Immunic, Inc. (IMUX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Immunic, Inc. (IMUX) emerge como un innovador innovador innovador, posicionándose estratégicamente a la vanguardia del tratamiento de enfermedades autoinmunes a través de un modelo de negocio meticulosamente elaborado. Al aprovechar el descubrimiento de fármacos moleculares de vanguardia, las asociaciones estratégicas y un enfoque centrado en el láser para abordar las necesidades médicas no satisfechas, la compañía está transformando el panorama de las soluciones terapéuticas para los trastornos del sistema inmunitario complejos. Su lienzo de modelo de negocio integral revela un plan sofisticado que entrelazan la innovación científica, la colaboración estratégica y la creación de valor dirigido, prometiendo posibles tratamientos innovadores que podrían revolucionar la atención al paciente en reumatología, gastroenterología y condiciones neurológicas.

Immunic, Inc. (IMUX) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación farmacéutica

Immunic, Inc. ha establecido asociaciones clave con las siguientes instituciones de investigación:

Institución	Área de enfoque	Alcance de la asociación
Universidad de Munich	Investigación de inmunología	Soporte de ensayos clínicos para IMU-838
Universidad Técnica de Dresde	Desarrollo de drogas	Colaboración de investigación preclínica

Asociación con Boehringer Ingelheim

En diciembre de 2022, Immunic firmó un acuerdo de colaboración estratégica con Boehringer Ingelheim para el desarrollo de IMU-838.

• Pago por adelantado de $ 30 millones recibidos de Boehringer Ingelheim
• Pagos potenciales de hitos de hasta $ 610 millones
• Regalías escalonadas sobre posibles ventas netas futuras

Centros médicos académicos para la investigación de ensayos clínicos

Centro médico	Ensayo clínico	Candidato a la droga
Clínica de mayonesa	Prueba de fase 2 UC	IMU-838
Clínica de Cleveland	Investigación de esclerosis múltiple	IMU-856

Posibles acuerdos de licencia

Immunic está explorando oportunidades de licencia para sus candidatos a drogas, con discusiones activas en múltiples áreas terapéuticas.

• Negociaciones continuas para licencias IMU-935
• Posentes asociaciones de distribución internacional
• Acuerdos de investigación colaborativos bajo evaluación

Immunic, Inc. (IMUX) - Modelo de negocio: actividades clave

Investigación y desarrollo farmacéutico

A partir del cuarto trimestre de 2023, Immunic, Inc. invirtió $ 34.2 millones en gastos de investigación y desarrollo. La compañía se enfoca en desarrollar nuevas terapias de moléculas pequeñas dirigidas a enfermedades inflamatorias y autoinmunes.

Área de investigación	Enfoque actual	Etapa de desarrollo
IMU-838	Enfermedad inflamatoria intestinal	Fase 2/3 ensayos clínicos
IMU-935	Esclerosis múltiple	Desarrollo preclínico
IMU-856	Colitis ulcerosa	Ensayos clínicos de fase 2

Ensayos clínicos para tratamientos de enfermedades inflamatorias y autoinmunes

A partir de enero de 2024, Immunic está realizando múltiples ensayos clínicos en diferentes áreas terapéuticas.

• Ensayos clínicos activos totales: 3
• Total de los pacientes inscritos: aproximadamente 250 en todos los ensayos
• Gastos de ensayos clínicos en 2023: $ 22.7 millones

Descubrimiento e innovación de drogas moleculares

Immunic mantiene un equipo de investigación dedicado de 45 científicos especializados en descubrimiento de fármacos moleculares.

Métrica de innovación	2023 datos
Solicitudes de patente presentadas	7
Publicaciones de investigación	12
Nuevas entidades moleculares identificadas	3

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Immunic mantiene estrategias regulatorias integrales en múltiples jurisdicciones.

• Interacciones de la FDA: 6 reuniones formales en 2023
• Sesiones de consulta de EMA: 4 en 2023
• Presupuesto de cumplimiento regulatorio: $ 5.3 millones en 2023

Gestión de propiedad intelectual

La propiedad intelectual representa un activo crítico para el modelo de negocio de Immunic.

Categoría de IP	Recuento total	Adiciones 2023
Patentes concedidas	18	5
Aplicaciones de patentes pendientes	22	7
Jurisdicciones de patentes en todo el mundo	12	2

Immunic, Inc. (IMUX) - Modelo de negocio: recursos clave

Plataformas de desarrollo de fármacos patentados

Immunic, Inc. utiliza múltiples plataformas de desarrollo de fármacos patentados centradas en tratamientos inmunológicos innovadores. A partir de 2024, la compañía ha desarrollado plataformas dirigidas a áreas terapéuticas específicas.

