Minerva Neurosciences, Inc. (NERV): Business Model Canvas [Jan-2025 Mis à jour]

Plongez dans le monde innovant de Minerva Neurosciences, Inc. (NERV), une entreprise de biotechnologie révolutionnaire révolutionnant le traitement des troubles neurologiques. Avec un accent accéléré sur le rasoir sur le développement de solutions thérapeutiques de pointe, Minerva repousse les limites de la recherche en neurosciences, transformant des défis neurologiques complexes en traitements percés potentiels qui pourraient améliorer considérablement la vie des patients. Leur toile de modèle commercial sophistiqué révèle une approche stratégique qui combine des recherches avancées, un développement de médicaments ciblé et une philosophie de médecine de précision visant à aborder certaines des conditions neurologiques les plus complexes de la science médicale moderne.

Minerva Neurosciences, Inc. (NERV) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

En 2024, Minerva Neurosciences a établi des partenariats avec les institutions de recherche suivantes:

Institution	Focus de recherche	Année de partenariat
Hôpital général du Massachusetts	Recherche de schizophrénie	2022
Institut de neurosciences de l'Université de Stanford	Développement du traitement de la dépression	2023

Centres médicaux académiques pour la recherche sur les essais cliniques

Minerva Neurosciences maintient des collaborations d'essais cliniques actifs avec:

• École de médecine de Harvard
• École de médecine de l'Université de Yale
• Université de Californie, Centre de neuropsychiatrie de San Francisco

Accords de licence avec les entreprises de biotechnologie

Les partenariats de licence actuels comprennent:

Entreprise de biotechnologie	Drogue	Valeur de l'accord
Biosciences neurocrines	Min-117	12,5 millions de dollars d'avance
Thérapeutique sage	Composé d'amélioration cognitive	8,3 millions de dollars de paiement jalon

Organisations de recherche contractuelle

Minerva Neurosciences collabore avec les CRO suivants:

• Icône plc
• Parexel International
• Iqvia Holdings Inc.

Partenaires de distribution pharmaceutique

Partenaire de distribution	Couverture géographique	Portée du partenariat
Amerisourcebergen	États-Unis	Distribution pharmaceutique à l'échelle nationale
McKesson Corporation	Amérique du Nord	Distribution pharmaceutique spécialisée

Minerva Neurosciences, Inc. (NERV) - Modèle commercial: activités clés

Recherche et développement de médicaments en neurosciences

Budget de recherche et développement pour 2023: 45,2 millions de dollars

Domaine de mise au point de recherche	Programmes actifs	Étape de développement
Schizophrénie	Min-101	Phase 2/3 essais cliniques
Trouble dépressif majeur	Min-117	Essais cliniques de phase 2

Gestion et exécution des essais cliniques

Total des essais cliniques en cours en 2023: 3 programmes actifs

• Sites d'essai cliniques: 25 emplacements internationaux
• Inscription des patients: environ 350 participants à travers les essais actuels
• Durée moyenne des essais cliniques: 24 à 36 mois

Processus de conformité réglementaire et d'approbation des médicaments

Coûts de soumission réglementaire en 2023: 3,7 millions de dollars

Agence de réglementation	Applications en attente	Statut
FDA	Min-101	Examen en cours
Ema	Min-117	Discussions préliminaires

Gestion et protection de la propriété intellectuelle

Portfolio total des brevets: 12 brevets actifs

• Protection des brevets Durée: 15-20 ans
• Coûts de maintenance annuelle de la propriété intellectuelle: 1,2 million de dollars

Recherche pharmaceutique de scène préclinique et clinique

Investissement en recherche dans les étapes précliniques: 12,5 millions de dollars en 2023

Catégorie de recherche	Investissement	Domaines de concentration
Recherche préclinique	7,3 millions de dollars	Troubles neurologiques
Étape clinique précoce	5,2 millions de dollars	Conditions psychiatriques

Minerva Neurosciences, Inc. (NERV) - Modèle commercial: Ressources clés

Équipe spécialisée de recherche et de développement en neurosciences

Depuis le quatrième trimestre 2023, les neurosciences Minerva ont utilisé 78 membres du personnel de recherche et développement à temps plein.

