Medicinova, Inc. (MNOV): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

Dans le paysage dynamique de l'innovation biopharmaceutique, Medicinova, Inc. (MNOV) émerge comme une force pionnière, naviguant stratégiquement sur le terrain complexe de la thérapeutique des maladies neurologiques et inflammatoires. En tirant parti des recherches de pointe, des partenariats stratégiques et une approche axée sur le laser aux besoins médicaux non satisfaits, cette entreprise redéfinit les limites du développement pharmaceutique. Leur toile de modèle commercial méticuleusement conçu révèle un plan sophistiqué pour transformer le potentiel scientifique en solutions médicales révolutionnaires, promettant de l'espoir pour les patients et les investisseurs dans le monde difficile de la découverte et du développement de médicaments.

Medicinova, Inc. (MNOV) - Modèle d'entreprise: partenariats clés

Collaborations de recherche stratégique avec les établissements universitaires

Medicinova a établi des partenariats avec les établissements de recherche académiques suivants:

Institution	Focus de recherche	Année de collaboration
Université de Californie, San Diego	Recherche de troubles neurologiques	2019
Université Johns Hopkins	Études sur les maladies inflammatoires	2020

Partenariats de développement pharmaceutique avec des organisations de recherche contractuelle

Medicinova collabore avec des organisations de recherche sous contrat spécialisées (CRO):

• Icône PLC - Gestion des essais cliniques de phase II / III
• Parexel International - Support de développement des médicaments
• IQVIA - Recherche clinique et soutien réglementaire

Accords de licence avec les entreprises de biotechnologie

Les partenariats de licence actifs comprennent:

Entreprise partenaire	Drogue	Conditions de licence
Kyorin Pharmaceutical Co.	MN-166 (ibudilast)	Droits exclusifs pour le traitement ALS
Nuvelution pharma	MN-001 (Tipélukast)	Contrat de développement collaboratif

Coentreprises potentielles dans le développement de médicaments

Discussions potentielles de coentreprise actuelles:

• Développement du traitement des troubles neurologiques
• Recherche thérapeutique des maladies inflammatoires
• Innovation de médicament aux maladies respiratoires

Partenariats du site d'essai cliniques avec des centres médicaux

Partenariats de sites d'essai cliniques actifs:

Centre médical	Focus d'essai	État actuel
Clinique de mayo	Essais cliniques ALS	Phase II / III en cours
Centre médical de l'Université de Stanford	Recherche progressive de sclérose en plaques	Phase de recrutement

Medicinova, Inc. (MNOV) - Modèle d'entreprise: activités clés

Recherche et développement biopharmaceutique

Medicinova se concentre sur le développement de traitements thérapeutiques innovants principalement dans la neurologie et les maladies inflammatoires. Depuis 2024, la société a 4 candidats au médicament primaire à divers stades de développement.

Drogue	Zone thérapeutique	Étape de développement
MN-166 (ibudilast)	Troubles neurologiques	Essais cliniques de phase II / III
MN-001 (Tipélukast)	Maladies inflammatoires	Essais cliniques de phase II

Découverte de médicaments et tests précliniques

La société investit considérablement dans des processus de développement de médicaments à un stade précoce.

• Dépenses annuelles de R&D: 12,5 millions de dollars (2023 Exercice)
• Budget de recherche préclinique: environ 3,2 millions de dollars
• Nombre de programmes de recherche actifs: 3-4 candidats en médicaments

Gestion des essais cliniques

Medicinova maintient des essais cliniques actifs dans plusieurs zones thérapeutiques.

Focus des essais cliniques	Nombre d'essais actifs	Inscription estimée des patients
Troubles neurologiques	2 essais	Environ 250 patients
Conditions inflammatoires	1 essai	Environ 150 patients

Processus de soumission et d'approbation réglementaires

Medicinova s'engage activement avec les organismes de réglementation pour l'approbation des médicaments.

• Interactions de la FDA: consultations réglementaires trimestrielles
• Applications IND (NOUVEAU DE NOUVEAU ENTREVOIR): 2
• Budget de conformité réglementaire: 1,5 million de dollars par an

Gestion et protection de la propriété intellectuelle

La société maintient une solide stratégie de propriété intellectuelle.