Nombre de la plataforma	Enfoque terapéutico	Etapa de desarrollo
IMU-838	Enfermedades autoinmunes	Ensayos clínicos
IMU-856	Enfermedades del intestino inflamatorio	Desarrollo preclínico
IMU-380	Enfermedades respiratorias	Etapa de investigación temprana

Equipo de investigación científica con experiencia en inmunología

La compañía mantiene un equipo de investigación especializado con experiencia en investigación inmunológica y desarrollo de medicamentos.

• Total de personal de investigación: 42 científicos a partir del cuarto trimestre 2023
• Titulares de doctorado: 28 miembros del equipo
• Experiencia de investigación promedio: 12.5 años

Portafolio de patentes para candidatos a drogas innovadores

Immunic, Inc. mantiene una sólida cartera de propiedades intelectuales que protege sus innovaciones de desarrollo de medicamentos.

Categoría de patente	Número de patentes	Cobertura geográfica
Patentes concedidas	17	Estados Unidos, Europa, Japón
Aplicaciones de patentes pendientes	9	Múltiples jurisdicciones internacionales

Instalaciones de laboratorio de investigación avanzada

La compañía opera instalaciones de investigación de vanguardia dedicadas al descubrimiento y desarrollo de drogas.

• Espacio total de la instalación de investigación: 22,000 pies cuadrados
• Ubicación: San Diego, California
• Inversión en equipos de investigación: $ 4.3 millones en 2023

Datos de ensayos clínicos e información de investigación

Immunic, Inc. mantiene amplios datos de ensayos clínicos e información de investigación de programas en curso de desarrollo de medicamentos.

Métrico de ensayo clínico	Estado actual	Valor
Ensayos clínicos activos	3 pruebas en curso	IMU-838 Fase 2/3
Inversión total de investigación	2023 año fiscal	$ 37.6 millones
Puntos de datos de investigación	Acumulado	Más de 10,000 puntos de datos del paciente

Immunic, Inc. (IMUX) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades autoinmunes

Immunic, Inc. se centra en el desarrollo de terapias específicas para enfermedades autoinmunes con candidatos de productos específicos:

Candidato al producto	Indicación objetivo	Etapa de desarrollo actual
IMU-838	Esclerosis múltiple	Ensayo clínico de fase 2
IMU-856	Enfermedad inflamatoria intestinal	Desarrollo preclínico
IMU-661	Soriasis	Investigación preclínica

Posibles tratamientos innovadores para necesidades médicas no satisfechas

La investigación de Immunic se dirige a necesidades médicas no satisfechas específicas con enfoques innovadores:

• Mecanismo de acción único dirigido a la enzima Dhodh
• Posibles terapias de molécula oral
• Enfoque de medicina de precisión para el tratamiento autoinmune

Terapias dirigidas con efectos secundarios reducidos

Mecanismo	Ventaja potencial	Beneficio comparativo
Inhibición de Dhodh	Modulación inmune selectiva	Reducción de la supresión inmune sistémica
Orientación molecular	Intervención precisa	Efectos minimizados fuera del objetivo

Nuevos enfoques moleculares para la modulación del sistema inmune

La investigación se centra en estrategias moleculares innovadoras:

• Dirección de vía enzimática
• Modulación selectiva de células inmunes
• Ingeniería molecular avanzada

Estrategias de tratamiento personalizadas

El enfoque de Immunic enfatiza el desarrollo terapéutico personalizado:

• Técnicas de medicina de precisión
• Perfil molecular específico del paciente
• Protocolos de tratamiento adaptativo

Immunic, Inc. (IMUX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Immunic, Inc. mantiene estrategias de participación directa con profesionales médicos a través de:

Método de compromiso	Frecuencia	Especialistas en el objetivo
Consultas clínicas individuales	Mensual	Gastroenterólogos, inmunólogos
Serie de seminarios web	Trimestral	Médicos de investigación
Reuniones de la Junta Asesora Médica	Biannual	Líderes de opinión clave

Programas de apoyo al paciente

Las iniciativas de apoyo al paciente incluyen:

• Programa dedicado de asistencia al paciente para los participantes de los ensayos clínicos IMU-838
• Portal de recursos de pacientes en línea
• Servicios de asesoramiento de pacientes personalizados