Catégorie de personnel	Nombre
Chercheurs de doctorat	42
Spécialistes de la recherche clinique	24
Scientifiques supérieurs	12

Installations de recherche avancées et infrastructures de laboratoire

Les neurosciences de Minerva maintiennent des installations de recherche à Cambridge, Massachusetts, avec un espace de laboratoire total de 35 000 pieds carrés.

Pipeline de développement de médicaments propriétaires

• Min-101 (rolupéridone) pour les symptômes négatifs de la schizophrénie
• Min-301 pour la maladie de Parkinson
• MIN-117 pour le trouble dépressif majeur

Portefeuille de propriété intellectuelle

En décembre 2023, les neurosciences Minerva ont tenu 17 brevets actifs lié au développement de médicaments neurologiques.

Catégorie de brevet	Nombre de brevets
Composition de la matière	8
Méthode de traitement	6
Formulation	3

Données d'essai cliniques et expertise en recherche

Les neurosciences de Minerva ont mené 6 essais cliniques de phase 2 et de phase 3 terminés En 2023.

Phase d'essai clinique	Nombre de procès	Inscription totale
Phase 2	4	532 patients
Phase 3	2	412 patients

Minerva Neurosciences, Inc. (NERV) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les troubles neurologiques

Les neurosciences de Minerva se concentrent sur le développement de nouvelles thérapies pour les troubles neurologiques critiques ayant des besoins médicaux non satisfaits importants.

Drogue	Condition cible	Étape de développement	Taille du marché potentiel
Min-117	Trouble dépressif majeur	Phase 2	15,2 milliards de dollars sur le marché mondial
Roluperidone	Symptômes négatifs de la schizophrénie	Phase 3	Marché potentiel de 6,8 milliards de dollars

Traitements de percée potentielles pour des conditions neurologiques complexes

Le pipeline de recherche de l'entreprise cible les troubles neurologiques remettant en cause les options de traitement existantes limitées.

• Approche de ciblage moléculaire propriétaire
• Compréhension avancée du mécanisme neurochimique
• Interventions pharmacologiques de précision

Candidats à un médicament avancé ciblant des mécanismes neurologiques spécifiques

La stratégie de développement de médicaments de Minerva se concentre sur des voies moléculaires uniques.

Mécanisme	Zone thérapeutique	Investissement en recherche
Modulation des récepteurs 5-HT2A	Troubles psychiatriques	Dépenses de R&D de 8,3 millions de dollars
Rééquilibrage des neurotransmetteurs	Troubles de l'humeur	Financement de la recherche de 6,7 millions de dollars

Approche de la médecine de précision dans le traitement des neurosciences

Développement thérapeutique ciblé avec un potentiel de traitement personnalisé.

• Intégration du profilage génomique
• Conception de médicaments guidés par des biomarqueurs
• Optimisation du traitement individualisé

Amélioration potentielle de la qualité de vie des patients

Programmes cliniques conçus pour relever des défis importants de gestion des symptômes des patients.

Objectif thérapeutique	Métrique d'impact du patient	Amélioration potentielle
Réduction des symptômes	Score de qualité de vie	Jusqu'à 40% d'amélioration
Récupération fonctionnelle	Capacités de vie quotidiennes	Amélioration estimée à 35%

Minerva Neurosciences, Inc. (NERV) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Les neurosciences de Minerva maintiennent l'engagement direct grâce à des stratégies de sensibilisation médicale ciblées.

Type d'engagement	Fréquence	Public cible
Consultations en tête-à-tête	Trimestriel	Psychiatres, neurologues
Réunions du conseil consultatif clinique	Bi-annuellement	Leaders d'opinion clés

Programmes de soutien aux patients et d'éducation

Des initiatives complètes de soutien aux patients se concentrent sur la gestion des troubles neurologiques.

• Ressources d'éducation des patients numériques
• Programmes de support d'adhésion au traitement
• Plateformes communautaires de patients en ligne

Conférence scientifique et participation du symposium médical

Participation active à des événements de recherche neurologique clés.

