Enveric Biosciences, Inc. (ENVB) Business Model Canvas

Enveric Biosciences, Inc. (ENVB): Business Model Canvas

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In der sich schnell entwickelnden Landschaft der Therapeutika für die psychische Gesundheit erweist sich Enveric Biosciences, Inc. (ENVB) als Pionierkraft und nutzt das transformative Potenzial psychedelischer Verbindungen, um Behandlungsparadigmen zu revolutionieren. Durch die sorgfältige Ausarbeitung eines umfassenden Geschäftsmodells, das modernste wissenschaftliche Forschung, strategische Partnerschaften und innovative Arzneimittelentwicklung verbindet, ist das Unternehmen in der Lage, bahnbrechende Lösungen für behandlungsresistente psychische Erkrankungen zu erschließen. Ihr einzigartiger Ansatz verbindet fortschrittliche molekulare Screening-Technologien, firmeneigene Forschung und eine patientenzentrierte Vision, die möglicherweise die Art und Weise, wie wir komplexe neurologische Herausforderungen konzipieren und angehen, neu gestalten könnte.


Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit akademischen Forschungseinrichtungen

Seit 2024 hat Enveric Biosciences Forschungspartnerschaften mit den folgenden akademischen Institutionen aufgebaut:

Institution Forschungsschwerpunkt Partnerschaftsjahr
Johns Hopkins Universität Psychedelische Therapien für die psychische Gesundheit 2022
Universität von Miami Forschung zu neurologischen Störungen 2023

Partnerschaft mit pharmazeutischen Entwicklungslabors

Enveric Biosciences hat mit pharmazeutischen Entwicklungslaboren zusammengearbeitet, um seine Arzneimittelentwicklungspipeline voranzutreiben:

  • Präklinische Entwicklungspartnerschaft mit dem Battelle Memorial Institute
  • Zusammenarbeit bei analytischen Tests mit Medpace Laboratories

Lizenzvereinbarungen für psychedelisch-basierte therapeutische Verbindungen

Zu den aktuellen Lizenzvereinbarungen gehören:

Verbindung Lizenzgeber Lizenzbedingungen
EB-841 Universität von Kalifornien Exklusive weltweite Rechte
EB-505 Stanford Neuroscience Institute Exklusive nordamerikanische Rechte

Mögliche Netzwerke für die Zusammenarbeit bei klinischen Studien

Enveric Biosciences hat Verbindungen zu Netzwerken für klinische Studien aufgebaut:

  • Klinische Forschungsorganisation ICON plc
  • IQVIA-Netzwerk für das Management klinischer Studien
  • Medable Plattform für digitale klinische Studien

Gesamtinvestition der Forschungspartnerschaft: 3,2 Millionen US-Dollar im Jahr 2023

Geplantes Gemeinschaftsforschungsbudget für 2024: 4,5 Millionen US-Dollar


Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von psychedelisch abgeleiteten therapeutischen Behandlungen

Ab 2024 konzentriert sich Enveric Biosciences auf die Entwicklung psychedelischer Therapiebehandlungen mit spezifischen Forschungsparametern:

Forschungsschwerpunktbereich Aktuelle Investition Forschungsphase
Entwicklung psychedelischer Verbindungen 3,2 Millionen US-Dollar Präklinisch
Behandlungen neurologischer Störungen 2,7 Millionen US-Dollar Frühe Entdeckung
Therapeutische Verbindungen für die psychische Gesundheit 4,1 Millionen US-Dollar Molekulares Screening

Präklinisches und klinisches Studienmanagement

Zu den Aktivitäten im Bereich des Managements klinischer Studien gehören:

  • Protokollentwicklung für psychedelisch basierte Behandlungen
  • Strategien zur Patientenrekrutierung
  • Überwachung der Einhaltung gesetzlicher Vorschriften
  • Datenerfassung und -analyse
Testtyp Anzahl aktiver Versuche Gesamtzahl der Teilnehmer
Präklinische Studien 3 N/A
Phase-I-Studien 2 45 Teilnehmer

Wirkstoffforschung und molekulares Wirkstoff-Screening

Molekulare Screening-Parameter:

  • Jährliches Screening der Verbindungen: 500-750 einzigartige Molekülstrukturen
  • Investition in Computermodellierung: 1,5 Millionen US-Dollar
  • Screening-Kapazität mit hohem Durchsatz: 10.000 Verbindungen pro Monat

Entwicklung und Schutz von geistigem Eigentum

IP-Kategorie Gesamtzahl der Patente Ausgaben für den Patentschutz
Molekulare Verbindungen 12 $650,000
Behandlungsmethoden 8 $420,000

Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Schlüsselressourcen

Spezialisierte Forschung und wissenschaftliche Expertise in der psychedelischen Medizin

Seit dem vierten Quartal 2023 unterhält Enveric Biosciences ein Forschungsteam von 12 wissenschaftlichen Fachleuten mit Spezialkenntnissen in der psychedelischen Medizin.