Presentaciones de conferencias científicas

Conferencia	Año	Presentaciones
Asociación Americana de Gastroenterología	2023	3 presentaciones de investigación
Organización europea de Crohn y Colitis	2023	2 presentaciones de datos clínicos

Comunicación de ensayos clínicos transparentes

Métricas de comunicación de ensayos clínicos para 2023:

• Actualizaciones de registro de ensayos clínicos: 12 actualizaciones completas
• Comunicación de reclutamiento de pacientes: 87% de tasa de comunicación digital
• Participación de los participantes de prueba: Boletines digitales mensuales

Plataformas de información de salud digital

Plataforma	Compromiso de usuario	Tipo de contenido
Sitio web de la empresa	45,000 visitantes mensuales	Actualizaciones de investigación, ensayos clínicos
Página corporativa de LinkedIn	22,000 seguidores	Publicaciones científicas, noticias de la empresa
Portal de relaciones con los inversores	3.500 visitantes únicos mensuales	Informes financieros, presentaciones

Immunic, Inc. (IMUX) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

A partir del cuarto trimestre de 2023, Immunic informó un compromiso directo de ventas con 47 centros médicos especializados centrados en enfermedades autoinmunes e inflamatorias.

Tipo de canal	Número de contactos institucionales	Frecuencia de compromiso
Hospitales especializados	37	Trimestral
Clínicas de investigación	10	Semestral

Presentaciones de conferencia médica

En 2023, Immunic participó en 12 conferencias médicas internacionales, presentando investigaciones sobre plataformas terapéuticas IMU-838 e IMU-935.

• Reunión anual de la Academia Americana de Neurología
• Comité Europeo de Tratamiento e Investigación en el Congreso de Esclerosis múltiple
• Conferencia de la Semana de la Enfermedades Digestivas

Redes de distribuidores farmacéuticos

Immunic mantiene asociaciones con 6 redes de distribución farmacéutica en América del Norte y Europa.

Región	Número de distribuidores	Cobertura del mercado
América del norte	3	Cobertura del 65%
Europa	3	55% de cobertura

Publicaciones científicas en línea

En 2023, Immunic publicó 8 artículos de investigación revisados ​​por pares en plataformas como Nature, The Lancet y Journal of Immunology.

Comunicaciones de inversores y comunitarios científicos

Immunic realizó 24 eventos de relaciones con los inversores en 2023, incluidas llamadas trimestrales de ganancias y 6 conferencias de inversores.

Tipo de comunicación	Frecuencia en 2023	Alcance participante
Llamadas de ganancias	4	250-350 participantes
Conferencias de inversores	6	500-750 asistentes

Immunic, Inc. (IMUX) - Modelo de negocio: segmentos de clientes

Especialistas en reumatología

Tamaño del mercado objetivo: aproximadamente 6.500 reumatólogos en los Estados Unidos a partir de 2023.

Característica de segmento	Datos específicos
Potencial de población de pacientes	2.1 millones de estadounidenses con artritis reumatoide
Valor de mercado anual	Mercado de tratamiento de reumatología de $ 25.4 mil millones

Practicantes de gastroenterología

Tamaño del mercado objetivo: aproximadamente 14,000 gastroenterólogos en los Estados Unidos.

Característica de segmento	Datos específicos
Pacientes con enfermedad inflamatoria intestinal	1,6 millones de estadounidenses diagnosticados
Valor de segmento de mercado	Mercado de gastroenterología de $ 37.6 mil millones

Neurólogos que tratan la esclerosis múltiple

Tamaño del mercado objetivo: aproximadamente 4,500 neurólogos especializados en esclerosis múltiple.

Característica de segmento	Datos específicos
Pacientes con esclerosis múltiple	Aproximadamente 1 millón de pacientes en los Estados Unidos
Mercado de tratamiento anual	Mercado de terapéutica de esclerosis múltiple de $ 20.9 mil millones

Instituciones de atención médica

• Centros médicos académicos: 155 en los Estados Unidos
• Clínicas de tratamiento especializadas: 3.200 a nivel nacional
• Redes hospitalarias: 6.090 hospitales totales

Tipo de institución	Tasa de adopción potencial
Grandes sistemas hospitalarios	42% tasa de adopción potencial
Centros de tratamiento especializados	68% de tasa de adopción potencial

Pacientes con trastornos autoinmunes

Total de la población de pacientes: 23.5 millones de estadounidenses con enfermedades autoinmunes.

