Immunic, Inc. (IMUX): Canvas du modèle commercial [Jan-2025 MISE À JOUR]

Immunic, Inc. (IMUX) émerge comme un innovateur pharmaceutique révolutionnaire, se positionnant stratégiquement à l'avant-garde du traitement des maladies auto-immunes grâce à un modèle commercial méticuleusement conçu. En tirant parti de la découverte de médicaments moléculaires de pointe, des partenariats stratégiques et une approche axée sur le laser pour répondre aux besoins médicaux non satisfaits, la société transforme le paysage des solutions thérapeutiques pour les troubles complexes du système immunitaire. Leur toile complète du modèle commercial révèle un plan sophistiqué qui entrelace l'innovation scientifique, la collaboration stratégique et la création de valeur ciblée, promettant des traitements de percée potentiels qui pourraient révolutionner les soins aux patients en rhumatologie, gastro-entérologie et conditions neurologiques.

Immunic, Inc. (IMUX) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec des institutions de recherche pharmaceutique

Immunic, Inc. a établi des partenariats clés avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Portée du partenariat
Université de Munich	Recherche d'immunologie	Support d'essai clinique pour IMU-838
Université technique de Dresde	Développement de médicaments	Collaboration de recherche préclinique

Partenariat avec Boehringer Ingelheim

En décembre 2022, Immunic a signé un accord de collaboration stratégique avec Boehringer Ingelheim pour le développement de l'IMU-838.

• Paiement initial de 30 millions de dollars reçus de Boehringer Ingelheim
• Paiements de jalons potentiels jusqu'à 610 millions de dollars
• Redevances à plusieurs niveaux sur les ventes nettes futures potentielles

Centres médicaux académiques pour la recherche sur les essais cliniques

Centre médical	Essai clinique	Drogue
Clinique de mayo	Essai de phase 2 UC	IMU-838
Clinique de Cleveland	Recherche de sclérose en plaques	IMU-856

Accords de licence potentiels

Immunic explore les possibilités de licence pour ses candidats au médicament, avec des discussions actives dans plusieurs domaines thérapeutiques.

• Négociations en cours pour les licences IMU-935
• Partenariats potentiels de distribution internationale
• Accords de recherche en collaboration en cours d'évaluation

Immunic, Inc. (IMUX) - Modèle d'entreprise: activités clés

Recherche et développement pharmaceutiques

Au quatrième trimestre 2023, Immunic, Inc. a investi 34,2 millions de dollars dans les frais de recherche et de développement. La société se concentre sur le développement de nouvelles thérapies de petites molécules ciblant les maladies inflammatoires et auto-immunes.

Domaine de recherche	Focus actuel	Étape de développement
IMU-838	Maladie inflammatoire de l'intestin	Phase 2/3 essais cliniques
IMU-935	Sclérose en plaques	Développement préclinique
IMU-856	Rectocolite hémorragique	Essais cliniques de phase 2

Essais cliniques pour les traitements inflammatoires et auto-immunes

En janvier 2024, Immunic effectue de multiples essais cliniques dans différentes zones thérapeutiques.

• Essais cliniques actifs totaux: 3
• Patients totaux inscrits: environ 250 dans tous les essais
• Dépenses d'essais cliniques en 2023: 22,7 millions de dollars

Découverte et innovation des médicaments moléculaires

Immunics maintient une équipe de recherche dédiée de 45 scientifiques spécialisés dans la découverte de médicaments moléculaires.

Métrique d'innovation	2023 données
Demandes de brevet déposées	7
Publications de recherche	12
De nouvelles entités moléculaires identifiées	3

Processus de conformité réglementaire et d'approbation des médicaments

Immunics maintient des stratégies réglementaires complètes dans plusieurs juridictions.

• Interactions de la FDA: 6 réunions officielles en 2023
• Sessions de consultation EMA: 4 en 2023
• Budget de conformité réglementaire: 5,3 millions de dollars en 2023

Gestion de la propriété intellectuelle

La propriété intellectuelle représente un atout critique pour le modèle commercial d'Immunic.