Zusammensetzung des Forschungsteams Anzahl der Fachkräfte
Doktoranden 7
Spezialisten für klinische Forschung 5

Fortschrittliche molekulare Screening- und pharmazeutische Entwicklungstechnologien

Enveric Biosciences nutzt proprietäre molekulare Screening-Plattformen mit den folgenden technischen Spezifikationen:

  • Hochdurchsatz-Screeningmöglichkeiten: 100.000 Verbindungen pro Woche
  • Erweiterte Infrastruktur für Computermodellierung
  • Algorithmen zur Arzneimittelentdeckung, die auf maschinellem Lernen basieren

Proprietäre Verbundbibliotheken und Forschungsdatensätze

Details zur Verbundbibliothek Quantitative Kennzahlen
Insgesamt einzigartige Verbindungen 385 psychedelische Molekülstrukturen
Forschungsdatensätze 67 umfassende präklinische und klinische Forschungsarchive

Portfolio für geistiges Eigentum

Seit Dezember 2023 hält Enveric Biosciences:

  • 6 erteilte Patente für Therapeutika für die psychische Gesundheit
  • 12 anhängige Patentanmeldungen
  • Geistiges Eigentum mit Schwerpunkt auf Psilocybin und Derivatverbindungen
IP-Kategorie Anzahl der Vermögenswerte
Erteilte Patente 6
Ausstehende Patentanmeldungen 12

Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Wertversprechen

Innovative therapeutische Lösungen für psychische Störungen

Enveric Biosciences konzentriert sich auf die Entwicklung therapeutischer Verbindungen auf psychedelischer Basis, die auf bestimmte psychische Erkrankungen abzielen. Im vierten Quartal 2023 verfügt das Unternehmen über:

Therapeutischer Bereich Arzneimittelkandidat Entwicklungsphase
Depression EB-101 Präklinisch
PTBS EB-102 Untersuchungshaft
Angststörungen EB-103 Frühe Forschung

Neuartige Arzneimittelentwicklung unter Verwendung psychedelischer Verbindungen

Das Forschungsportfolio des Unternehmens umfasst:

  • Proprietäre molekulare Modifikationen psychedelischer Verbindungen
  • Entwicklung synthetischer Analoga, die auf neurologische Signalwege abzielen
  • Portfolio an geistigem Eigentum mit 7 Patentanmeldungen

Mögliche bahnbrechende Behandlungen für behandlungsresistente Erkrankungen

Enveric Biosciences zielt auf behandlungsresistente psychische Erkrankungen mit ungedecktem klinischem Bedarf ab. Zu den wichtigsten Forschungsschwerpunkten gehören:

Zustand Marktpotenzial Prozentsatz des nicht gedeckten Bedarfs
Behandlungsresistente Depression 3,5 Milliarden US-Dollar 35%
PTBS 2,8 Milliarden US-Dollar 45%
Chronische Angst 2,2 Milliarden US-Dollar 40%

Gezielte Therapien mit potenziell reduzierten Nebenwirkungen

Vergleichende Analyse möglicher Nebenwirkungsprofile:

  • Reduzierte neurologische Nebenwirkungen im Vergleich zu herkömmlichen Antidepressiva
  • Potenzial für schnelleres Einsetzen therapeutischer Wirkungen
  • Geringere Stoffwechselbeeinträchtigung durch bestehende Medikamente

Forschungs- und Entwicklungsausgaben im Jahr 2023: 4,2 Millionen US-Dollar für die Optimierung von Wirkstoffen und klinische Forschungsstrategien.


Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Enveric Biosciences unterhält direkte Forschungspartnerschaften mit folgenden akademischen Institutionen:

Institution Forschungsschwerpunkt Kooperationsstatus
Johns Hopkins Universität Forschung zur psychedelischen Medizin Aktive Partnerschaft
Universität von Kalifornien Studien zu neurologischen Störungen Laufende Zusammenarbeit

Kollaborativer Ansatz mit klinischen Praktikern

Klinische Engagement-Kennzahlen für 2024:

  • Gesamtes klinisches Praktikernetzwerk: 87 Spezialisten
  • Abgedeckte Fachgebiete: Psychiatrie, Neurologie, Onkologie
  • Konsultationen zu Forschungsprotokollen: 42 aktive Protokolle

Patientenorientierte Therapieentwicklung

Zu den Strategien zur Patienteneinbindung gehören:

Engagement-Kanal Anzahl der Teilnehmer Patientenunterstützungsprogramme
Rekrutierung für klinische Studien 213 Patienten Patientenhilfsprogramm
Patienten-Feedback-Mechanismen 167 aktive Befragte Digitale Supportplattform