Categoría de enfermedades	Número de paciente
Artritis reumatoide	1.3 millones de pacientes
Esclerosis múltiple	1 millón de pacientes
Enfermedad inflamatoria intestinal	1.6 millones de pacientes

Immunic, Inc. (IMUX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Immunic, Inc. reportó gastos de I + D de $ 44.7 millones.

Año	Gastos de I + D	Aumento porcentual
2022	$ 38.2 millones	17.0%
2023	$ 44.7 millones	17.0%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para IMU-838 y otros candidatos de tuberías totalizaron $ 26.3 millones en 2023.

• Ensayos de fase 2 para colitis ulcerosa
• Desarrollo clínico de esclerosis múltiple
• Investigación continua de Covid-19

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio fueron aproximadamente $ 5.2 millones en 2023.

Mantenimiento de patentes

Los costos anuales de mantenimiento de patentes y protección de propiedad intelectual fueron $ 2.1 millones en 2023.

Sobrecarga administrativa y operativa

Sobrecarga administrativa y operativa total para 2023 fue $ 22.5 millones.

Categoría de costos	Cantidad
Gastos de personal	$ 15.3 millones
Costos de oficina e instalaciones	$ 4.2 millones
Tecnología e infraestructura	$ 3.0 millones

Estructura total de costos integrales para Immunic, Inc. en 2023 fue $ 100.8 millones.

Immunic, Inc. (IMUX) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir del cuarto trimestre de 2023, Immunic, Inc. no ha informado ningún acuerdos activos de licencia de medicamentos que generen ingresos directos.

Ventas de productos farmacéuticos futuros

La tubería de productos actual se centró en IMU-838 e IMU-380 con posibles flujos de ingresos futuros.

Candidato a la droga	Área terapéutica	Etapa de desarrollo	Valor de mercado potencial
IMU-838	Esclerosis múltiple	Ensayos clínicos de fase 2	Mercado potencial estimado de $ 500 millones
IMU-380	Enfermedad inflamatoria intestinal	Etapa preclínica	Mercado potencial estimado de $ 300 millones

Subvenciones de investigación

En el año fiscal 2022, Inmunic, Inc. informó $ 3.4 millones en ingresos de subvenciones de varias fuentes de financiación de investigación.

Pagos de hitos de las asociaciones

• No se informaron pagos de hitos significativos en los estados financieros 2022-2023
• Pagos potenciales de hitos futuros que dependen del progreso del desarrollo clínico

Ingresos potenciales de regalías

No hay ingresos actuales de regalías documentados en informes financieros recientes.

Métrica financiera	Valor 2022	Valor 2023
Ingresos totales	$ 4.2 millones	$ 3.8 millones
Ingresos de subvención de investigación	$ 3.4 millones	$ 2.9 millones

Immunic, Inc. (IMUX) - Canvas Business Model: Value Propositions

You're looking at the core advantages Immunic, Inc. is banking on with vidofludimus calcium (IMU-838) to capture a significant share of the multiple sclerosis (MS) market. The value proposition centers on delivering a differentiated, convenient, and comprehensive treatment option.

Oral therapy for Multiple Sclerosis (MS) with easy use

The primary convenience factor is that vidofludimus calcium is an orally administered, small molecule therapy. This offers patients a treatment opportunity that is very unique and easy to use compared to injectable or infusion-based treatments currently on the market. The company is targeting a potential transformation of the oral MS therapy landscape.

Unique dual mechanism: Nurr1 activation and DHODH inhibition

Vidofludimus calcium is positioned as having a first-in-class, dual mode of action designed to address the full spectrum of MS pathophysiology. This mechanism is what sets it apart from many existing options.

• Nurr1 activation provides direct neuroprotective effects.
• Selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) provides anti-inflammatory and anti-viral effects.

The company believes this dual approach can tackle processes responsible for smoldering MS and PIRA (Progressive Inflammatory Response Activity). Intellectual property is also a key part of this value, with a Notice of Allowance received in September 2025 for a patent covering dose strengths for the treatment of progressive MS, expected to provide protection into 2041.

Potential to slow disability progression in Progressive MS

A major value driver is the potential to slow disability worsening, particularly in progressive forms of MS (PMS). Data from the Phase 2 CALLIPER trial in PMS has been presented to support this claim, showing clinically measurable neuroprotective effects consistent with the Nurr1 activation mechanism.

