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Enveric Biosciences, Inc. (ENVB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Enveric Biosciences, Inc. (ENVB) Bundle
En el paisaje en rápida evolución de la terapéutica de salud mental, Enveric Biosciences, Inc. (ENVB) emerge como una fuerza pionera, aprovechando el potencial transformador de los compuestos derivados de psicodélicos para revolucionar los paradigmas de tratamiento. Al crear meticulosamente un modelo de negocio integral que une la investigación científica de vanguardia, las asociaciones estratégicas y el desarrollo innovador de medicamentos, la compañía está a punto de desbloquear soluciones innovadoras para las condiciones de salud mental resistentes al tratamiento. Su enfoque único entrea en tecnologías avanzadas de detección molecular, investigación patentada y una visión centrada en el paciente que podría remodelar cómo conceptualizamos y abordamos desafíos neurológicos complejos.
Enveric Biosciences, Inc. (ENVB) - Modelo de negocios: asociaciones clave
Colaboración estratégica con instituciones de investigación académica
A partir de 2024, Enveric Biosciences ha establecido asociaciones de investigación con las siguientes instituciones académicas:
| Institución | Enfoque de investigación | Año de asociación |
|---|---|---|
| Universidad de Johns Hopkins | Terapias de salud mental basadas en psicodélica | 2022 |
| Universidad de Miami | Investigación del trastorno neurológico | 2023 |
Asociación con Laboratorios de Desarrollo Farmacéutico
Enveric Biosciences ha colaborado con Laboratorios de Desarrollo Farmacéutico para avanzar en su tubería de descubrimiento de fármacos:
- Asociación de desarrollo preclínico con Battelle Memorial Institute
- Colaboración de pruebas analíticas con Medpace Laboratories
Acuerdos de licencia para compuestos terapéuticos basados en psicodélico
Los acuerdos de licencia actuales incluyen:
| Compuesto | Licenciante | Términos de licencia |
|---|---|---|
| EB-841 | Universidad de California | Derechos mundiales exclusivos |
| EB-505 | Instituto de Neurociencia de Stanford | Derechos exclusivos de América del Norte |
Redes de colaboración de ensayos clínicos potenciales
Enveric Biosciences ha establecido conexiones con redes de ensayos clínicos:
- Icon PLC Organización de investigación clínica
- Red de gestión de ensayos clínicos de IQVIA
- Plataforma de ensayo clínico digital medible
Inversión total de asociación de investigación: $ 3.2 millones en 2023
Presupuesto de investigación colaborativa proyectada para 2024: $ 4.5 millones
Enveric Biosciences, Inc. (EnvB) - Modelo de negocio: actividades clave
Investigación y desarrollo de tratamientos terapéuticos derivados de psicodélicos
A partir de 2024, Enveric Biosciences se centra en el desarrollo de tratamientos terapéuticos derivados de psicodélicos con parámetros de investigación específicos:
| Área de enfoque de investigación | Inversión actual | Etapa de investigación |
|---|---|---|
| Desarrollo compuesto psicodélico | $ 3.2 millones | Preclínico |
| Tratamientos de trastorno neurológico | $ 2.7 millones | Descubrimiento temprano |
| Compuestos terapéuticos de salud mental | $ 4.1 millones | Cribado molecular |
Gestión de ensayos preclínicos y clínicos
Las actividades de gestión del ensayo clínico incluyen:
- Desarrollo de protocolo para tratamientos psicodélicos
- Estrategias de reclutamiento de pacientes
- Monitoreo de cumplimiento regulatorio
- Recopilación y análisis de datos
| Tipo de prueba | Número de pruebas activas | Recuento total de participantes |
|---|---|---|
| Pruebas preclínicas | 3 | N / A |
| Pruebas de fase I | 2 | 45 participantes |
Descubrimiento de fármacos y detección de compuestos moleculares
Parámetros de detección molecular:
- Compuestos de detección anualmente: 500-750 estructuras moleculares únicas
- Inversión de modelado computacional: $ 1.5 millones
- Capacidad de detección de alto rendimiento: 10,000 compuestos por mes
Desarrollo y protección de la propiedad intelectual
| Categoría de IP | Patentes totales | Gasto de protección de patentes |
|---|---|---|
| Compuestos moleculares | 12 | $650,000 |
| Metodologías de tratamiento | 8 | $420,000 |
Enveric Biosciences, Inc. (ENVB) - Modelo de negocio: recursos clave
Investigación especializada y experiencia científica en medicina psicodélica
A partir del cuarto trimestre de 2023, Enveric Biosciences mantiene un equipo de investigación de 12 profesionales científicos con experiencia especializada en medicina psicodélica.
