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Enveric Biosciences, Inc. (EnvB): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Enveric Biosciences, Inc. (ENVB) Bundle
No cenário em rápida evolução da terapêutica da saúde mental, a Enveric Biosciences, Inc. (ENVB) surge como uma força pioneira, alavancando o potencial transformador dos compostos derivados psicodélicos para revolucionar os paradigmas de tratamento. Ao criar meticulosamente um modelo de negócios abrangente que preenche a pesquisa científica de ponta, parcerias estratégicas e desenvolvimento inovador de medicamentos, a empresa está pronta para desbloquear soluções inovadoras para condições de saúde mental resistentes ao tratamento. Sua abordagem única entrelaça as tecnologias avançadas de triagem molecular, a pesquisa proprietária e uma visão centrada no paciente que poderia potencialmente remodelar como conceituamos e abordamos desafios neurológicos complexos.
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: Parcerias -chave
Colaboração estratégica com instituições de pesquisa acadêmica
A partir de 2024, a Enveric Biosciences estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:
| Instituição | Foco na pesquisa | Ano de parceria |
|---|---|---|
| Universidade Johns Hopkins | Terapias de saúde mental psicodélica | 2022 |
| Universidade de Miami | Pesquisa em transtorno neurológico | 2023 |
Parceria com laboratórios de desenvolvimento farmacêutico
A Enveric Biosciences colaborou com os laboratórios de desenvolvimento farmacêutico para avançar em seu pipeline de descoberta de medicamentos:
- Parceria de desenvolvimento pré -clínico com o Battelle Memorial Institute
- Colaboração de testes analíticos com Medpace Laboratories
Acordos de licenciamento para compostos terapêuticos psicodélicos
Os contratos de licenciamento atuais incluem:
| Composto | Licenciante | Termos de licenciamento |
|---|---|---|
| EB-841 | Universidade da Califórnia | Direitos mundiais exclusivos |
| EB-505 | Instituto de Neurociência de Stanford | Direitos norte -americanos exclusivos |
Potenciais redes de colaboração de ensaios clínicos
A Enveric Biosciences estabeleceu conexões com redes de ensaios clínicos:
- Organização de pesquisa clínica do ICON PLC
- Rede de gerenciamento de ensaios clínicos da IQVIA
- Plataforma de ensaio clínico digital medível
Investimento em parceria de pesquisa total: US $ 3,2 milhões em 2023
Orçamento de pesquisa colaborativa projetada para 2024: US $ 4,5 milhões
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: Atividades -chave
Pesquisa e desenvolvimento de tratamentos terapêuticos derivados de psicodélicos
A partir de 2024, a Enveric Biosciences se concentra no desenvolvimento de tratamentos terapêuticos derivados de psicodélicos com parâmetros de pesquisa específicos:
| Área de foco de pesquisa | Investimento atual | Estágio de pesquisa |
|---|---|---|
| Desenvolvimento de compostos psicodélicos | US $ 3,2 milhões | Pré -clínico |
| Tratamentos de transtorno neurológico | US $ 2,7 milhões | Descoberta precoce |
| Compostos terapêuticos de saúde mental | US $ 4,1 milhões | Triagem molecular |
Gerenciamento de ensaios pré -clínicos e clínicos
As atividades de gerenciamento de ensaios clínicos incluem:
- Desenvolvimento de protocolo para tratamentos baseados em psicodélicos
- Estratégias de recrutamento de pacientes
- Monitoramento da conformidade regulatória
- Coleta e análise de dados
| Tipo de teste | Número de ensaios ativos | Contagem total de participantes |
|---|---|---|
| Ensaios pré -clínicos | 3 | N / D |
| Ensaios de Fase I. | 2 | 45 participantes |
Descoberta de medicamentos e triagem de composto molecular
Parâmetros de triagem molecular:
- Compostos de triagem anualmente: 500-750 estruturas moleculares únicas
- Investimento de modelagem computacional: US $ 1,5 milhão
- Capacidade de triagem de alto rendimento: 10.000 compostos por mês
Desenvolvimento e proteção da propriedade intelectual
| Categoria IP | Total de patentes | Despesas de proteção de patentes |
|---|---|---|
| Compostos moleculares | 12 | $650,000 |
| Metodologias de tratamento | 8 | $420,000 |
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: Recursos -chave
Pesquisa especializada e experiência científica em medicina psicodélica
No quarto trimestre 2023, a Enveric Biosciences mantém uma equipe de pesquisa de 12 profissionais científicos com experiência especializada em medicina psicodélica.