Here's a quick look at the key efficacy numbers from the Phase 2 CALLIPER trial in PMS compared to placebo:

Metric	Population	Reduction vs. Placebo
Time to 24-Week Confirmed Disability Worsening (24wCDW)	Overall PMS Study Population	23.8%
Time to 24-Week Confirmed Disability Worsening (24wCDW)	Primary Progressive MS (PPMS) Subgroup	31.3%
Time to 24-Week Confirmed Disability Worsening (24wCDW)	Non-Active SPMS (naSPMS) Subgroup	19.2%

The trial demonstrated a statistically significant 24-week confirmed disability improvement in the overall PMS patient population. Top-line data from the twin Phase 3 ENSURE trials in relapsing MS are expected by the end of 2026, with both trials fully enrolled (ENSURE-1 with 1,121 patients and ENSURE-2 with 1,100 patients).

Favorable long-term safety and tolerability profile

The long-term safety profile is reinforced by data from the Phase 2 EMPhASIS open-label extension (OLE) trial in relapsing-remitting MS (RRMS) patients. This data shows the drug was well-tolerated for treatment durations of up to 5.5 years.

The long-term tolerability is quantified by these figures from the OLE period:

• Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled approximately 952 treatment years.
• The annualized discontinuation rate was only approximately 6.4%.
• Most adverse events were rated as mild.
• There were low rates of renal and liver-related events, with no new safety signals observed.

Financially, Immunic, Inc. reported a Net Loss for the third quarter of 2025 of $25.6 million, or $0.13 per share, with a cash balance of $35.1 million as of September 30, 2025. The market opportunity is estimated at $3-7 billion peak sales potential for vidofludimus calcium in MS.

Immunic, Inc. (IMUX) - Canvas Business Model: Customer Relationships

You're looking at how Immunic, Inc. manages its critical relationships with the scientific community, investors, and the patient base as of late 2025. For a late-stage biotech, these relationships are the lifeblood, especially with top-line data for the lead asset expected in 2026.

High-touch engagement with Key Opinion Leaders (KOLs)

Engagement with KOLs is primarily driven through scientific presentations and one-on-one meetings at major medical congresses. The presence of top scientific and medical personnel, like Chief Scientific Officer Hella Kohlhof, Ph.D., at these events signals a commitment to deep scientific exchange.

• Members of Immunic, Inc.'s medical, clinical, and preclinical teams attended the 41st Congress of ECTRIMS in Barcelona, Spain, in September 2025.
• Data on vidofludimus calcium (IMU-838) were presented in one oral presentation and four poster presentations at ECTRIMS 2025.
• The Phase 2 CALLIPER trial data in progressive MS were selected for the Best of ECTRIMS 2025 slide deck.
• Chief Scientific Officer Hella Kohlhof, Ph.D., presented an overview of vidofludimus calcium at the 7th Neuroimmunology Drug Development Summit in Boston in February 2025.

Close collaboration with clinical trial investigators

The relationship with clinical trial investigators is quantified by the scale and geographic reach of the ongoing Phase 3 program. This collaboration is essential for hitting the expected data readout milestones.

The twin Phase 3 ENSURE trials for relapsing multiple sclerosis (RMS) reached a significant operational milestone in June 2025 with the on-time completion of enrollment. Here are the hard numbers reflecting the investigator network:

Trial Component	Metric	Value
ENSURE-1 Randomized Patients	Number of Patients	1,121
ENSURE-2 Randomized Patients	Number of Patients	1,100
Total ENSURE Enrollment	Total Randomized Patients	2,221
Investigator Sites	Number of Sites	More than 100
Geographic Reach	Number of Countries	15
Expected Top-Line Data	Target Date	End of 2026

Furthermore, long-term data from the Phase 2 EMPhASIS trial showed durability: at week 144, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW). For the IMU-856 program in celiac disease, a post hoc analysis of the Phase 1b trial showed up to a 250% increase in GLP-1 levels versus placebo in fasting patients.

Investor relations and scientific conference presentations

Investor relations is highly active, focusing on direct engagement with the financial community through one-on-one meetings scheduled around major industry conferences. Jessica Breu, Vice President Investor Relations and Communications, is the key contact for scheduling these interactions.

Here's a look at the key investor-facing events attended or scheduled through late 2025:

Conference Name	Date(s) 2025	Key Immunic, Inc. Attendees
8th Annual Evercore ISI Healthcare Conference	December 4	Daniel Vitt, Ph.D. (CEO), Jason Tardio (COO)
BIO-Europe	November 3-5	Daniel Vitt (CEO), Hella Kohlhof (CSO), Jessica Breu (VP IR)
Jefferies Global Healthcare Conference - London	November 19-20	Daniel Vitt (CEO), Jason Tardio (COO)
H.C. Wainwright 27th Annual Global Investment Conference	September 8-10	Jason Tardio (COO), Daniel Vitt (CEO), Jessica Breu (VP IR)
Leerink Partners Biopharma Summit	September 17-19	Daniel Vitt (CEO)
Jefferies Healthcare Conference	June 3-5	Daniel Vitt (CEO), Jason Tardio (COO), Glenn Whaley (CFO), Jessica Breu (VP IR)

The company also announced a proposed public offering in May 2025, intending to use the net proceeds to fund clinical trials and operations. This offering involved Series A warrants expiring on December 31, 2025.

