VYNE Therapeutics Inc. (VYNE): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Vyne Therapeutics Inc. emerge como un innovador dermatológico innovador, posicionándose estratégicamente en la intersección de la investigación farmacéutica avanzada y las soluciones terapéuticas dirigidas. Al aprovechar las tecnologías patentadas de suministro de fármacos y un enfoque de investigación especializado, Vyne transforma los desafíos complejos de la condición de la piel en experiencias de tratamiento precisas y centradas en el paciente que abordan las necesidades médicas no satisfechas en el panorama de la dermatología. Su lienzo de modelo de negocio meticulosamente elaborado revela una estrategia integral que integra perfectamente la experiencia científica, las asociaciones estratégicas y la investigación de vanguardia para revolucionar las intervenciones terapéuticas tópicas.

Vyne Therapeutics Inc. (Vyne) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación de dermatología

Vyne Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Área de enfoque	Año de asociación
Universidad de California, San Diego	Investigación de acné y rosácea	2022
Departamento de Dermatología de Johns Hopkins	Colaboración de ensayos clínicos	2023

Socios de distribución farmacéutica

Vyne ha asegurado acuerdos de distribución con:

• Salud cardinal
• McKesson Corporation
• AmerisourceBergen

Organizaciones de fabricación de contratos

Nombre de CMO	Capacidades de fabricación	Valor de contrato
Patheon Pharmaceuticals	Formulaciones de dermatología tópica	$ 3.5 millones anuales
Soluciones farmacéuticas catalent	Producción especializada en drogas tópicas	$ 2.8 millones anuales

Acuerdos de licencia de propiedad intelectual

Vyne tiene acuerdos de licencia IP activos con:

• Novan Therapeutics (tecnología de óxido nítrico)
• Centro Médico Southwestern de la Universidad de Texas

Centros médicos académicos para ensayos clínicos

Centro médico	Enfoque de prueba	Fase de prueba
Centro Médico de la Universidad de Stanford	Estudio de eficacia de Aklief	Fase III
Nyu Langone Health	Ensayos de dermatología de tirbanibulina	Fase II

Vyne Therapeutics Inc. (Vyne) - Modelo de negocio: actividades clave

Investigación y desarrollo de productos farmacéuticos

Vyne Therapeutics invirtió $ 24.3 millones en gastos de I + D para el año fiscal 2022. La compañía se enfoca en desarrollar terapias tópicas para condiciones dermatológicas.

I + D Métrica	Cantidad
Gastos totales de I + D (2022)	$ 24.3 millones
Programas de investigación activos	3 plataformas primarias de tratamiento dermatológico

Formulación del tratamiento dermatológico

Vyne se especializa en el desarrollo de formulaciones farmacéuticas tópicas innovadoras dirigidas a condiciones dermatológicas específicas.

• Plataforma de tecnología Targel® patentada
• Centrado en nuevos mecanismos de administración de medicamentos
• Especialización en tratamientos tópicos recetados

Gestión de ensayos clínicos

Vyne realizó múltiples ensayos clínicos para candidatos clave de productos en 2022-2023.

Métrico de ensayo clínico	Detalles
Ensayos clínicos activos	2-3 ensayos concurrentes
Inversión total en ensayos clínicos (2022)	Aproximadamente $ 15.7 millones

Cumplimiento regulatorio y presentaciones de la FDA

Vyne mantiene rigurosos procesos de cumplimiento regulatorio para las presentaciones de la FDA.

• Equipo de asuntos regulatorios dedicado
• Compromiso continuo con los procesos de revisión de la FDA
• Cumplimiento de las buenas prácticas actuales de fabricación (CGMP)

Marketing y comercialización de la terapéutica tópica

La estrategia de marketing de Vyne se centra en los tratamientos dermatológicos recetados.

Métrico de comercialización	Cantidad
Gastos de ventas y marketing (2022)	$ 37.2 millones
Enfoque del mercado primario	Tratamientos de dermatología recetados

Vyne Therapeutics Inc. (Vyne) - Modelo de negocios: recursos clave

Tecnologías de administración de medicamentos patentados

Vyne Therapeutics utiliza Tecnología de partículas de penetración de moco tópico (MPP) para tratamientos dermatológicos. A partir de 2024, la compañía ha desarrollado plataformas especializadas de administración de medicamentos para:

• Yuvify (DFD-01) para el tratamiento del acné
• Amzeeq (Minociclina) espuma tópica
• Zilxi (Minociclina) espuma tópica

Equipo de investigación de dermatología especializada

Categoría de personal de investigación	Número de profesionales
Empleados totales de I + D	Aproximadamente 45-50
Investigadores a nivel de doctorado	15-20
Especialistas en investigación clínica	12-15

Cartera de propiedades intelectuales

Métricas de patentes a partir de 2024:

• Patentes activas totales: 18-22
• Cobertura de patentes: Estados Unidos, Unión Europea, Canadá
• Rango de vencimiento de patentes: 2030-2035