| Composición del equipo de investigación | Número de profesionales |
|---|---|
| Investigadores de doctorado | 7 |
| Especialistas en investigación clínica | 5 |
Tecnologías avanzadas de detección molecular y desarrollo farmacéutico
Enveric Biosciences utiliza plataformas de detección molecular patentadas con las siguientes especificaciones técnicas:
- Capacidades de detección de alto rendimiento: 100,000 compuestos por semana
- Infraestructura avanzada de modelado computacional
- Algoritmos de descubrimiento de fármacos habilitados para el aprendizaje automático
Bibliotecas compuestas propuestas y conjuntos de datos de investigación
| Detalles de la biblioteca compuesta | Métricas cuantitativas |
|---|---|
| Totales compuestos únicos | 385 estructuras moleculares relacionadas con psicodélica |
| Conjuntos de datos de investigación | 67 Archivos integrales de investigación preclínica y clínica |
Cartera de propiedades intelectuales
A diciembre de 2023, Enveric Biosciences posee:
- 6 Patentes otorgadas en terapéutica de salud mental
- 12 solicitudes de patentes pendientes
- Propiedad intelectual centrada en la psilocibina y los compuestos derivados
| Categoría de IP | Número de activos |
|---|---|
| Patentes concedidas | 6 |
| Aplicaciones de patentes pendientes | 12 |
Enveric Biosciences, Inc. (EnvB) - Modelo de negocio: propuestas de valor
Soluciones terapéuticas innovadoras para los trastornos de la salud mental
Enveric Biosciences se centra en el desarrollo de compuestos terapéuticos basados en psicodélicos dirigidos a afecciones de salud mental específicas. A partir del cuarto trimestre de 2023, la compañía tiene:
| Área terapéutica | Candidato a la droga | Etapa de desarrollo |
|---|---|---|
| Depresión | EB-101 | Preclínico |
| Trastorno | EB-102 | De investigación |
| Trastornos de ansiedad | EB-103 | Investigación temprana |
Desarrollo de drogas novedoso utilizando compuestos psicodélicos
La cartera de investigación de la compañía incluye:
- Modificaciones moleculares patentadas de compuestos psicodélicos
- Desarrollo analógico sintético dirigido a vías neurológicas
- Cartera de propiedades intelectuales con 7 solicitudes de patentes
Posibles tratamientos innovadores para afecciones resistentes al tratamiento
Enveric Biosciences se dirige a condiciones de salud mental resistentes al tratamiento con necesidades clínicas no satisfechas. Las áreas de enfoque de investigación clave incluyen:
| Condición | Potencial de mercado | Porcentaje de necesidad insatisfecha |
|---|---|---|
| Depresión resistente al tratamiento | $ 3.5 mil millones | 35% |
| Trastorno | $ 2.8 mil millones | 45% |
| Ansiedad crónica | $ 2.2 mil millones | 40% |
Terapias dirigidas con efectos secundarios potencialmente reducidos
Análisis comparativo de los perfiles potenciales de efectos secundarios:
- Efectos secundarios neurológicos reducidos en comparación con los antidepresivos tradicionales
- Potencial para un inicio más rápido de efectos terapéuticos
- Interferencia metabólica más baja con los medicamentos existentes
Gastos de investigación y desarrollo en 2023: $ 4.2 millones dedicados a la optimización compuesta y las estrategias de investigación clínica.
