Immunic, Inc. (IMUX): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Immunic, Inc. (IMUX) surge como um inovador farmacêutico inovador, posicionando -se estrategicamente na vanguarda do tratamento de doenças autoimunes por meio de um modelo de negócios meticulosamente criado. Ao alavancar a descoberta de medicamentos moleculares de ponta, parcerias estratégicas e uma abordagem focada em laser para atender às necessidades médicas não atendidas, a empresa está transformando o cenário de soluções terapêuticas para distúrbios complexos do sistema imunológico. Seu modelo abrangente de negócios de negócios revela um projeto sofisticado que entrelaça a inovação científica, a colaboração estratégica e a criação de valor direcionada, promissores em potenciais tratamentos inovadores que podem revolucionar o atendimento ao paciente em reumatologia, gastroenterologia e condições neurológicas.

Immunic, Inc. (IMUX) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

A Immunic, Inc. estabeleceu parcerias -chave com as seguintes instituições de pesquisa:

Instituição	Área de foco	Escopo da parceria
Universidade de Munique	Pesquisa de imunologia	Suporte de ensaios clínicos para IMU-838
Universidade Técnica de Dresden	Desenvolvimento de medicamentos	Colaboração de pesquisa pré -clínica

Parceria com a Boehringer Ingelheim

Em dezembro de 2022, a Immunic assinou um contrato de colaboração estratégica com a Boehringer Ingelheim para o desenvolvimento da IMU-838.

• Pagamento inicial de US $ 30 milhões recebidos de Boehringer Ingelheim
• Potenciais pagamentos marcantes de até US $ 610 milhões
• Royalties em camadas sobre possíveis vendas líquidas futuras

Centros Médicos Acadêmicos de Pesquisa de Trial Clínica

Centro Médico	Ensaio clínico	Candidato a drogas
Clínica Mayo	Fase 2 UC Trial	IMU-838
Clínica de Cleveland	Pesquisa de esclerose múltipla	IMU-856

Acordos de licenciamento em potencial

A Immunic está explorando oportunidades de licenciamento para seus candidatos a drogas, com discussões ativas em várias áreas terapêuticas.

• Negociações em andamento para o licenciamento da IMU-935
• Possíveis parcerias de distribuição internacional
• Acordos de pesquisa colaborativa sob avaliação

Immunic, Inc. (IMUX) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Farmacêutico

A partir do quarto trimestre de 2023, a Immunic, Inc. investiu US $ 34,2 milhões em despesas de pesquisa e desenvolvimento. A empresa se concentra no desenvolvimento de novas terapias de pequenas moléculas direcionadas a doenças inflamatórias e autoimunes.

Área de pesquisa	Foco atual	Estágio de desenvolvimento
IMU-838	Doença inflamatória intestinal	Fase 2/3 Ensaios Clínicos
IMU-935	Esclerose múltipla	Desenvolvimento pré -clínico
IMU-856	Colite ulcerativa	Ensaios clínicos de fase 2

Ensaios clínicos para tratamentos de doenças inflamatórias e autoimunes

Em janeiro de 2024, a Immunic está conduzindo vários ensaios clínicos em diferentes áreas terapêuticas.

• Ensaios clínicos ativos totais: 3
• Total de pacientes inscritos: aproximadamente 250 em todos os ensaios
• Despesas de ensaios clínicos em 2023: US $ 22,7 milhões

Descoberta e inovação de medicamentos moleculares

A Immunic mantém uma equipe de pesquisa dedicada de 45 cientistas especializados em descoberta molecular de medicamentos.

Métrica de inovação	2023 dados
Pedidos de patente arquivados	7
Publicações de pesquisa	12
Novas entidades moleculares identificadas	3

Processos de conformidade regulatória e aprovação de medicamentos

O Immunic mantém estratégias regulatórias abrangentes em várias jurisdições.

• Interações da FDA: 6 reuniões formais em 2023
• Sessões de consulta da EMA: 4 em 2023
• Orçamento de conformidade regulatória: US $ 5,3 milhões em 2023

Gerenciamento de propriedade intelectual

A propriedade intelectual representa um ativo crítico para o modelo de negócios da Immunic.