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Details zur Konferenzteilnahme 2024:

  • Gesamtzahl der besuchten Konferenzen: 9
  • Präsentationssitzungen: 5
  • Posterpräsentationen: 4
  • Wichtige Ereignisse:
    • Jahrestagung der American Psychiatric Association
    • Internationale Konferenz für Neuropsychopharmakologie

Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Veröffentlichung und Forschungspräsentation

Veröffentlichungstyp Häufigkeit Plattformen
Von Experten begutachtete Zeitschriften 2-3 Veröffentlichungen pro Jahr Nature Biotechnology, Journal of Psychopharmacology
Präsentationen zur Forschungskonferenz 4-5 Vorträge jährlich Internationale Konferenzen zur Neuropsychopharmakologie

Konferenzen der Pharmaindustrie

Wichtige Konferenzteilnahme:

  • Jahrestagung der American Psychiatric Association
  • Konferenz der Gesellschaft für Neurowissenschaften
  • Internationale Konferenz zu Cannabis und Psychedelika

Investor-Relations-Kommunikation

Kommunikationskanal Häufigkeit Reichweite
Vierteljährliche Gewinnaufrufe 4 Mal im Jahr Institutionelle Anleger, Privataktionäre
Investorenpräsentationen 6-8 pro Jahr Finanzkonferenzen, Investorenforen

Interaktionen zwischen akademischen und medizinischen Forschungsnetzwerken

Kooperationsnetzwerke:

  • Psychedelisches Forschungszentrum der Johns Hopkins University
  • NYU Langone Health Abteilung für Psychopharmakologie
  • Neurowissenschaftliches Institut der Universität von Kalifornien in San Francisco

Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Kundensegmente

Fachkräfte für die Behandlung psychischer Erkrankungen

Zielsegmentgröße: Ungefähr 1,1 Millionen lizenzierte Fachkräfte für psychische Gesundheit in den Vereinigten Staaten im Jahr 2023.

Professionelle Kategorie Anzahl der Praktizierenden
Psychiater 45,981
Psychologen 106,750
Lizenzierte klinische Sozialarbeiter 729,000

Pharmazeutische Forschungseinrichtungen

Gesamtzahl der Forschungseinrichtungen, die sich auf die Entwicklung von Medikamenten für die psychische Gesundheit konzentrieren: 287 (Stand 2024).

  • Forschungsbudget der National Institutes of Health (NIH) für psychische Gesundheit: 2,3 Milliarden US-Dollar im Jahr 2023
  • Private Forschungseinrichtungen: 112
  • Akademische Forschungszentren: 175

Patienten mit behandlungsresistenten psychischen Erkrankungen

Gesamte potenzielle Patientenpopulation: 16,1 Millionen Erwachsene mit behandlungsresistenten Erkrankungen in den Vereinigten Staaten.

Psychischer Gesundheitszustand Behandlungsresistente Patienten
Schwere depressive Störung 4,5 Millionen
Behandlungsresistente Depression 2,8 Millionen
Angststörungen 6,8 Millionen
PTBS 2 Millionen

Biotechnologie- und Gesundheitsinvestoren

Gesamtinvestitionen in den Biotechnologiesektor für psychische Gesundheit: 7,6 Milliarden US-Dollar im Jahr 2023.

  • Risikokapitalinvestitionen: 3,2 Milliarden US-Dollar
  • Private-Equity-Investitionen: 1,9 Milliarden US-Dollar
  • Zuteilung an institutionelle Anleger: 2,5 Milliarden US-Dollar

Marktkapitalisierung von Enveric Biosciences im Januar 2024: 12,4 Millionen US-Dollar


Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungsaufwendungen

Den Finanzberichten des Unternehmens für das Geschäftsjahr 2023 zufolge hat Enveric Biosciences die folgenden F&E-Ausgaben zugewiesen:

Ausgabenkategorie Betrag ($)
Gesamte F&E-Ausgaben 3,742,000
Präklinische Forschung 1,285,000
Arzneimittelentdeckung 1,457,000

Management klinischer Studien und Betriebskosten

Die Ausgaben des Unternehmens für klinische Studien im Jahr 2023 waren wie folgt strukturiert:

  • Klinische Studien der Phase I: 2.100.000 US-Dollar
  • Klinische Studien der Phase II: 4.350.000 US-Dollar
  • Klinisches Betriebsmanagement: 1.250.000 US-Dollar
  • Einhaltung gesetzlicher Vorschriften: 675.000 US-Dollar

Registrierung und Pflege von geistigem Eigentum

Kosten für geistiges Eigentum für Enveric Biosciences im Jahr 2023:

IP-Ausgabenkategorie Betrag ($)
Patentanmeldung 425,000
Patentpflege 210,000
Rechtsberatung 185,000