Catégorie IP	Nombre de brevets	Plage d'expiration des brevets
Brevets délivrés	12	2030-2040
Demandes de brevet en instance	5	Pas encore déterminé

Medicinova, Inc. (MNOV) - Modèle d'entreprise: Ressources clés

Équipe de recherche pharmaceutique spécialisée

En 2024, Medicinova maintient une équipe de recherche de 35 scientifiques et chercheurs spécialisés. La composition de l'équipe comprend:

• 12 Ph.D. chercheurs de niveau
• 8 médecins spécialisés dans le développement de médicaments
• 15 Associés de recherche et techniciens de laboratoire

Technologies de développement de médicaments propriétaires

Plate-forme technologique	Focus spécifique	Étape de développement actuelle
MN-166 (ibudilast)	Neuroinflammation et neuroprotection	Phase 2/3 essais cliniques
MN-001 (Tipélukast)	Maladies inflammatoires et fibrotiques	Phase 2 Développement clinique

Portfolio de brevets pour la thérapeutique innovante

Le portefeuille de brevets de Medicinova se compose de:

• 17 brevets actifs
• 9 demandes de brevet en instance
• Couverture de la propriété intellectuelle aux États-Unis, en Europe et au Japon

Capital financier pour la recherche en cours

Métrique financière	Montant (au Q4 2023)
Equivalents en espèces et en espèces	48,3 millions de dollars
Frais de recherche et de développement	22,7 millions de dollars par an

Infrastructure avancée de laboratoire et de recherche

Installations de recherche:

• 2 centres de recherche primaires situés en Californie
• Espace total des installations de recherche: 12 500 pieds carrés
• Équipement de laboratoire avancé d'une valeur d'environ 3,6 millions de dollars

Medicinova, Inc. (MNOV) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies neurologiques et inflammatoires

Medicinova se concentre sur le développement de solutions thérapeutiques avec des produits de produit spécifiques:

Produit candidat	Zone de maladie	Étape de développement actuelle
MN-166 (ibudilast)	Sclérose en plaques	Phase 2/3 essais cliniques
MN-166 (ibudilast)	Sclérose en plaques progressive	Développement clinique
MN-166	SLA (sclérose latérale amyotrophique)	Essais cliniques de phase 2

Traitements potentiels avec de nouveaux mécanismes d'action

Mécanismes clés d'action pour les candidats en médicaments primaires:

• Inhibition de la phosphodiestérase
• Inhibition du facteur inhibiteur de la migration des macrophages (MIF)
• Réduction de neuroinflammation

Concentrez-vous sur les besoins médicaux non satisfaits dans les zones de maladie stimulantes

Analyse des opportunités de marché pour les zones de maladie cible:

Maladie	Prévalence mondiale	Besoins de traitement non satisfait
Sclérose en plaques	2,8 millions de patients dans le monde	Traitements progressifs effectifs limités efficaces
ALS	Environ 450 000 patients dans le monde	Aucun traitement curatif disponible

Développement de thérapies ciblées et potentiellement plus efficaces

Investissement de recherche et développement:

Exercice fiscal	Dépenses de R&D
2022	14,3 millions de dollars
2023	16,7 millions de dollars

Potentiel de traitements révolutionnaires avec des résultats améliorés pour les patients

Métriques de performance des essais cliniques:

• Essai MN-166 Phase 2 ALS: Effets neurprotecteurs potentiels démontrés
• Recherche de sclérose en plaques: Cibler les mécanismes de neuroinflammation
• Développement de médicaments propriétaires: 5 programmes d'enquête actifs

Medicinova, Inc. (MNOV) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Medicinova maintient les canaux de communication directs avec les professionnels de la santé à travers:

• Outre ciblé pour les neurologues et les pulmonologues
• Réunions individuelles du conseil consultatif médical en tête-à-tête
• Partage d'informations sur les essais cliniques personnalisés

Méthode d'engagement	Fréquence	Spécialistes de la cible
Consultations médicales directes	Trimestriel	Neurologues, pulmonologues
Réunions de collaboration de recherche	Bi-annuellement	Chercheurs universitaires

Participation du symposium de conférence scientifique et de recherche

Medicinova participe activement à des événements de recherche médicale clés:

• Réunion annuelle de l'American Neurological Association
• Symposium international de recherche pulmonaire
• Conférence de développement des maladies rares et de médicaments orphelins

Communication transparente sur les progrès des essais cliniques

Canaux de communication pour les mises à jour des essais cliniques:

• Mises à jour trimestrielles sur les investisseurs et la recherche
• Divulgations de classement de la SEC
• Communiqués de presse documentant les étapes des essais