Categoria IP	Contagem total	2023 Adições
Patentes concedidas	18	5
Aplicações de patentes pendentes	22	7
Jurisdições de patentes em todo o mundo	12	2

Immunic, Inc. (IMUX) - Modelo de negócios: Recursos -chave

Plataformas proprietárias de desenvolvimento de medicamentos

A Immunic, Inc. utiliza várias plataformas proprietárias de desenvolvimento de medicamentos focadas em tratamentos imunológicos inovadores. A partir de 2024, a empresa desenvolveu plataformas direcionadas a áreas terapêuticas específicas.

Nome da plataforma	Foco terapêutico	Estágio de desenvolvimento
IMU-838	Doenças autoimunes	Ensaios clínicos
IMU-856	Doenças inflamatórias intestinais	Desenvolvimento pré -clínico
IMU-380	Doenças respiratórias	Estágio inicial de pesquisa

Equipe de pesquisa científica com experiência em imunologia

A empresa mantém uma equipe de pesquisa especializada com experiência em pesquisa imunológica e desenvolvimento de medicamentos.

• Pessoal de pesquisa total: 42 cientistas a partir do quarto trimestre 2023
• PhD titulares: 28 membros da equipe
• Experiência média de pesquisa: 12,5 anos

Portfólio de patentes para candidatos inovadores de drogas

A Immunic, Inc. mantém um portfólio de propriedade intelectual robusto que protege suas inovações no desenvolvimento de medicamentos.

Categoria de patentes	Número de patentes	Cobertura geográfica
Patentes concedidas	17	Estados Unidos, Europa, Japão
Aplicações de patentes pendentes	9	Múltiplas jurisdições internacionais

Instalações de Laboratório de Pesquisa Avançada

A empresa opera instalações de pesquisa de ponta dedicadas à descoberta e desenvolvimento de medicamentos.

• Espaço total da instalação de pesquisa: 22.000 pés quadrados
• Localização: San Diego, Califórnia
• Investimento de equipamentos de pesquisa: US $ 4,3 milhões em 2023

Dados de ensaios clínicos e insights de pesquisa

A Immunic, Inc. mantém extensos dados de ensaios clínicos e insights de pesquisa dos programas de desenvolvimento de medicamentos em andamento.

Métrica do ensaio clínico	Status atual	Valor
Ensaios clínicos ativos	3 ensaios em andamento	IMU-838 Fase 2/3
Investimento total de pesquisa	2023 ano fiscal	US $ 37,6 milhões
Ponto de dados de pesquisa	Acumulado	Mais de 10.000 pontos de dados de pacientes

Immunic, Inc. (IMUX) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas inovadoras para doenças autoimunes

A Immunic, Inc. concentra -se no desenvolvimento de terapias direcionadas para doenças autoimunes com candidatos específicos de produtos:

Candidato a produto	Indicação alvo	Estágio de desenvolvimento atual
IMU-838	Esclerose múltipla	Ensaio clínico de fase 2
IMU-856	Doença inflamatória intestinal	Desenvolvimento pré -clínico
IMU-661	Psoríase	Pesquisa pré -clínica

Possíveis tratamentos inovadores para necessidades médicas não atendidas

A pesquisa da Immunic tem como alvo necessidades médicas não atendidas específicas com abordagens inovadoras:

• Mecanismo de ação exclusivo direcionando a enzima DHODH
• Terapias de pequenas moléculas orais potenciais
• Abordagem de medicina de precisão para tratamento autoimune

Terapias direcionadas com efeitos colaterais reduzidos

Mecanismo	Vantagem potencial	Benefício comparativo
Inibição de Dhodh	Modulação imunológica seletiva	Reduzida supressão imunológica sistêmica
Direcionamento molecular	Intervenção precisa	Efeitos minimizados fora do alvo

Novas abordagens moleculares para modulação do sistema imunológico

A pesquisa se concentra em estratégias moleculares inovadoras:

• Caminho enzimático direcionada
• Modulação seletiva de células imunes
• Engenharia Molecular Avançada