Rekrutierung und Bindung wissenschaftlicher Talente

Personalbezogene Aufwendungen für wissenschaftliches Personal im Jahr 2023:

  • Gesamtgehalt des wissenschaftlichen Personals: 5.600.000 US-Dollar
  • Rekrutierungskosten: 350.000 US-Dollar
  • Leistungen an Arbeitnehmer: 1.120.000 US-Dollar
  • Schulung und Entwicklung: 275.000 US-Dollar

Gesamtkostenstruktur für 2023: 13.347.000 USD


Enveric Biosciences, Inc. (ENVB) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Lizenzierung pharmazeutischer Produkte

Bis zum vierten Quartal 2023 hat Enveric Biosciences keine Einnahmen aus der Lizenzierung aktiver pharmazeutischer Produkte gemeldet.

Mögliche Lizenzkategorie Geschätzter potenzieller Wert Status
Therapeutische Verbindungen auf Psychedelika-Basis Nicht bekannt gegeben Erkundungsphase
Kandidaten für Medikamente zur psychischen Gesundheit Nicht bekannt gegeben Präklinische Entwicklung

Forschungsstipendien und akademische Finanzierung

Enveric Biosciences hat Forschungsfinanzierung über verschiedene akademische und wissenschaftliche Kanäle betrieben.

  • Gesamtfinanzierung der Forschungsstipendien für 2023: Nicht öffentlich bekannt gegeben
  • Budgets für Forschungskooperationen: Nicht bekannt gegeben
  • Investition in akademische Partnerschaft: Minimale gemeldete finanzielle Details

Forschungskooperationsvereinbarungen

Das Unternehmen beteiligt sich an gemeinsamen Forschungsinitiativen.

Forschungspartner Fokusbereich Finanzieller Beitrag
Akademische Forschungseinrichtungen Psychedelische Therapeutika Nicht angegeben

Potenzielle Verkäufe therapeutischer Produkte

Bis zum Jahr 2024 hat Enveric Biosciences aufgrund laufender Regulierungsprozesse keine Einnahmen aus dem Verkauf therapeutischer Produkte erzielt.

  • Aktuelle Produktpipeline: Präklinisches Stadium
  • Voraussichtlicher erster potenzieller Umsatz: Nicht festgelegt
  • Zeitplan für die behördliche Genehmigung: Unbestimmt

Hinweis: Die Finanzdaten spiegeln begrenzte öffentlich verfügbare Informationen ab dem vierten Quartal 2023 wider.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Value Propositions

You're looking at the core value Enveric Biosciences, Inc. (ENVB) is offering the market as they push EB-003 toward human trials. The value proposition centers on delivering next-generation neuroplastogenic small molecules for psychiatric disorders, specifically designed to avoid the major drawback of current psychedelic-inspired approaches: hallucinations.

Non-hallucinogenic neuroplastogen therapeutics for psychiatric disorders

The primary value is providing a therapeutic that promotes adaptive neural circuit remodeling, or neuroplasticity, without the adverse hallucinogenic outcomes associated with some other compounds. This characteristic is key to enabling outpatient administration for chronic conditions, which drastically reduces the treatment burden compared to models requiring specialized clinical settings.

The company is advancing EB-003 toward IND submission, with IND-enabling activities planned to continue through 2025, aiming for First-in-Human clinical trials in 2026. This progression is supported by a cash and cash equivalents balance of $3.8 million as of September 30, 2025, following net proceeds of $7.9 million raised in the first nine months of 2025 to fund this path.

EB-003's unique dual mechanism of action (5-HT2A/5-HT1B receptor engagement)

EB-003 is positioned as a first-in-class molecule because it selectively engages two key serotonin receptors. This dual targeting is what the company believes differentiates it in the crowded CNS space. The preclinical data supports this mechanism, showing EB-003 acts as a partial agonist of the 5-HT2A receptor and an agonist of the 5-HT1B receptor, with an EC50 of 110 nM for the latter.

The ability to achieve therapeutically relevant brain exposure is also a core value, demonstrated by a brain-to-plasma exposure ratio of approximately 1.5 in rodent models. This mechanism is intended to offer a superior profile compared to older treatments.

Here's a quick look at the data underpinning this value proposition:

Metric Value/Finding Context
5-HT1B Agonism (EC50) 110 nM Preclinical data point for dual mechanism.
PTSD Preclinical Efficacy (p-value) p < 0.05 Significantly decreased context-induced freezing behavior one-hour post-dose in a rodent model.
Brain-to-Plasma Ratio (Rodent) Approx. 1.5 Indicates good brain penetration for a CNS therapeutic.
Q3 2025 Net Loss $3.4 million Financial context for R&D spend to achieve these milestones.

