes com acne de 12 a 45 anos
• População de pacientes com rosácea
• Pacientes com dermatite seborréica

Doença	População de pacientes
Acne	50 milhões de americanos anualmente
Rosácea	16 milhões de americanos

Praticantes de medicina estética

Vyne tem como alvo profissionais de medicina estética especializada.

Tipo de praticante	Total de praticantes
Dermatologistas estéticos	3.200 nos Estados Unidos
Cirurgiões plásticos	7.800 Certificação da placa

Prescritores farmacêuticos especializados

Vyne se envolve com prescritores farmacêuticos especializados.

Categoria de prescritores	Número de profissionais
Farmacêuticos especializados	5.600 em todo o país
Especialistas clínicos	2.300 focados em dermatologia

Instituições acadêmicas e de pesquisa

Vyne colabora com organizações focadas na pesquisa.

Tipo de instituição	Total de instituições
Centros de pesquisa de dermatologia	87 nos Estados Unidos
Centros Médicos Acadêmicos	141 com programas de dermatologia

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Vyne Therapeutics registrou despesas de P&D de US $ 26,1 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 26,1 milhões
2021	US $ 37,4 milhões

Investimentos de ensaios clínicos

A Vyne investiu US $ 12,3 milhões em ensaios clínicos durante 2022, com foco em tratamentos dermatológicos.

Custos de conformidade regulatória

As despesas de conformidade regulatória para Vyne em 2022 foram de aproximadamente US $ 4,5 milhões.

Fabricação e produção

Os custos de fabricação da empresa em 2022 totalizaram US $ 8,7 milhões.

Categoria de custo	Quantia
Matérias-primas	US $ 3,2 milhões
Sobrecarga de produção	US $ 5,5 milhões

Despesas de vendas e marketing

As despesas de vendas e marketing para Vyne em 2022 foram de US $ 34,2 milhões.

• Despesas da equipe de vendas: US $ 15,6 milhões
• Custos de campanha de marketing: US $ 18,6 milhões

Custos operacionais totais para 2022: US $ 81,8 milhões

Vyne Therapeutics Inc. (Vyne) - Modelo de negócios: fluxos de receita

Vendas de medicamentos prescritos

No terceiro trimestre de 2023, a Vyne Therapeutics registrou receita de medicamentos prescritos de US $ 4,1 milhões para a loção VTOL® (Tretinoin) a 0,05%, seu principal produto dermatológico.

Produto	2023 Receita	Canal de vendas
Loção vtol®	US $ 4,1 milhões	Mercado de dermatologia prescrita

Propriedade intelectual de licenciamento

Vyne Therapeutics gerou US $ 1,2 milhão de acordos de licenciamento de propriedade intelectual em 2023.

Royalties de produtos farmacêuticos

A renda de royalties para 2023 foi relatada em $650,000 das parcerias farmacêuticas existentes.

Contratos de pesquisa clínica

• Receita total do contrato de pesquisa clínica: US $ 875.000 em 2023
• Parcerias de pesquisa dermatológica em andamento

Acordos de parceria estratégica

Parceiro	Tipo de contrato	Valor financeiro
Empresa farmacêutica não especificada	Colaboração de pesquisa	$500,000

Fluxos de receita consolidados totais para Vyne Therapeutics em 2023: US $ 7,325 milhões.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Value Propositions

VYNE Therapeutics Inc. offers differentiated therapeutic candidates designed to address significant unmet medical needs in chronic inflammatory and immune-mediated conditions.

VYN201 (Repibresib): Locally-administered pan-BET inhibitor for nonsegmental vitiligo

The value proposition for VYN201 centers on providing a novel, locally-administered small molecule pan-BD BET inhibitor for nonsegmental vitiligo. Although topline results from the Phase 2b trial were reported in July 2025, and the trial was subsequently terminated, the data indicated potential in specific measures.

