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Enveric Biosciences, Inc. (ENVB): Business Model Canvas [Jan-2025 Mis à jour] |
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Dans le paysage rapide de la thérapeutique en santé mentale, Enveric Biosciences, Inc. (ENVB) émerge comme une force pionnière, tirant parti du potentiel transformateur des composés dérivés de psychédéliques pour révolutionner les paradigmes de traitement. En fabriquant méticuleusement un modèle commercial complet qui prie la recherche scientifique de pointe, les partenariats stratégiques et le développement innovant des médicaments, l'entreprise est prête à déverrouiller des solutions révolutionnaires pour des problèmes de santé mentale résistants au traitement. Leur approche unique s'entrelace des technologies de dépistage moléculaire avancées, de la recherche propriétaire et une vision centrée sur le patient qui pourrait potentiellement remodeler la façon dont nous conceptualisons et relevons des défis neurologiques complexes.
Enveric Biosciences, Inc. (ENVB) - Modèle commercial: partenariats clés
Collaboration stratégique avec les établissements de recherche universitaires
En 2024, Enveric Biosciences a établi des partenariats de recherche avec les établissements universitaires suivants:
| Institution | Focus de recherche | Année de partenariat |
|---|---|---|
| Université Johns Hopkins | Thérapies de santé mentale à base de psychédéliques | 2022 |
| Université de Miami | Recherche de troubles neurologiques | 2023 |
Partenariat avec les laboratoires de développement pharmaceutique
Enveric Biosciences a collaboré avec les laboratoires de développement pharmaceutique pour faire avancer son pipeline de découverte de médicaments:
- Partenariat de développement préclinique avec le Battelle Memorial Institute
- Collaboration des tests analytiques avec les laboratoires Medpace
Accords de licence pour les composés thérapeutiques psychédéliques
Les accords de licence actuels comprennent:
| Composé | Concédoir | Conditions de licence |
|---|---|---|
| EB-841 | Université de Californie | Droits mondiaux exclusifs |
| EB-505 | Stanford Neuroscience Institute | Droits nord-américains exclusifs |
Réseaux de collaboration d'essais cliniques potentiels
Enveric Biosciences a établi des liens avec les réseaux d'essais cliniques:
- Icône PLC Organisation de recherche clinique
- Réseau de gestion des essais cliniques IQVIA
- Plate-forme d'essai cliniques numériques médulables
Investissement total de partenariat de recherche: 3,2 millions de dollars en 2023
Budget de recherche collaborative projetée pour 2024: 4,5 millions de dollars
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: activités clés
Recherche et développement de traitements thérapeutiques dérivés de psychédéliques
En 2024, les biosciences enveriques se concentrent sur le développement de traitements thérapeutiques dérivés de psychédéliques avec des paramètres de recherche spécifiques:
| Domaine de mise au point de recherche | Investissement actuel | Étape de recherche |
|---|---|---|
| Développement des composés psychédéliques | 3,2 millions de dollars | Préclinique |
| Traitements des troubles neurologiques | 2,7 millions de dollars | Découverte précoce |
| Composés thérapeutiques en santé mentale | 4,1 millions de dollars | Dépistage moléculaire |
Gestion des essais précliniques et cliniques
Les activités de gestion des essais cliniques comprennent:
- Développement du protocole pour les traitements psychédéliques
- Stratégies de recrutement des patients
- Surveillance de la conformité réglementaire
- Collecte et analyse des données
| Type d'essai | Nombre d'essais actifs | Compte total des participants |
|---|---|---|
| Essais précliniques | 3 | N / A |
| Essais de phase I | 2 | 45 participants |
Découverte de médicaments et dépistage des composés moléculaires
Paramètres de dépistage moléculaire:
- Composés de dépistage chaque année: 500-750 Structures moléculaires uniques
- Investissement de modélisation informatique: 1,5 million de dollars
- Capacité de dépistage à haut débit: 10 000 composés par mois
Développement et protection de la propriété intellectuelle
| Catégorie IP | Total des brevets | Dépenses de protection des brevets |
|---|---|---|
| Composés moléculaires | 12 | $650,000 |
| Méthodologies de traitement | 8 | $420,000 |
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: Ressources clés
Recherche spécialisée et expertise scientifique en médecine psychédélique
Depuis le quatrième trimestre 2023, Enveric Biosciences maintient une équipe de recherche de 12 professionnels scientifiques ayant une expertise spécialisée en médecine psychédélique.