Patient advocacy groups for disease awareness

While specific partnership dollar amounts or joint campaign statistics aren't public, disease awareness is intrinsically linked to scientific data dissemination, which Immunic, Inc. actively pursues. Presenting data at major medical meetings serves to educate the broader community, including patient groups.

• The company presented data at the 41st Congress of ECTRIMS in September 2025, focusing on MS.
• Two abstracts discussing clinical and preclinical data on IMU-856 were presented as digital oral presentations at the 19th Congress of ECCO (European Crohn's and Colitis Organisation) in February 2025.
• The company is exploring potential financing, licensing, or partnership opportunities for IMU-856, which has shown potential for weight management, suggesting outreach to relevant disease/condition-specific communities beyond just MS.

The focus on an orally administered therapy, like vidofludimus calcium, is itself a key message for patient convenience, which advocacy groups often prioritize.

Immunic, Inc. (IMUX) - Canvas Business Model: Channels

You're looking at how Immunic, Inc. gets its value proposition-novel oral therapies like vidofludimus calcium-to the customer, which is currently the clinical trial investigator and, eventually, the patient. For a late-stage biotech, the channels are heavily weighted toward clinical execution and scientific communication right now, with commercial distribution being a future, partnership-dependent step.

Global Network of Clinical Trial Sites

The current primary channel is the global clinical trial infrastructure used to test vidofludimus calcium. This network is quite extensive, supporting their Phase 3 ENSURE trials for relapsing multiple sclerosis (RMS).

• Number of Sites: More than 100 sites per trial.
• Geographic Reach: Trials span 15 countries.
• Key Regions: Included the United States, India, Middle East and North Africa, Latin America, and Central and Eastern Europe.
• Enrollment Status (as of June 2025): ENSURE-1 randomized 1,121 patients; ENSURE-2 randomized 1,100 patients.

This large, multi-national footprint is essential for hitting enrollment targets, which they achieved on time for the Phase 3 trials in June 2025. The cost to maintain this channel is significant; for instance, Research and Development (R&D) Expenses for the three months ended September 30, 2025, were $20.0 million.

Scientific and Medical Conferences

Scientific conferences serve as a critical channel for communicating clinical data to the medical community, key opinion leaders, and potential partners. Immunic, Inc. made a major push through this channel in late 2025.

The 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September 2025 was a key focus, where they presented data from the Phase 2 CALLIPER trial and long-term data from the EMPhASIS trial. This scientific validation is a channel unto itself for building credibility.

Conference/Event	Date (2025)	Presentation Type	Key Data Highlighted
41st Congress of ECTRIMS	September 24-26	1 Oral Presentation, 4 Poster Presentations	Phase 2 CALLIPER trial results in Progressive MS (PMS)
H.C. Wainwright Global Investment Conference	September 8-10	Company Overview Presentation	Corporate and pipeline update
BIO-Europe	November 3-5	Partnering Activities	Engaging for potential IMU-856 partnership
Evercore ISI Healthcare Conference	December 4	Fireside Chat	Corporate and clinical program updates

Their presence at these events helps drive awareness for vidofludimus calcium, which is crucial before commercial launch.

Future Pharmaceutical Distribution Channels (Post-Approval)

As Immunic, Inc. is currently pre-commercialization, the specific distribution network is not yet established, but the strategy is implied by their pipeline focus. Given their lead asset is an oral therapy, the channel will likely involve established pharmaceutical wholesalers and specialty pharmacies, similar to other oral MS treatments.

• The company is preparing for end-of-Phase 2 discussions with the FDA and EMA to set up the Phase 3 program, which precedes commercialization planning.
• For their second asset, IMU-856 (targeting gastrointestinal disorders), the company is explicitly preparing for further clinical testing contingent on financing, licensing or partnering.

This suggests that for commercial scale-up, Immunic, Inc. will likely rely on a strategic partnership to access an established pharmaceutical distribution and sales force, rather than building one from scratch, especially considering their cash position as of September 30, 2025, which was $35.1 million, with a net loss of $25.6 million for Q3 2025.