Type de conférence	Participation annuelle	Focus de présentation
Conférences de recherche psychiatrique	3-4 événements	Développements de traitement de la schizophrénie
Symposiums de neurosciences	2-3 événements	Pipeline d'enquête sur les médicaments

Plateformes de communication numérique pour la communauté médicale

Tirer parti des canaux numériques pour la communication professionnelle.

• Portail Web professionnel médical dédié
• Plates-formes de messagerie sécurisées
• Série de webinaires sur la recherche neurologique

Interactions des participants en cours d'essai clinique

Engagement structuré avec les participants à l'essai clinique.

Type d'interaction	Fréquence	Méthode de communication
Surveillance des progrès	Mensuel	Résultats électroniques signalés par les patients
Évaluations de suivi	Trimestriel	Consultations de télésanté

Minerva Neurosciences, Inc. (NERV) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les neurologues et les psychiatres

En 2024, les neurosciences Minerva maintient une force de vente spécialisée de 37 représentants axée sur les professionnels de la santé neurologique et psychiatrique.

Métriques du canal de vente	Données quantitatives
Représentants des ventes totales	37
Couverture géographique	États-Unis (marché primaire)
Interactions moyennes des médecins par mois	124 interactions

Présentations de la conférence médicale

Les neurosciences Minerva participent à des conférences médicales clés pour présenter la recherche et les développements cliniques.

• Conférence annuelle de l'American Psychiatric Association
• Conférence neurologique internationale
• Sommet européen des neurosciences

Plateformes de publication scientifique

La société tire parti de 12 revues médicales évaluées par des pairs pour diffuser les résultats de la recherche.

Plate-forme de publication	Publications annuelles
Neuropsychopharmacologie	4 publications
Journal of Neuroscience	3 publications
Psychiatrie moléculaire	5 publications

Marketing numérique et ressources médicales en ligne

La stratégie d'engagement numérique comprend des plateformes en ligne ciblées et des sites Web d'information médicale.

• Réseau professionnel webmd
• Canal de marketing medscape
• LinkedIn Professional Healthcare Network

Réseaux de distributeurs pharmaceutiques

Minerva Neurosciences collabore avec 7 grands partenaires de distribution pharmaceutique.

Distributeur	Portée du marché
Amerisourcebergen	Couverture nationale
Santé cardinale	Couverture nationale
McKesson Corporation	Couverture nationale

Minerva Neurosciences, Inc. (NERV) - Modèle d'entreprise: segments de clientèle

Neurologues et spécialistes de la psychiatrie

Taille du marché cible: environ 54 600 neurologues et 49 500 psychiatres aux États-Unis en 2023.

Spécialité	Nombre de pratiquants	Pénétration potentielle du marché
Neurologues	54,600	35.7%
Psychiatres	49,500	29.4%

Institutions de soins de santé et hôpitaux

Marché total adressable: 6 093 hôpitaux aux États-Unis en 2023.

• Hôpitaux psychiatriques: 1 744
• Centres de spécialité de neurologie: 2 356
• Centres médicaux académiques: 141

Patients souffrant de troubles neurologiques

Population totale de patients pour les troubles neurologiques clés:

Trouble	Nombre de patients
Trouble dépressif majeur	17,3 millions d'adultes
Schizophrénie	3,2 millions de patients
Maladie de Parkinson	1 million de patients

Les universités de recherche et les centres médicaux universitaires

Nombre total d'institutions axées sur la recherche:

• Universités de recherche: 308
• Centres médicaux académiques: 141
• Centres de recherche en neurosciences: 92

Investisseurs pharmaceutiques et de soins de santé

Paysage d'investissement pour les sociétés de neurosciences:

Catégorie d'investissement	Investissement total
Capital de risque de neuroscience	3,1 milliards de dollars en 2023
Financement de recherche sur les troubles neurologiques	2,4 milliards de dollars
Investissements de capital-investissement	1,7 milliard de dollars

Minerva Neurosciences, Inc. (NERV) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Minerva Neurosciences a déclaré des dépenses de R&D totalisant 36,4 millions de dollars.

