Enveric Biosciences Signs Out-Licensing Agreement with MycoMedica Life Sciences for EB-002
Enveric Biosciences (NASDAQ: ENVB) has signed a licensing agreement with MycoMedica Life Sciences for its EVM201 program, including drug candidate EB-002, a synthetic prodrug for treating neuropsychiatric disorders. The agreement includes potential milestone payments up to $62 million plus tiered single-digit royalties on future sales. MycoMedica receives exclusive global rights and will assume responsibility for all development phases. This strategic move allows Enveric to focus on advancing EB-003, their novel non-hallucinogenic neuroplastogen drug candidate, while maintaining potential future revenue streams from EB-002. The company plans to file an Investigational New Drug application for EB-003 in 2025.
Enveric Biosciences (NASDAQ: ENVB) ha firmato un accordo di licenza con MycoMedica Life Sciences per il suo programma EVM201, inclusa la candidata farmaceutica EB-002, un pro-farmaco sintetico per il trattamento dei disturbi neuropsichiatrici. L'accordo prevede potenziali pagamenti di traguardo fino a 62 milioni di dollari più royalty a percentuale singola a due cifre sulle vendite future. MycoMedica riceve diritti esclusivi a livello globale e si assumerà la responsabilità di tutte le fasi di sviluppo. Questa mossa strategica consente a Enveric di concentrarsi sull'avanzamento di EB-003, la loro nuova candidata farmaceutica neuroplastica non allucinogena, mantenendo nel contempo potenziali flussi di entrate futuri da EB-002. L'azienda prevede di presentare una domanda di Nuovo Farmaco in Sperimentazione per EB-003 nel 2025.
Enveric Biosciences (NASDAQ: ENVB) ha firmado un acuerdo de licencia con MycoMedica Life Sciences para su programa EVM201, que incluye el candidato a fármaco EB-002, un pro-fármaco sintético para el tratamiento de trastornos neuropsiquiátricos. El acuerdo incluye posibles pagos por hitos que pueden alcanzar hasta 62 millones de dólares más regalías en un solo dígito en las ventas futuras. MycoMedica recibe derechos globales exclusivos y asumirá la responsabilidad de todas las fases de desarrollo. Este movimiento estratégico permite a Enveric centrarse en el avance de EB-003, su novedoso candidato a fármaco neuroplástico no alucinógeno, mientras mantiene posibles flujos de ingresos futuros de EB-002. La empresa planea presentar una solicitud de Nuevo Fármaco en Investigación para EB-003 en 2025.
Enveric Biosciences (NASDAQ: ENVB)는 MycoMedica Life Sciences와 EVM201 프로그램에 대한 라이센스 계약을 체결했습니다. 이 프로그램에는 신경정신 장애 치료를 위한 합성 프로드럭 EB-002가 포함됩니다. 계약에는 최대 6200만 달러의 잠재적 마일스톤 지급과 미래 판매에 따른 단일 자리 로열티가 포함되어 있습니다. MycoMedica는 독점적인 전 세계 권리를 받으며 모든 개발 단계에 대한 책임을 집니다. 이 전략적 조치는 Enveric이 비환각성 신경플라스틱 약물 후보 EB-003의 발전에 집중할 수 있도록 하면서 EB-002에서의潜在 수익 흐름을 유지할 수 있도록 합니다. 회사는 2025년 EB-003에 대한 새로운 약물 연구 신청서를 제출할 계획입니다.
Enveric Biosciences (NASDAQ: ENVB) a signé un accord de licence avec MycoMedica Life Sciences pour son programme EVM201, y compris le candidat médicament EB-002, un pro-drogue synthétique pour le traitement des troubles neuropsychiatriques. L'accord comprend des paiements d'étape potentiels allant jusqu'à 62 millions de dollars, ainsi que des redevances à un chiffre de niveau échelonné sur les ventes futures. MycoMedica reçoit des droits exclusifs mondiaux et assumera la responsabilité de toutes les phases de développement. Ce mouvement stratégique permet à Enveric de se concentrer sur l'avancement de EB-003, leur nouveau candidat médicament neuroplastogène non hallucinogène, tout en maintenant d'éventuelles sources de revenus futurs provenant de EB-002. L'entreprise prévoit de déposer une demande de médicament d'investigation pour EB-003 en 2025.