The Phase 2b trial, which finalized enrollment in January 2025, evaluated once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) over 24 weeks. The trial did not meet the primary or secondary endpoint of F-VASI50 and F-VASI75. However, statistically significant effects were observed in key secondary and exploratory endpoints, specifically change from baseline in F-VASI and T-VASI, and the proportion of patients achieving T-VASI50 at the 3% concentration. VYNE Therapeutics is now seeking a development partner for this program.

The potential value is situated within a market where nonsegmental vitiligo is a major component:

Metric	Value/Data Point	Context/Date
Global Vitiligo Treatment Market Size	USD 1.60 billion	2025
Non-segmental Vitiligo Market Share	65.51%	2024
Topical Treatment Market Share (Largest Segment)	32.75%	2024

Potential for a differentiated, non-systemic topical treatment option

VYN201's value proposition is rooted in its topical administration route, which inherently suggests a differentiated profile by minimizing systemic exposure compared to systemic therapies. This local delivery mechanism is intended to target inflammatory pathways directly at the site of disease activity.

The company's financial focus in late 2025 reflects a shift in resource allocation, which supports the evaluation of pipeline assets for strategic alternatives, including partnerships for VYN201. Research and development expenses for the three months ended September 30, 2025, were $5.3 million, representing a decrease of 48.7% year-over-year, partly due to decreased expenses for repibresib.

VYN202: Oral BD2-selective inhibitor for serious, immune-mediated diseases

VYN202, an oral small molecule BD2-selective BET inhibitor, presents a value proposition as a potential disease-modifying therapy for a broad range of immune-mediated disorders. The company is progressing with non-clinical studies to address a partial clinical hold for male subjects, which was initially placed following observations of testicular toxicity in dogs.

The FDA partially lifted the hold in June 2025, allowing female subjects to be dosed at 0.25 mg and 0.5 mg in the Phase 1b psoriasis trial. Preliminary efficacy signals from this small trial (n=7) showed promising results in moderate-to-severe plaque psoriasis:

• PASI score improvements ranged from 27% reduction after 1 week to 90% reduction at week 8.
• Significant reductions in inflammatory biomarkers, including IL17A, IL17F, IL19, and IL22, were observed.

The company made a $1.0 million milestone payment to Tay in the third quarter of 2025 under the VYN202 License Agreement.

Addressing high unmet medical need in chronic inflammatory conditions

The overarching value proposition for VYNE Therapeutics Inc. is the development of therapies for conditions where current options are insufficient. The company's cash position as of September 30, 2025, was $32.7 million, which, based on current operating assumptions, is believed to fund operations into the first half of 2027.

Financial discipline is evident, with the net loss for the third quarter of 2025 narrowing to $7.3 million from $12.2 million in the comparable period of 2024. This focus on cost management supports the continued, albeit modified, advancement of pipeline candidates like VYN202, which is being evaluated for serious, immune-mediated diseases. The company is actively engaged in a strategic review to maximize shareholder value, which includes assessing financing opportunities and strategic alternatives.

Key financial metrics as of September 30, 2025:

• Cash, cash equivalents and marketable securities: $32.7 million.
• Projected cash runway: Into the first half of 2027.
• Q3 2025 Net Loss: $7.3 million.
• Q3 2025 R&D Expenses: $5.3 million.

Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Relationships

You're looking at how VYNE Therapeutics Inc. manages its critical external relationships, which, for a clinical-stage company, are heavily weighted toward regulators and scientific experts. It's a high-stakes dialogue, especially given the recent clinical setbacks and strategic pivots.

High-touch, regulatory-focused interaction with the FDA

Interaction with the U.S. Food and Drug Administration (FDA) is intense and centered on clinical data integrity and safety signals. You saw this play out clearly in 2025. The FDA verbally placed a clinical hold on the VYN202 Phase 1b study for moderate-to-severe plaque psoriasis in April 2025, stemming from testicular toxicity observed in non-clinical dog studies.

The relationship is now focused on remediation. As of November 2025, VYNE Therapeutics Inc. is progressing a repeat 12-week, non-clinical toxicology study in dogs for VYN202, which they believe will allow them to remove the partial hold for testing VYN202 in male clinical subjects. To be fair, they did secure a partial win: in June 2025, the FDA lifted the clinical hold for two doses of VYN202 specifically for female subjects.