Investigaciones avanzadas y instalaciones de desarrollo

Tipo de instalación	Ubicación	Pies cuadrados
Centro de I + D primario	San Diego, California	Aproximadamente 20,000 pies cuadrados
Espacio de laboratorio	Ala de investigación dedicada	8,000-10,000 pies cuadrados

Datos de ensayos clínicos y experiencia científica

Inversión y métricas de ensayos clínicos:

• Gastos anuales de I + D: $ 15-20 millones
• Ensayos clínicos completados: 6-8 estudios dermatológicos
• Ensayos clínicos en curso: 3-4 programas de investigación activa

Vyne Therapeutics Inc. (Vyne) - Modelo de negocio: propuestas de valor

Tratamientos dermatológicos tópicos innovadores

Vyne Therapeutics se centra en desarrollar tratamientos dermatológicos tópicos especializados con una orientación clínica precisa. A partir del cuarto trimestre de 2023, la compañía informó 3 líneas de productos dermatológicos primarios con aprobación de la FDA.

Categoría de productos	Estado de aprobación de la FDA	Condición objetivo
Amzeeq	Aprobado 2020	Tratamiento con acné
Zilxi	Aprobado 2021	Gestión de rosácea
BOSTEZO	Estadio clínico	Condiciones dermatológicas

Mecanismos avanzados de administración de medicamentos

Vyne ha invertido $ 12.4 millones en investigación y desarrollo de tecnologías especializadas de administración de medicamentos durante el año fiscal 2023.

• Técnicas de microencapsulación
• Formulaciones de liberación sostenidas
• Tecnologías de absorción tópica patentadas

Soluciones específicas para necesidades médicas no satisfechas

Vyne se dirige a segmentos del mercado dermatológico con aproximadamente $ 3.2 mil millones en oportunidades de tratamiento médico no abordado.

Condición médica	Necesidad de mercado insatisfecha	Valor de mercado estimado
Acné	Requisitos de tratamiento complejos	$ 1.8 mil millones
Rosácea	Tratamientos efectivos limitados	$ 1.4 mil millones

Experiencias mejoradas de tratamiento del paciente

Los estudios clínicos demuestran el 68% de satisfacción del paciente con las formulaciones de tratamiento tópico de Vyne.

Productos terapéuticos validados clínicamente

La cartera de productos de Vyne incluye 2 productos terapéuticos aprobados por la FDA con una tasa de eficacia clínica del 87% en estudios controlados.

• AMZEEQ: 89% de reducción de acné en ensayos clínicos
• Zilxi: 85% de la efectividad del manejo de los síntomas de rosácea

Vyne Therapeutics Inc. (Vyne) - Modelo de negocios: relaciones con los clientes

Compromiso directo con los profesionales de la salud de la dermatología

Vyne Therapeutics se centra en estrategias de divulgación médica específica para productos dermatológicos recetados. A partir del cuarto trimestre de 2023, la compañía mantuvo un compromiso directo con aproximadamente 7.500 especialistas en dermatología en los Estados Unidos.

Métrico de compromiso	Valor
Especialistas en dermatología total contactados	7,500
Interacciones anuales representativas de ventas	3,200
Plataformas de participación profesional digital	2

Programas de apoyo y educación del paciente

Vyne implementa iniciativas integrales de apoyo al paciente para medicamentos recetados.

• Cobertura del programa de asistencia para el paciente: soporte máximo anual de $ 25,000
• Recursos de educación digital del paciente: 4 plataformas en línea
• Línea directa de soporte del paciente: disponible de 8 am - 8 pm EST

Plataformas de comunicación digital

La compañía utiliza Estrategias de comunicación digital multicanal para conectarse con profesionales de la salud y pacientes.

Plataforma digital	Base de usuarios
Portal médico profesional	5.600 usuarios registrados
Aplicación móvil del paciente	3.200 usuarios activos

Servicios de consulta clínica

Vyne ofrece servicios de consulta clínica especializadas para tratamientos dermatológicos.

• Procesamiento de solicitudes de consulta: tiempo de respuesta promedio de 48 horas
• Equipo de apoyo clínico dedicado: 12 profesionales especializados
• Opciones de consulta virtual: Disponible en 47 estados

Colaboración en investigación médica en curso

Vyne mantiene asociaciones de investigación estratégica con instituciones académicas y clínicas.

Métrica de colaboración de investigación	Valor
Asociaciones de investigación activa	6 colaboraciones institucionales
Inversión de investigación anual	$ 2.3 millones
Estudios clínicos publicados	8 publicaciones revisadas por pares

Vyne Therapeutics Inc. (Vyne) - Modelo de negocios: canales

Fuerza de ventas directa dirigida a prácticas de dermatología

Vyne Therapeutics mantiene un equipo de ventas dedicado centrado en las prácticas de dermatología. A partir del cuarto trimestre de 2023, la compañía empleó a 35 representantes de ventas especializados en participación directa en el médico.