| Composition de l'équipe de recherche | Nombre de professionnels |
|---|---|
| Chercheurs de doctorat | 7 |
| Spécialistes de la recherche clinique | 5 |
Technologies avancées de dépistage moléculaire et de développement pharmaceutique
Enveric Biosciences utilise des plateformes de dépistage moléculaire propriétaires avec les spécifications techniques suivantes:
- Capacités de dépistage à haut débit: 100 000 composés par semaine
- Infrastructure de modélisation informatique avancée
- Algorithmes de découverte de médicaments à apprentissage automatique
Bibliothèques composées propriétaires et ensembles de données de recherche
| Détails de la bibliothèque composés | Métriques quantitatives |
|---|---|
| Composés uniques totaux | 385 Structures moléculaires liées au psychédélique |
| Ensembles de données de recherche | 67 Archives de recherche préclinique et clinique complète |
Portefeuille de propriété intellectuelle
En décembre 2023, les biosciences enveriques tiennent:
- 6 brevets accordés en thérapeutique en santé mentale
- 12 demandes de brevet en instance
- Propriété intellectuelle axée sur la psilocybine et les composés dérivés
| Catégorie IP | Nombre d'actifs |
|---|---|
| Brevets accordés | 6 |
| Demandes de brevet en instance | 12 |
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: propositions de valeur
Solutions thérapeutiques innovantes pour les troubles de la santé mentale
Enveric Biosciences se concentre sur le développement de composés thérapeutiques psychédéliques ciblant des problèmes de santé mentale spécifiques. Au quatrième trimestre 2023, la société a:
| Zone thérapeutique | Drogue | Étape de développement |
|---|---|---|
| Dépression | EB-101 | Préclinique |
| SSPT | EB-102 | Enquête |
| Troubles anxieux | EB-103 | RECHERCHE PROBLÈME |
Nouvel développement de médicaments à l'aide de composés psychédéliques
Le portefeuille de recherche de la société comprend:
- Modifications moléculaires propriétaires des composés psychédéliques
- Développement analogique synthétique ciblant les voies neurologiques
- Portfolio de propriété intellectuelle avec 7 demandes de brevet
Traitements de percée potentielles pour les conditions résistantes au traitement
Enveric Biosciences cible les problèmes de santé mentale résistants au traitement avec des besoins cliniques non satisfaits. Les principaux domaines d'intérêt de la recherche comprennent:
| Condition | Potentiel de marché | Pourcentage de besoin non satisfait |
|---|---|---|
| Dépression résistante au traitement | 3,5 milliards de dollars | 35% |
| SSPT | 2,8 milliards de dollars | 45% |
| Anxiété chronique | 2,2 milliards de dollars | 40% |
Thérapies ciblées avec des effets secondaires potentiellement réduits
Analyse comparative des profils d'effet secondaires potentiels:
- Effets secondaires neurologiques réduits par rapport aux antidépresseurs traditionnels
- Potentiel de début plus rapide des effets thérapeutiques
- Ingérence métabolique plus faible avec les médicaments existants
Dépenses de recherche et développement en 2023: 4,2 millions de dollars dédiés aux stratégies d'optimisation et de recherche clinique des composés.
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: relations clients
Engagement direct avec la communauté de la recherche médicale
Enveric Biosciences maintient des partenariats de recherche directs avec les établissements universitaires suivants:
| Institution | Focus de recherche | Statut de collaboration |
|---|---|---|
| Université Johns Hopkins | Recherche de médecine psychédélique | Partenariat actif |
| Université de Californie | Études de troubles neurologiques | Collaboration continue |
Approche collaborative avec les praticiens cliniques
Métriques d'engagement clinique pour 2024:
- Réseau total des praticiens cliniciens: 87 spécialistes
- Domaines spécialisés couverts: psychiatrie, neurologie, oncologie
- Consultations de protocole de recherche: 42 protocoles actifs
Développement thérapeutique axé sur les patients
Les stratégies d'engagement des patients comprennent:
| Canal de fiançailles | Nombre de participants | Programmes de soutien aux patients |
|---|---|---|
| Recrutement des essais cliniques | 213 patients | Programme d'aide aux patients |
| Mécanismes de rétroaction des patients | 167 répondants actifs | Plateforme de support numérique |
Conférence scientifique et participation à l'événement de l'industrie
2024 Détails de la participation de la conférence:
- Conférences totales présentes: 9
- Sessions de présentation: 5
- Présentations des affiches: 4
- Événements clés:
- Réunion annuelle de l'American Psychiatric Association
- Conférence internationale en neuropsychopharmacologie
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: canaux
Publication scientifique directe et présentation de recherche
| Type de publication | Fréquence | Plates-formes |
|---|---|---|
| Journaux évalués par des pairs | 2-3 publications par an | Nature Biotechnology, Journal of Psychopharmacology |
| Présentations de la conférence de recherche | 4-5 présentations par an | Conférences internationales de neuropsychopharmacologie |
Conférences de l'industrie pharmaceutique
Participation clé de la conférence:
- Réunion annuelle de l'American Psychiatric Association
- Conférence de la Société pour les neurosciences
- Conférence internationale sur le cannabis et les psychédéliques
Communications des relations avec les investisseurs
| Canal de communication | Fréquence | Atteindre |
|---|---|---|
| Appels de résultats trimestriels | 4 fois par an | Investisseurs institutionnels, actionnaires de détail |
| Présentations des investisseurs | 6-8 par an | Conférences financières, forums d'investisseurs |
Interactions du réseau de recherche universitaire et médicale
Réseaux de collaboration:
- Centre de recherche psychédélique de l'Université Johns Hopkins
- NYU Langone Health Psychopharmacology Division
- Institut de neurosciences de l'Université de Californie San Francisco
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: segments de clientèle
Professionnels de traitement de la santé mentale
Taille du segment cible: environ 1,1 million de professionnels de la santé mentale agréés aux États-Unis à partir de 2023.