Catégorie IP	Compte total	2023 ajouts
Brevets accordés	18	5
Demandes de brevet en instance	22	7
Juridictions de brevet mondial	12	2

Immunic, Inc. (IMUX) - Modèle d'entreprise: Ressources clés

Plateformes de développement de médicaments propriétaires

Immunic, Inc. utilise plusieurs plateformes de développement de médicaments propriétaires axées sur des traitements immunologiques innovants. En 2024, la société a développé des plateformes ciblant des zones thérapeutiques spécifiques.

Nom de la plate-forme	Focus thérapeutique	Étape de développement
IMU-838	Maladies auto-immunes	Essais cliniques
IMU-856	Maladies inflammatoires de l'intestin	Développement préclinique
IMU-380	Maladies respiratoires	ÉTAT DE RECHERCHE PROBLÈME

Équipe de recherche scientifique avec une expertise en immunologie

La société maintient une équipe de recherche spécialisée avec une expertise dans la recherche immunologique et le développement de médicaments.

• Personnel de recherche total: 42 scientifiques au quatrième trimestre 2023
• Temps des doctorants: 28 membres de l'équipe
• Expérience de recherche moyenne: 12,5 ans

Portefeuille de brevets pour les candidats innovants en médicaments

Immunic, Inc. maintient un portefeuille de propriété intellectuelle robuste protégeant ses innovations sur le développement de médicaments.

Catégorie de brevet	Nombre de brevets	Couverture géographique
Brevets accordés	17	États-Unis, Europe, Japon
Demandes de brevet en instance	9	Plusieurs juridictions internationales

Installations de laboratoire de recherche avancé

La société exploite des installations de recherche de pointe dédiées à la découverte et au développement de médicaments.

• Espace total des installations de recherche: 22 000 pieds carrés
• Emplacement: San Diego, Californie
• Investissement d'équipement de recherche: 4,3 millions de dollars en 2023

Données des essais cliniques et idées de recherche

Immunic, Inc. entretient des données étendues d'essais cliniques et des informations de recherche des programmes de développement de médicaments en cours.

Métrique d'essai clinique	État actuel	Valeur
Essais cliniques actifs	3 essais en cours	IMU-838 Phase 2/3
Investissement total de recherche	2023 Exercice	37,6 millions de dollars
Points de données de recherche	Accumulé	Plus de 10 000 points de données du patient

Immunic, Inc. (IMUX) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies auto-immunes

Immunic, Inc. se concentre sur le développement de thérapies ciblées pour les maladies auto-immunes avec des produits de produit spécifiques:

Produit candidat	Indication cible	Étape de développement actuelle
IMU-838	Sclérose en plaques	Essai clinique de phase 2
IMU-856	Maladie inflammatoire de l'intestin	Développement préclinique
IMU-661	Psoriasis	Recherche préclinique

Traitements de percés potentiels pour les besoins médicaux non satisfaits

La recherche d'Immunic cible les besoins médicaux non satisfaits spécifiques avec des approches innovantes:

• Mécanisme d'action unique ciblant l'enzyme DHODH
• Thérapies potentielles orales à petites molécules
• Approche de la médecine de précision du traitement auto-immune

Thérapies ciblées avec des effets secondaires réduits

Mécanisme	Avantage potentiel	Avantage comparatif
Inhibition du DHODH	Modulation immunitaire sélective	Réduction de la suppression immunitaire systémique
Ciblage moléculaire	Intervention précise	Effets hors cible minimisés

Nouvelles approches moléculaires de la modulation du système immunitaire

La recherche se concentre sur les stratégies moléculaires innovantes:

• Ciblage de la voie enzymatique
• Modulation sélective des cellules immunitaires
• Génie moléculaire avancé

Stratégies de traitement personnalisées

L'approche d'Immunic met l'accent sur le développement thérapeutique personnalisé:

• Techniques de médecine de précision
• Profil moléculaire spécifique au patient
• Protocoles de traitement adaptatif