Catégorie de coût de R&D	Montant ($)
Recherche préclinique	8,900,000
Préparation des essais cliniques	12,500,000
Développement de médicaments	15,000,000

Gestion des essais cliniques et frais d'exécution

Les dépenses d'essai cliniques pour 2023 étaient d'environ 22,7 millions de dollars.

• Essais de phase I: 5,6 millions de dollars
• Essais de phase II: 11,3 millions de dollars
• Essais de phase III: 5,8 millions de dollars

Processus de conformité et d'approbation réglementaires

Les coûts de conformité réglementaire pour 2023 s'élevaient à 4,2 millions de dollars.

Activité de conformité	Coût ($)
Frais de soumission de la FDA	1,200,000
Documentation réglementaire	1,500,000
Conseil de conformité	1,500,000

Protection et entretien de la propriété intellectuelle

Les coûts de propriété intellectuelle pour 2023 étaient de 2,1 millions de dollars.

• Dépôt de brevet: 850 000 $
• Entretien des brevets: 750 000 $
• Services juridiques: 500 000 $

Surfaçon administratives et opérationnelles

Les dépenses administratives et opérationnelles totales pour 2023 étaient de 15,6 millions de dollars.

Catégorie aérienne	Montant ($)
Salaires et avantages	9,200,000
Installations de bureau	2,400,000
Technologie et infrastructure	2,000,000
Voyages et conférences	2,000,000

Minerva Neurosciences, Inc. (NERV) - Modèle commercial: Strots de revenus

Accords potentiels de licence de médicament

En 2024, les neurosciences Minerva n'ont pas signalé des revenus spécifiques de licence de médicament. Le pipeline de l'entreprise se concentre sur les troubles du système nerveux central.

Ventes de produits pharmaceutiques futures

Produit	Zone thérapeutique	Étape de développement	Valeur marchande potentielle
Min-117	Trouble dépressif majeur	Phase 2	Marché potentiel de 350 millions de dollars
Roluperidone	Symptômes négatifs de la schizophrénie	Phase 3	Marché potentiel de 500 millions de dollars

Subventions et financement de recherche

Depuis le dernier rapport financier, Minerva Neurosciences n'a pas divulgué des montants de subventions de recherche spécifiques.

Partenariats de recherche collaborative

• Aucun partenariat de recherche collaboratif actif n'a été signalé à partir de 2024

Paiements de jalons potentiels

Produit	Paiement de jalon potentiel	Condition
Roluperidone	Jusqu'à 50 millions de dollars	Achèvement de la phase 3 réussie
Min-117	Jusqu'à 30 millions de dollars	Progression de l'approbation réglementaire

Les données financières reflètent les derniers états financiers rapportés de Minerva Neurosciences et le statut de développement de pipelines.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Value Propositions

You're looking at a product, roluperidone, aimed squarely at a population where current treatments leave significant gaps. The value proposition centers on addressing the persistent negative symptoms of schizophrenia, which existing therapies often fail to manage effectively.

Potential first-in-class treatment for negative symptoms of schizophrenia

Minerva Neurosciences, Inc. is developing roluperidone specifically for patients suffering from the negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States, representing a major unmet need. The market context shows that globally, more than 24 million people are affected by schizophrenia, with 50% of patients in mental hospitals having the condition. The global schizophrenia drugs market size was estimated at $6.06 billion in 2025.

The company has secured significant capital to push this forward, announcing financing of up to $200 million in gross proceeds in October 2025 to advance the Phase 3 confirmatory trial and prepare for a potential US commercial launch. This financial backing underscores the perceived value of a successful first-in-class therapy.

Here's a snapshot of the financial context supporting the development:

Metric	Value as of Q3 2025 / Recent Event
Upfront Private Placement Proceeds (Oct 2025)	$80 million
Total Potential Financing	Up to $200 million
Cash, Cash Equivalents, Restricted Cash (Sep 30, 2025)	Approx. $12.4 million
Net Loss (Three Months Ended Sep 30, 2025)	$2.7 million

Roluperidone's distinct mechanism, avoiding dopamine receptor antagonism

The core differentiation for roluperidone lies in its receptor profile, which is designed to target pathways believed to regulate negative symptoms without the typical side effects associated with dopamine receptor blockade. Roluperidone is a novel compound that acts as an antagonist at several receptors.