| Composição da equipe de pesquisa | Número de profissionais |
|---|---|
| Pesquisadores de doutorado | 7 |
| Especialistas em pesquisa clínica | 5 |
Tecnologias avançadas de triagem molecular e desenvolvimento farmacêutico
As biosciências enver e utilizam plataformas de triagem molecular proprietárias com as seguintes especificações técnicas:
- Recursos de triagem de alto rendimento: 100.000 compostos por semana
- Infraestrutura de modelagem computacional avançada
- Algoritmos de descoberta de medicamentos habilitados para aprendizado de máquina
Bibliotecas de compostos proprietários e conjuntos de dados de pesquisa
| Detalhes da biblioteca composta | Métricas quantitativas |
|---|---|
| Compostos únicos totais | 385 estruturas moleculares relacionadas a psicodélicos |
| Conjuntos de dados de pesquisa | 67 arquivos abrangentes de pesquisa pré -clínica e clínica |
Portfólio de propriedade intelectual
Em dezembro de 2023, a Enveric Biosciences possui:
- 6 Patentes concedidas em terapêutica de saúde mental
- 12 pedidos de patente pendente
- Propriedade intelectual focada em psilocibina e compostos derivados
| Categoria IP | Número de ativos |
|---|---|
| Patentes concedidas | 6 |
| Aplicações de patentes pendentes | 12 |
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: proposições de valor
Soluções terapêuticas inovadoras para distúrbios de saúde mental
A Biosciências Enveréricas concentra-se no desenvolvimento de compostos terapêuticos psicodélicos direcionados a condições específicas de saúde mental. A partir do quarto trimestre 2023, a empresa possui:
| Área terapêutica | Candidato a drogas | Estágio de desenvolvimento |
|---|---|---|
| Depressão | EB-101 | Pré -clínico |
| TEPT | EB-102 | Investigação |
| Transtornos de ansiedade | EB-103 | Pesquisa antecipada |
Novos Desenvolvimento de Medicamentos usando compostos baseados em psicodélico
O portfólio de pesquisa da empresa inclui:
- Modificações moleculares proprietárias de compostos psicodélicos
- Desenvolvimento analógico sintético direcionado às vias neurológicas
- Portfólio de propriedade intelectual com 7 pedidos de patente
Possíveis tratamentos inovadores para condições resistentes ao tratamento
A biosciences envericular tem como alvo as condições de saúde mental resistentes ao tratamento com necessidades clínicas não atendidas. As principais áreas de foco de pesquisa incluem:
| Doença | Potencial de mercado | Porcentagem de necessidade não atendida |
|---|---|---|
| Depressão resistente ao tratamento | US $ 3,5 bilhões | 35% |
| TEPT | US $ 2,8 bilhões | 45% |
| Ansiedade crônica | US $ 2,2 bilhões | 40% |
Terapias direcionadas com efeitos colaterais potencialmente reduzidos
Análise comparativa de possíveis perfis de efeito colateral:
- Efeitos colaterais neurológicos reduzidos em comparação aos antidepressivos tradicionais
- Potencial para um início mais rápido de efeitos terapêuticos
- Menor interferência metabólica com medicamentos existentes
Despesas de pesquisa e desenvolvimento em 2023: US $ 4,2 milhões dedicados à otimização de compostos e estratégias de pesquisa clínica.