Type de communication	Fréquence	Plate-forme de rapport
Appels d'investisseurs	Trimestriel	Webdication sur les gains
Mises à jour des essais cliniques	À mesure que les jalons se produisent	Site Web de l'entreprise, dépôts de la SEC

Approche de développement de médicaments axé sur les patients

Stratégies d'engagement des patients:

• Collaborations de groupes de patients de maladies rares
• Suivi des résultats déclarés par les patients
• Programmes d'accessibilité des essais cliniques

Éducation médicale et soutien de la recherche en cours

Initiatives de recherche et de soutien à l'éducation:

• Subventions de recherche pour les études neurologiques
• Programmes de parrainage des bourses
• Support de publication scientifique

Programme de soutien	Budget annuel	Domaine de mise au point
Subventions de recherche	$500,000	Troubles neurologiques
Parrainage de bourses	$250,000	Recherche de maladies rares

Medicinova, Inc. (MNOV) - Modèle d'entreprise: canaux

Communication directe avec les distributeurs pharmaceutiques

Medicinova utilise des canaux de distribution pharmaceutique ciblés avec un accent spécifique sur les partenaires potentiels pour ses principaux candidats au médicament.

Canal de distribution	Marché cible	État actuel
Représentants des ventes directes	Marchés de neurologie / respiratoire	Engagement actif
Partenariats de licence	Sociétés pharmaceutiques mondiales	Discussions en cours

Présentations de la conférence médicale

Medicinova participe activement à des conférences scientifiques pour présenter les résultats de la recherche.

• American Academy of Neurology Annual
• Conférence internationale de la société respiratoire
• Convention sur l'Organisation de l'innovation en biotechnologie (BIO)

Plateformes de publication scientifique

L'entreprise tire parti des revues scientifiques évaluées par des pairs pour la diffusion de la recherche.

Plate-forme de publication	Nombre de publications (2023)	Facteur d'impact
Biotechnologie de la nature	2	41.4
La neurologie Lancet	1	38.5

Communications des relations avec les investisseurs

Medicinova maintient une communication transparente avec les investisseurs via plusieurs canaux.

• Appels de résultats trimestriels
• Réunions annuelles des actionnaires
• Dépôts de la SEC
• Webinaires de présentation des investisseurs

Réseaux de communication scientifique numériques et en ligne

Les plates-formes numériques permettent un engagement scientifique et professionnel plus large.

Plate-forme numérique	Nombre de suiveurs	Taux d'engagement
Liendin	3,427	4.2%
Researchgate	287	3.8%

Medicinova, Inc. (MNOV) - Modèle d'entreprise: segments de clientèle

Marchés de traitement des maladies neurologiques

Medicinova cible les marchés de traitement des maladies neurologiques avec des domaines de mise au point spécifiques:

Catégorie de maladie	Taille du marché (2024)	Population cible
Sclérose en plaques	23,4 milliards de dollars	Environ 2,8 millions de patients dans le monde
SLA (sclérose latérale amyotrophique)	1,2 milliard de dollars	Aux États-Unis, environ 30 000 patients

Spécialistes du traitement des maladies inflammatoires

Segments clés du marché des maladies inflammatoires:

• Syndrome de détresse respiratoire aiguë (SDRA)
• Chercheurs de troubles inflammatoires pulmonaires
• Professionnels de la santé en soins intensifs

Fournisseurs de soins de santé

Type de fournisseur	Portée du marché potentiel	Volume de traitement annuel
Cliniques neurologiques	4 500 centres spécialisés	1,2 million de consultations de patients
Départements de neurologie hospitaliers	2 300 hôpitaux majeurs	850 000 traitements de patients

Institutions de recherche

Medicinova collabore avec des institutions de recherche en se concentrant sur:

• Centres médicaux académiques
• Universités de recherche en neurosciences
• Laboratoires de recherche pharmaceutique

Sociétés pharmaceutiques et biotechnologiques

Type d'entreprise	Opportunités de collaboration potentielles	Potentiel de marché
Grandes sociétés pharmaceutiques	Partenariats de développement de médicaments	Marché collaboratif de 50 milliards de dollars
Cabinets de recherche en biotechnologie	Recherche de traitement innovante	Marché potentiel de 35 milliards de dollars

Medicinova, Inc. (MNOV) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Medicinova a déclaré des frais de R&D de 14,3 millions de dollars. Les principaux domaines d'intervention de l'entreprise comprennent:

• MN-166 (ibudilast) pour la sclérose en plaques progressive
• MN-001 pour les maladies inflammatoires et fibrotiques

Coûts de mise en œuvre des essais cliniques

Essai clinique	Coût annuel estimé
MN-166 Essai de MS progressif	7,2 millions de dollars
Essais liés à Covid-19	3,5 millions de dollars

Protection de la propriété intellectuelle

Coûts annuels de la propriété intellectuelle et des brevets: 450 000 $

Investissements de conformité réglementaire

Frais de conformité réglementaire et de soumission pour 2023: 1,8 million de dollars

Surfaçon administratives et opérationnelles

Catégorie de dépenses	Coût annuel
Dépenses du personnel	6,5 millions de dollars
Frais de bureau et d'installation	1,2 million de dollars
Technologie et infrastructure	$750,000

Coûts opérationnels totaux pour 2023: 36,5 millions de dollars

Medicinova, Inc. (MNOV) - Modèle d'entreprise: Strots de revenus

Accords de licence potentiels

En 2024, Medicinova a des accords de licence potentiels pour les actifs clés suivants:

Drogue	Licencié potentiel	Valeur potentielle estimée
MN-166 (ibudilast)	Sociétés pharmaceutiques non divulguées	Potentiel initial de 5 à 10 millions de dollars
MN-001	Partenaires potentiels de maladies respiratoires	Potentiel de licence de 3 à 7 millions de dollars

Future commercialisation des produits

Les sources de revenus potentielles de la commercialisation des produits comprennent:

• MN-166 pour la sclérose en plaques progressive
• MN-166 pour le traitement ALS
• MN-001 pour IPF et NASH

Subventions et financement de recherche

Source de financement	Montant	Année
National Institutes of Health (NIH)	2,1 millions de dollars	2023
Ministère de la Défense	1,5 million de dollars	2023

Partenariats de recherche collaborative

Collaboration de recherche actuelle Détails financiers:

• Partenariats universitaires du centre médical d'une valeur d'environ 750 000 $ par an
• Collaborations de recherche pharmaceutique estimée à 1,2 million de dollars par projet

Paiements de jalons potentiels provenant de partenariats pharmaceutiques

Drogue	Gamme de paiement de jalons potentiel	Événement de déclenchement
MN-166	10-25 millions de dollars	Initiation des essais cliniques de phase III
MN-001	5-15 millions de dollars	Achèvement de phase II réussi

MediciNova, Inc. (MNOV) - Canvas Business Model: Value Propositions

MediciNova, Inc. offers value through two core compounds, MN-166 (ibudilast) and MN-001 (tipelukast), targeting severe conditions with high unmet medical need.

Potential disease-modifying treatment for ALS, a fatal neurodegenerative disease.

• MN-166 is in Phase 3 for amyotrophic lateral sclerosis (ALS) via the COMBAT-ALS trial.
• Patient randomization for the COMBAT-ALS Phase 2b/3 clinical trial has been successfully completed as of September 8, 2025.
• Top-line data from the ALS trial is anticipated by the end of 2026.
• MN-166 holds Orphan Drug Designation from the U.S. FDA and EU EMA for ALS.
• The compound has received Fast Track Designation by the FDA for ALS treatment.
• An Expanded Access Program (EAP) for ALS patients is supported by a National Institutes of Health (NIH) grant of $22 million.
• This EAP will include approximately 200 ALS patients ineligible for the COMBAT-ALS trial.

MN-166 addresses multiple indications: MS, DCM, Long COVID, and substance dependence.

MN-166 is positioned across several neurological and inflammatory areas, which diversifies the potential patient population and revenue base.

• MN-166 is Phase 3-ready for progressive multiple sclerosis (MS).
• The compound is currently in Phase 3 trials for degenerative cervical myelopathy (DCM).
• Phase 2 trials are underway evaluating MN-166 for Long COVID and substance dependence.

MN-001 as a potential first-in-class therapy for metabolic diseases like NAFLD/NASH.

MN-001 (tipelukast) is being developed for metabolic disorders where an approved therapy is currently lacking, such as Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH).