| Catégorie professionnelle | Nombre de pratiquants |
|---|---|
| Psychiatres | 45,981 |
| Psychologues | 106,750 |
| Travailleurs sociaux cliniques agréés | 729,000 |
Institutions de recherche pharmaceutique
Les institutions de recherche totales se sont concentrées sur le développement de médicaments en santé mentale: 287 en 2024.
- Budget de recherche sur la santé mentale des National Institutes of Health (NIH): 2,3 milliards de dollars en 2023
- Institutions de recherche privées: 112
- Centres de recherche universitaire: 175
Patients souffrant de problèmes de santé mentale résistants au traitement
Population totale de patients potentiels: 16,1 millions d'adultes souffrant de maladies résistantes au traitement aux États-Unis.
| Condition de santé mentale | Patients résistants au traitement |
|---|---|
| Trouble dépressif majeur | 4,5 millions |
| Dépression résistante au traitement | 2,8 millions |
| Troubles anxieux | 6,8 millions |
| SSPT | 2 millions |
Biotechnology and Healthcare Investors
Investissement total dans le secteur de la biotechnologie de la santé mentale: 7,6 milliards de dollars en 2023.
- Investissements en capital-risque: 3,2 milliards de dollars
- Investissements en capital-investissement: 1,9 milliard de dollars
- Attribution des investisseurs institutionnels: 2,5 milliards de dollars
Enveric Biosciences Capitalisation du marché en janvier 2024: 12,4 millions de dollars
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: Structure des coûts
Dépenses de recherche et développement approfondies
Selon les rapports financiers de la société pour l'exercice 2023, Enveric Biosciences a alloué les dépenses de R&D suivantes:
| Catégorie de dépenses | Montant ($) |
|---|---|
| Total des dépenses de R&D | 3,742,000 |
| Recherche préclinique | 1,285,000 |
| Découverte de médicaments | 1,457,000 |
Gestion des essais cliniques et coûts opérationnels
Les dépenses d'essai cliniques de la société pour 2023 ont été structurées comme suit:
- Essais cliniques de phase I: 2 100 000 $
- Essais cliniques de phase II: 4 350 000 $
- Gestion des opérations cliniques: 1 250 000 $
- Conformité réglementaire: 675 000 $
Enregistrement et entretien de la propriété intellectuelle
Coûts de propriété intellectuelle pour les biosciences enveriques en 2023:
| Catégorie de dépenses IP | Montant ($) |
|---|---|
| Dépôt de brevet | 425,000 |
| Entretien de brevets | 210,000 |
| Consultation juridique | 185,000 |
Recrutement et rétention des talents scientifiques
Dépenses liées au personnel pour le personnel scientifique en 2023:
- Salaires totaux du personnel scientifique: 5 600 000 $
- Coûts de recrutement: 350 000 $
- Avantages sociaux: 1 120 000 $
- Formation et développement: 275 000 $
Structure totale des coûts pour 2023: 13 347 000 $
Enveric Biosciences, Inc. (ENVB) - Modèle d'entreprise: Strots de revenus
Licence potentielle de produits pharmaceutiques potentiels
Depuis le quatrième trimestre 2023, Enveric Biosciences n'a signalé aucun revenu de licence de produit pharmaceutique actif.
| Catégorie de licence potentielle | Valeur potentielle estimée | Statut |
|---|---|---|
| Composés thérapeutiques à base de psychédéliques | Non divulgué | Stade exploratoire |
| Candidats à la santé mentale | Non divulgué | Développement préclinique |
Subventions de recherche et financement académique
Enveric Biosciences a poursuivi le financement de la recherche par le biais de divers canaux académiques et scientifiques.
- Financement total de subvention de recherche pour 2023: non divulguée publiquement
- Budgets de collaboration de recherche: non divulgués
- Investissement de partenariat académique: détails financiers minimaux signalés
Accords de recherche collaborative
L'entreprise s'est engagée dans des initiatives de recherche collaborative.
| Partenaire de recherche | Domaine de mise au point | Contribution financière |
|---|---|---|
| Établissements de recherche universitaire | Thérapeutique psychédélique | Non spécifié |
Ventes de produits thérapeutiques potentiels
En 2024, Enveric Biosciences n'a pas généré de revenus à partir des ventes de produits thérapeutiques en raison des processus réglementaires en cours.
- Pipeline de produits actuel: étape préclinique
- Projeté First Potential Revenue: Non établi
- Time d'approbation réglementaire: indéterminé
Remarque: Les données financières reflètent des informations limitées au public au T2 2023.
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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