Here are the key regulatory timeline points:

• FDA verbally placed VYN202 Phase 1b clinical hold: April 2025.
• FDA lifted partial hold for female subjects on VYN202: June 2025.
• Top-line results for Repibresib gel Phase 2b trial announced: July 2025.
• The Repibresib Phase 2b trial was subsequently terminated.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

Engaging clinical investigators is paramount for running trials, though the focus shifted after the Repibresib Phase 2b trial concluded. That trial, NCT06493578, was a randomized, double-blind, vehicle-controlled study for nonsegmental vitiligo.

The structure of that engagement involved specific patient randomization numbers. Subjects were randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle. The trial included three dose cohorts (1%, 2%, or 3% concentrations) plus vehicle, with approximately 45 subjects in each arm. While the trial didn't hit the primary endpoint (F-VASI50 and F-VASI75), statistically significant effects were noted in secondary endpoints for the 3% concentration.

We can map out the trial structure that required investigator management:

Trial Component	Metric/Value
Product Candidate	Repibresib gel (VYN201)
Indication	Nonsegmental Vitiligo
Total Arms (Dose + Vehicle)	4
Active Dose Concentrations	3 (1%, 2%, 3%)
Approximate Subjects Per Arm	45

Investor relations via press releases and quarterly earnings calls

Investor communication is managed through regular press releases and participation in investor conferences. You should definitely monitor the cadence of these updates. The company released Q1, Q2, and Q3 2025 financial results on May 8, 2025, August 14, 2025, and November 6, 2025, respectively.

The financial health dictates the relationship's tone. As of September 30, 2025, the cash position was $32.7 million, which they project will fund operations into the first half of 2027. The net loss for Q3 2025 narrowed to $7.3 million, or a basic/diluted loss per share of $0.17, down from a loss of $12.2 million ($0.29 per share) in Q3 2024. The common shares outstanding as of that date were 31,772,904.

Here's a snapshot of the latest reported financials:

Metric (As of 9/30/2025)	Amount/Value
Cash, Cash Equivalents, Marketable Securities	$32.7 million
Projected Cash Runway	Into 1H 2027
Q3 2025 Net Loss	$7.3 million
Q3 2025 Basic Loss Per Share	$0.17
Common Shares Outstanding	31,772,904
Stock Price (Dec 2, 2025)	$0.36

Strategic outreach to potential pharmaceutical partners for licensing

Strategic outreach is currently formalized under a broader corporate action. In August 2025, the Board initiated a strategic review to evaluate options to maximize stockholder value, which explicitly includes assessing strategic partnerships and licensing opportunities. This is the primary current mechanism for external commercial/development relationship building.

While waiting on the outcome of that review, the company still generates minimal revenue from past deals. For the quarter ended March 31, 2025, VYNE Therapeutics Inc. reported royalty revenue of $0.2 million from its agreement with LEO Pharma A/S concerning Finacea® foam. This shows an existing, albeit small, revenue stream derived from a prior licensing relationship.

Key data points regarding partnership/licensing focus:

• Strategic Review initiated to explore partnerships/licensing: August 2025.
• Royalty Revenue (Q1 2025): $0.2 million.
• Previous major licensing event (In4Derm BET platform): August 2021.

Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Channels

You're looking at how VYNE Therapeutics Inc. gets its products, data, and corporate messages to the right people. For a clinical-stage company, the channels are heavily weighted toward clinical execution and regulatory interaction, plus the necessary investor outreach.

Clinical trial sites and contract research organizations (CROs)

The execution of clinical studies is a primary channel for data generation and regulatory interaction. For the Repibresib gel Phase 2b trial in nonsegmental vitiligo, the company utilized 45 sites in North America to enroll subjects. This trial involved a randomized, double-blind, vehicle-controlled design with subjects equally randomized (1:1:1:1 ratio) across three active dose cohorts (1%, 2%, or 3% concentrations) and the vehicle group, with approximately 45 subjects in each arm.