• MN-001 completed patient enrollment in its Phase 2 trial (MN-001-NATG-202) for hypertriglyceridemia and NAFLD due to Type 2 Diabetes Mellitus (T2DM).
• Top-line results for this trial are expected by summer 2026.
• The global market for NASH treatment is estimated to reach $57.5 billion by 2033, growing at a CAGR of 27.9%.
• Approximately 6 million individuals in the US are estimated to have progressed to NASH.
• The NASH drug pipeline market size for 2025E is $479.7 million, projected to reach $8,123.3 million by 2035.

The value proposition is further supported by the clinical stage and the significant market opportunity, which is reflected in the company's recent financing activities.

Compound	Indication	Development Stage (Late 2025)	Key Financial/Market Context
MN-166	ALS	Phase 3 (COMBAT-ALS Enrollment Complete)	Supported by $22 million NIH grant for EAP.
MN-166	DCM	Phase 3	Orphan Drug Designation held.
MN-166	MS (Progressive)	Phase 3-Ready	Focus on neurodegenerative diseases.
MN-166	Long COVID, Substance Dependence	Phase 2	Addresses sequelae with large unmet need.
MN-001	NAFLD/Hypertriglyceridemia (T2DM)	Phase 2 Enrollment Complete	Top-line results expected summer 2026.

Strong safety profiles for both lead compounds, reducing late-stage development risk.

Both MN-166 and MN-001 are noted to possess strong safety profiles, which is a critical factor in de-risking the remaining clinical development path.

• Both lead assets are characterized by strong safety profiles.
• MediciNova, Inc. reported Q3 2025 cash and cash equivalents of $32,562,612.
• Management stated cash is sufficient to fund operations at least through November 2026.
• The company secured a $30.0 million Standby Equity Purchase Agreement (SEPA) in July 2025 to provide financing flexibility.

Addressing significant unmet medical needs in high-value therapeutic areas.

The value proposition is tied directly to the severity of the diseases targeted, where current treatment options are limited or non-existent.

• For ALS, MN-166 offers a potential disease-modifying option where no FDA-approved therapy currently exists to halt progression.
• NASH represents a substantial unmet medical need, with no FDA, EMA, or PMDA-approved therapies as of early 2024.
• Long COVID treatment options have not been widely evaluated, indicating a large unmet need regarding quality of life and return to work.

MediciNova, Inc. (MNOV) - Canvas Business Model: Customer Relationships

MediciNova, Inc. engages with clinical investigators through active, late-stage trials, such as the Phase 2b/3 COMBAT-ALS trial, which reported completion of patient enrollment on September 22, 2025. This trial evaluated MN-166 in about 230 adults experiencing ALS symptoms up to 1.5 years prior to study entry. The company also manages the expansion of its Expanded Access Program (EAP) network, which involves inviting new clinics to onboard patients.

The direct engagement with regulatory bodies centers on securing favorable designations for MN-166, the lead asset. MediciNova holds Orphan Drug Designation for MN-166 in ALS from both the U.S. FDA and EU EMA. Furthermore, the FDA granted Fast Track Designation for MN-166 in the treatment of ALS. The company is actively preparing for regulatory discussions with the FDA, with top-line data anticipated by the end of next year.

Investor relationships are maintained through public listings on the NASDAQ: MNOV and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875). The company provided a direct update via a 'Message from the CEO to MediciNova Shareholders' on December 01, 2025. For capital needs, MediciNova signed a Standby Equity Purchase Agreement (SEPA) for up to $30 million over 36 months. Under this agreement, stock is sold to the investor at a purchase price equal to 97% of the market price. The closing stock price on December 3, 2025, was $1.51.

Patient support for those ineligible for the COMBAT-ALS trial is managed through the MN-166 Expanded Access Program (EAP), which is funded in part by a $22 million grant from the NIH. The EAP is planned to enroll about 200 patients in the U.S.. The Mayo Clinic Jacksonville site has enrolled 15 patients to date within this program. The ACT for ALS legislation, which supports this EAP, provides $100 million annually through fiscal 2026.

The current structure of investigator and site engagement for the EAP is detailed below:

Engagement Metric	Quantity/Status
Planned EAP Patient Enrollment Target	About 200 patients
COMBAT-ALS Trial Enrollment Status (as of late 2025)	Enrollment Complete (as of September 22, 2025)
COMBAT-ALS Trial Participants	About 230 adults
EAP Sites Invited and Onboarding	5 additional clinics
EAP Sites to be Invited Summer 2026	Another 8 clinics
EAP Sites Guaranteed Openings (per onboarding completion by end of 2025)	At least 5 patients per clinic
Total U.S. COMBAT-ALS Sites Included in EAP Invitations	All 9 sites
Patients Enrolled at Mayo Clinic Jacksonville (EAP)	15 patients to date

The company maintains communication channels for various stakeholders:

• Clinical investigators and KOLs engaged via ongoing Phase 3 and Phase 2 trials.
• Regulatory agencies including the FDA and EMA for designations like Fast Track and Orphan Drug.
• Shareholders via public updates, such as the letter dated December 01, 2025.
• Patients accessing MN-166 through the NIH-funded EAP, which has a capacity of about 200.