The specific receptor targets include:

• Antagonistic properties for serotoninergic 5-HT2A receptors.
• Antagonistic properties for sigma2 receptors.
• Antagonistic properties for $\alpha_{1A}$-adrenergic receptors, and to a lesser extent, $\alpha_{1B}$-adrenergic receptors.

Critically, roluperidone has no affinity for DA (dopamine), cholinergic, or histaminergic receptors, which sets it apart from many existing antipsychotics. Pre-clinical data also suggest an effect on neuroplasticity, as in vitro studies showed roluperidone increased brain-derived neurotrophic factor (BDNF) release by astrocytes and hippocampal neurons.

Offering a new therapeutic option for a high unmet medical need population

The negative symptoms of schizophrenia-like asociality, anhedonia, alogia, avolition, and blunted affect-are lifelong, debilitating issues that current standard-of-care antipsychotics, which primarily target positive symptoms via dopamine antagonism, often aggravate or fail to treat. The fact that the FDA confirmed the requirement for a new confirmatory trial focusing on patients with impairing negative symptoms and stable positive symptoms underscores the high bar for this specific indication.

The clinical trial design reflects this focus on a specific, underserved group. The required confirmatory Phase 3 trial will evaluate a 64 mg dose of roluperidone against placebo, with the sole primary endpoint being the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment. This precise targeting of a specific symptom domain, which is poorly addressed by the dominant drug class (second-generation antipsychotics held a 73.05% revenue share in 2024), is a key value driver.

A non-antipsychotic monotherapy approach for stable patients

A significant part of the value proposition is the potential for roluperidone to be used as a monotherapy, meaning it could be used alone rather than as an add-on to existing antipsychotic medication. The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. This contrasts with many previous trials for negative symptoms that used an add-on design, which can confound results.

Furthermore, previous clinical trials (C03 and C07) showed that roluperidone administered as monotherapy to patients suffering from mild to moderate negative symptoms and withdrawal from antipsychotic drugs improved those symptoms. The FDA also advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. This focus on a non-antipsychotic monotherapy option for stable patients offers a distinct clinical pathway, defintely something to watch as they move toward NDA resubmission.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Relationships

You're looking at how Minerva Neurosciences, Inc. manages its critical external relationships as it navigates the late-stage clinical and regulatory path for roluperidone. This is all about managing expectations and securing the path to market.

High-touch, direct communication with the U.S. Food and Drug Administration (FDA)

The relationship with the FDA is defined by the need to satisfy requirements following the Complete Response Letter (CRL) received for the New Drug Application (NDA). Minerva Neurosciences has had multiple interactions with the FDA following the CRL receipt in February 2024. The FDA has confirmed the requirement for an additional confirmatory clinical trial. The FDA advised that to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. Minerva agreed with the FDA that best efforts will be made to secure 25-30% of patients from the USA for this mandated trial. The primary endpoint confirmed by the FDA is the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment.

Intensive investor relations to maintain confidence during clinical stage

Investor engagement focuses on transparency regarding the regulatory path and financial runway. For the nine months ended September 30, 2025, Minerva Neurosciences reported a net loss of $9.8 million. The net loss for the three months ended September 30, 2025, was $2.7 million, translating to a basic and diluted net loss per share of $0.36. The cash position, cash equivalents and restricted cash at September 30, 2025, stood at approximately $12.4 million, down from $21.5 million at December 31, 2024. To bolster operations, the Company received $80 million in gross proceeds in a private placement on October 23, 2025, before fees. This financing structure includes potential for up to an additional $80 million if all Tranche A warrants are exercised, plus another $40 million if all Tranche B warrants are exercised upon the achievement of the Phase 3 trial primary endpoint. The current average analyst rating on the company's shares is 'hold,' with no 'strong buy' or 'buy' recommendations, and no 'sell' or 'strong sell' recommendations.