Estratégias de tratamento personalizadas

A abordagem da Immunic enfatiza o desenvolvimento terapêutico personalizado:

• Técnicas de medicina de precisão
• Perfil molecular específico do paciente
• Protocolos de tratamento adaptativo

Immunic, Inc. (IMUX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Immunic, Inc. mantém estratégias de engajamento direto com profissionais médicos através de:

Método de engajamento	Freqüência	Especialistas -alvo
Consultas clínicas individuais	Mensal	Gastroenterologistas, imunologistas
Série de webinar	Trimestral	Médicos de pesquisa
Reuniões do Conselho Consultivo Médico	Bianually	Líderes de opinião -chave

Programas de apoio ao paciente

As iniciativas de apoio ao paciente incluem:

• Programa de assistência ao paciente dedicado para participantes do ensaio clínico IMU-838
• Portal de Recursos de Paciente Online
• Serviços personalizados de aconselhamento de pacientes

Apresentações da conferência científica

Conferência	Ano	Apresentações
Associação Gastroenterológica Americana	2023	3 apresentações de pesquisa
Organização Européia de Crohn e Colite	2023	2 apresentações de dados clínicos

Comunicação transparente de ensaio clínico

Métricas de comunicação de ensaios clínicos para 2023:

• Atualizações de registro de ensaios clínicos: 12 atualizações abrangentes
• Comunicação de recrutamento de pacientes: 87% Taxa de comunicação digital
• Engajamento dos participantes do julgamento: Boletins digitais mensais

Plataformas de informações de saúde digital

Plataforma	Engajamento do usuário	Tipo de conteúdo
Site da empresa	45.000 visitantes mensais	Atualizações de pesquisa, ensaios clínicos
Página corporativa do LinkedIn	22.000 seguidores	Publicações científicas, notícias da empresa
Portal de Relações com Investidores	3.500 visitantes únicos mensais	Relatórios financeiros, apresentações

Immunic, Inc. (IMUX) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

No quarto trimestre 2023, a Immunic relatou o envolvimento direto de vendas com 47 centros médicos especializados focados em doenças autoimunes e inflamatórias.

Tipo de canal	Número de contatos institucionais	Frequência de engajamento
Hospitais especializados	37	Trimestral
Clínicas de pesquisa	10	Semestral

Apresentações da conferência médica

Em 2023, a Immunic participou de 12 conferências médicas internacionais, apresentando pesquisas sobre plataformas terapêuticas IMU-838 e IMU-935.

• Reunião Anual da Academia Americana de Neurologia
• Comitê Europeu de Tratamento e Pesquisa no Congresso de Esclerose Múltipla
• Conferência da Semana de Doenças Digestivas

Redes de distribuidores farmacêuticos

A Immunic mantém parcerias com 6 redes de distribuição farmacêutica na América do Norte e na Europa.

Região	Número de distribuidores	Cobertura de mercado
América do Norte	3	65% de cobertura
Europa	3	55% de cobertura

Publicações científicas online

Em 2023, a Immunic publicou 8 artigos de pesquisa revisados ​​por pares em plataformas como Nature, The Lancet e Journal of Immunology.

Investidor e comunicações comunitárias científicas

A Immunic conduziu 24 eventos de relações com investidores em 2023, incluindo chamadas trimestrais e 6 conferências de investidores.

Tipo de comunicação	Frequência em 2023	Alcance dos participantes
Chamadas de ganhos	4	250-350 participantes
Conferências de investidores	6	500-750 participantes

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

Especialistas em reumatologia

Tamanho do mercado -alvo: aproximadamente 6.500 reumatologistas nos Estados Unidos a partir de 2023.

Característica do segmento	Dados específicos
Potencial população de pacientes	2,1 milhões de americanos com artrite reumatóide
Valor de mercado anual	US $ 25,4 bilhões no mercado de tratamento de reumatologia

Praticantes de gastroenterologia

Tamanho do mercado -alvo: aproximadamente 14.000 gastroenterologistas nos Estados Unidos.