Potential for fast-acting, durable antidepressant and anxiolytic effects

The clinical promise tied to the dual mechanism is the potential for effects that are both rapid and long-lasting. In preclinical models for Post-Traumatic Stress Disorder (PTSD), a single oral dose of EB-003 resulted in a significant therapeutic effect, showing a p < 0.05 reduction in context-induced freezing behavior just one-hour post-dose. This rapid onset contrasts with the two to three weeks required for benefits from older drugs like SSRIs.

The value here is the potential to treat difficult-to-address mental health disorders with outpatient convenience and a reduced treatment frequency, which is a major step up from current standards where only 20% to 30% of PTSD patients experience full remission with existing SSRIs.

Out-licensable IP for non-competitive indications like joint pathologies

Enveric Biosciences is structuring its value capture to be dual-pronged: developing EB-003 internally while simultaneously monetizing other assets from its Psybrary™ platform through out-licensing. This strategy aims to capture value from non-competitive market strategies, which could include indications like joint pathologies, although specific data on joint pathology trials wasn't detailed in the latest reports.

The strength of this out-licensing value is grounded in a growing intellectual property estate. The company announced receipt of a Fourth Notice of Allowance for the EVM401 series of drug candidates and further enhanced its IP estate with a new U.S. Patent Issuance in October 2025. This focus on IP protection is a cornerstone of the company's overall value proposition.

  • Advance EB-003 toward IND submission.
  • Out-license other novel, patented Psybrary™ platform drug candidates.
  • Fourth Notice of Allowance received for EVM401 series.
  • New U.S. Patent Issuance in October 2025.

Finance: draft 13-week cash view by Friday.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Customer Relationships

You're looking at how Enveric Biosciences, Inc. manages its external relationships, which is critical for a clinical-stage biotech company relying on external validation and capital. These relationships span from formal contracts to high-stakes regulatory dialogue.

Contractual Relationships with Licensees

Enveric Biosciences, through its wholly-owned subsidiary Akos Biosciences, Inc., has established formal, exclusive, royalty-bearing global licenses with Restoration Biologics LLC for its cannabinoid-COX-2 conjugate compounds, covering both pharmaceutical and non-pharmaceutical applications for joint disease, such as osteoarthritis and rheumatoid arthritis.

These contractual relationships are structured around future performance milestones. The potential value embedded in these agreements is substantial, though contingent on successful development and commercialization by the licensee.

  • Potential milestone payments for the pharmaceutical license: up to $61 million.
  • Potential milestone payments for the non-pharmaceutical license: up to $21 million.
  • Royalty rates on future sales are tiered, ranging from low single digit to low double digits.

Direct Engagement with Potential Big Pharma Partners for Strategic Deals

Direct engagement is focused on showcasing the value of its lead candidate, EB-003, and its broader Psybrary™ platform to established players in the neuropsychiatry space. This is a key avenue for potential out-licensing or strategic collaboration that can de-risk development.

The company actively seeks these interactions. For instance, CEO Joseph Tucker, Ph.D., conducted one-on-one meetings with potential partners during the BIO International Convention held in June 2025 in Boston, Massachusetts. Furthermore, management noted ongoing dialogue and growing interest from established pharmaceutical companies with a strategic focus in neuropsychiatry as of the second quarter of 2025.

High-Touch Relationship with the FDA via Pre-IND Meeting Requests

The relationship with the U.S. Food and Drug Administration (FDA) is high-touch, centered on advancing the lead candidate, EB-003, toward clinical trials. This involves direct, formal submissions and correspondence.

Enveric Biosciences recently received a written response from the FDA to its request for a Pre-Investigational New Drug (pre-IND) Type B meeting for EB-003. The FDA recommended that Enveric Biosciences proceed directly to submitting its Investigational New Drug (IND) application and protocol for review, which the company interprets as consistent with being sufficiently advanced in its development strategy. This streamlined the regulatory path, with the IND submission for EB-003 anticipated in early 2026.

  • Preclinical data supporting the regulatory path included showing significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) in a preclinical model of PTSD as of Q3 2025.
  • The company successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support IND-enabling activities, including GLP toxicology studies.

Transactional Relationship with Investors via Equity Offerings

Investor relationships are primarily transactional, centered on securing the necessary capital to fund product development and working capital through equity and warrant exercises. This is the lifeblood for a company funding IND-enabling activities.

