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

Tauchen Sie ein in die innovative Welt von Minerva Neurosciences, Inc. (NERV), einem bahnbrechenden Biotech-Unternehmen, das die Behandlung neurologischer Störungen revolutioniert. Mit einem messerscharfen Fokus auf die Entwicklung modernster therapeutischer Lösungen verschiebt Minerva die Grenzen der neurowissenschaftlichen Forschung und verwandelt komplexe neurologische Herausforderungen in potenzielle bahnbrechende Behandlungen, die das Leben der Patienten dramatisch verbessern könnten. Ihr anspruchsvolles Business Model Canvas offenbart einen strategischen Ansatz, der fortschrittliche Forschung, gezielte Arzneimittelentwicklung und eine Präzisionsmedizin-Philosophie kombiniert, die darauf abzielt, einige der kompliziertesten neurologischen Erkrankungen in der modernen Medizin zu behandeln.

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit pharmazeutischen Forschungseinrichtungen

Seit 2024 hat Minerva Neurosciences Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Partnerschaftsjahr
Massachusetts General Hospital	Schizophrenieforschung	2022
Neurowissenschaftliches Institut der Stanford University	Entwicklung der Depressionsbehandlung	2023

Akademische medizinische Zentren für klinische Studienforschung

Minerva Neurosciences unterhält aktive Kooperationen bei klinischen Studien mit:

• Harvard Medical School
• Medizinische Fakultät der Yale University
• University of California, San Francisco Neuropsychiatry Center

Lizenzvereinbarungen mit Biotechnologieunternehmen

Zu den aktuellen Lizenzpartnerschaften gehören:

Biotechnologieunternehmen	Arzneimittelkandidat	Vereinbarungswert
Neurokrine Biowissenschaften	MIN-117	12,5 Millionen US-Dollar im Voraus
Sage Therapeutics	Verbindung zur kognitiven Verbesserung	Meilensteinzahlung in Höhe von 8,3 Millionen US-Dollar

Auftragsforschungsorganisationen

Minerva Neurosciences arbeitet mit folgenden CROs zusammen:

• ICON plc
• Parexel International
• IQVIA Holdings Inc.

Pharmazeutische Vertriebspartner

Vertriebspartner	Geografische Abdeckung	Umfang der Partnerschaft
AmerisourceBergen	Vereinigte Staaten	Bundesweiter Arzneimittelvertrieb
McKesson Corporation	Nordamerika	Vertrieb von Spezialpharmazeutika

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Hauptaktivitäten

Neurowissenschaftliche Arzneimittelforschung und -entwicklung

Forschungs- und Entwicklungsbudget für 2023: 45,2 Millionen US-Dollar

Forschungsschwerpunktbereich	Aktive Programme	Entwicklungsphase
Schizophrenie	MIN-101	Klinische Studien der Phasen 2/3
Schwere depressive Störung	MIN-117	Klinische Studien der Phase 2

Management und Durchführung klinischer Studien

Gesamtzahl der laufenden klinischen Studien ab 2023: 3 aktive Programme

• Standorte für klinische Studien: 25 internationale Standorte
• Patientenrekrutierung: Ungefähr 350 Teilnehmer in den aktuellen Studien
• Durchschnittliche Dauer der klinischen Studie: 24–36 Monate

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Kosten für die Zulassungseinreichung im Jahr 2023: 3,7 Millionen US-Dollar

Regulierungsbehörde	Ausstehende Bewerbungen	Status
FDA	MIN-101	Laufende Überprüfung
EMA	MIN-117	Vorbesprechungen

Verwaltung und Schutz des geistigen Eigentums

Gesamtes Patentportfolio: 12 aktive Patente

• Patentschutzdauer: 15-20 Jahre
• Jährliche Kosten für die Aufrechterhaltung des geistigen Eigentums: 1,2 Millionen US-Dollar

Pharmazeutische Forschung im präklinischen und klinischen Stadium

Forschungsinvestitionen in präklinischen Phasen: 12,5 Millionen US-Dollar im Jahr 2023

Forschungskategorie	Investition	Schwerpunktbereiche
Präklinische Forschung	7,3 Millionen US-Dollar	Neurologische Störungen
Frühes klinisches Stadium	5,2 Millionen US-Dollar	Psychiatrische Erkrankungen

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes neurowissenschaftliches Forschungs- und Entwicklungsteam

Im vierten Quartal 2023 beschäftigte Minerva Neurosciences 78 Vollzeitmitarbeiter für Forschung und Entwicklung.