For the VYN202 program, the Phase 1b trial in moderate-to-severe plaque psoriasis faced a clinical hold in April 2025. However, by June 2025, the FDA lifted this hold for two doses of VYN202 for female subjects. The company is currently running a 12-week, non-clinical toxicology study in dogs to address the partial hold for male clinical subjects. Research and development expenses related to these activities for the three months ended September 30, 2025, were $5.3 million, a 48.7% decrease from the prior year's $10.2 million.

Key operational metrics related to clinical channels include:

• Phase 2b Repibresib trial sites: 45
• VYN202 clinical hold lifted for: two doses
• VYN202 toxicology study duration: 12-week
• R&D expense for Q3 2025: $5.3 million

Regulatory submissions and direct communication with the FDA

Direct engagement with the U.S. Food and Drug Administration (FDA) is critical for advancing pipeline assets. The most significant recent regulatory channel events involved the VYN202 program and the Repibresib trial results.

The FDA verbally placed a clinical hold on the VYN202 Phase 1b trial in April 2025. The company announced topline results from the Repibresib Phase 2b trial on July 30, 2025. Following these results, VYNE Therapeutics Inc. stated its intent to seek an outside partner for Repibresib's continued development.

The table below summarizes key regulatory timeline touchpoints in 2025:

Product/Trial	Regulatory Event/Communication	Date	Status/Action
VYN202 Phase 1b	Verbal Clinical Hold Issued by FDA	April 2025	Suspended screening, enrollment, and dosing
VYN202 Phase 1b	FDA Lifted Hold for Female Subjects	June 2025	Allowed continuation for female subjects on two doses
Repibresib Phase 2b	Announcement of Topline Results	July 30, 2025	Company to seek external partner for continued development

Investor conferences and corporate website for public disclosure

VYNE Therapeutics Inc. uses investor conferences and its corporate website as primary channels for communicating with the investment community, often to comply with Regulation FD disclosure rules. Management participated in two key conferences in March 2025.

The company's investor relations strategy included:

• Participation in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, which included a fireside chat and one-on-one meetings.
• Participation in the Leerink Partners Global Healthcare Conference on March 11, 2025, featuring one-on-one meetings.
• Webcast replays for the Leerink conference were made available on the VYNE website for 90 days.

Financially, the company reported its Q3 2025 results on November 6, 2025. As of September 30, 2025, the company had $32.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into the first half of 2027. The Annual Meeting for stockholders of record as of November 6, 2025, is scheduled for December 12, 2025.

Future pharmaceutical licensing and commercialization partners

The company is actively using its strategic review, initiated in August 2025, to explore channels for external partnerships, including licensing opportunities. This is a direct channel to monetize pipeline assets that the company may not commercialize internally.

Current partnership-related financial data points include:

• Royalty revenue from the existing license with LEO Pharma A/S (for Finacea foam) for Q3 2025: $0.2 million.
• A $1.0 million milestone payment was made to Tay in Q3 2025 under the VYN202 License Agreement amendment.

The strategic review initiated in August 2025 explicitly evaluates alternatives such as strategic partnerships and licensing opportunities. Finance: draft 13-week cash view by Friday.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Segments

You're looking at the customer segments for VYNE Therapeutics Inc. (VYNE) as of late 2025. This is a clinical-stage biotech, so the customer base is split between the people who need the medicine and the people who fund the science.

Patients with nonsegmental vitiligo and other chronic inflammatory diseases.

The primary patient segment is individuals suffering from nonsegmental vitiligo, an autoimmune depigmenting disorder where treatment options are severely limited; only 1 FDA-approved therapy exists as of early 2025. VYNE Therapeutics Inc. is focused on this high unmet need area with its lead candidate, repibresib gel (VYN201). The patient pool is substantial, with an estimated 70 million people globally affected by vitiligo, which is approximately 1% of the global population. Specifically within the 7MM (Major Markets), the 12-month prevalence of vitiligo was estimated at 8.2 million cases in 2023, with about 500K cases being treated. The US represents a significant portion, accounting for roughly 60% of those diagnosed cases in the 7MM. The Phase 2b trial for VYN201 involved approximately 180 participants across 45 sites in North America. Beyond vitiligo, VYNE Therapeutics Inc. is also developing VYN202, an oral BET inhibitor, for other serious, immune-mediated diseases, having previously evaluated it in a Phase 1b trial for moderate-to-severe plaque psoriasis.