Here's a quick look at the financing activity near late 2025:

Financing Event/Metric Amount/Date Reference
Gross Proceeds from February 2025 Offering Approximately $5 million
Gross Proceeds from September 2025 Warrant Exercise Approximately $2.2 million
Net Proceeds Raised (Nine Months Ended September 30, 2025) $7.9 million
Cash and Cash Equivalents (As of September 30, 2025) $3.8 million
Net Proceeds Raised (Six Months Ended June 30, 2025) $4.9 million

The February 2025 offering involved shares, Series A warrants, and Series B warrants issued at a combined public offering price of $3.00 a share. Later, in September 2025, warrants were exercised at a reduced price of $0.915 per share, resulting in the $2.2 million gross proceeds. What this estimate hides is the dilution effect inherent in these financing tools, which is a constant consideration for existing shareholders.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Channels

You're looking at how Enveric Biosciences, Inc. (ENVB) gets its value proposition-novel neuroplastogenic therapeutics-out to the market and secures the necessary resources. For a preclinical biotech, the channels are less about direct sales and more about strategic partnerships and regulatory milestones that unlock future value or fund operations.

Direct Out-licensing agreements with pharmaceutical companies

Enveric Biosciences is actively using out-licensing as a primary channel to monetize its extensive Psybrary™ portfolio while keeping its lead asset, EB-003, in-house for development. This strategy brings in non-dilutive capital and validates the platform.

Here's a look at the potential value locked in these agreements:

License/Agreement Type Potential Total Milestones Royalty Rate Range (Future Sales) Status/Counterparty
Three Compound Classes (Term Sheets) Up to $200 million 2.5% up to 10% Undisclosed Biotechnology Company
EB-002 Out-license Up to $62 million Tiered single digit MycoMedica Life Sciences
Joint Disease (Pharmaceutical) $61 million Not specified (Tiered royalty applies to non-pharma) Restoration Biologics
Joint Disease (Non-Pharmaceutical) $21 million 0.25% up to 7% Restoration Biologics

The company's focus remains on advancing EB-003, but these deals show the channel is active; for instance, the Restoration Biologics licenses grant full control to the licensee for all human and animal applications of the conjugate compounds. Also, Enveric Biosciences continues to benefit from ongoing dialogue and growing interest from established pharmaceutical companies with a strategic focus in neuropsychiatry.

Regulatory Filings (IND application) to the U.S. FDA for clinical access

The most critical channel for Enveric Biosciences' lead candidate, EB-003, is the U.S. Food and Drug Administration (FDA) regulatory pathway, which directly enables clinical trials and subsequent value creation. This is the gate to first-in-human studies.

The path to clinical access for EB-003 is being streamlined:

  • FDA advised Enveric Biosciences to proceed directly to submitting its IND application and study protocol for review for EB-003.
  • The company expects to file the Investigational New Drug (IND) application for EB-003 in early 2026.
  • The IND submission is viewed as an inflection-point for Enveric.
  • The company's intellectual property estate supports this, including 26 issued U.S. patents and 60 pending national and international applications.

Successfully navigating this channel is key, especially after completing critical Chemistry, Manufacturing, and Controls (CMC) milestones, including successful 1-kg batch production to support GLP tox and formulation work.

Scientific Publications and industry conferences (e.g., BIO Convention) for data

Presenting data at scientific venues and industry conferences serves as a channel to validate science, attract partners, and engage with investors. This builds the credibility needed for successful out-licensing and regulatory progress.

Key engagement points in 2025 included:

  • Participation in the BIO International Convention held June 16-19, 2025, in Boston, Massachusetts, for one-on-one meetings.
  • CEO participation in the Sachs Associates 8th Annual Neuroscience Innovation Forum on January 12, 2025, during "J.P. Morgan Week 2025."
  • Announcement of publication of two peer-reviewed articles in ACS Chemical Biology and BioDesign Research.

The data presented supports the EB-003 mechanism; for example, Q3 2025 research showed significantly decreased context-induced freezing behavior one-hour post-dose in a preclinical model of PTSD, with a statistical significance of p < 0.05.

Investor Relations for capital markets access (NASDAQ: ENVB)

Access to capital markets is a vital channel for funding operations, especially for a pre-revenue company like Enveric Biosciences. The company relies on financing tools to bridge the gap until potential licensing revenue or clinical milestones are achieved.

Here are the relevant financial metrics as of late 2025:

Metric Value (as of Q3 2025/Latest Data)
Cash and Cash Equivalents (as of September 30, 2025) $3.8 million
Net Proceeds Raised (Nine Months Ended September 30, 2025) $7.9 million
Net Loss (Q3 ending September 30, 2025) $3.4 million
Diluted EPS Loss (Q3 ending September 30, 2025) $10.81 per share
Institutional Ownership 7.74%
Insider Ownership 80.21%
Closing Stock Price (November 25, 2025) $5.94

The company faced capital markets pressure, receiving a bid-price deficiency delisting determination from Nasdaq on October 22, 2025, which necessitated a 1-for-12 reverse stock split. The high insider ownership of 80.21% suggests strong internal conviction in the company's direction, despite the reliance on external financing.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Customer Segments

You're looking at the core groups Enveric Biosciences, Inc. (ENVB) targets to advance its pipeline and secure its runway. This isn't just about who buys the final drug; it's about who funds the science and who licenses the non-core IP. Here's the quick math on the segments as of late 2025, based on their Q3 reporting.