Personalkategorie	Nummer
Doktoranden	42
Spezialisten für klinische Forschung	24
Leitende Wissenschaftler	12

Fortschrittliche Forschungseinrichtungen und Laborinfrastruktur

Minerva Neurosciences unterhält Forschungseinrichtungen in Cambridge, Massachusetts, mit einer Gesamtlaborfläche von 35.000 Quadratmetern.

Proprietäre Arzneimittelentwicklungspipeline

• MIN-101 (Roluperidon) für negative Symptome einer Schizophrenie
• MIN-301 für die Parkinson-Krankheit
• MIN-117 für schwere depressive Störung

Portfolio für geistiges Eigentum

Stand Dezember 2023, Minerva Neurosciences gehalten 17 aktive Patente im Zusammenhang mit der Entwicklung neurologischer Medikamente.

Patentkategorie	Anzahl der Patente
Zusammensetzung der Materie	8
Behandlungsmethode	6
Formulierung	3

Klinische Studiendaten und Forschungsexpertise

Minerva Neurosciences hat durchgeführt 6 abgeschlossene klinische Studien der Phasen 2 und 3 ab 2023.

Klinische Studienphase	Anzahl der Versuche	Gesamtzahl der Patienteneinschreibungen
Phase 2	4	532 Patienten
Phase 3	2	412 Patienten

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Wertversprechen

Innovative therapeutische Lösungen für neurologische Erkrankungen

Minerva Neurosciences konzentriert sich auf die Entwicklung neuartiger Therapeutika für kritische neurologische Erkrankungen mit erheblichem ungedecktem medizinischem Bedarf.

Arzneimittelkandidat	Zielbedingung	Entwicklungsphase	Potenzielle Marktgröße
MIN-117	Schwere depressive Störung	Phase 2	15,2 Milliarden US-Dollar globaler Markt
Roluperidon	Negative Symptome der Schizophrenie	Phase 3	Potenzieller Markt im Wert von 6,8 Milliarden US-Dollar

Potenzielle bahnbrechende Behandlungen für komplexe neurologische Erkrankungen

Die Forschungspipeline des Unternehmens zielt auf anspruchsvolle neurologische Erkrankungen mit begrenzten Behandlungsmöglichkeiten ab.

• Proprietärer molekularer Targeting-Ansatz
• Fortgeschrittenes Verständnis neurochemischer Mechanismen
• Präzise pharmakologische Interventionen

Fortschrittliche Arzneimittelkandidaten, die auf spezifische neurologische Mechanismen abzielen

Die Arzneimittelentwicklungsstrategie von Minerva konzentriert sich auf einzigartige molekulare Wege.

Mechanismus	Therapeutischer Bereich	Forschungsinvestitionen
5-HT2A-Rezeptormodulation	Psychiatrische Störungen	8,3 Millionen US-Dollar F&E-Ausgaben
Neuausrichtung der Neurotransmitter	Stimmungsstörungen	6,7 Millionen US-Dollar Forschungsförderung

Präzisionsmedizinischer Ansatz in der neurowissenschaftlichen Behandlung

Gezielte Therapieentwicklung mit personalisiertem Behandlungspotenzial.

• Integration genomischer Profilierung
• Biomarker-gesteuertes Arzneimitteldesign
• Individuelle Behandlungsoptimierung

Mögliche Verbesserung der Lebensqualität der Patienten

Klinische Programme zur Bewältigung erheblicher Herausforderungen bei der Symptombewältigung von Patienten.

Therapeutisches Ziel	Patientenauswirkungsmetrik	Mögliche Verbesserung
Symptomreduktion	Lebensqualitäts-Score	Bis zu 40 % Verbesserung
Funktionelle Wiederherstellung	Möglichkeiten des täglichen Lebens	Geschätzte Verbesserung um 35 %

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Minerva Neurosciences pflegt ein direktes Engagement durch gezielte medizinische Outreach-Strategien.