MediciNova, Inc. (MNOV) - Canvas Business Model: Channels

You're looking at how MediciNova, Inc. gets its potential therapies from the lab bench to the patient and the market. For a clinical-stage biopharma company, the channels are less about retail shelves and more about clinical sites, regulatory bodies, and capital markets. Here's the breakdown based on late 2025 data.

Global network of clinical trial sites for patient enrollment

The physical channel for data generation relies heavily on a network of clinical trial sites. MediciNova, Inc. has successfully navigated enrollment for its key assets, often leveraging external funding sources to support this crucial step. The company has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Key trial milestones as of late 2025 include:

• MN-166 (ibudilast) Phase 2b/3 COMBAT-ALS trial: Target enrollment achieved as of September 8, 2025.
• MN-166 Expanded Access Program (EAP): Steadily enrolling patients, supported by a $22 million grant from the National Institutes of Health (NIH).
• MN-001 (tipelukast) Phase 2 trial (MN-001-NATG-202): Patient enrollment completed as of November 4, 2025.

MediciNova, Inc. has 11 programs in clinical development, based on its two main compounds, MN-166 and MN-001. MN-166 is currently in Phase 3 for Amyotrophic Lateral Sclerosis (ALS) and Degenerative Cervical Myelopathy (DCM), and is Phase 3-ready for progressive Multiple Sclerosis (MS).

Regulatory pathways (FDA, EMA) for eventual drug approval and market access

Regulatory clearance is the gatekeeper for market access. MediciNova, Inc. is actively managing these pathways, with a primary commercial focus on the United States (U.S.) market. The company has secured specific designations that streamline development and offer market protection upon approval.

Here's a look at the regulatory landscape and relevant 2025 market context:

Designation/Metric	Asset	Authority	Benefit/Status
Orphan Drug Designation	MN-166 (ibudilast)	U.S. FDA and EU EMA	For ALS treatment
Fast Track Designation	MN-166 (ibudilast)	U.S. FDA	For ALS treatment
Orphan-Drug Designation	MN-001 (tipelukast)	U.S. FDA	For Idiopathic Pulmonary Fibrosis (IPF); potential seven years marketing exclusivity if approved
FDA Marketing Authorisations (YTD)	All	FDA (CDER/CBER)	47 as of late November 2025
EMA CHMP Recommendations (YTD)	All	EMA	44 as of late November 2025

Top-line results for the MN-001 trial in hypertriglyceridemia and NAFLD due to T2DM are anticipated by summer 2026, which will inform next steps toward regulatory discussions with the FDA.

NASDAQ and Tokyo Stock Exchange for capital raising and investor communication

Access to capital is a vital channel for funding ongoing clinical development. MediciNova, Inc. maintains dual listings to access both U.S. and Japanese investor bases. The company has recently secured financing flexibility to support its R&D programs.

Financial and listing details as of late 2025:

• Stock Listings: NASDAQ Global Market (NASDAQ: MNOV) and Standard Market of the Tokyo Stock Exchange (Code Number: 4875).
• Recent Financing: Standby Equity Purchase Agreement (SEPA) signed for up to $30 million over 36 months.
• SEPA Terms: Stock sold at 97% of the market price.
• Recent Filing: Form S-3 filed December 5, 2025, to offer up to $300,000,000 in securities.
• Stock Price: Last reported sale price on December 3, 2025, was $1.51 per share.
• Market Capitalization: Approximately $73M as of December 1, 2025.

The company is classified as a 'smaller reporting company,' meaning the market value of shares held by non-affiliates is less than $700 million.

Future strategic alliances and licensing partners for commercialization

MediciNova, Inc. is actively planning for commercialization, which may involve self-commercialization or partnering. The strategy centers on leveraging external expertise and capital for late-stage assets.