Enveric Biosciences, Inc. (EnvB) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com a comunidade de pesquisa médica
A Enveric Biosciences mantém parcerias diretas de pesquisa com as seguintes instituições acadêmicas:
| Instituição | Foco na pesquisa | Status de colaboração |
|---|---|---|
| Universidade Johns Hopkins | Pesquisa de medicina psicodélica | Parceria ativa |
| Universidade da Califórnia | Estudos de transtorno neurológico | Colaboração em andamento |
Abordagem colaborativa com profissionais clínicos
Métricas de engajamento clínico para 2024:
- Rede de praticantes clínicos totais: 87 especialistas
- Áreas especializadas cobertas: psiquiatria, neurologia, oncologia
- Consultas do protocolo de pesquisa: 42 protocolos ativos
Desenvolvimento terapêutico focado no paciente
As estratégias de envolvimento do paciente incluem:
| Canal de engajamento | Número de participantes | Programas de apoio ao paciente |
|---|---|---|
| Recrutamento de ensaios clínicos | 213 pacientes | Programa de assistência ao paciente |
| Mecanismos de feedback do paciente | 167 entrevistados ativos | Plataforma de suporte digital |
Conferência Científica e Participação de Eventos da Indústria
2024 Detalhes da participação da conferência:
- Total de conferências participadas: 9
- Sessões de apresentação: 5
- Apresentações de pôsteres: 4
- Eventos -chave:
- Reunião Anual da Associação Psiquiátrica Americana
- Conferência Internacional de Neuropsicopharmacologia
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: canais
Publicação científica direta e apresentação de pesquisa
| Tipo de publicação | Freqüência | Plataformas |
|---|---|---|
| Revistas revisadas por pares | 2-3 publicações por ano | Biotecnologia da natureza, Journal of Psychopharmacology |
| Apresentações da conferência de pesquisa | 4-5 apresentações anualmente | Conferências internacionais de neuropsopharmacologia |
Conferências da indústria farmacêutica
Principal Participação da Conferência:
- Reunião Anual da Associação Psiquiátrica Americana
- Conferência da Sociedade para Neurociência
- Conferência Internacional de Cannabis e Psychedelics
Comunicações de Relações com Investidores
| Canal de comunicação | Freqüência | Alcançar |
|---|---|---|
| Chamadas de ganhos trimestrais | 4 vezes por ano | Investidores institucionais, acionistas de varejo |
| Apresentações de investidores | 6-8 por ano | Conferências financeiras, fóruns de investidores |
Interações da rede de pesquisa acadêmica e médica
Redes de colaboração:
- Centro de Pesquisa Psicodélica da Universidade Johns Hopkins
- Divisão de Psicofarmacologia da Saúde NYU Langone
- Instituto de Neurociência da Universidade da Califórnia em São Francisco
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: segmentos de clientes
Profissionais de tratamento de saúde mental
Tamanho do segmento -alvo: aproximadamente 1,1 milhão de profissionais de saúde mental licenciados nos Estados Unidos a partir de 2023.
| Categoria profissional | Número de praticantes |
|---|---|
| Psiquiatras | 45,981 |
| Psicólogos | 106,750 |
| Assistentes sociais clínicos licenciados | 729,000 |
Instituições de pesquisa farmacêutica
O total de instituições de pesquisa focada no desenvolvimento de medicamentos para saúde mental: 287 a partir de 2024.
- Institutos Nacionais de Saúde (NIH) Orçamento de pesquisa em saúde mental: US $ 2,3 bilhões em 2023
- Instituições de Pesquisa Privada: 112
- Centros de pesquisa acadêmica: 175
Pacientes com condições de saúde mental resistentes ao tratamento
População total de pacientes em potencial: 16,1 milhões de adultos com condições resistentes ao tratamento nos Estados Unidos.
| Condição de saúde mental | Pacientes resistentes ao tratamento |
|---|---|
| Transtorno depressivo maior | 4,5 milhões |
| Depressão resistente ao tratamento | 2,8 milhões |
| Transtornos de ansiedade | 6,8 milhões |
| TEPT | 2 milhões |
Investidores de biotecnologia e saúde
Investimento total no setor de biotecnologia de saúde mental: US $ 7,6 bilhões em 2023.