Enveric Biosciences (NASDAQ: ENVB) hat einen Lizenzvertrag mit MycoMedica Life Sciences für sein EVM201-Programm unterzeichnet, das den Arzneikandidaten EB-002 umfasst, ein synthetisches Prodrug zur Behandlung von neuropsychiatrischen Störungen. Der Vertrag umfasst potenzielle Meilensteinzahlungen von bis zu 62 Millionen Dollar sowie gestaffelte Einstellig-Royaltys auf zukünftige Verkäufe. MycoMedica erhält exklusive globale Rechte und übernimmt die Verantwortung für alle Entwicklungsphasen. Dieser strategische Schritt ermöglicht es Enveric, sich auf die Weiterentwicklung von EB-003, ihrem neuartigen nicht-halluzinogenen Neuroplastogen-Arzneikandidaten, zu konzentrieren und gleichzeitig potenzielle zukünftige Einnahmequellen aus EB-002 zu sichern. Das Unternehmen plant, 2025 einen Antrag auf ein Neues Arzneimittel für EB-003 einzureichen.
- Potential milestone payments up to $62 million plus royalties
- Strategic focus on core drug candidate EB-003
- Maintains revenue potential while reducing development costs
- Strong intellectual property foundation with multiple US patents
- Divestment of EVM201 program including EB-002 asset
- Only 'modest' upfront payments mentioned
Insights
The licensing agreement with MycoMedica represents a significant financial opportunity for Enveric Biosciences, with potential milestone payments of up to
The deal structure includes upfront payments (amount undisclosed), development milestones, sales milestones and tiered single-digit royalties. While immediate financial impact may be modest, the long-term revenue potential is substantial if EB-002 succeeds in development. The inclusion of sublicensing rights and cash buyout options provides additional flexibility for future value creation.
The strategic pivot to focus on EB-003 while maintaining upside exposure to EB-002 appears well-reasoned from a capital allocation perspective, especially given the company's resources.
The out-licensing of EB-002, a synthetic psilocin prodrug, demonstrates the growing interest in psychedelic medicine for neuropsychiatric disorders. The compound's intellectual property position, with multiple U.S. patents and international applications, strengthens its commercial potential. MycoMedica's commitment to advancing this asset, particularly for depression treatment, aligns with current therapeutic trends.
Enveric's strategic focus on EB-003, a non-hallucinogenic neuroplastogen, represents a differentiated approach in the neuroplastogen space. The planned IND filing in 2025 provides a clear development timeline. The distinction between hallucinogenic (EB-002) and non-hallucinogenic (EB-003) compounds offers different risk-reward profiles in the evolving psychedelic medicine landscape.
Agreement includes development and sales milestones payments potentially totaling up to
Pursuant to the terms of licensing agreement, MycoMedica will seek to develop EB-002, formerly EB-373, a synthetic prodrug of the active metabolite psilocin, in treatment of neuropsychiatric disorders such as depression. MycoMedica will receive an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound. MycoMedica would assume responsibility for all future preclinical, clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications. As part of the license agreement, if certain conditions are met, Enveric is eligible to receive upfront, development, and sales milestones potentially totaling up to
Enveric has established a strong foundation of intellectual property supporting the value potential for the EVM201 program, including EB-002, with numerous patents issued in the
“Given Enveric’s strategic decision to prioritize EB-003, our novel, non-hallucinogenic neuroplastogen drug candidate, we have entered into a definitive license agreement with MycoMedica to out-license EB-002 with modest upfront payments that allow the EB-002 technology to move forward, followed by potentially transformational milestone and royalty payments. Doing so enables Enveric to fully allocate its operations and development resources to the advancement of EB-003, while creating excellent potential for realization of longer-term revenue from EB-002,” said Joseph Tucker, Ph.D., CEO of Enveric.
“We are excited to enter into this licensing agreement with Enveric and continue the development of EB-002 as we seek to advance new treatment options for patients with neuropsychiatric disorders,” said Sanjay Dubé M.D., MycoMedica’s Chief Executive Officer and Chief Medical Officer.
Enveric’s efforts are now focused on the development of EB-003, the Company’s novel, potentially first-in-class, neuroplastogen, with the intention to file an Investigational New Drug application in 2025.
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing all other novel, patented Psybrary™ drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in
About MycoMedica Life Sciences, PBC
MycoMedica Life Sciences is a clinical-stage biotech company with a mission to provide better treatment solutions for patients with neuropsychiatric disorders. Its clinical trials are designed to evaluate the safety of low doses of psilocybin, utilizing a novel dosing paradigm to optimize pharmacology while maximizing access and reducing the burden for patients and providers. MycoMedica’s first candidate is for the treatment of pre-menstrual dysphoric disorder (PMDD).
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “budgets,” “explores,” “scheduled,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include historical statements and statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Tiberend Strategic Advisors, Inc.
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Source: Enveric Biosciences, Inc.
FAQ
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