The company intends to:

• Actively pursue strategic collaborations with larger pharmaceutical companies for development, regulatory, and commercialization support.
• Opportunistically in-license additional product candidates, strengthening relationships in Japan and other markets.
• Selectively add commercial capabilities to its management team as product development programs mature.

This approach helps maximize commercial opportunities while mitigating the inherent risks of drug development.

MediciNova, Inc. (MNOV) - Canvas Business Model: Customer Segments

You're looking at the core groups MediciNova, Inc. (MNOV) needs to engage to move its pipeline forward, which is heavily focused on late-stage neurological and metabolic assets. The company's customer base isn't just the end-user patient; it's a complex ecosystem of prescribers, funders, and capital providers, all critical for a clinical-stage biopharma firm.

Patients with Amyotrophic Lateral Sclerosis (ALS) and Progressive Multiple Sclerosis (MS).

These patients represent the ultimate beneficiaries of the MN-166 program. MediciNova, Inc. announced that target enrollment was successfully achieved in its COMBAT-ALS Phase 2b/3 clinical trial for ALS as of September 2025. Furthermore, MN-166 is Phase 3-ready for progressive Multiple Sclerosis (MS). The company is also conducting a large Expanded Access Program (EAP) for MN-166, which is supported by a significant external funding source.

• Patients in the MN-166 Phase 3-ready program for Progressive MS.
• Patients enrolled in the COMBAT-ALS Phase 2b/3 trial, which achieved target enrollment as of September 2025.
• Patients participating in the MN-166 Expanded Access Program (EAP).

Patients with metabolic disorders: Hypertriglyceridemia and Non-Alcoholic Fatty Liver Disease (NAFLD).

This segment is targeted by the MN-001 (tipelukast) asset, which is being evaluated for its potential in conditions sharing lipid dysregulation pathologies. As of December 2025, patient enrollment was completed in the Phase 2 trial (MN-001-NATG-202) for patients with hypertriglyceridemia and NAFLD due to Type 2 Diabetes (T2DM). Top-line results from this trial are anticipated by summer 2026.

• Patients with Hypertriglyceridemia and NAFLD due to T2DM enrolled in the Phase 2 study.
• Physicians treating complex metabolic and cardiovascular disease profiles.

Neurologists, pulmonologists, and other specialists treating these complex diseases.

These specialists are the key opinion leaders and prescribers who will ultimately evaluate and recommend MN-166 and MN-001. Their trust is built on clinical data, which, as of late 2025, is being generated across multiple trials. The company's focus is on the U.S. market for commercialization.

Government and non-profit organizations funding clinical research, like the NIH.

These entities are crucial partners, providing non-dilutive capital for specific development activities. A concrete example of this segment's support is the large Expanded Access Program (EAP) for MN-166, which is explicitly supported by a $22 million grant from the National Institutes of Health (NIH). The company notes a history of securing investigator-sponsored trials funded through government grants for its non-core programs as well.

Institutional and retail investors providing capital for R&D.

As a publicly-held company trading on NASDAQ (MNOV), MediciNova, Inc. relies on capital markets to fund its operations, which saw a Net Loss of $9.20 Million in the first three quarters of 2025. As of November 10, 2025, the Market Cap stood at $69.2M, with 49,046,246 shares outstanding. To maintain liquidity for its development stage profile, the company established a $30.0 million Standby Equity Purchase Agreement (SEPA) in July 2025. Institutional investors held approximately 10.48% of the shares as of September 30, 2025.

Here's the quick math on the financial backing and burn rate as of the Q3 2025 filing:

Metric	Value (as of Q3 2025 Nine Months)
Cash and Equivalents	$32,562,612
Cumulative Revenue (YTD)	$0.26 Million
Operating Cash Outflows (Nine Months)	$7,793,264
SEPA Facility Size	$30.0 Million

What this estimate hides is the runway; management stated cash is sufficient to fund operations at least through November 2026. Finance: draft 13-week cash view by Friday.

MediciNova, Inc. (MNOV) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for MediciNova, Inc. as they push their late-stage pipeline. For a clinical-stage biopharma company, the cost structure is heavily weighted toward the science and the trials needed to prove that science works. It's a high-burn environment by design, so you need to watch these numbers closely.

The primary drivers of MediciNova, Inc.'s operating costs for the nine months ended September 30, 2025, fall into a few key buckets. These expenses reflect the ongoing commitment to advancing their lead compounds, particularly MN-166 (ibudilast) through its late-stage trials.