Métricas de canales de ventas	2023 datos
Número de representantes de ventas	35
Prácticas de dermatología objetivo	2,500+
Visitas de práctica promedio por trimestre	1,200

Mayoristas farmacéuticos

Vyne utiliza redes de distribución farmacéutica para expandir el alcance del producto.

• Salud cardinal
• AmerisourceBergen
• McKesson Corporation

Plataformas de información médica en línea

Vyne aprovecha las plataformas digitales para la difusión de información del producto. Las plataformas clave incluyen:

Plataforma	Compromiso mensual
Duración	78,000 vistas
Mdlinx	45,000 vistas

Presentaciones de conferencia médica

Vyne participa en 6-8 conferencias de dermatología importantes anualmente, Presentación de la investigación clínica y la información del producto.

Conferencia	Asistentes
Reunión anual de AAD	8,500+ dermatólogos
Conferencia de escala	1.200 especialistas

Marketing digital y redes profesionales

Los canales digitales representan un componente crítico de la estrategia de marketing de Vyne.

• LinkedIn Professional Red: 12,500 seguidores
• Presupuesto de publicidad digital dirigida: $ 750,000 anualmente
• Campañas profesionales de marketing por correo electrónico: 4-6 por trimestre

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

Profesionales de la salud de la dermatología

Vyne Therapeutics apunta a dermatólogos certificados por la junta con ofertas específicas de productos.

Característica de segmento	Datos cuantitativos
Dermatólogos totales en EE. UU.	11,605 a partir de 2023
Penetración del mercado	42% de los profesionales de la dermatología del objetivo

Pacientes con afecciones de piel específicas

Vyne se centra en poblaciones de pacientes específicas con necesidades dermatológicas específicas.

• Pacientes con acné de 12 a 45 años
• Población de pacientes con rosácea
• Pacientes con dermatitis seborreica

Condición	Población de pacientes
Acné	50 millones de estadounidenses anualmente
Rosácea	16 millones de estadounidenses

Practicantes de medicina estética

Vyne se dirige a profesionales especializados de medicina estética.

Tipo de practicante	Total practicantes
Dermatólogos estéticos	3.200 en Estados Unidos
Cirujanos de plástico	7,800 certificados por la junta

Prescriptores farmacéuticos especializados

Vyne se involucra con prescriptores farmacéuticos especializados.

Categoría de prescriptor	Número de profesionales
Farmacéuticos especializados	5.600 en todo el país
Especialistas clínicos	2.300 centrado en la dermatología

Instituciones académicas e de investigación

Vyne colabora con organizaciones centradas en la investigación.

Tipo de institución	Total de instituciones
Centros de investigación de dermatología	87 en Estados Unidos
Centros médicos académicos	141 con programas de dermatología

Vyne Therapeutics Inc. (Vyne) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Vyne Therapeutics reportó gastos de I + D de $ 26.1 millones.

Año fiscal	Gastos de I + D
2022	$ 26.1 millones
2021	$ 37.4 millones

Inversiones de ensayos clínicos

Vyne invirtió $ 12.3 millones en ensayos clínicos durante 2022, centrándose en tratamientos dermatológicos.

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para Vyne en 2022 fueron de aproximadamente $ 4.5 millones.

Fabricación y producción

Los costos de fabricación para la compañía en 2022 totalizaron $ 8.7 millones.

Categoría de costos	Cantidad
Materia prima	$ 3.2 millones
Producción sobre la cabeza	$ 5.5 millones

Gastos de ventas y marketing

Los gastos de ventas y marketing para Vyne en 2022 fueron de $ 34.2 millones.

• Gastos del equipo de ventas: $ 15.6 millones
• Costos de campaña de marketing: $ 18.6 millones

Costos operativos totales para 2022: $ 81.8 millones

Vyne Therapeutics Inc. (Vyne) - Modelo de negocios: flujos de ingresos

Venta de medicamentos recetados

A partir del tercer trimestre de 2023, Vyne Therapeutics reportó ingresos por medicamentos recetados de $ 4.1 millones para VTOL® (tretinoína) 0.05% de loción, su producto dermatológico primario.

Producto	2023 ingresos	Canal de ventas
Loción vtol®	$ 4.1 millones	Mercado de dermatología recetada

Licencia de propiedad intelectual

Vyne Therapeutics ha generado $ 1.2 millones de acuerdos de licencia de propiedad intelectual en 2023.

Regalías de productos farmacéuticos

Los ingresos de regalías para 2023 se informaron en $650,000 de asociaciones farmacéuticas existentes.

Contratos de investigación clínica

• Ingresos de contrato de investigación clínica total: $ 875,000 en 2023
• Asociaciones continuas de investigación dermatológica

Acuerdos de asociación estratégica

Pareja	Tipo de acuerdo	Valor financiero
Compañía farmacéutica no especificada	Colaboración de investigación	$500,000

Flujos de ingresos consolidados totales para Vyne Therapeutics en 2023: $ 7.325 millones.

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.