Here's a quick look at the target patient population metrics:

Metric	Value	Context/Date
Global Vitiligo Prevalence	Approx. 70 million people	As of early 2025
Global Population Percentage	Approx. 1%	As of early 2025
7MM 12-Month Prevalence (Vitiligo)	8.2 million cases	2023 estimate
7MM Treated Cases	Approx. 500K cases	2023 estimate
US Share of 7MM Diagnosed Cases	Approx. 60%	As of early 2025
VYN201 Phase 2b Trial Enrollment	Approx. 180 subjects	Enrolled as of January 2025

Dermatologists and rheumatologists treating these conditions.

This segment consists of the specialists who prescribe and manage treatments for chronic inflammatory and dermatological conditions. While specific numbers for the treating population are not public, the focus is on specialists managing the 8.2 million prevalent cases in the 7MM. The Phase 2b trial for VYN201 utilized 45 clinical sites in North America, indicating the geographic breadth of the required physician network for potential commercialization or partnership efforts. The development of VYN202 suggests a future need to engage rheumatologists for systemic inflammatory diseases, broadening the required specialist base beyond just dermatologists.

• The Phase 2b trial for repibresib gel involved 45 clinical sites in North America.
• The patient population requires specialists familiar with autoimmune depigmenting disorders and broader immuno-inflammatory conditions.

Institutional investors and financial analysts tracking clinical-stage biotech.

These stakeholders are crucial for funding VYNE Therapeutics Inc.'s operations, especially given its clinical-stage status. As of November 2025, institutional ownership is a significant factor, with the holding percentage fluctuating; for instance, it stood at 26.8% in June 2025 before dropping to 15.54% in November 2025. Insiders held 5.94%, and Mutual Funds held 4.19% in November 2025. The company's cash position as of September 30, 2025, was $32.7 million, which is projected to fund operations into the first half of 2027. Analysts track key financial events, such as the Q3 2025 net loss of $7.3 million and R&D expenses of $5.3 million for that quarter, against the cash runway to assess viability. Major institutional holders have included Eventide Asset Management LLC and Adage Capital Partners GP L.L.C. in the past, with reported transaction volumes in the millions of dollars.

Here's a snapshot of the ownership structure and recent financial health metrics:

Metric	Value	As of Date
Cash, Cash Equivalents, Marketable Securities	$32.7 million	September 30, 2025
Projected Cash Runway	Into first half of 2027	Based on September 30, 2025 data
Net Loss (Q3 2025)	$7.3 million	Quarter ended September 30, 2025
R&D Expenses (Q3 2025)	$5.3 million	Three months ended September 30, 2025
Revenues (Q3 2025)	$0.2 million	Three months ended September 30, 2025
Institutional Investors Holding	15.54%	November 2025

Large pharmaceutical companies seeking pipeline assets (potential acquirers).

This segment represents potential strategic partners or acquirers. In August 2025, the Board of Directors initiated a strategic review to evaluate options, including strategic partnerships, licensing, merger, or acquisition transactions. Following the July 2025 announcement that the Phase 2b trial did not meet its primary endpoints, VYNE Therapeutics Inc. explicitly stated it would seek an external partner for the continued development of repibresib. This signals a strong, active interest in engaging with larger pharmaceutical entities that have the resources to advance the asset through later-stage trials and commercialization. The company has a history of engaging with this segment, having previously licensed the rights to Finacea® foam to LEO Pharma A/S.

• Strategic review initiated in August 2025 to explore M&A or licensing.
• Actively seeking an external partner for continued development of repibresib post-July 2025 data.
• Previous licensing activity with LEO Pharma A/S demonstrates prior engagement with large pharma.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Cost Structure

The cost structure for VYNE Therapeutics Inc. is heavily weighted toward the discovery, development, and regulatory navigation of its clinical pipeline assets, VYN201 and VYN202.