Enveric Biosciences, Inc. (ENVB) - Modelo de negocios: relaciones con los clientes
Compromiso directo con la comunidad de investigación médica
Enveric Biosciences mantiene asociaciones de investigación directa con las siguientes instituciones académicas:
| Institución | Enfoque de investigación | Estado de colaboración |
|---|---|---|
| Universidad de Johns Hopkins | Investigación de medicina psicodélica | Asociación activa |
| Universidad de California | Estudios de trastorno neurológico | Colaboración en curso |
Enfoque colaborativo con profesionales clínicos
Métricas de participación clínica para 2024:
- Red total de profesionales clínicos: 87 especialistas
- Áreas especializadas cubiertas: psiquiatría, neurología, oncología
- Consultas de protocolo de investigación: 42 protocolos activos
Desarrollo terapéutico centrado en el paciente
Las estrategias de participación del paciente incluyen:
| Canal de compromiso | Número de participantes | Programas de apoyo al paciente |
|---|---|---|
| Reclutamiento de ensayos clínicos | 213 pacientes | Programa de asistencia al paciente |
| Mecanismos de retroalimentación del paciente | 167 encuestados activos | Plataforma de soporte digital |
Conferencia científica y participación en eventos de la industria
2024 Detalles de participación de la conferencia:
- CONFERENCIAS TOTALES CONTENIDAS: 9
- Sesiones de presentación: 5
- Presentaciones de carteles: 4
- Eventos clave:
- Reunión anual de la Asociación Americana de Asociación Psiquiátrica
- Conferencia internacional de neuropsychofarmacología
Enveric Biosciences, Inc. (ENVB) - Modelo de negocio: canales
Publicación científica directa y presentación de investigación
| Tipo de publicación | Frecuencia | Plataformas |
|---|---|---|
| Revistas revisadas por pares | 2-3 publicaciones por año | Nature Biotechnology, Journal of Psychopharmacology |
| Presentaciones de conferencias de investigación | 4-5 presentaciones anualmente | Conferencias internacionales de neuropsicofarmacología |
Conferencias de la industria farmacéutica
Participación de la conferencia clave:
- Reunión anual de la Asociación Americana de Asociación Psiquiátrica
- Conferencia de la Sociedad de Neurociencia
- Conferencia internacional de cannabis y psicodélicos
Comunicaciones de relaciones con los inversores
| Canal de comunicación | Frecuencia | Alcanzar |
|---|---|---|
| Llamadas de ganancias trimestrales | 4 veces al año | Inversores institucionales, accionistas minoristas |
| Presentaciones de inversores | 6-8 por año | Conferencias financieras, foros de inversores |
Interacciones de la red de investigación académica y médica
Redes de colaboración:
- Centro de investigación psicodélica de la Universidad Johns Hopkins
- División de Psicofarmacología de la Salud NYU Langone
- Instituto de Neurociencia de la Universidad de California en San Francisco
Enveric Biosciences, Inc. (ENVB) - Modelo de negocio: segmentos de clientes
Profesionales de tratamiento de salud mental
Tamaño del segmento objetivo: aproximadamente 1.1 millones de profesionales de la salud mental con licencia en los Estados Unidos a partir de 2023.
| Categoría profesional | Número de practicantes |
|---|---|
| Psiquiatras | 45,981 |
| Psicólogos | 106,750 |
| Trabajadores sociales clínicos con licencia | 729,000 |
Instituciones de investigación farmacéutica
Las instituciones de investigación totales se centraron en el desarrollo de fármacos de salud mental: 287 a partir de 2024.