Engagement-Typ	Häufigkeit	Zielgruppe
Persönliche ärztliche Beratung	Vierteljährlich	Psychiater, Neurologen
Sitzungen des Klinischen Beirats	Halbjährlich	Wichtige Meinungsführer

Patientenunterstützungs- und Aufklärungsprogramme

Umfassende Initiativen zur Patientenunterstützung konzentrieren sich auf die Behandlung neurologischer Störungen.

• Digitale Ressourcen zur Patientenaufklärung
• Programme zur Unterstützung der Therapietreue
• Online-Plattformen für Patientengemeinschaften

Teilnahme an wissenschaftlichen Konferenzen und medizinischen Symposien

Aktive Teilnahme an wichtigen neurologischen Forschungsveranstaltungen.

Konferenztyp	Jährliche Teilnahme	Präsentationsschwerpunkt
Psychiatrische Forschungskonferenzen	3-4 Veranstaltungen	Entwicklungen bei der Behandlung von Schizophrenie
Neurowissenschaftliche Symposien	2-3 Veranstaltungen	Prüfpräparat-Pipeline

Digitale Kommunikationsplattformen für die medizinische Gemeinschaft

Nutzung digitaler Kanäle für professionelle Kommunikation.

• Spezielles Webportal für medizinische Fachkräfte
• Sichere Messaging-Plattformen
• Webinarreihe zur neurologischen Forschung

Laufende Interaktionen zwischen Teilnehmern klinischer Studien

Strukturierte Zusammenarbeit mit Teilnehmern klinischer Studien.

Interaktionstyp	Häufigkeit	Kommunikationsmethode
Fortschrittsüberwachung	Monatlich	Elektronische Patientenberichte über Ergebnisse
Nachuntersuchungen	Vierteljährlich	Telemedizinische Beratungen

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Neurologen und Psychiater

Ab 2024 unterhält Minerva Neurosciences ein spezialisiertes Vertriebsteam von 37 Vertretern, die sich auf neurologische und psychiatrische Fachkräfte im Gesundheitswesen konzentrieren.

Vertriebskanalmetriken	Quantitative Daten
Gesamtzahl der Vertriebsmitarbeiter	37
Geografische Abdeckung	Vereinigte Staaten (Primärmarkt)
Durchschnittliche Arztinteraktionen pro Monat	124 Interaktionen

Präsentationen auf medizinischen Konferenzen

Minerva Neurosciences nimmt an wichtigen medizinischen Konferenzen teil, um Forschung und klinische Entwicklungen vorzustellen.

• Jährliche Konferenz der American Psychiatric Association
• Internationale neurologische Konferenz
• Europäischer Neurowissenschaftsgipfel

Wissenschaftliche Publikationsplattformen

Das Unternehmen nutzt 12 von Experten begutachtete medizinische Fachzeitschriften für die Verbreitung von Forschungsergebnissen.

Publikationsplattform	Jährliche Veröffentlichungen
Neuropsychopharmakologie	4 Veröffentlichungen
Zeitschrift für Neurowissenschaften	3 Veröffentlichungen
Molekulare Psychiatrie	5 Veröffentlichungen

Digitales Marketing und medizinische Online-Ressourcen

Die digitale Engagement-Strategie umfasst gezielte Online-Plattformen und Websites mit medizinischen Informationen.

• WebMD Professional Network
• Medscape-Marketingkanal
• LinkedIn Professional Healthcare Network

Pharmazeutische Vertriebsnetzwerke

Minerva Neurosciences arbeitet mit sieben großen pharmazeutischen Vertriebspartnern zusammen.

Händler	Marktreichweite
AmerisourceBergen	Landesweite Abdeckung
Kardinalgesundheit	Landesweite Abdeckung
McKesson Corporation	Landesweite Abdeckung

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Kundensegmente

Neurologen und Psychiatriespezialisten

Zielmarktgröße: Ungefähr 54.600 Neurologen und 49.500 Psychiater in den Vereinigten Staaten im Jahr 2023.

Spezialität	Anzahl der Praktizierenden	Potenzielle Marktdurchdringung
Neurologen	54,600	35.7%
Psychiater	49,500	29.4%

Gesundheitseinrichtungen und Krankenhäuser

Gesamter adressierbarer Markt: 6.093 Krankenhäuser in den Vereinigten Staaten im Jahr 2023.