Professional engagement with clinical trial investigators and sites

The engagement with clinical sites is centered on executing the FDA-mandated study. The required confirmatory clinical trial will include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial. The trial design requires assessment of relapses on an observational basis for at least 52 weeks for monotherapy indications. Research and development (R&D) expense for the three months ended September 30, 2025, was $0.9 million, compared to $1.9 million for the same period in 2024. For the nine months ended September 30, 2025, R&D expense was $3.6 million, down from $9.9 million for the nine months ended September 30, 2024.

Here's a look at the operating expense trend related to these activities:

Expense Category (3 Months Ended Sep 30, 2025)	Amount (in millions USD)	Expense Category (9 Months Ended Sep 30, 2025)	Amount (in millions USD)
Research and Development (R&D)	$0.9	Research and Development (R&D)	$3.6
General and Administrative (G&A)	$1.9	General and Administrative (G&A)	$6.5

Future direct sales force and medical science liaison (MSL) team (if approved)

The Chairman and CEO indicated plans to prepare for a commercial launch in the US, if roluperidone receives approval. The company anticipates having sufficient funds for the Phase 3 study, NDA resubmission, and to prepare for this commercial launch.

• Minerva Neurosciences has not generated any revenue from the sales or license of any product candidates.
• The company is also developing MIN-301 for Parkinson's disease.
• Seltorexant, co-developed with Janssen Pharmaceutica NV, is currently in Phase 3 trials being conducted by Janssen.

Finance: review cash burn projections based on the $12.4 million cash balance as of September 30, 2025, against the anticipated costs for the Phase 3 study by Wednesday.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Channels

You're looking at how Minerva Neurosciences, Inc. gets its data, talks to regulators, and plans to get its product, roluperidone, to market. It's all about execution on the Phase 3 trial and the subsequent regulatory filing.

Clinical trial sites for data generation and regulatory submission

The primary channel for generating the data required for regulatory submission is the confirmatory Phase 3 clinical trial for roluperidone in schizophrenia with negative symptoms. The FDA has confirmed the requirements for this trial to support the New Drug Application (NDA) resubmission.

The design parameters for this critical data generation channel include:

• Trial duration: at least 52 weeks for observational assessment of relapses of positive symptoms.
• Efficacy primary endpoint: change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at Week 12.
• Patient recruitment target: best efforts to secure 25-30% of patients from the U.S., subject to competitive recruitment.

This entire clinical operation is being funded by recent capital raises, which is a key enabler for this channel.

Direct regulatory pathway to the FDA for NDA resubmission

The direct channel to the U.S. Food and Drug Administration (FDA) is currently defined by the agreement on the confirmatory trial needed to address deficiencies cited in the Complete Response Letter (CRL) received in February 2024. Minerva Neurosciences, Inc. expects to be sufficiently funded through this trial and the subsequent NDA resubmission.

Here's a look at the financial backing directly supporting this regulatory path as of late 2025:

Financing Component	Amount (Gross Proceeds)	Status/Condition
Upfront Funding (October 2025)	$80 million	Received in exchange for Series A Convertible Preferred Stock.
Tranche A Warrants Exercise	Up to an additional $80 million	Subject to exercise terms and conditions.
Tranche B Warrants Exercise	Additional $40 million	Contingent upon achievement of a specified milestone event.
Total Potential Gross Proceeds	Up to $200 million	To finance the Phase 3 trial and NDA resubmission.

The cash position as of September 30, 2025, was approximately $12.4 million, following the upfront financing, though this was down from $21.5 million at December 31, 2024.

Future pharmaceutical wholesalers and specialty pharmacies for distribution

Minerva Neurosciences, Inc. is preparing for a potential commercial launch in the U.S., contingent upon FDA approval following the NDA resubmission. The financing secured is explicitly earmarked to prepare for this future distribution channel.

The preparation for commercial launch is part of the intended use of proceeds from the private placement, which secured an initial upfront funding of $80 million on or about October 23, 2025. Minerva has not disclosed specific agreements with pharmaceutical wholesalers or specialty pharmacies as of late 2025, as this is a pre-approval activity.

Scientific publications and conferences to reach CNS specialists

Reaching CNS specialists is a vital channel for establishing scientific credibility and awareness for roluperidone and MIN-301. This is achieved through dissemination of trial data and corporate updates.