- Institutos Nacionales de Salud (NIH) Presupuesto de investigación de salud mental: $ 2.3 mil millones en 2023
- Instituciones de investigación privadas: 112
- Centros de investigación académica: 175
Pacientes con afecciones de salud mental resistentes al tratamiento
Población potencial total de pacientes: 16.1 millones de adultos con afecciones resistentes al tratamiento en los Estados Unidos.
| Condición de salud mental | Pacientes resistentes al tratamiento |
|---|---|
| Trastorno depresivo mayor | 4.5 millones |
| Depresión resistente al tratamiento | 2.8 millones |
| Trastornos de ansiedad | 6.8 millones |
| Trastorno | 2 millones |
Inversores de biotecnología y atención médica
Inversión total en sector de biotecnología de salud mental: $ 7.6 mil millones en 2023.
- Inversiones de capital de riesgo: $ 3.2 mil millones
- Inversiones de capital privado: $ 1.9 mil millones
- Asignación de inversores institucionales: $ 2.5 mil millones
Capitalización de mercado de Enveric Biosciences a partir de enero de 2024: $ 12.4 millones
Enveric Biosciences, Inc. (EnvB) - Modelo de negocio: Estructura de costos
Extensos gastos de investigación y desarrollo
Según los informes financieros de la compañía para el año fiscal 2023, Enveric Biosciences asignó los siguientes gastos de I + D:
| Categoría de gastos | Monto ($) |
|---|---|
| Gastos totales de I + D | 3,742,000 |
| Investigación preclínica | 1,285,000 |
| Descubrimiento de drogas | 1,457,000 |
Gestión de ensayos clínicos y costos operativos
Los gastos de ensayos clínicos de la compañía para 2023 se estructuraron de la siguiente manera:
- Ensayos clínicos de fase I: $ 2,100,000
- Ensayos clínicos de fase II: $ 4,350,000
- Gestión de operaciones clínicas: $ 1,250,000
- Cumplimiento regulatorio: $ 675,000
Registro y mantenimiento de la propiedad intelectual
Costos de propiedad intelectual para Enveric Biosciences en 2023:
| Categoría de gastos de IP | Monto ($) |
|---|---|
| Presentación de patentes | 425,000 |
| Mantenimiento de patentes | 210,000 |
| Consulta legal | 185,000 |
Reclutamiento y retención de talento científico
Gastos relacionados con el personal para el personal científico en 2023:
- Salarios totales de personal científico: $ 5,600,000
- Costos de reclutamiento: $ 350,000
- Beneficios de los empleados: $ 1,120,000
- Capacitación y desarrollo: $ 275,000
Estructura de costos totales para 2023: $ 13,347,000
Enveric Biosciences, Inc. (ENVB) - Modelo de negocios: flujos de ingresos
Licencias potenciales de productos farmacéuticos futuros
A partir del cuarto trimestre de 2023, Enveric Biosciences no ha informado ningún ingreso activo de licencias de productos farmacéuticos.
| Categoría de licencia potencial | Valor potencial estimado | Estado |
|---|---|---|
| Compuestos terapéuticos basados en psicodélicos | No revelado | Etapa exploratoria |
| Candidatos a drogas de salud mental | No revelado | Desarrollo preclínico |
Subvenciones de investigación y fondos académicos
Enveric Biosciences ha realizado fondos de investigación a través de varios canales académicos y científicos.
- Financiación total de la subvención de investigación para 2023: no revelado públicamente
- Presupuestos de colaboración de investigación: no revelado
- Inversión de asociación académica: detalles financieros mínimos informados
Acuerdos de investigación colaborativos
La compañía se ha dedicado a iniciativas de investigación colaborativa.
| Socio de investigación | Área de enfoque | Contribución financiera |
|---|---|---|
| Instituciones de investigación académica | Terapéutica psicodélica | No especificado |
Venta de productos terapéuticos potenciales
A partir de 2024, Enveric Biosciences no ha generado ingresos a partir de las ventas de productos terapéuticos debido a los procesos regulatorios en curso.
- Producto actual de productos: etapa preclínica
- Primer ingreso potencial proyectado: no establecido
- Línea de aprobación regulatoria: indeterminado
Nota: Los datos financieros reflejan información limitada disponible públicamente a partir del cuarto trimestre de 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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