Direct Communication via Corporate and Investor Websites

The corporate website, specifically the InvestorRoom section, acts as the primary direct channel for disseminating official, time-sensitive information to investors and the public.

This channel provides:

• News Releases, such as the Third Quarter 2025 Financial Results released on November 13, 2025.
• Archived Webcasts and Presentations from past events.
• Financials and SEC Filings, like the 10-K filed on March 31, 2025.
• Corporate Governance details.

This direct line ensures that stakeholders receive unfiltered, official updates, like the announcement of a new US patent allowance for vidofludimus calcium in September 2025.

Immunic, Inc. (IMUX) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Immunic, Inc. (IMUX) as of late 2025. This is a company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, primarily targeting specific patient groups where they see a clear unmet need and potential for a differentiated product profile.

The primary focus for their lead asset, vidofludimus calcium (IMU-838), is clearly on the Multiple Sclerosis (MS) patient base. This segment is further broken down based on disease progression, which dictates the specific clinical trial focus and potential market positioning. The company has made substantial progress here, with $\text{two identical Phase 3 clinical trials}$ (ENSURE-1 and ENSURE-2) fully enrolled in patients with Relapsing Multiple Sclerosis (RMS) as of June 2025.

For the Progressive MS (PMS) segment, Immunic, Inc. has shown promising Phase 2 data from the CALLIPER trial, which demonstrated statistically significant 24-week Confirmed Disability Improvement. Management has specifically highlighted the potential in Primary Progressive Multiple Sclerosis (PPMS), viewing it as an underserved market with an estimated value of over $\text{\$6+ billion}$. Furthermore, a patent received in September 2025 covers dose strengths for vidofludimus calcium for the treatment of PMS, potentially providing market exclusivity into $\text{2041}$ in the United States.

The second major therapeutic area involves chronic gastrointestinal diseases, where their asset IMU-856 is the focus. This program is contingent on financing, licensing, or partnering, but it has already completed a Phase 1b clinical trial in celiac disease patients in 2024. A key finding from that trial, relevant to this customer segment, was a post hoc analysis showing up to a $\text{250% increase in GLP-1 levels}$ versus placebo in fasting celiac disease patients. This positions IMU-856 as a potential restorative therapy for intestinal barrier function in this patient group.

The final segment isn't a patient group, but rather the entities that will ultimately commercialize or acquire the assets: large pharmaceutical companies. As of late 2025, Immunic, Inc. is actively exploring potential financing, licensing, or partnership opportunities to advance IMU-856. This strategic need for external capital is underscored by the company's financial position; for the nine months ended September 30, 2025, the net loss was approximately $\text{\$77.9 million}$, and cash and cash equivalents stood at $\text{\$35.1 million}$ as of that same date. This financial reality makes securing a deal with a large partner a critical component of the business model.

Here's a quick look at the key patient populations and associated data points driving the customer segment strategy:

• Patients with Relapsing Multiple Sclerosis (RMS): $\text{1,121}$ patients randomized in ENSURE-1 and $\text{1,100}$ in ENSURE-2 for Phase 3 trials.
• Patients with Progressive Multiple Sclerosis (PMS): Target market estimated at over $\text{\$6 billion}$ for PPMS indication.
• Patients with Celiac Disease: IMU-856 trial showed up to a $\text{250%}$ increase in GLP-1 levels.
• Potential Partners: Exploring licensing or partnership opportunities for IMU-856 contingent on financing.

You can see the focus areas laid out here:

Customer Segment	Target Indication/Asset	Key Statistical/Financial Data Point (as of late 2025)	Development Status
Patients with RMS	Vidofludimus Calcium (IMU-838)	Enrollment complete for twin Phase 3 ENSURE trials ($\text{1,121}$ in ENSURE-1, $\text{1,100}$ in ENSURE-2).	Phase 3
Patients with PMS	Vidofludimus Calcium (IMU-838)	PPMS market potential estimated at $\text{\$6+ billion}$; patent protection expected into $\text{2041}$.	Phase 2 data available; next steps contingent on regulatory discussion.
Patients with Celiac Disease	IMU-856	Phase 1b trial showed up to $\text{250%}$ increase in GLP-1 levels.	Phase 1b complete; further testing contingent on financing/partnering.
Large Pharmaceutical Companies	Licensing/Acquisition	Company cash position as of September 30, 2025: $\text{\$35.1 million}$.	Active exploration for advancement funding.