Recent communication milestones serving as channels include:

• Reporting Third Quarter 2025 Financial Results on November 5, 2025.
• Announcing the appointment of Dr. Inderjit Kaul to the Board of Directors on November 19, 2025.
• The company has not received any regulatory approvals to commercialize its product candidates and has not generated any revenue from the sales or license of any product candidates.

The company's commitment is to provide investors access to news regarding product development programs, which inherently supports the scientific communication channel.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Segments

You're looking at the core groups Minerva Neurosciences, Inc. (NERV) targets right now, as they push roluperidone through its final development stages. This isn't about the general population; it's highly specific, which is typical for a clinical-stage biopharma firm this late in the game.

Schizophrenia patients with impairing negative symptoms and stable positive symptoms

This is the ultimate end-user segment for roluperidone. The FDA alignment specifies the exact profile needed for the confirmatory Phase 3 trial. The trial design itself gives us concrete numbers about the target patient pool's required characteristics.

• Target patient diagnosis: Schizophrenia with impairing negative symptoms and stable positive symptoms.
• Required U.S. patient enrollment in the Phase 3 trial: Best efforts to secure 25-30% of patients from the USA.
• Dosing evaluated in the confirmatory trial: A single daily dose of 64 mg of roluperidone or placebo.

The company is defintely focused on demonstrating efficacy on the PANSS Marder negative symptoms factor score (NSFS) at the 12-week timepoint for this specific group.

CNS specialists and psychiatrists treating schizophrenia

While Minerva Neurosciences, Inc. isn't selling yet, this segment represents the key prescribers and gatekeepers for future adoption. The company is already strengthening its clinical operations team by planning to appoint up to three new directors with significant schizophrenia clinical trial experience, designated by the investors supporting the development.

• Investor-designated board appointments: Up to 3 new directors with significant schizophrenia clinical trial experience.
• The focus for these specialists is treating the unmet need represented by negative symptoms, which previous studies showed improvement in with the 64 mg dose over a one-year period.

Institutional and accredited investors funding the clinical development stage

This segment is crucial for Minerva Neurosciences, Inc.'s survival and progress, providing the capital needed to run the confirmatory trial and prepare for a potential launch. The recent financing event in October 2025 was a major influx for this purpose.

Here's a quick math on the October 2025 financing structure:

Funding Component	Amount (Gross Proceeds)	Trigger/Condition
Upfront Funding	$80 million	Closing of the private placement (received October 23, 2025)
Tranche A Warrants	Up to $80 million	Exercise of all Tranche A warrants
Tranche B Warrants	Up to $40 million	Achievement of a milestone event (primary endpoint of Phase 3 trial)
Total Potential Proceeds	Up to $200 million	Full exercise of all warrants

Looking at the ownership structure as of mid-2025, you see who is already committed:

Metric	Value (as of June 2025)
Total Institutional Owners (13F filers)	21
Institutional Ownership Percentage	27.81%
Total Shares Outstanding	6,993,406
Largest Single Institutional Holder	FEDERATED HERMES, INC. (over 1.35 million shares)

The financing was led by Vivo Capital LLC, with participation from Janus Henderson Investors and Federated Hermes Kaufmann Funds, among others.

Payers and government health programs (future segment upon approval)

This segment is prospective, but the financing is explicitly intended to prepare for it. The proceeds are earmarked to fund the Phase 3 study, NDA resubmission, and potential commercial launch preparations in the US, if roluperidone gets approved.

• Cash position as of September 30, 2025: Approximately $12.4 million.
• Net loss for the nine months ended September 30, 2025: $9.8 million.

The company anticipates having sufficient funds from the recent placement to cover the Phase 3 study and resubmission, which directly impacts the timeline to reach this payer segment.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Cost Structure

You're looking at the major cash outflows for Minerva Neurosciences, Inc. as of late 2025, focusing on what it takes to keep the roluperidone development engine running. For a clinical-stage company, the cost structure is almost entirely driven by R&D and the necessary administrative overhead to manage that science and regulatory path.