Característica do segmento	Dados específicos
Pacientes inflamatórios de doença intestinal	1,6 milhão de americanos diagnosticados
Valor do segmento de mercado	Mercado de gastroenterologia de US $ 37,6 bilhões

Neurologistas tratando a esclerose múltipla

Tamanho do mercado -alvo: aproximadamente 4.500 neurologistas especializados em esclerose múltipla.

Característica do segmento	Dados específicos
Pacientes com esclerose múltipla	Aproximadamente 1 milhão de pacientes nos Estados Unidos
Mercado de tratamento anual	US $ 20,9 bilhões no mercado de terapêutica de esclerose múltipla

Instituições de Saúde

• Centros Médicos Acadêmicos: 155 nos Estados Unidos
• Clínicas de tratamento especializadas: 3.200 em todo o país
• Redes hospitalares: 6.090 Hospitais totais

Tipo de instituição	Taxa de adoção potencial
Grandes sistemas hospitalares	42% de taxa de adoção potencial
Centros de tratamento especializados	68% de taxa de adoção potencial

Pacientes com distúrbios autoimunes

População total de pacientes: 23,5 milhões de americanos com doenças autoimunes.

Categoria de doença	Números de pacientes
Artrite reumatoide	1,3 milhão de pacientes
Esclerose múltipla	1 milhão de pacientes
Doença inflamatória intestinal	1,6 milhão de pacientes

Immunic, Inc. (IMUX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Immunic, Inc. relatou despesas de P&D de US $ 44,7 milhões.

Ano	Despesas de P&D	Aumento percentual
2022	US $ 38,2 milhões	17.0%
2023	US $ 44,7 milhões	17.0%

Investimentos de ensaios clínicos

Investimentos de ensaios clínicos para o IMU-838 e outros candidatos a pipeline totalizaram US $ 26,3 milhões em 2023.

• Ensaios de fase 2 para colite ulcerosa
• Desenvolvimento clínico de esclerose múltipla
• Pesquisa CoVID-19 em andamento

Custos de conformidade regulatória

As despesas de conformidade regulatória foram aproximadamente US $ 5,2 milhões em 2023.

Manutenção de patentes

Os custos anuais de manutenção de patentes e proteção intelectual foram US $ 2,1 milhões em 2023.

Overhead administrativo e operacional

A sobrecarga administrativa e operacional total para 2023 foi US $ 22,5 milhões.

Categoria de custo	Quantia
Despesas de pessoal	US $ 15,3 milhões
Custos de escritório e instalação	US $ 4,2 milhões
Tecnologia e infraestrutura	US $ 3,0 milhões

Estrutura total de custos abrangentes para a Immunic, Inc. em 2023 foi US $ 100,8 milhões.

Immunic, Inc. (IMUX) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Immunic, Inc. não relatou nenhum contrato de licenciamento de medicamentos ativo gerando receita direta.

Vendas futuras de produtos farmacêuticos

O pipeline de produtos atual focou-se nos IMU-838 e IMU-380 com possíveis fluxos futuros de receita.

Candidato a drogas	Área terapêutica	Estágio de desenvolvimento	Valor potencial de mercado
IMU-838	Esclerose múltipla	Ensaios clínicos de fase 2	Estimação de US $ 500 milhões em potencial mercado
IMU-380	Doença inflamatória intestinal	Estágio pré -clínico	Estimação de US $ 300 milhões em potencial mercado

Bolsas de pesquisa

No ano fiscal de 2022, a Immunic, Inc. relatou US $ 3,4 milhões em receita de concessão de várias fontes de financiamento de pesquisa.

Pagamentos marcos de parcerias

• Não há pagamentos significativos de marcos relatados em 2022-2023 demonstrações financeiras
• Potenciais pagamentos futuros de marco dependentes do progresso do desenvolvimento clínico

Potenciais receitas de royalties

Nenhuma receita atual de royalties documentada em relatórios financeiros recentes.

Métrica financeira	2022 Valor	2023 valor
Receita total	US $ 4,2 milhões	US $ 3,8 milhões
Pesquisa concede receita	US $ 3,4 milhões	US $ 2,9 milhões

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.