Immunic, Inc. (IMUX) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Immunic, Inc.'s late-stage development strategy as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward getting their lead asset, vidofludimus calcium, through pivotal trials.

The primary cost centers are clearly R&D, which funds the ongoing Phase 3 ENSURE studies, followed by the necessary overhead to manage the company and protect its assets.

Here's a quick look at the key operating expenses reported for the third quarter ended September 30, 2025:

Expense Category	Q3 2025 Amount	Comparison Detail
Research and Development (R&D) Expenses	$20.0 million	Decreased from $21.4 million in Q3 2024.
General and Administrative (G&A) Expenses	$6.0 million	Increased from $4.4 million in Q3 2024.
Total Operating Expenses (Q3 2025)	$26.0 million	Resulted in a Net Loss of $25.6 million for the quarter.

High Research and Development (R&D) expenses (Q3 2025: $20.0 million)

R&D spending is the lifeblood of Immunic, Inc., directly funding the progression of vidofludimus calcium. While the Q3 2025 R&D expense was $20.0 million, which was a decrease year-over-year, this figure reflects a shifting mix of external costs.

The nine-month figures give a clearer picture of the investment into the lead program:

• For the nine months ended September 30, 2025, R&D expenses totaled $63.0 million.
• This nine-month spend included a $6.2 million increase in external development costs specifically tied to the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS).
• The R&D decrease in Q3 was partly due to lower external costs related to IMU-856 and the completion of the phase 2 CALLIPER trial.

Clinical trial costs for Phase 3 ENSURE studies are the major component of this R&D spend. Immunic, Inc. completed enrollment for both identical, multicenter, randomized, double-blind trials, ENSURE-1 and ENSURE-2, which together enrolled over 2,200 RMS patients. Top-line data from these pivotal trials is anticipated by the end of 2026. The cost of running these large, global trials is substantial, even if the external spend component for the ENSURE program was partially offset by cost reductions elsewhere in R&D during the third quarter.

General and Administrative (G&A) expenses (Q3 2025: $6.0 million)

G&A expenses rose to $6.0 million for the third quarter of 2025, up from $4.4 million in the prior year period. This increase signals growing operational needs as the company nears potential commercialization milestones for its lead asset.

The nine-month G&A spend was $17.0 million, driven by several factors:

• Personnel expenses increased by $1.8 million for the nine months, with $0.8 million of that being non-cash stock compensation.
• The Q3 increase was primarily attributed to higher personnel costs, including non-cash share-based compensation.

Intellectual property maintenance and legal fees

Protecting the innovation is a non-negotiable cost. Immunic, Inc. strengthened its IP moat during the quarter. Legal and consultancy expenses contributed to the rise in G&A, with a $0.6 million increase noted in these areas for the nine months ended September 30, 2025. This spending supports the commercial defensibility of their assets. Specifically, the company received a Notice of Allowance from the U.S. Patent and Trademark Office for a key patent covering vidofludimus calcium dose strengths for progressive MS, which is expected to provide protection into 2041, with potential for further Patent Term Extension.

Finance: draft 13-week cash view by Friday.

Immunic, Inc. (IMUX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Immunic, Inc. (IMUX) as of late 2025, which is typical for a late-stage biotech heavily invested in clinical trials. Right now, the revenue picture is focused on non-product sources while awaiting key data readouts.

The primary current cash inflow, outside of financing activities, comes from managing their available capital.

• Interest income on cash reserves was $0.4 million for the three months ended September 30, 2025.

As for product sales, the expectation remains zero for the current fiscal year, which is standard when a lead asset is still in Phase 3 trials.

Here's a quick look at the analyst consensus for product revenue in 2025:

Revenue Component	2025 Forecast (USD)
Current Product Revenue	$0
Lowest Analyst Revenue Forecast (2025)	$0
Highest Analyst Revenue Forecast (2025)	$0

The structure for future, significant revenue generation is built around successful development and commercialization, which is where the collaboration component fits in.

• Upfront and milestone payments from collaborations, such as the one with Boehringer Ingelheim, represent a key, though lumpy, revenue stream contingent on clinical or regulatory achievements.
• Future tiered royalties on net sales represent the long-term, post-approval revenue potential from licensed assets like vidofludimus calcium.

The company is managing its current cash position, which stood at $35.1 million as of September 30, 2025, while driving toward the expected top-line data from the twin Phase 3 ENSURE trials by the end of 2026. That data is the trigger for unlocking the larger royalty and potential milestone streams.

Finance: draft 13-week cash view by Friday.