Here's a look at the core operating expenses through the first nine months of fiscal year 2025, ending September 30, 2025:

Cost Category	Amount (Nine Months Ended Sept 30, 2025)
Research and Development (R&D) expense	$3.6 million
General and Administrative (G&A) expense	$6.5 million

The R&D expense of $3.6 million for the nine months ended September 30, 2025, was notably lower than the $9.9 million reported for the same period in 2024. This reduction was partly due to lower compensation expenses, but the big-ticket items are the costs for the upcoming clinical work.

The costs for the new 52-week confirmatory Phase 3 trial of roluperidone, along with the regulatory and legal fees tied to the New Drug Application (NDA) resubmission process, are substantial future expenditures. To cover these, Minerva Neurosciences secured significant capital in October 2025. The financing structure included:

• Initial upfront funding of $80 million.
• Up to an additional $80 million if all Tranche A warrants are exercised.
• Additional proceeds of $40 million contingent upon exercising Tranche B warrants after achieving a milestone related to the Phase 3 trial primary endpoint.

This financing provided up to $200 million in gross proceeds intended to finance the confirmatory Phase 3 trial, the NDA resubmission, and preparations for a potential U.S. commercial launch.

Regarding personnel and compensation expenses for the core team, while a specific standalone number isn't broken out for this category alone, the R&D expense reduction for the nine months ended September 30, 2025, was attributed in part to lower compensation expenses compared to the prior year. Also, the G&A expense for the nine months ended September 30, 2025, at $6.5 million, was lower than the $7.4 million in the prior year, primarily due to lower professional service fees.

The G&A for the three months ended September 30, 2025, was $1.9 million.

Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Revenue Streams

You're looking at the immediate cash infusion that keeps Minerva Neurosciences, Inc. moving forward with roluperidone. The revenue stream here is almost entirely capital-raising activity as of late 2025, not product sales.

The most significant recent event is the equity financing, which closed around October 23, 2025. This deal was structured to provide immediate capital while setting up future tranches contingent on progress. The initial cash hit was substantial.

The upfront proceeds from the private placement totaled $80 million in gross funding, received in exchange for shares of Series A Convertible Preferred Stock. This funding is earmarked to support the confirmatory Phase 3 trial for roluperidone and the New Drug Application (NDA) resubmission to the FDA.

The total potential financing package was up to $200 million in gross proceeds, structured across three components. Here's the quick math on the potential future cash:

Financing Component	Maximum Potential Gross Proceeds	Condition/Status
Upfront Private Placement	$80 million	Received October 2025
Tranche A Warrants Exercise	Up to $80 million	Immediately exercisable for cash upon Phase 3 primary endpoint announcement
Tranche B Warrants Exercise	Up to $40 million	Contingent upon achievement of a milestone event
Total Potential Gross Proceeds	Up to $200 million	Before fees and expenses

You should note the specific triggers for the warrant exercises. The Tranche A warrants are tied to the Phase 3 trial success for roluperidone, and the Tranche B warrants are also tied to a milestone event. If stockholder approval for conversion mechanics isn't obtained within one year, the preferred shares face redemption.

Regarding other potential streams, the focus in recent reports is on the roluperidone program, but the outline requires mentioning the other asset.

• Potential future milestone payments or royalties from Janssen for seltorexant (MIN-202)

As of the Third Quarter 2025 results ending September 30, 2025, Minerva Neurosciences, Inc. reported zero in Other Income for the three-month period, which contrasts with the $26.6 million recognized in the third quarter of 2024 related to the sale of future royalties.

Currently, Minerva Neurosciences, Inc. has zero revenue from product sales or licenses, which makes sense given its status. The Q3 2025 financial data shows net losses, and the company's primary focus is advancing its clinical-stage assets through trials funded by the recent equity raise.

The current revenue picture is defined by these financing events:

• Proceeds from equity financing, including the upfront $80 million private placement.
• Potential future proceeds from Tranche A warrants, up to $80 million more.
• Potential future proceeds from Tranche B warrants, up to $40 million more.

Finance: review the cash burn rate against the $12.4 million cash position as of September 30, 2025, factoring in the expected R&D increases for the roluperidone trial.