Here's a breakdown of the major reported costs for the nine months ended September 30, 2025:

Cost Component	Amount (Nine Months Ended 9/30/2025)
Research, Development, and Patent Expenses	$5.36 million
General and Administrative Costs	$4.21 million
Stock-based Compensation Expense	$648,532
Net Loss (Burn Rate Indicator)	$9.20 million

Clinical trial execution and manufacturing costs for late-stage assets are embedded within the Research, Development, and Patents line item, but they represent a critical, often variable, part of the spend. Since MediciNova, Inc. relies on third parties to conduct these trials and manufacture product candidates, managing those contracts is a key operational cost control point.

The overall financial performance for the period shows a significant cash burn, which is typical for a company with multiple assets in late-stage development. The net loss of $9.20 million for the nine months ended September 30, 2025, clearly signals this high burn rate, meaning capital preservation and financing strategy are paramount to sustaining operations.

The cost structure is characterized by these main areas of expenditure:

• Research, development, and patent expenses of $5.36 million.
• General and administrative costs totaling $4.21 million.
• Stock-based compensation expense of $648,532.
• Significant, though unquantified here, costs for clinical trial execution.
• The resulting net loss of $9.20 million.

Honestly, for a company at this stage, R&D will always dominate the cost structure. Finance: draft 13-week cash view by Friday.

MediciNova, Inc. (MNOV) - Canvas Business Model: Revenue Streams

You're looking at the core ways MediciNova, Inc. (MNOV) brings in cash to fund its clinical pipeline. For a clinical-stage biopharma, revenue is often a mix of non-dilutive funding, operational sales, and capital raises, so you need to track all of it.

The current revenue streams for MediciNova, Inc. (MNOV) as of late 2025 are built around several distinct sources:

• Minimal product sales revenue of $\text{USD } \mathbf{0.26 \text{ million}}$ for the nine months ended September 30, 2025.
• Interest income from cash reserves, totaling $\text{USD } \mathbf{1.00 \text{ million}}$ for the nine months ended September 30, 2025.
• Non-dilutive grant funding, such as the $\text{USD } \mathbf{22 \text{ million}}$ NIH grant, which is defintely a key stream.
• Future milestone payments and royalties from potential strategic alliances.
• Proceeds from equity financing, like the $\text{USD } \mathbf{30 \text{ million}}$ SEPA with Yorkville Advisors.

It's important to see how these streams stack up against the operational burn. The equity financing is a right, not an obligation, giving you flexibility. The grant funding is non-dilutive cash that directly supports a major trial.

Here's a quick look at the confirmed financial figures supporting these streams for the nine months ended September 30, 2025, where available:

Revenue Stream Component	Reported/Stated Amount (USD)	Period/Context
Cumulative Revenue (Sales)	$0.26 million	Nine months ended September 30, 2025
Interest Income (Stated Target)	$1.00 million	Nine months ended September 30, 2025 (As per outline)
NIH Grant Funding (Non-Dilutive)	$22 million	Total Award for Expanded Access Protocol (EAP)
SEPA Capacity (Equity Financing)	$30 million	Total capacity over 36 months with Yorkville Advisors
Q3 2025 Revenue (Mayo Agreement)	$0.123319 million	Three months ended September 30, 2025

The non-dilutive grant is a massive de-risking factor for the MN-166 ALS program. This $\text{USD } \mathbf{22 \text{ million}}$ NIH/NINDS funding supports an Expanded Access Protocol (EAP) trial, which is separate from the main $\text{COMBAT-ALS Phase 2b/3}$ trial.

The Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors provides access to up to $\text{USD } \mathbf{30 \text{ million}}$ in capital over 36 months, with shares sold at $\mathbf{97\%}$ of the market price, and importantly, without additional warrants. This facility is there to support R&D programs and general corporate activities if needed.

Product sales revenue remains minimal, reflecting the company's pre-commercial stage. For the nine months ending September 30, 2025, total revenue was $\text{USD } \mathbf{0.257918 \text{ million}}$. This revenue is tied to specific agreements, such as the one with Mayo for ALS research, which generated $\text{USD } \mathbf{123,319}$ in Q3 2025.

You should also watch for potential future income streams:

• Milestone payments tied to successful clinical readouts for MN-166 (ibudilast) in ALS or MN-001 (tipelukast) in hypertriglyceridemia/fatty liver disease.
• Royalties from any out-licensed programs or future commercial partnerships.

Finance: draft 13-week cash view by Friday.