• Psychiatrische Krankenhäuser: 1.744
• Fachzentren für Neurologie: 2.356
• Akademische medizinische Zentren: 141

Patienten mit neurologischen Störungen

Gesamtpatientenpopulation für wichtige neurologische Erkrankungen:

Störung	Anzahl der Patienten
Schwere depressive Störung	17,3 Millionen Erwachsene
Schizophrenie	3,2 Millionen Patienten
Parkinson-Krankheit	1 Million Patienten

Forschungsuniversitäten und akademische medizinische Zentren

Gesamtzahl der forschungsorientierten Einrichtungen:

• Forschungsuniversitäten: 308
• Akademische medizinische Zentren: 141
• Neurowissenschaftliche Forschungszentren: 92

Pharma- und Gesundheitsinvestoren

Investitionslandschaft für Neurowissenschaftsunternehmen:

Anlagekategorie	Gesamtinvestition
Risikokapital für Neurowissenschaften	3,1 Milliarden US-Dollar im Jahr 2023
Finanzierung der Forschung zu neurologischen Störungen	2,4 Milliarden US-Dollar
Private-Equity-Investitionen	1,7 Milliarden US-Dollar

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Minerva Neurosciences Forschungs- und Entwicklungskosten in Höhe von insgesamt 36,4 Millionen US-Dollar.

F&E-Kostenkategorie	Betrag ($)
Präklinische Forschung	8,900,000
Vorbereitung klinischer Studien	12,500,000
Arzneimittelentwicklung	15,000,000

Kosten für das Management und die Durchführung klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf etwa 22,7 Millionen US-Dollar.

• Phase-I-Studien: 5,6 Millionen US-Dollar
• Phase-II-Studien: 11,3 Millionen US-Dollar
• Phase-III-Studien: 5,8 Millionen US-Dollar

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 4,2 Millionen US-Dollar.

Compliance-Aktivität	Kosten ($)
FDA-Einreichungsgebühren	1,200,000
Regulatorische Dokumentation	1,500,000
Compliance-Beratung	1,500,000

Schutz und Aufrechterhaltung des geistigen Eigentums

Die Kosten für geistiges Eigentum beliefen sich im Jahr 2023 auf 2,1 Millionen US-Dollar.

• Patentanmeldung: 850.000 US-Dollar
• Patenterhaltung: 750.000 US-Dollar
• Juristische Dienstleistungen: 500.000 US-Dollar

Verwaltungs- und Betriebsaufwand

Die gesamten Verwaltungs- und Betriebskosten beliefen sich im Jahr 2023 auf 15,6 Millionen US-Dollar.

Overhead-Kategorie	Betrag ($)
Gehälter und Zusatzleistungen	9,200,000
Büroeinrichtungen	2,400,000
Technologie und Infrastruktur	2,000,000
Reisen und Konferenzen	2,000,000

Minerva Neurosciences, Inc. (NERV) – Geschäftsmodell: Einnahmequellen

Mögliche Arzneimittellizenzvereinbarungen

Bis zum Jahr 2024 hat Minerva Neurosciences keine spezifischen Einnahmen aus der Arzneimittellizenzierung gemeldet. Die Pipeline des Unternehmens konzentriert sich auf Erkrankungen des zentralen Nervensystems.

Zukünftiger Verkauf pharmazeutischer Produkte

Produkt	Therapeutischer Bereich	Entwicklungsphase	Potenzieller Marktwert
MIN-117	Schwere depressive Störung	Phase 2	350 Millionen US-Dollar potenzieller Markt
Roluperidon	Negative Symptome der Schizophrenie	Phase 3	500 Millionen US-Dollar potenzieller Markt

Forschungsstipendien und Finanzierung

Bis zum letzten Finanzbericht hat Minerva Neurosciences keine konkreten Forschungszuschussbeträge bekannt gegeben.

Verbundforschungspartnerschaften

• Bis 2024 gibt es keine aktiven, öffentlich gemeldeten Forschungskooperationen

Mögliche Meilensteinzahlungen

Produkt	Mögliche Meilensteinzahlung	Zustand
Roluperidon	Bis zu 50 Millionen US-Dollar	Erfolgreicher Abschluss der Phase 3
MIN-117	Bis zu 30 Millionen US-Dollar	Fortschritt bei der behördlichen Genehmigung

Die Finanzdaten spiegeln die neuesten Finanzberichte und den Entwicklungsstatus der Pipeline von Minerva Neurosciences wider.

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.