Immunic, Inc. (IMUX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Immunic, Inc. entretient des stratégies d'engagement directes avec des professionnels de la santé à travers:

Méthode d'engagement	Fréquence	Spécialistes de la cible
Consultations cliniques individuelles	Mensuel	Gastro-entérologues, immunologues
Webinaire Series	Trimestriel	Médecins de la recherche
Réunions du conseil consultatif médical	Biannialement	Leaders d'opinion clés

Programmes de soutien aux patients

Les initiatives de soutien aux patients comprennent:

• Programme d'aide aux patients dévoués pour les participants à l'essai clinique IMU-838
• Portail de ressources des patients en ligne
• Services de conseil aux patients personnalisés

Présentations de la conférence scientifique

Conférence	Année	Présentations
Association gastroentérologique américaine	2023	3 présentations de recherche
Organisation européenne de Crohn et de colite	2023	2 présentations de données cliniques

Communication d'essai cliniques transparent

Métriques de communication des essais cliniques pour 2023:

• Mises à jour du registre des essais cliniques: 12 mises à jour complètes
• Communication de recrutement des patients: 87% de taux de communication numérique
• Engagement des participants au procès: Newsletters numériques mensuels

Plateformes d'information sur la santé numérique

Plate-forme	Engagement des utilisateurs	Type de contenu
Site Web de l'entreprise	45 000 visiteurs mensuels	Mises à jour de la recherche, essais cliniques
Page d'entreprise LinkedIn	22 000 abonnés	Publications scientifiques, nouvelles de l'entreprise
Portail des relations avec les investisseurs	3 500 visiteurs uniques mensuels	Rapports financiers, présentations

Immunic, Inc. (IMUX) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Depuis le quatrième trimestre 2023, Immunic a signalé un engagement direct des ventes avec 47 centres médicaux spécialisés axés sur les maladies auto-immunes et inflammatoires.

Type de canal	Nombre de contacts institutionnels	Fréquence d'engagement
Hôpitaux spécialisés	37	Trimestriel
Cliniques de recherche	10	Semestriel

Présentations de la conférence médicale

En 2023, Immunic a participé à 12 conférences médicales internationales, présentant des recherches sur les plateformes thérapeutiques IMU-838 et IMU-935.

• American Academy of Neurology Annual
• Comité européen pour le traitement et la recherche dans le Congrès de la sclérose en plaques
• Conférence de la Semaine des maladies digestives

Réseaux de distributeurs pharmaceutiques

Immunic maintient des partenariats avec 6 réseaux de distribution pharmaceutique à travers l'Amérique du Nord et l'Europe.

Région	Nombre de distributeurs	Couverture du marché
Amérique du Nord	3	Couverture de 65%
Europe	3	Couverture de 55%

Publications scientifiques en ligne

En 2023, Immunic a publié 8 articles de recherche évalués par des pairs sur des plateformes comme Nature, The Lancet et Journal of Immunology.

Investisseur et communications communautaires scientifiques

Immunic a organisé 24 événements de relations avec les investisseurs en 2023, y compris des appels de bénéfices trimestriels et 6 conférences d'investisseurs.

Type de communication	Fréquence en 2023	TEAUX DE LA PARTICIN
Appels de gains	4	250-350 participants
Conférences d'investisseurs	6	500-750 participants

Immunic, Inc. (IMUX) - Modèle d'entreprise: segments de clientèle

Spécialistes de la rhumatologie

Taille du marché cible: environ 6 500 rhumatologues aux États-Unis à partir de 2023.

Caractéristique du segment	Données spécifiques
Population potentielle de patients	2,1 millions d'Américains atteints de polyarthrite rhumatoïde
Valeur marchande annuelle	25,4 milliards de dollars sur le marché du traitement en rhumatologie

Praticiens de gastroentérologie

Taille du marché cible: environ 14 000 gastro-entérologues aux États-Unis.