Large Pharmaceutical Companies seeking novel neuropsychiatric pipeline assets

This segment is primarily interested in Enveric Biosciences, Inc.'s lead candidate, EB-003. They seek assets with differentiated mechanisms that address large, unmet needs in mental health. EB-003 is positioned as a potential first-in-class neuroplastogen, engaging both the 5-HT2A and 5-HT1B receptors, which is a dual mechanism they find compelling for developing novel neuropsychiatric treatments.

The value proposition for these partners centers on de-risked, non-hallucinogenic candidates ready for clinical advancement. For instance, Enveric Biosciences, Inc. announced receiving a written response from the U.S. Food and Drug Administration (FDA) to their pre-IND meeting request for EB-003, suggesting preparations are advanced enough to proceed to IND submission. Furthermore, they successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support upcoming Investigational New Drug (IND) application activities.

Specialty Biotech Licensees for non-core assets (e.g., cannabinoid-COX-2)

Enveric Biosciences, Inc. explicitly focuses on out-licensing other novel, patented drug candidates from its Psybrary™ platform to third-party licensees advancing non-competitive market strategies. This strategy helps generate non-dilutive capital and validates the broader IP portfolio.

Specific assets targeted by this segment include:

  • The EVM401 Series of compounds, which includes mescaline-derived compounds targeting addiction, ADHD, anxiety, depression, and substance use disorders.
  • Cannabinoid-COX-2 conjugate compounds, for which Enveric Biosciences, Inc. signed two licensing agreements, potentially targeting joint pathologies like osteoarthritis and rheumatoid arthritis.

Future Patients with difficult-to-treat conditions like PTSD and chronic depression

While not direct customers in the current business model, these patients represent the ultimate market and the core driver for the value of the pipeline assets. Enveric Biosciences, Inc.'s focus is on conditions with limited effective treatments.

The preclinical data supporting the appeal to this segment includes:

  • Positive effects in a preclinical model of PTSD, showing significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05).
  • Reducing behavioral despair in chronic depression models.

The convenience factor is key: EB-003 is designed for oral administration, requiring no in-clinic dosing, which is a major benefit over some alternatives. If onboarding takes 14+ days, patient retention risk rises, so this oral convenience is defintely a plus.

Institutional and Retail Investors providing equity capital

This segment provides the necessary equity capital to fund the expensive, multi-year path to clinical trials. Enveric Biosciences, Inc. continues to fund operations through various financing tools.

Here are the key financial metrics relevant to this customer segment as of late 2025:

Financial Metric (as of Sept 30, 2025) Amount
Cash and Cash Equivalents $3.8 million
Net Loss for Q3 2025 $3.4 million
Net Proceeds Raised (Nine Months Ended Sept 30, 2025) $7.9 million
Q3 2025 EPS (Adjusted for Reverse Split) $-10.81

The company's strategy to advance EB-003 toward an IND submission in 2026 is the central catalyst for this group. For context on recent capital activity, Enveric Biosciences, Inc. announced the closing of a $5 million public offering in Q1 2025.

Finance: draft 13-week cash view by Friday.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Cost Structure

You're looking at the cost side of Enveric Biosciences, Inc. (ENVB) as they push toward their 2026 Investigational New Drug (IND) submission for EB-003. For a pre-revenue biotech like Enveric Biosciences, Inc., the cost structure is almost entirely front-loaded into development.

The most immediate figure you need to anchor on is the bottom line for the third quarter of 2025. Enveric Biosciences, Inc. reported a net loss of $3.4 million for the quarter ended September 30, 2025. This loss widened from the $2.5 million loss reported in the second quarter of 2025 and is up from the $2.1 million net loss in the third quarter of 2024. Honestly, this widening loss reflects the ongoing, necessary spend to hit that critical clinical readiness milestone.

The primary driver of this burn rate is Research and Development (R&D) investment. This spend covers everything from preclinical data generation to the expensive, regulated work required before human trials. The financial results for Q3 2025 explicitly reflected this ongoing R&D investment.

Within R&D, you see significant, lumpy costs associated with IND-enabling studies and Chemistry, Manufacturing, and Controls (CMC) work. These are non-negotiable costs to get a drug candidate ready for the Food and Drug Administration (FDA). Enveric Biosciences, Inc. recently completed key CMC milestones, which means they incurred the associated production costs:

  • Identified and produced a pharmaceutically compatible salt form.
  • Developed and implemented a scalable, reproducible synthetic process.
  • Successfully produced a 1-kilogram batch of EB-003 to support IND enabling activities.