- Investimentos de capital de risco: US $ 3,2 bilhões
- Investimentos de private equity: US $ 1,9 bilhão
- Alocação de investidores institucionais: US $ 2,5 bilhões
Capitalização de mercado de Biosciências Enveréricas em janeiro de 2024: US $ 12,4 milhões
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: estrutura de custos
Extensas despesas de pesquisa e desenvolvimento
De acordo com os relatórios financeiros da Companhia para o ano fiscal de 2023, a Enveric Biosciences alocou as seguintes despesas de P&D:
| Categoria de despesa | Valor ($) |
|---|---|
| Despesas totais de P&D | 3,742,000 |
| Pesquisa pré -clínica | 1,285,000 |
| Descoberta de medicamentos | 1,457,000 |
Gerenciamento de ensaios clínicos e custos operacionais
As despesas de ensaios clínicos da empresa para 2023 foram estruturados da seguinte forma:
- Ensaios clínicos de fase I: US $ 2.100.000
- Fase II Ensaios Clínicos: US $ 4.350.000
- Gerenciamento de operações clínicas: US $ 1.250.000
- Conformidade regulatória: US $ 675.000
Registro e manutenção da propriedade intelectual
Custos de propriedade intelectual para biosciences envercitados em 2023:
| Categoria de despesa IP | Valor ($) |
|---|---|
| Registro de patentes | 425,000 |
| Manutenção de patentes | 210,000 |
| Consulta legal | 185,000 |
Recrutamento e retenção de talentos científicos
Despesas relacionadas ao pessoal para a equipe científica em 2023:
- Salários de pessoal científico total: US $ 5.600.000
- Custos de recrutamento: US $ 350.000
- Benefícios dos funcionários: US $ 1.120.000
- Treinamento e desenvolvimento: US $ 275.000
Estrutura de custo total para 2023: US $ 13.347.000
Enveric Biosciences, Inc. (EnvB) - Modelo de negócios: fluxos de receita
Potencial futuro licenciamento de produtos farmacêuticos
A partir do quarto trimestre 2023, a Enveric Biosciences não relatou nenhuma receita ativa de licenciamento de produtos farmacêuticos.
| Categoria de licenciamento potencial | Valor potencial estimado | Status |
|---|---|---|
| Compostos terapêuticos psicodélicos | Não divulgado | Estágio exploratório |
| Candidatos a drogas em saúde mental | Não divulgado | Desenvolvimento pré-clínico |
Subsídios de pesquisa e financiamento acadêmico
A Enveric Biosciences buscou financiamento de pesquisa por meio de vários canais acadêmicos e científicos.
- Total Research Grant Financiamento para 2023: Não divulgado publicamente
- Orçamentos de colaboração de pesquisa: não revelado
- Investimento de parceria acadêmica: detalhes financeiros mínimos relatados
Acordos de pesquisa colaborativa
A empresa se envolveu em iniciativas de pesquisa colaborativa.
| Parceiro de pesquisa | Área de foco | Contribuição financeira |
|---|---|---|
| Instituições de pesquisa acadêmica | Terapêutica psicodélica | Não especificado |
Vendas potenciais de produtos terapêuticos
A partir de 2024, a Enveric Biosciences não gerou receita com as vendas terapêuticas de produtos devido a processos regulatórios em andamento.
- Oleoduto atual: estágio pré-clínico
- Primeira receita potencial projetada: não estabelecida
- Cronograma de aprovação regulatória: indeterminado
NOTA: Os dados financeiros refletem informações limitadas disponíveis ao público a partir do quarto trimestre 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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