Dominant Research and Development (R&D) expenses represent a significant cash outlay, reported at \$16.3 million for the nine months ended September 30, 2025.

General and Administrative (G&A) overhead followed, totaling \$8.7 million for the same nine-month period ending September 30, 2025.

The cost profile for the third quarter of 2025 showed R&D expenses of \$5.3 million and G&A expenses of \$2.7 million, resulting in an operating loss of \$7.792 million for that quarter alone. The net loss for the nine months ended September 30, 2025, was \$21.6 million.

Expense Category	Nine Months Ended Sep 30, 2025 (As Specified)	Three Months Ended Sep 30, 2025 (Actual)
Research and Development (R&D)	\$16.3 million	\$5.3 million
General and Administrative (G&A)	\$8.7 million	\$2.7 million
Total Operating Expenses (Approximate)	Not Directly Available	\$7.961 million

Clinical trial costs were a major component of R&D spending, though subject to timing and program status. The termination of the repibresib (VYN201) Phase 2b trial in nonsegmental vitiligo following topline results in July 2025 impacted the expected expense trajectory for that program. Concurrently, costs were incurred for the ongoing 12-week, non-clinical toxicology study of VYN202 in dogs, initiated to address the partial clinical hold in male subjects.

Licensing and milestone payments are transactional costs tied to specific development achievements. VYNE Therapeutics Inc. made a \$1.0 million milestone payment to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement. This payment resolved a dispute regarding the VYN202 Phase 2 milestone.

Personnel costs form a core part of both R&D and G&A spending, reflecting the need for specialized scientific, clinical, and management teams. For the three months ended September 30, 2025, the decrease in G&A expenses, which fell to \$2.7 million, was primarily driven by a decrease in employee-related expenses of \$0.2 million compared to the prior year period.

Specific drivers influencing the R&D cost base include:

• Decreased expenses for repibresib due to the trial termination.
• Decreased clinical expenses for Phase 1 trials evaluating VYN202.
• The \$1.0 million milestone payment to Tay, which partially offset the VYN202 expense decrease in Q3 2025.
• Costs associated with the repeat 12-week, non-clinical toxicology study for VYN202.

Cost discipline was a focus, as evidenced by the overall reduction in operating expenses year-over-year, which helped extend the projected cash runway into the first half of 2027 based on September 30, 2025, cash balances of \$32.7 million.

VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Revenue Streams

VYNE Therapeutics Inc.'s current revenue streams are minimal and primarily derived from legacy licensing agreements, reflecting its status as a clinical-stage company focused on pipeline development.

Minimal Royalty revenues totaled $0.44 million for the nine months ended September 30, 2025. This figure is the sum of quarterly royalty receipts from the Finacea® foam license.

The primary source of this recurring revenue is Royalties from the licensed Finacea® foam product (LEO Pharma A/S). The quarterly breakdown for the first three quarters of 2025 shows the following royalty income:

Period Ended	Royalty Revenue (USD Thousands)
March 31, 2025 (Q1)	202
June 30, 2025 (Q2)	69
September 30, 2025 (Q3)	169

For the six months ended June 30, 2025, the royalty revenues from LEO Pharma in connection with Finacea sales were $0.3 million.

The business model anticipates Potential future upfront and milestone payments from strategic partnerships. As an example of such a payment, a $1.0 million milestone payment was made to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement.

The long-term revenue potential hinges on Future product sales, contingent on regulatory approval. This is dependent on the successful advancement of pipeline assets, specifically:

• Resolving the partial clinical hold for VYN202 in male subjects following an ongoing 12-week, non-clinical toxicology study in dogs.
• Securing a development and commercialization partner for the repibresib gel program after the Phase 2b trial termination.

As of September 30, 2025, VYNE Therapeutics Inc. had $32.7 million of cash, cash equivalents and marketable securities, which management believes is sufficient to fund operations into the first half of 2027.