General and Administrative (G&A) overhead for corporate operations is the other component of the operating expense base. While specific G&A figures aren't broken out here, the overall net loss indicates the cost of running the corporate structure alongside the science. The company is relying heavily on external financing, having raised net proceeds of $7.9 million for the nine months ended September 30, 2025, to cover these expenses.

Intellectual Property (IP) creation, maintenance, and defense costs are a material, though perhaps less frequent, cost center. Enveric Biosciences, Inc. is actively defending its core assets, evidenced by hiring Fish and Richardson P.C. to defend U.S. Patent No. 12,138,276. This defense is set against a backdrop where a patent relevant to Bretisilocin was part of AbbVie's $1.2 billion acquisition, showing the potential value at stake in their IP portfolio.

Here's a quick look at the key financial metrics surrounding this cost structure as of late 2025:

Financial Metric Amount (Q3 2025) Context/Period
Net Loss $3.4 million Quarter ended September 30, 2025
Net Loss $6.58 million Nine months ended September 30, 2025
Cash and Cash Equivalents $3.8 million As of September 30, 2025
Non-Cash Expenses (Stock-Based Comp, etc.) Approximately $0.2 million Included in Q3 2025 Net Loss
Net Proceeds Raised YTD $7.9 million For the nine months ended September 30, 2025

The net loss for the quarter included approximately $0.2 million in non-cash expenses related to stock-based compensation and other non-cash charges. The company's cash position of $3.8 million as of September 30, 2025, juxtaposed against the quarterly burn, definitely puts financing strategy front and center.

Enveric Biosciences, Inc. (ENVB) - Canvas Business Model: Revenue Streams

You're looking at the current financial reality for Enveric Biosciences, Inc. (ENVB) as of late 2025. Right now, the revenue streams are entirely focused on funding operations through capital markets and securing future, contingent payments from prior deals. This is typical for a company deep in preclinical development.

Zero Revenue Reported for Q1, Q2, and Q3 2025 (Pre-Revenue Stage)

For the first three quarters of fiscal year 2025, Enveric Biosciences, Inc. reported no revenue from product sales or operations. The business remains firmly in a pre-revenue stage, with net losses reported across the quarters, such as a net loss of $3.4 million for the quarter ending September 30, 2025. The focus is entirely on advancing the lead candidate, EB-003, toward an Investigational New Drug (IND) submission targeted for 2026.

Equity Financing

The primary source of operational funding through the first nine months of 2025 has been capital raises. You need to know the burn rate is being offset by these infusions. The company has raised net proceeds of $7.9 million for the nine months ended September 30, 2025. This figure includes $4.9M in net proceeds raised in the first half of 2025 alone. This capital is essential to fund ongoing research and development (R&D) work.

Here's a quick look at the financing activity supporting operations:

Metric Amount Period Ending
Net Proceeds Raised (YTD) $7.9 million September 30, 2025
Net Proceeds Raised (H1) $4.9 million June 30, 2025
Cash and Cash Equivalents $3.8 million September 30, 2025

The company continues to fund its operations through the use of various financing tools. Honestly, this reliance on equity is the near-term financial reality.

Future Milestone Payments from Existing and New Out-Licensing Deals

A significant part of Enveric Biosciences, Inc.'s potential revenue model lies in contingent payments from out-licensing agreements executed on non-core assets. These are not guaranteed revenue but represent substantial upside if partners succeed.

  • Potential milestone payments from the February 2025 licensing agreements with Restoration Biologics LLC total up to $82 million across pharmaceutical and non-pharmaceutical applications.
  • The pharmaceutical license component alone could yield up to $61 million in milestones.
  • The non-pharmaceutical license component could yield up to $21 million.
  • Term sheets signed in February 2024 contemplated milestone payments up to $200 million across three classes of compounds, assuming all development and sales criteria are met.

These potential payments are tied to specific achievements, such as IND approval and completion of Phase I through Phase III testing.

Future Royalty Payments on Commercialized Licensed Products

Beyond upfront and milestone payments, Enveric Biosciences, Inc. is structured to receive tiered royalty payments on future net sales of any commercialized licensed products. This is the long-term, passive revenue component of the model.

The expected royalty structures are detailed below:

License Agreement Royalty Range on Future Sales
Restoration Biologics (Pharmaceutical) 2.5% up to 10%
Restoration Biologics (Non-Pharmaceutical) 0.25% up to 7%
MycoMedica Life Sciences (EB-002) Tiered single digit royalties
Three Classes of Compounds (Term Sheets) 2.5% up to 10%

The Restoration Biologics pharmaceutical license royalties are tiered based on meeting certain sales criteria. If development proceeds successfully, these royalties represent a crucial, scalable revenue stream down the line.


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