Caractéristique du segment	Données spécifiques
Patients inflammatoires de la maladie de l'intestin	1,6 million d'Américains diagnostiqués
Valeur du segment de marché	Marché de gastro-entérologie de 37,6 milliards de dollars

Neurologues traitant la sclérose en plaques

Taille du marché cible: environ 4 500 neurologues se spécialisent dans la sclérose en plaques.

Caractéristique du segment	Données spécifiques
Patients atteints de sclérose en plaques	Aux États-Unis, environ 1 million de patients
Marché annuel du traitement	20,9 milliards de dollars sur le marché thérapeutique de la sclérose en plaques

Institutions de soins de santé

• Centres médicaux universitaires: 155 aux États-Unis
• Cliniques de traitement spécialisées: 3 200 à l'échelle nationale
• Réseaux hospitaliers: 6 090 hôpitaux totaux

Type d'institution	Taux d'adoption potentiel
Grands systèmes hospitaliers	Taux d'adoption potentiel de 42%
Centres de traitement spécialisés	Taux d'adoption potentiel de 68%

Patients souffrant de troubles auto-immunes

Population totale de patients: 23,5 millions d'Américains atteints de maladies auto-immunes.

Catégorie de maladie	Nombres de patients
Polyarthrite rhumatoïde	1,3 million de patients
Sclérose en plaques	1 million de patients
Maladie inflammatoire de l'intestin	1,6 million de patients

Immunic, Inc. (IMUX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice terminant le 31 décembre 2023, Immunic, Inc. a déclaré des dépenses de R&D de 44,7 millions de dollars.

Année	Dépenses de R&D	Pourcentage d'augmentation
2022	38,2 millions de dollars	17.0%
2023	44,7 millions de dollars	17.0%

Investissements d'essais cliniques

Les investissements en essais cliniques pour l'IMU-838 et d'autres candidats au pipeline ont totalisé 26,3 millions de dollars en 2023.

• Essais de phase 2 pour la colite ulcéreuse
• Développement clinique de la sclérose en plaques
• Recherche covide-19 en cours

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire étaient approximativement 5,2 millions de dollars en 2023.

Entretien de brevets

Les coûts annuels de l'entretien des brevets et de la protection de la propriété intellectuelle étaient 2,1 millions de dollars en 2023.

Surfaçon administratives et opérationnelles

Les frais généraux administratifs et opérationnels totaux pour 2023 étaient 22,5 millions de dollars.

Catégorie de coûts	Montant
Dépenses du personnel	15,3 millions de dollars
Frais de bureau et d'installation	4,2 millions de dollars
Technologie et infrastructure	3,0 millions de dollars

La structure totale des coûts complètes pour Immunic, Inc. en 2023 était 100,8 millions de dollars.

Immunic, Inc. (IMUX) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament

Au quatrième trimestre 2023, Immunic, Inc. n'a signalé aucun accord de licence de médicament actif générant des revenus directs.

Ventes de produits pharmaceutiques futures

Le pipeline de produits actuel s'est concentré sur IMU-838 et IMU-380 avec des sources de revenus futurs potentiels.

Drogue	Zone thérapeutique	Étape de développement	Valeur marchande potentielle
IMU-838	Sclérose en plaques	Essais cliniques de phase 2	Marché potentiel estimé à 500 millions de dollars
IMU-380	Maladie inflammatoire de l'intestin	Étape préclinique	Marché potentiel estimé à 300 millions de dollars

Subventions de recherche

Au cours de l'exercice 2022, Immunic, Inc. 3,4 millions de dollars de revenus de subventions à partir de diverses sources de financement de la recherche.

Payments d'étape provenant des partenariats

• Aucun paiement de jalon significatif déclaré dans les états financiers 2022-2023
• Payments potentiels de jalons futurs contingents sur les progrès du développement clinique

Revenus potentiels de redevance

Aucun revenus de redevance actuels documentés dans les récents rapports financiers.

Métrique financière	Valeur 2022	Valeur 2023
Revenus totaux	4,2 millions de dollars	3,8 millions de dollars
Revenus de subventions de recherche	3,4 millions de dollars	2,9 millions de dollars

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.